DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
11	重症筋無力症	7
13	多発性硬化症／視神経脊髄炎	41
14	慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー	5
17	多系統萎縮症	1
19	ライソゾーム病	2
35	天疱瘡	23
36	表皮水疱症	1
41	巨細胞性動脈炎	1
42	結節性多発動脈炎	1
43	顕微鏡的多発血管炎	36
44	多発血管炎性肉芽腫症	30
45	好酸球性多発血管炎性肉芽腫症	4
46	悪性関節リウマチ	224
49	全身性エリテマトーデス	19
50	皮膚筋炎／多発性筋炎	6
51	全身性強皮症	18
52	混合性結合組織病	3
53	シェーグレン症候群	15
55	再発性多発軟骨炎	1
56	ベーチェット病	1
60	再生不良性貧血	4
61	自己免疫性溶血性貧血	10
63	特発性血小板減少性紫斑病	20
64	血栓性血小板減少性紫斑病	13
65	原発性免疫不全症候群	4
66	IgA腎症	4
83	アジソン病	0
84	サルコイドーシス	1
85	特発性間質性肺炎	6
86	肺動脈性肺高血圧症	2
93	原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］	3
94	原発性硬化性胆管炎	1
96	クローン病	1
97	潰瘍性大腸炎	1
162	類天疱瘡（後天性表皮水疱症を含む。）	10
222	一次性ネフローゼ症候群	35
229	肺胞蛋白症（自己免疫性又は先天性）	2
256	筋型糖原病	5
271	強直性脊椎炎	3
274	骨形成不全症	1
283	後天性赤芽球癆	1
284	ダイアモンド・ブラックファン貧血	2
285	ファンコニ貧血	1
288	自己免疫性後天性凝固因子欠乏症［自己免疫性出血病XIII (~2017.3)］	3
296	胆道閉鎖症	1
300	IgG4関連疾患	2
331	特発性多中心性キャッスルマン病	5

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02950155 (ClinicalTrials.gov)	October 16, 2016	28/10/2016	A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis	A Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Safety and Efficacy of Rituximab (Mabthera®) in Patients With New Onset Generalized Myasthenia Gravis (MG)	Generalized Myasthenia Gravis	Drug: Rituximab;Drug: Sodium Chloride solution	Fredrik Piehl	NULL	Active, not recruiting	18 Years	N/A	All	47	Phase 3	Sweden
2	EUCTR2015-005749-30-SE (EUCTR)	23/06/2016	28/04/2016	A clinical trial investigating the effect and safety of the drug rituximab in patients with new onset myasthenia gravis, an autoimmune condition affecting muscle strenght	A randomized, doubleblind, placebo-controlled multicenter trial to evaluate the safety and efficacy of rituximab (Mabthera) in subjects with new onset myasthenia gravis; the RINOMAX study - Rinomax	New onset myasthenia gravis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera INN or Proposed INN: RITUXIMAB	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 3	Sweden
3	JPRN-UMIN000016564	2015/03/13	23/02/2015	Rituximab for intractable myasthenia gravis		myasthenia gravis	rituximab	Tokushima University Hospital	NULL	Pending	15years-old	80years-old	Male and Female	1	Not selected	Japan
4	NCT02110706 (ClinicalTrials.gov)	May 2014	7/4/2014	BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis	B Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia Gravis	Myasthenia Gravis	Drug: Rituximab;Drug: Placebo	Yale University	National Institute of Neurological Disorders and Stroke (NINDS)	Completed	21 Years	90 Years	All	52	Phase 2	United States
5	JPRN-UMIN000012089	2013/10/15	23/10/2013	Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study	Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study - Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study	MuSK antibody-positive myasthenia gravis	Administration of Rituximab at the standard dose of 375 mg/m2 every week for 4 consecutive weeks and then monthly for the next 3 months.	Department of NeurologyUniversity of Tokyo, Graduate School of Medicine	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	5	Not selected	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT00774462 (ClinicalTrials.gov)	January 2008	16/10/2008	Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia Gravis	FORCE: Rituximab (CD 20+-B Cell-depleting Monoclonal Antibody) for the Treatment of Refractory Inflammatory Myopathies With Specific Antibodies and Refractory Myasthenia Gravis	Myositis;Myasthenia Gravis	Drug: Rituximab	Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France;Roche Pharma AG	Completed	18 Years	80 Years	Both	30	Phase 2	France
7	NCT00619671 (ClinicalTrials.gov)	April 2004	14/1/2008	A Pilot Trial of Rituxan in Refractory Myasthenia Gravis	Phase 1-2 Pilot Study of Rituximab (Rituxan) in Refractory Myasthenia Gravis.	Refractory Myasthenia Gravis	Drug: Rituximab (Rituxan)	University of Vermont	Genentech, Inc.	Completed	18 Years	80 Years	Both	10	Phase 1;Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04640818 (ClinicalTrials.gov)	November 30, 2020	18/11/2020	Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy	Safety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot Study	Multiple Sclerosis	Drug: Cladribine Oral Tablet;Drug: Rituximab;Drug: Ocrelizumab	Claudio Gobbi	Merck AG Switzerland	Not yet recruiting	18 Years	80 Years	All	45		Switzerland
2	NCT04578639 (ClinicalTrials.gov)	November 2, 2020	22/9/2020	Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease	Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing	Relapsing Remitting Multiple Sclerosis	Drug: Rituximab;Drug: Ocrelizumab	Haukeland University Hospital	University Hospital, Akershus;Oslo University Hospital;Helse Stavanger HF;St. Olavs Hospital;University Hospital of North Norway	Recruiting	18 Years	60 Years	All	211	Phase 3	Norway
3	NCT04480307 (ClinicalTrials.gov)	June 17, 2020	10/7/2020	Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis	A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS)	Multiple Sclerosis	Drug: temelimab 18 mg/kg;Drug: temelimab 36 mg/kg;Drug: temelimab 54 mg/kg;Drug: Placebo	GeNeuro Innovation SAS	NULL	Recruiting	18 Years	55 Years	All	40	Phase 2	Sweden
4	EUCTR2019-004822-15-SE (EUCTR)	18/05/2020	17/01/2020	A Clinical Trial Examining the Effects of Temelimab Following Rituximab Treatment in Patients with Multiple Sclerosis	A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients with Relapsing Forms of Multiple Sclerosis (RMS) - ProTEct-MS	Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab	GeNeuro Innovation SAS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	Sweden
5	NCT03829566 (ClinicalTrials.gov)	November 2019	1/2/2019	Autologous Transplant To End NMO Spectrum Disorder	Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD)	Neuromyelitis Optica;Devic's Disease;NMO Spectrum Disorder	Drug: Rituximab;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells	Northwestern University	NULL	Withdrawn	18 Years	65 Years	All	0	Phase 2;Phase 3	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT04121403 (ClinicalTrials.gov)	October 16, 2019	23/9/2019	Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)	Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) A Prospective Randomized Open-label Blinded Endpoint (PROBE) Multicenter Non-inferiority Study	Relapsing Multiple Sclerosis;Multiple Sclerosis	Biological: Rituximab;Drug: Cladribine	Oslo University Hospital	University of Oslo;Göteborg University;Sykehuset Ostfold;Sykehuset Telemark;Vestre Viken Hospital Trust;Sorlandet Hospital HF;Helse Stavanger HF;Sykehuset Innlandet HF;Sykehuset i Vestfold HF;Helse Forde;University Hospital of North Norway;St. Olavs Hospital	Recruiting	18 Years	65 Years	All	264	Phase 3	Norway
7	ChiCTR1900025744	2019-09-01	2019-09-07	Clinical effectiveness and safety of Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial	Clinical effectiveness and safety Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial	neuromyelitis optica spectrum disorder (NMOSD)	1:Intravenous 200mg Rituximab, 1/week*2, if the proportion of CD19+ B lymphocytes in peripheral blood is above 1% then repeat administration (200mg);2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (750~3000mg/day);	The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital	NULL	Recruiting	18	70	Both	1:30;2:30;	Phase 4	China
8	EUCTR2019-001505-24-NO (EUCTR)	25/07/2019	28/05/2019	A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple Sclerosis	Norwegian study of Oral cladribine versus Rituximab in Multiple Sclerosis (NOR-MS). A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study. - NOR-MS	Relapsing Multiple Sclerosis (RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	264	Phase 3	Norway
9	EUCTR2018-000721-31-SE (EUCTR)	04/07/2018	24/04/2018	A clincial study comparing the effectiveness of two doses of the drug Rituximab during long-term treatment of the neurological disease Multiple Sclerosis.	RItuximab Long-Term DOSE Trial in Multiple Sclerosis – RIDOSE-MSA randomized trial of long-term dosage of rituximab in multiple sclerosisThe RIDOSE-MS trial is a multi-centre trial of long-term treatment with rituximab in MS, randomised between two different dosing regimens. Population: Patients with RRMS that has completed the RIFUND-MS trial in either the rituximab or DMF arm. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.Intervention: Treatment with rituximab (Mabthera®) 500 mg every six months. Both the previous rituximab and DMF arms from the RIFUND trial will be treated with rituximab in the RIDOSE trial.Control: After one year of treatment in RIDOSE-MS, patients will be randomised 1:1 to either continue with 500 mg every 6 months or 500 mg every 12 months and continue on this treatment schedule for another 3 years.Outcome: Primary outcome will be the proportion of patients remaining with no evidence of disease activity (NEDA) -3 over the randomised period of 3 years. As secondary endpoints progression of disability, brain atrophy, cognitive function and level of serum Neurofilament-Light will be evaluated. In addition, Patient-related outcome scales measuring fatigue, work ability and treatment satisfaction will be analysed. - RIDOSE-MS	Patients with multiple sclerosis (MS), 20 - 52 years of age, that have completed the RIFUND-MS trial (EudraCT 2015-004116-38) will be offered to continue in this extension trial, RODOSE-MS. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	Sweden
10	NCT03979456 (ClinicalTrials.gov)	July 4, 2018	3/6/2019	RItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MS	RItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MS. A Randomized Trial of Long-term Dosage of Rituximab in Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Drug: Rituximab	Karolinska Institutet	NULL	Recruiting	20 Years	52 Years	All	200	Phase 3	Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2017-000426-35-AT (EUCTR)	17/04/2018	12/03/2018	The efficacy of treatment of patients with multiple sclerosis, a chronic, inflammatory, autoimmune, disease that leads to neurologic deficits and aggravates with flairs, with low doses of rituximab, an antibody directed against the CD20 epitope on B Lymphocytes, specific cells of the immune system contributing to the progression of the disease - a pilot trial	Efficacy of Rituximab at low doses in Multiple Sclerosis – A prospective, randomized, double-blind, active controlled, pilo trial - Low-dose Rituximab in MS	Relapse Remitting Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera or biosimilar rituximab product Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Mabthera or biosimilar rituximab product Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB	Medical University of Vienna - Department of Neurology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 2	Austria
12	NCT03315923 (ClinicalTrials.gov)	December 1, 2017	17/10/2017	Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients	Comparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer Acetate	Secondary Progressive Multiple Sclerosis	Drug: Rituximab;Drug: Glatiramer Acetate	Isfahan University of Medical Sciences	NULL	Completed	18 Years	55 Years	All	84	Phase 2;Phase 3	Iran, Islamic Republic of
13	EUCTR2017-002634-24-SE (EUCTR)	29/09/2017	06/07/2017	MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis.	MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS	Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name:	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Sweden
14	EUCTR2016-003587-39-SE (EUCTR)	22/05/2017	23/03/2017	This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval.	COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS)	Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3700	Phase 4	Sweden
15	NCT03193866 (ClinicalTrials.gov)	February 1, 2017	20/4/2017	COMparison Between All immunoTherapies for Multiple Sclerosis.	COMparison Between All immunoTherapies for Multiple Sclerosis. An Observational Long-term Prospective Cohort Study of Safety, Efficacy and Patient's Satisfaction of MS Disease Modulatory Treatments in Relapsing-remitting Multiple Sclerosis	Relapsing-remitting Multiple Sclerosis	Drug: Rituximab	Karolinska Institutet	Patient-Centered Outcomes Research Institute;Kaiser Foundation Research Institute	Active, not recruiting	18 Years	N/A	All	3526		Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT02980042 (ClinicalTrials.gov)	January 1, 2017	9/11/2016	Tolerability and Safety of Switching From Rituximab to Ocrelizumab in Patients With Relapsing Forms of Multiple Sclerosis	Evaluating the Tolerability and Safety Profile of Switching From Rituximab to Ocrelizumab: A Real World Evaluation of Patients With Relapsing Forms of Multiple Sclerosis	Multiple Sclerosis	Drug: Ocrelizumab;Drug: Rituximab	University of Colorado, Denver	NULL	Completed	18 Years	65 Years	All	200	Phase 3	United States
17	NCT02746744 (ClinicalTrials.gov)	May 2016	18/4/2016	RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.	RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. A Randomized Phase 3 Study Comparing Rituximab With Dimethyl Fumarate in Early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.	Multiple Sclerosis, Relapsing-Remitting	Drug: Rituximab;Drug: Dimethyl fumarate;Drug: Sodium Chloride solution	Anders Svenningsson	NULL	Active, not recruiting	18 Years	50 Years	All	200	Phase 3	Sweden
18	EUCTR2015-004116-38-SE (EUCTR)	18/12/2015	20/10/2015	A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis.	RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MSA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple SclerosisObjective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design.Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion.Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months.Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion.Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed.	Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE	Department of Clinical Sciences, Danderyd Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	Sweden
19	NCT02545959 (ClinicalTrials.gov)	November 30, 2015	7/9/2015	Intrathecal Rituximab in Progressive Multiple Sclerosis	Intrathecal Rituximab in Progressive Multiple Sclerosis	Multiple Sclerosis, Chronic Progressive;Nervous System Diseases	Drug: Rituximab IT;Drug: methylprednisolone IV;Drug: Rituximab IV	Centre Hospitalier de PAU	University Hospital, Bordeaux	Completed	45 Years	N/A	All	10	Phase 2	France
20	NCT03002038 (ClinicalTrials.gov)	September 2015	21/12/2016	Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients	Comparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum Disorders	Neuromyelitis Optica Spectrum Disorder	Drug: Azathioprine;Drug: Rituximab	Isfahan University of Medical Sciences	NULL	Completed	18 Years	50 Years	All	86	Phase 2;Phase 3	Iran, Islamic Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2014-005493-11-FR (EUCTR)	31/08/2015	15/03/2018	Study the action of a single dose of intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets, assuming that a definitive action upon CSF biological targets would be strongly predictive of a delayed clinical action in patients with Progressive Multiple Sclerosis.	Intrathecal Rituximab in Progressive Multiple Sclerosis - EFFRITE	Patients included in our study suffer from a progressive form of Multiple sclerosis and will be treated by intravenous and intrathecal rituximab, with intravenous methylprednisolone.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Centre Hospitalier de Pau	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	France
22	JPRN-UMIN000017217	2015/04/21	21/04/2015	An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica	An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica - RIN-2	Neuromyelitis optica	Rituximab intravenous infusion	Clinical Research Center, Utano National Hospital, National Hospital Organization	Zenyaku Kogyo Co., Ltd.	Complete: follow-up complete	16years-old	80years-old	Male and Female	40	Phase 2;Phase 3	Japan
23	EUCTR2013-002378-26-SE (EUCTR)	13/11/2014	15/08/2013	Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes	Switch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext	The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial. MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera® Product Name: Mabthera	Västerbottens Läns Landsting	NULL	Not Recruiting			Female: yes Male: yes	74	Phase 2	Sweden
24	NCT02253264 (ClinicalTrials.gov)	November 2014	29/9/2014	A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients	A Phase 1 Open-label Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients With Magnetic Resonance Imaging Evidence of Leptomeningeal Enhancement	Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis	Drug: Rituximab	Johns Hopkins University	NULL	Completed	18 Years	N/A	All	8	Phase 1	United States
25	ChiCTR-ICR-15007177	2014-08-30	2014-05-30	A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis	A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis	Neuromyelitis Optica associated Optic Neuritis	1:Intravenous 100mg Rituximab, 1/week*4 ;2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (1000-1500mg/day);	The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital	NULL	Recruiting	18	70	Both	1:30;2:30;		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	JPRN-UMIN000013453	2014/05/10	18/03/2014	A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody	A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody - RIN-1	Neuromyelitis optica	Rituximab intravenous infusion Placebo	Clinical Research Center, NHO Utano National Hospital	Zenyaku Kogyo Co., Ltd.	Complete: follow-up complete	16years-old	80years-old	Male and Female	40	Phase 2;Phase 3	Japan
27	NCT04256252 (ClinicalTrials.gov)	April 2014	2/2/2020	Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)	Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical Trial	Neuromyelitis Optica Spectrum Disorder	Drug: Rituximab	Tang-Du Hospital	NULL	Completed	16 Years	75 Years	All	108	Phase 4	NULL
28	EUCTR2012-004436-36-DK (EUCTR)	19/04/2013	22/04/2013	Effect of rituximab in secondary progressive multiple sclerosis	A prospective pilotstudy of immunological and radiological effects of intrathecal rituximab in patients with secondary progressive multiple sclerosis	Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabThera (Rituximab) Product Name: MabThera INN or Proposed INN: RITUXIMAB	Odense University Hospital	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 2	Denmark
29	NCT02040116 (ClinicalTrials.gov)	February 2013	14/1/2014	Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases	Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases	Multiple Sclerosis	Drug: Rituximab Infusion	Wake Forest University Health Sciences	NULL	Completed	18 Years	80 Years	All	19	Phase 4	United States
30	EUCTR2012-000721-53-SE (EUCTR)	07/12/2012	16/10/2012	An extension trial of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis	ITT-PMS ExtensionAn extension study of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis - ITT-PMS Ext	Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Dept of Neurology, Umeå University Hospital, Umeå, Sweden	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	JPRN-UMIN000009421	2012/06/28	28/11/2012	Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children		neuromyelitis optica (NMO), opsoclonus-myoclonus syndrome (OMS)	administration of rituximab	Department of Pediatrics, Kobe Universtiy Graduate School of Medicine	NULL	Recruiting	Not applicable	18years-old	Male and Female	10	Not applicable	Japan
32	NCT01569451 (ClinicalTrials.gov)	February 2012	30/3/2012	Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate	A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis	Multiple Sclerosis	Drug: Rituximab;Drug: Glatiramer Acetate;Other: Placebo	University of Colorado, Denver	Rocky Mountain MS Research Group, LLC	Completed	18 Years	55 Years	All	53	Phase 2	United States
33	EUCTR2010-023021-38-SE (EUCTR)	23/02/2011	26/11/2010	Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS	Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS	Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Trade Name: Mabthera INN or Proposed INN: RITUXIMAB	Västerbottens läns landsting	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Sweden
34	NCT01212094 (ClinicalTrials.gov)	September 2010	29/9/2010	Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)	Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)	Multiple Sclerosis	Drug: Rituximab;Other: normal saline	National Institute of Neurological Disorders and Stroke (NINDS)	NULL	Terminated	18 Years	65 Years	All	44	Phase 1;Phase 2	United States
35	NCT01719159 (ClinicalTrials.gov)	November 2009	25/10/2012	Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis	Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis	Progressive Multiple Sclerosis	Drug: Rituximab	Anders Svenningsson	Västerbotten County Council, Sweden	Completed	18 Years	65 Years	Both	23	Phase 2	Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	NCT00787722 (ClinicalTrials.gov)	October 10, 2009	31/10/2008	Hematopoietic Stem Cell Transplant in Devic's Disease	Trial of High Dose Immunosuppressive Therapy With Hematopoietic Stem Cell Support in Devic's Disease	Devic's Disease	Procedure: Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Drug: G-CSF;Drug: rATG;Drug: Mesna;Drug: Rituximab;Drug: Methylprednisolone	Northwestern University	NULL	Completed	16 Years	65 Years	All	13	Phase 1;Phase 2	United States
37	EUCTR2008-002626-11-SE (EUCTR)	02/07/2009	24/04/2009	Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis	Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis - PMSIT	Severe progressive multiple sclerosis in which there is no other documented treatment avalilable or allready tested. It is estimated that the prognosis for these patients are poor without any effective treatment MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Trade Name: Mabthera Other descriptive name: RITUXIMAB	Dept of Neurology	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Sweden
38	NCT00097188 (ClinicalTrials.gov)	December 2004	18/11/2004	A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple Sclerosis	A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis	Drug: rituximab	Genentech, Inc.	NULL	Completed	18 Years	55 Years	Both	104	Phase 2	United States
39	NCT00087529 (ClinicalTrials.gov)	June 2004	9/7/2004	A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis	A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis	Multiple Sclerosis	Drug: placebo;Drug: rituximab	Genentech, Inc.	NULL	Completed	18 Years	65 Years	All	439	Phase 2;Phase 3	Canada;United States
40	NCT00501748 (ClinicalTrials.gov)	January 2004	12/7/2007	Safety and Tolerability of Rituximab in Neuromyelitis Optica	Open Label Study of Safety and Tolerability of Rituximab in Neuromyelitis Optica, Recurrent Transverse Myelitis and Recurrent Bilateral Simultaneous Optic Neuritis	Neuromyelitis Optica	Drug: Rituximab	University of California, San Francisco	Genentech, Inc.	Completed	12 Years	86 Years	Both	20	Phase 1	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2008-005773-35-IT (EUCTR)		15/01/2013	AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM	AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM	MULTIPLE SCLEROSIS MedDRA version: 15.1;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: ENDOXAN BAXTER INN or Proposed INN: Cyclophosphamide Trade Name: FLUDARA INN or Proposed INN: Fludarabine Trade Name: THYMOGLOBULINE INN or Proposed INN: Antithymocyte immunoglobulin (rabbit) Trade Name: MABTHERA INN or Proposed INN: Rituximab	AZIENDA OSPEDALIERA DI PADOVA	NULL	NA			Female: yes Male: yes		Phase 1	Italy

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04480450 (ClinicalTrials.gov)	November 2020	16/7/2020	Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II Study	Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II Study	Chronic Inflammatory Demyelinating Polyneuropathy	Drug: Rituximab	University of Kansas Medical Center	NULL	Not yet recruiting	18 Years	N/A	All	48	Phase 2	NULL
2	JPRN-jRCT2041180037	28/03/2019	31/01/2019	RECIPE Trial	The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial	Chronic Inflammatory Demyelinating Polyneuropathy Chronic Inflammatory Demyelinating Polyneuropathy	CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) or placebo IV infusion once weekly for 4 doses. CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.	Iijima Masahiro	NULL	Not Recruiting	>= 12age old	Not applicable	Both	25	Phase 2	Japan
3	NCT03864185 (ClinicalTrials.gov)	March 28, 2019	19/2/2019	The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies	The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients With Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial	Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)	Biological: Rituximab (genetical recombination);Other: Placebo	Nagoya University	Japan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.	Active, not recruiting	12 Years	N/A	All	25	Phase 2	Japan
4	JPRN-UMIN000035753	2019/03/28	02/02/2019	The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial	The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial	Chronic Inflammatory Demyelinating Polyneuropathy	CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer placebo IV infusion once weekly for 4 doses. CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.	Nagoya University Hospital	Zenyaku Kogyo Co., Ltd.	Complete: follow-up continuing	12years-old	Not applicable	Male and Female	25	Phase 2	Japan
5	EUCTR2017-005034-36-IT (EUCTR)	22/05/2018	04/11/2020	Study evaluating the effect of rituximab in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)	An Italian database-based randomized controlled trial with Rituximab in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - A randomized controlled trial of rituximab in CIDP (CIDPRIT)	Chronic inflammatory demyelinating polyradiculoneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10072650;Term: CIDP;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML Product Name: Rituximab Product Code: [Rituximab] INN or Proposed INN: RITUXIMAB Trade Name: TACHIPIRINA - 1000 MG COMPRESSE 8 COMPRESSE Product Name: Paracetamolo Product Code: [Paracetamolo] INN or Proposed INN: PARACETAMOLO Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: Metilprednisolone sodio succinato Product Code: [Metilprednisolone sodio succinato] INN or Proposed INN: METILPREDNISOLONE SODIO SUCCINATO Trade Name: TRIMETON - 10 MG/1 ML SOLUZIONE INIETTABILE 5 FIALE 1 ML Product Name: Clorfenamina maleato Product Code: [Clorfenamina maleato] INN or Proposed INN: CLORFENAMINA MALEATO	IRCCS ISTITUTO CLINICO HUMANITAS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 3	Italy

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04004819 (ClinicalTrials.gov)	August 15, 2019	27/6/2019	Rituximab for Multiple System Atrphy	Rituximab Therapy for the Patients With Multiple Syetem Atrophy	Multiple System Atrophy	Drug: Rituximab	First Affiliated Hospital of Fujian Medical University	NULL	Recruiting	18 Years	80 Years	All	50	Phase 2	China

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03952637 (ClinicalTrials.gov)	August 19, 2019	15/5/2019	A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human <=-Galactosidase in Type I and Type II GM1 Gangliosidosis	A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 Gangliosidosis	Lysosomal Diseases;Gangliosidosis;GM1	Biological: AAV9-GLB1;Drug: Rituximab;Drug: Sirolimus;Drug: Methylprednisolone;Drug: Prednisone;Diagnostic Test: Audiology assessmentwith ABR;Diagnostic Test: Bone density scan (DEXA;Diagnostic Test: Electrocardiogram (EKG);Diagnostic Test: Echocardiogram;Other: Electroencephalogram (EEG) awake andextended overnight;Diagnostic Test: Laboratory tests;Procedure: Lumbar puncture;Procedure: Brain MRI/MRS/fMRI;Behavioral: Neurocognitive testing;Other: Neurology exam;Behavioral: PICC line placement;Procedure: Skeletal survey;Procedure: Skin biopsy;Procedure: Speech and modified barium swallow study;Procedure: Ophthalmology exam	National Human Genome Research Institute (NHGRI)	Axovant Sciences, Inc.	Recruiting	6 Months	12 Years	All	45	Phase 1;Phase 2	United States
2	EUCTR2017-002430-23-IT (EUCTR)	14/03/2018	09/03/2020	Gene therapy study with autologous hemapoietic stem cells for patients affected by MPSIH	A phase I/II study evaluating safety and efficacy of autologous hematopoietic stem and progenitor cells genetically modified with IDUA lentiviral vector encoding for the human a-L-iduronidase gene for the treatment of patients affected by Mucopolysaccharidosis Type I, Hurler variant - TigetT10_MPS1H	Mucopolysaccharidosis type I Hurler MedDRA version: 20.1;Level: PT;Classification code 10056886;Term: Mucopolysaccharidosis I;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Other descriptive name: Cellule CD34+ autologhe trasdotte con IDUA LV codificante per il cDNA dell'alfa-L-iduronidasi Trade Name: BUSILVEX - 6 MG/ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO - 10 ML 8 FLACONCINI INN or Proposed INN: BUSULFANO Other descriptive name: BUSULFANO Trade Name: FLUDARABINA ACCORD - 25 MG/ML CONCENTRATO PER SOLUZIONE INIETTABILE O PER INFUSIONE 5 FLACONCINI IN VETRO DA 2 ML INN or Proposed INN: FLUDARABINA FOSFATO Other descriptive name: FLUDARABINA FOSFATO Trade Name: MABTHERA - 2 FIALE 100 MG 10 ML INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: MYELOSTIM - 34 1 FLACONCINO LIOFILIZZATO 33.6 MIU + SIRINGA PRERIEMPITA SOLVENTE 1 ML INN or Proposed INN: LENOGRASTIM Other descriptive name: LENOGRASTIM Trade Name: MOZOBIL - 20 MG/ML - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - F	OSPEDALE SAN RAFFAELE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	6	Phase 1	Italy

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04400994 (ClinicalTrials.gov)	June 20, 2020	27/4/2020	IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus	The Use of IVIG in Combination With Rituximab VS Rituximab as the First Line Treatment of Pemphigus	Pemphigus	Drug: Rituximab;Other: IVIg	The University of Hong Kong	NULL	Recruiting	18 Years	70 Years	All	20	Phase 2	Hong Kong
2	NCT03790293 (ClinicalTrials.gov)	December 2019	8/10/2018	Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial	Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial With Medico-economic Evaluation of the Treatment.	Autoimmune Diseases	Drug: Rituximab;Drug: corticosteroids'therapy	University Hospital, Rouen	NULL	Unknown status	18 Years	80 Years	All	90	Phase 3	NULL
3	ChiCTR1800020382	2019-01-01	2018-12-27	Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus	Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus	Pemphigus	Group 1:Rituximab 500mg single infusion combined with routinedose of corticosteriods therapy;Group 2:Rituximab 100mg single infusion combined with routinedose of corticosteriods therapy;Group 3:Oral or intravenous infusion of routinedose of corticosteriods (prednisone or methylprednisolone);	West China Hospital, Sichuna University	NULL	Recruiting	18	80	Both	Group 1:14;Group 2:14;Group 3:14;		China
4	EUCTR2018-001417-32-FR (EUCTR)	13/07/2018	11/06/2018	Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3	Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3. Immunological, clinical and medicoeconomic evaluation	Patients with Bullous pemphigoid included in RITUXIMAB3 study MedDRA version: 20.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: MABTHERA INN or Proposed INN: RITUXIMAB Trade Name: Prednisone Product Name: CORTANCYL 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: CORTANCYL 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE	CHU-Hôpitaux de Rouen	NULL	Not Recruiting			Female: yes Male: yes	77	Phase 3	France
5	JPRN-jRCTs031180405	11/05/2017	22/03/2019	Rituximab therapy for refractory pemphigus	Safety evaluation study about rituximab therapy for refractory pemphigus	Refactory Pemphigus Other disease of skin or skin tissue	Infuse rituximab 1000mg/body twice biweekly.	Funakoshi Takeru	NULL	Recruiting	>= 20age old	<= 80age old	Both	20	N/A	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	JPRN-UMIN000026004	2017/05/08	08/03/2017	Safety evaluation study about rituximab therapy for refractory pemphigus		pemphigus	Infuse rituximab 1000mg/body twice biweekly	Keio University, School of Medicine	NULL	Recruiting	20years-old	80years-old	Male and Female	10	Not applicable	Japan
7	JPRN-UMIN000024265	2016/10/04	04/10/2016	Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus	Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus - Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus	steroid treatment-resistant pemphigus	Rituximab (genetic recombination)	Department of Dermatology,Keio University School of Medicine	HOKKAIDO UNIVERSITY HOSPITALOKAYAMA UNIVERSITY HOSPITALKURUME UNIVERSITY HOSPITAL	Complete: follow-up complete	20years-old	80years-old	Male and Female	10	Phase 2	Japan
8	NCT02383589 (ClinicalTrials.gov)	May 26, 2015	4/3/2015	A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)	A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris	Pemphigus Vulgaris	Drug: Mycophenolate Mofetil Placebo;Drug: Mycophenolate Mofetil;Drug: Rituximab;Drug: Rituximab Placebo	Hoffmann-La Roche	Genentech, Inc.	Completed	18 Years	75 Years	All	135	Phase 3	United States;Argentina;Australia;Brazil;Canada;France;Germany;Israel;Italy;Spain;Turkey;Ukraine
9	EUCTR2014-000382-41-FR (EUCTR)	02/04/2015	24/06/2015	A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris	A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX	Pemphigus Vulgaris (PV) MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 3	United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
10	EUCTR2014-000382-41-IT (EUCTR)	12/03/2015	02/02/2015	A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris	A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX	Pemphigus Vulgaris (PV) MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: MABTHERA® Product Name: Rituximab Product Code: RO0452294/V02 INN or Proposed INN: RITUXIMAB Trade Name: CELLCEPT® Product Name: Mycophenolate mofetil Product Code: RO1061443/F02 INN or Proposed INN: Mycophenolate mofetil	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 3	United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2014-000382-41-ES (EUCTR)	09/03/2015	22/12/2014	A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris	A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX	Pemphigus Vulgaris (PV) MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 3	France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
12	EUCTR2014-000382-41-DE (EUCTR)	06/03/2015	09/12/2014	A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Patients With Pemphigus Vulgaris	A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX	Pemphigus Vulgaris (PV) MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	132	Phase 3	France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
13	JPRN-UMIN000015451	2014/11/13	25/10/2014	Exploratory research on effectiveness and safety of Rituximab treatment including maintenance administration for steroid intractable autoimmune bullous diseases of the skin.Rtx-BD Trial (Rituximab of Intractable Autoimmune Bullous Disease Trial) 2		Pemphigus, Pemphigoid	Rituximab 375mg/sqm, q1w, 4 doses. Maintenance administration of rituximab is possible if PDA or BPDAI is between 1 and 10 on week 24 to 48	Department of Dermatology,Keio University School of Medicine	Hokkaido University, Kurume University, Okayama University, Kawasaki Medical School	Complete: follow-up complete	20years-old	80years-old	Male and Female	20	Phase 1;Phase 2	Japan
14	JPRN-jRCTs031180220	01/05/2014	15/03/2019	Rituximab treatment of blistering disease	Treatment of refractory autoimmuno blistering disease with rituximab	Pemphigus vulgaris, paraneoplastic pemphigus, bullous pemphigoid	Infusion of rituximab (1000mg) intravenously. Approximately two weeks after the first dose, a second dose of rituximab is administered in a similar manner.	Kanaoka Miwa	Michiko Aihara	Not Recruiting	>= 20age old	< 80age old	Both	10	N/A	Japan
15	NCT01974518 (ClinicalTrials.gov)	November 2013	4/10/2013	Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus	A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS	Pemphigus	Drug: Rituximab and Cyclophosphamide IV	Uprety Shraddha	Postgraduate Institute of Medical Education and Research	Active, not recruiting	18 Years	N/A	Both	20	Phase 3	India
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT01299857 (ClinicalTrials.gov)	June 2011	17/2/2011	Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab	EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB	Pemphigus	Drug: Rituximab	University Hospital, Rouen	NULL	Completed	18 Years	N/A	Both	22	Phase 3	France
17	JPRN-UMIN000004428	2010/11/01	01/11/2010	Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita.		pemphigus, bullous pemphigoid, epidermolysis bullosa acquisita	Rituximab	Research group of rare intractable dermatologial disorder	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Phase 2	Japan
18	NCT01338103 (ClinicalTrials.gov)	January 2010	17/4/2011	Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex	Treatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex Test	Pemphigus	Drug: Rituximab	Rabin Medical Center	Leumit Health Services	Recruiting	18 Years	70 Years	Both	10	N/A	Israel
19	NCT00784589 (ClinicalTrials.gov)	July 2009	3/11/2008	Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus	Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus	Pemphigus Disease	Drug: General Corticotherapy;Drug: Rituximab	University Hospital, Rouen	NULL	Completed	18 Years	80 Years	All	90	Phase 3	France
20	NCT00960713 (ClinicalTrials.gov)	June 2009	16/7/2009	The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders	The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders	Pemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;Cryoglobulinemia	Drug: Rituximab (MABTHERA® or RITUXAN®).	University Hospital, Toulouse	NULL	Completed	18 Years	N/A	Both	35	N/A	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2008-005266-31-FR (EUCTR)	06/02/2009	13/03/2009	COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab III	COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab III	Pemphogoide bulleuse MedDRA version: 9.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid	Trade Name: mabthéra Product Name: mathéra Trade Name: Prednisone Product Name: CORTANCYL 20 mg	CHU-Hôpitaux de Rouen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
22	NCT00656656 (ClinicalTrials.gov)	January 2008	7/4/2008	Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus	Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab	Pemphigus	Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine	University of Luebeck	NULL	Completed	18 Years	N/A	All	23	Phase 2	Germany
23	EUCTR2007-005711-26-IT (EUCTR)	15/11/2007	05/02/2008	An open prospective, monocenter, consecutive non randomized clinical trial on therapy with monoclonal antibodies anti-CD20 in the treatment of pemphigus vulgare or foliaceus, serious and resistant to common therapies - ND	An open prospective, monocenter, consecutive non randomized clinical trial on therapy with monoclonal antibodies anti-CD20 in the treatment of pemphigus vulgare or foliaceus, serious and resistant to common therapies - ND	Pemphigus vulgaris, pemphigus foliaceus MedDRA version: 9.1;Level: LLT;Classification code 10034280;Term: Pemphigus	Trade Name: MABTHERA INN or Proposed INN: Rituximab	ISTITUTO DERMOPATICO IMMACOLATA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000004428	2010/11/01	01/11/2010	Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita.		pemphigus, bullous pemphigoid, epidermolysis bullosa acquisita	Rituximab	Research group of rare intractable dermatologial disorder	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Phase 2	Japan

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-003964-30-GB (EUCTR)	22/10/2020	31/07/2020	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)	Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-003964-30-GB (EUCTR)	22/10/2020	31/07/2020	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)	Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03920722 (ClinicalTrials.gov)	September 2019	18/2/2019	Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis	Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis	Microscopic Polyangiitis (MPA)	Drug: Rituximab;Drug: placebo	Assistance Publique - Hôpitaux de Paris	French Vasculitis Study Group	Not yet recruiting	18 Years	N/A	All	106	Phase 3	France
2	EUCTR2018-000637-12-FR (EUCTR)	29/03/2019	31/01/2019	Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis	Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis - RITUXGOPRO	Patients with newly diagnosed or relapsing MPA, without any poor prognosis marker (FFS=0). Stratification will be made according to peripheral nerve involvement. MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	106	Phase 3	France
3	EUCTR2016-001121-14-NO (EUCTR)	06/10/2017	07/02/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden
4	EUCTR2016-001121-14-NL (EUCTR)	15/06/2017	18/01/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
5	EUCTR2016-001121-14-BE (EUCTR)	08/05/2017	06/02/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2016-001121-14-HU (EUCTR)	24/04/2017	23/01/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
7	EUCTR2016-001121-14-DK (EUCTR)	07/04/2017	01/02/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
8	EUCTR2016-001121-14-GB (EUCTR)	06/04/2017	23/12/2016	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Sweden
9	EUCTR2016-001121-14-ES (EUCTR)	21/03/2017	20/01/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
10	EUCTR2016-001121-14-CZ (EUCTR)	20/03/2017	12/01/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2016-001121-14-SE (EUCTR)	13/02/2017	21/12/2016	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
12	EUCTR2016-001121-14-AT (EUCTR)	13/02/2017	10/01/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
13	NCT02115997 (ClinicalTrials.gov)	July 6, 2015	14/4/2014	A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis		Wegener's Granulomatosis or Microscopic Polyangiitis	Drug: Methylprednisolone;Drug: Prednisone;Drug: Rituximab	Hoffmann-La Roche	NULL	Recruiting	18 Years	N/A	All	30	Phase 4	India
14	EUCTR2015-001807-29-FR (EUCTR)	09/06/2015	23/07/2015	Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis	Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis : a predictive factor of clinical outcome? (MONITUX) - A multicentric study - MONITUX	Granulomatosis with polyangiitis Microscopic polyangiitis MedDRA version: 18.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]	Trade Name: Rituximab Product Name: Rituximab	CHU de Saint-Etienne	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 4	France
15	EUCTR2012-001102-14-CZ (EUCTR)	15/04/2015	03/01/2013	RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis	An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study	ANCA vasculitis. MedDRA version: 18.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera® 500MG Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Azathioprine Product Name: Azathioprine INN or Proposed INN: Azathioprine Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate Trade Name: Mycophenolate Mofetil Product Name: Mycophenolate mofetil INN or Proposed INN: Mycophenolate mofetil Trade Name: MabThera® 100MG INN or Proposed INN: RITUXIMAB	Cambridge University Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 3	Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2012-001102-14-IE (EUCTR)	10/10/2014	14/08/2014	RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis	An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study	ANCA vasculitis. MedDRA version: 18.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Azathioprine Product Name: Azathioprine INN or Proposed INN: Azathioprine Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate Trade Name: Mycophenolate Product Name: Mycophenolate INN or Proposed INN: Mycophenolic acid	University College Cork , Ireland	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 3	Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Sweden
17	NCT02198248 (ClinicalTrials.gov)	October 2014	18/7/2014	Low-dose Glucocorticoid Vasculitis Induction Study	Low-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control Trial	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis	Drug: Rituximab;Drug: Glucocorticoids	Chiba University	National Hospital Organization Chiba East Hospital	Active, not recruiting	20 Years	N/A	All	140	Phase 4	Japan
18	EUCTR2012-001102-14-IT (EUCTR)	12/09/2014	18/12/2013	RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis	An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study	ANCA vasculitis. MedDRA version: 16.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 16.1;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Azathioprine Product Name: Azathioprine INN or Proposed INN: Azathioprine Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate Trade Name: Mycophenolate Mofetil Product Name: Mycophenolate mofetil INN or Proposed INN: Mycophenolate mofetil	Cambridge University Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 3	Spain;Ireland;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
19	JPRN-UMIN000012409	2014/06/26	04/12/2013	An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis	An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM	Granulomatosis With Polyangiitis (Wegener's) Microscopic Polyangiitis	Experimental: Rituximab Maintenance. Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper. Active Comparator: Azathioprine Maintenance. Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation). Azathioprine withdrawn at month 27.	University of Miyazaki Hospital	The European Vasculitis SocietyVasculitis Clinical Research Consortium	Complete: follow-up complete	18years-old	Not applicable	Male and Female	190	Phase 3	Japan,North America,South America,Australia,Europe
20	NCT02169219 (ClinicalTrials.gov)	June 2014	19/6/2014	Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis	Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis	Granulomatosis With Polyangiitis;Microscopic Polyangiitis	Drug: Glucocorticoids;Drug: Rituximab	Massachusetts General Hospital	Genentech, Inc.	Completed	18 Years	85 Years	All	20	Phase 4	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2012-001102-14-ES (EUCTR)	21/06/2013	16/05/2013	RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis	An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study	ANCA vasculitis. MedDRA version: 16.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 16.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Azathioprine Product Name: Azathioprine INN or Proposed INN: Azathioprine	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	190		New Zealand;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;Sweden
22	NCT01750697 (ClinicalTrials.gov)	May 23, 2013	13/12/2012	A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis	A Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis	Granulomatosis With Polyangiitis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	2 Years	17 Years	All	25	Phase 2	United States;Canada;France;Germany;Italy;Serbia;Turkey;United Kingdom
23	NCT01697267 (ClinicalTrials.gov)	April 2013	31/8/2012	Rituximab Vasculitis Maintenance Study	An International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated Vasculitis	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis	Biological: Rituximab;Drug: Azathioprine	Cambridge University Hospitals NHS Foundation Trust	Arthritis Research UK;Roche Pharma AG;Genentech, Inc.;University of Pennsylvania	Completed	15 Years	N/A	All	188	Phase 3	United States;Australia;Canada;Czechia;Ireland;Italy;Japan;New Zealand;Sweden;United Kingdom;Czech Republic
24	EUCTR2012-002062-13-DE (EUCTR)	14/03/2013	13/09/2012	A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis	A Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis	granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: MabThera® Product Code: RO0452294/V01 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Code: RO0452294/V02 INN or Proposed INN: RITUXIMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	25	Phase 2	Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom
25	EUCTR2012-002062-13-IT (EUCTR)	28/01/2013	11/01/2013	A PHASE IIA, INTERNATIONAL, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF 4 x 375 mg/m2 INTRAVENOUS RITUXIMAB IN PEDIATRIC PATIENTS WITH SEVERE GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S) OR MICROSCOPIC POLYANGIITIS	A PHASE IIA, INTERNATIONAL, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF 4 x 375 mg/m2 INTRAVENOUS RITUXIMAB IN PEDIATRIC PATIENTS WITH SEVERE GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S) OR MICROSCOPIC POLYANGIITIS	granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis MedDRA version: 14.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB	F. HOFFMANN - LA ROCHE LTD.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25	Phase 2A	United States;Turkey;United Kingdom;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	EUCTR2012-002062-13-GB (EUCTR)	18/01/2013	23/08/2012	A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis	A Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis	granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: MabThera® Product Code: RO0452294/V01 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Code: RO0452294/V02 INN or Proposed INN: RITUXIMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	25	Phase 2	United States;Serbia;France;Canada;Turkey;Germany;Italy;United Kingdom
27	NCT01731561 (ClinicalTrials.gov)	November 16, 2012	12/10/2012	Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis	MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis II	Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Renal Limited Forms	Drug: Rituximab (Arm B);Drug: Rituximab (Arm A)	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	All	166	Phase 3	France
28	NCT01613599 (ClinicalTrials.gov)	June 20, 2012	4/6/2012	An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis	Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab	Granulomatosis With Polyangiitis;Microscopic Polyangiitis	Drug: Rituximab	Genentech, Inc.	NULL	Completed	18 Years	N/A	All	100		United States
29	NCT00748644 (ClinicalTrials.gov)	October 2008	5/9/2008	Efficacy Study of Two Treatments in the Remission of Vasculitis	MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis	Wegener Granulomatosis;Microscopic Polyangiitis	Drug: Rituximab;Drug: Azathioprine	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	75 Years	All	117	Phase 3	France
30	EUCTR2005-003610-15-CZ (EUCTR)	29/08/2006	23/02/2006	An international, randomised, open label trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. - RITUXVAS	An international, randomised, open label trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. - RITUXVAS	The ANCA associated vasculitides (AASV), namely Wegener’s granulomatosis, microscopic polyangiitis, and renal limited vasculitis.	INN or Proposed INN: Rituximab	Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	66		United Kingdom;Czech Republic;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	NCT00104299 (ClinicalTrials.gov)	January 2005	24/2/2005	Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis	Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)	Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis	Drug: Rituximab plus cyclophosphamide placebo (rituximab group);Drug: Cyclophosphamide plus rituximab placebo (control group);Drug: Azathioprine;Drug: Methylprednisolone (or other glucocorticoid);Drug: Prednisone	National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN);Genentech, Inc.	Completed	15 Years	N/A	All	197	Phase 2;Phase 3	United States;Netherlands
32	NCT00307593 (ClinicalTrials.gov)	May 2004	24/3/2006	RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides	Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies	Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis	Drug: Infliximab;Drug: Rituximab	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	Both	20	N/A	France
33	EUCTR2016-001121-14-IE (EUCTR)		21/12/2016	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
34	EUCTR2012-001102-14-GB (EUCTR)		07/09/2012	RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis	An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study	ANCA vasculitis. MedDRA version: 15.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 15.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Cambridge University Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 3	Spain;Ireland;Austria;Italy;United Kingdom;Czech Republic;Canada;Switzerland;Mexico;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
35	EUCTR2016-001121-14-FR (EUCTR)		22/06/2018	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2016-001121-14-DE (EUCTR)		23/12/2016	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 21.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03920722
(ClinicalTrials.gov)

September 2019

18/2/2019

Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis

Microscopic Polyangiitis (MPA)

Drug: Rituximab;Drug: placebo

Assistance Publique - Hôpitaux de Paris

French Vasculitis Study Group

Not yet recruiting

18 Years

N/A

All

106

Phase 3

France

EUCTR2018-000637-12-FR
(EUCTR)

29/03/2019

31/01/2019

Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis

Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis - RITUXGOPRO

Patients with newly diagnosed or relapsing MPA, without any poor prognosis marker (FFS=0). Stratification will be made according to peripheral nerve involvement.
MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

106

Phase 3

France

EUCTR2016-001121-14-NO
(EUCTR)

06/10/2017

07/02/2017

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden

EUCTR2016-001121-14-NL
(EUCTR)

15/06/2017

18/01/2017

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

EUCTR2016-001121-14-BE
(EUCTR)

08/05/2017

06/02/2017

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-001121-14-HU
(EUCTR)

24/04/2017

23/01/2017

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

EUCTR2016-001121-14-DK
(EUCTR)

07/04/2017

01/02/2017

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden

EUCTR2016-001121-14-GB
(EUCTR)

06/04/2017

23/12/2016

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Sweden

EUCTR2016-001121-14-ES
(EUCTR)

21/03/2017

20/01/2017

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

EUCTR2016-001121-14-CZ
(EUCTR)

20/03/2017

12/01/2017

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-001121-14-SE
(EUCTR)

13/02/2017

21/12/2016

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

EUCTR2016-001121-14-AT
(EUCTR)

13/02/2017

10/01/2017

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

NCT02115997
(ClinicalTrials.gov)

July 6, 2015

14/4/2014

A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis

Wegener's Granulomatosis or Microscopic Polyangiitis

Drug: Methylprednisolone;Drug: Prednisone;Drug: Rituximab

Hoffmann-La Roche

NULL

Recruiting

18 Years

N/A

All

Phase 4

India

EUCTR2015-001807-29-FR
(EUCTR)

09/06/2015

23/07/2015

Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis

Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis : a predictive factor of clinical outcome? (MONITUX) - A multicentric study - MONITUX

Granulomatosis with polyangiitis Microscopic polyangiitis
MedDRA version: 18.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trade Name: Rituximab
Product Name: Rituximab

CHU de Saint-Etienne

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

France

EUCTR2012-001102-14-CZ
(EUCTR)

15/04/2015

03/01/2013

RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis

An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study

ANCA vasculitis.
MedDRA version: 18.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MabThera® 500MG
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Azathioprine
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Trade Name: Mycophenolate Mofetil
Product Name: Mycophenolate mofetil
INN or Proposed INN: Mycophenolate mofetil
Trade Name: MabThera® 100MG
INN or Proposed INN: RITUXIMAB

Cambridge University Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 3

Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-001102-14-IE
(EUCTR)

10/10/2014

14/08/2014

RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis

Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Azathioprine
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Trade Name: Mycophenolate
Product Name: Mycophenolate
INN or Proposed INN: Mycophenolic acid

University College Cork , Ireland

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 3

Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Sweden

NCT02198248
(ClinicalTrials.gov)

October 2014

18/7/2014

Low-dose Glucocorticoid Vasculitis Induction Study

Low-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control Trial

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis

Drug: Rituximab;Drug: Glucocorticoids

Chiba University

National Hospital Organization Chiba East Hospital

Active, not recruiting

20 Years

N/A

All

140

Phase 4

Japan

EUCTR2012-001102-14-IT
(EUCTR)

12/09/2014

18/12/2013

RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis

ANCA vasculitis.
MedDRA version: 16.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.1;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Azathioprine
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Trade Name: Mycophenolate Mofetil
Product Name: Mycophenolate mofetil
INN or Proposed INN: Mycophenolate mofetil

Cambridge University Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 3

Spain;Ireland;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

JPRN-UMIN000012409

2014/06/26

04/12/2013

An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis

An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM

Granulomatosis With Polyangiitis (Wegener's) Microscopic Polyangiitis

Experimental: Rituximab Maintenance.
Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper.

Active Comparator: Azathioprine Maintenance.
Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation). Azathioprine withdrawn at month 27.

University of Miyazaki Hospital

The European Vasculitis SocietyVasculitis Clinical Research Consortium

Complete: follow-up complete

18years-old

Not applicable

Male and Female

190

Phase 3

Japan,North America,South America,Australia,Europe

NCT02169219
(ClinicalTrials.gov)

June 2014

19/6/2014

Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis

Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis

Granulomatosis With Polyangiitis;Microscopic Polyangiitis

Drug: Glucocorticoids;Drug: Rituximab

Massachusetts General Hospital

Genentech, Inc.

Completed

18 Years

85 Years

All

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-001102-14-ES
(EUCTR)

21/06/2013

16/05/2013

RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis

ANCA vasculitis.
MedDRA version: 16.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Azathioprine
Product Name: Azathioprine
INN or Proposed INN: Azathioprine

Cambridge University Hospitals NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

190

New Zealand;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;Sweden

NCT01750697
(ClinicalTrials.gov)

May 23, 2013

13/12/2012

A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

A Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

Granulomatosis With Polyangiitis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

2 Years

17 Years

All

Phase 2

United States;Canada;France;Germany;Italy;Serbia;Turkey;United Kingdom

NCT01697267
(ClinicalTrials.gov)

April 2013

31/8/2012

Rituximab Vasculitis Maintenance Study

An International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated Vasculitis

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis

Biological: Rituximab;Drug: Azathioprine

Cambridge University Hospitals NHS Foundation Trust

Arthritis Research UK;Roche Pharma AG;Genentech, Inc.;University of Pennsylvania

Completed

15 Years

N/A

All

188

Phase 3

United States;Australia;Canada;Czechia;Ireland;Italy;Japan;New Zealand;Sweden;United Kingdom;Czech Republic

EUCTR2012-002062-13-DE
(EUCTR)

14/03/2013

13/09/2012

A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis

A Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis

granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis
MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Trade Name: MabThera®
Product Code: RO0452294/V01
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom

EUCTR2012-002062-13-IT
(EUCTR)

28/01/2013

11/01/2013

A PHASE IIA, INTERNATIONAL, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF 4 x 375 mg/m2 INTRAVENOUS RITUXIMAB IN PEDIATRIC PATIENTS WITH SEVERE GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S) OR MICROSCOPIC POLYANGIITIS

granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis
MedDRA version: 14.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB

F. HOFFMANN - LA ROCHE LTD.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2A

United States;Turkey;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-002062-13-GB
(EUCTR)

18/01/2013

23/08/2012

Trade Name: MabThera®
Product Code: RO0452294/V01
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;France;Canada;Turkey;Germany;Italy;United Kingdom

NCT01731561
(ClinicalTrials.gov)

November 16, 2012

12/10/2012

Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis

MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis II

Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Renal Limited Forms

Drug: Rituximab (Arm B);Drug: Rituximab (Arm A)

Assistance Publique - Hôpitaux de Paris

NULL

Completed

18 Years

N/A

All

166

Phase 3

France

NCT01613599
(ClinicalTrials.gov)

June 20, 2012

4/6/2012

An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab

Granulomatosis With Polyangiitis;Microscopic Polyangiitis

Drug: Rituximab

Genentech, Inc.

NULL

Completed

18 Years

N/A

All

100

United States

NCT00748644
(ClinicalTrials.gov)

October 2008

5/9/2008

Efficacy Study of Two Treatments in the Remission of Vasculitis

MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis

Wegener Granulomatosis;Microscopic Polyangiitis

Drug: Rituximab;Drug: Azathioprine

Assistance Publique - Hôpitaux de Paris

NULL

Completed

18 Years

75 Years

All

117

Phase 3

France

EUCTR2005-003610-15-CZ
(EUCTR)

29/08/2006

23/02/2006

An international, randomised, open label trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. - RITUXVAS

The ANCA associated vasculitides (AASV), namely Wegener’s granulomatosis, microscopic polyangiitis, and renal limited vasculitis.

INN or Proposed INN: Rituximab

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Czech Republic;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00104299
(ClinicalTrials.gov)

January 2005

24/2/2005

Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis

Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)

Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis

Drug: Rituximab plus cyclophosphamide placebo (rituximab group);Drug: Cyclophosphamide plus rituximab placebo (control group);Drug: Azathioprine;Drug: Methylprednisolone (or other glucocorticoid);Drug: Prednisone

National Institute of Allergy and Infectious Diseases (NIAID)

Immune Tolerance Network (ITN);Genentech, Inc.

Completed

15 Years

N/A

All

197

Phase 2;Phase 3

United States;Netherlands

NCT00307593
(ClinicalTrials.gov)

May 2004

24/3/2006

RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies

Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis

Drug: Infliximab;Drug: Rituximab

Assistance Publique - Hôpitaux de Paris

NULL

Completed

18 Years

N/A

Both

N/A

France

EUCTR2016-001121-14-IE
(EUCTR)

21/12/2016

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

EUCTR2012-001102-14-GB
(EUCTR)

07/09/2012

RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis

ANCA vasculitis.
MedDRA version: 15.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 15.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Cambridge University Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 3

Spain;Ireland;Austria;Italy;United Kingdom;Czech Republic;Canada;Switzerland;Mexico;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

EUCTR2016-001121-14-FR
(EUCTR)

22/06/2018

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-001121-14-DE
(EUCTR)

23/12/2016

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 21.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03967925 (ClinicalTrials.gov)	February 1, 2019	18/1/2019	Rituximab and Belimumab Combination Therapy in PR3 Vasculitis	A Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated Vasculitis	ANCA Associated Vasculitis;Granulomatosis With Polyangiitis	Drug: Belimumab;Drug: Rituximab;Drug: Prednisolone	Rachel Jones	GlaxoSmithKline;Medical Research Council;Imperial College London;University College, London;Newcastle University;University of Glasgow;University of Cambridge	Recruiting	18 Years	N/A	All	30	Phase 2	United Kingdom
2	NCT03164473 (ClinicalTrials.gov)	March 7, 2018	22/5/2017	Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis.	MAINtenance of Remission With RITuximab Versus Azathioprine for Patients With Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Prospective, Randomized, Controlled, Double-blind Study: the MAINRITSEG Trial	Eosinophilic Granulomatosis With Polyangiitis	Drug: Rituximab;Drug: Azathioprine;Drug: Placebo-rituximab;Drug: Placebo-azathioprine	Assistance Publique - Hôpitaux de Paris	French Vasculitis Study Group	Recruiting	18 Years	N/A	All	98	Phase 4	France
3	EUCTR2016-001121-14-NO (EUCTR)	06/10/2017	07/02/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden
4	EUCTR2016-001121-14-NL (EUCTR)	15/06/2017	18/01/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
5	EUCTR2016-001121-14-BE (EUCTR)	08/05/2017	06/02/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2016-001121-14-HU (EUCTR)	24/04/2017	23/01/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
7	EUCTR2016-001121-14-DK (EUCTR)	07/04/2017	01/02/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
8	EUCTR2016-001121-14-GB (EUCTR)	06/04/2017	23/12/2016	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Sweden
9	EUCTR2016-001121-14-ES (EUCTR)	21/03/2017	20/01/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
10	EUCTR2016-001121-14-CZ (EUCTR)	20/03/2017	12/01/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2016-001121-14-SE (EUCTR)	13/02/2017	21/12/2016	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
12	EUCTR2016-001121-14-AT (EUCTR)	13/02/2017	10/01/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
13	NCT02807103 (ClinicalTrials.gov)	December 5, 2016	20/5/2016	Rituximab in Eosinophilic Granulomatosis With Polyangiitis	Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind Study	Eosinophilic Granulomatosis With Polyangiitis (EGPA)	Drug: Rituximab;Drug: Placebo-rituximab;Drug: Cyclophosphamide;Drug: Placebo-cyclophosphamide	Assistance Publique - Hôpitaux de Paris	French Vasculitis Study Group	Recruiting	18 Years	N/A	All	108	Phase 3	France
14	EUCTR2016-000275-25-FR (EUCTR)	21/03/2016	13/04/2016	Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS	Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS	Patients with a diagnosis of EGPA with newly-diagnosed disease or with a relapsing disease at the time of screening MedDRA version: 19.0;Level: PT;Classification code 10048594;Term: Allergic granulomatous angiitis;System Organ Class: 10021428 - Immune system disorders	Trade Name: RITUXIMAB Product Name: RITUXIMAB INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: CYCLOPHOSPHAMIDE Product Name: CYCLOPHOSPHAMIDE INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: MESNA Product Name: MESNA INN or Proposed INN: mesna Other descriptive name: MESNA	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 3	France
15	NCT02626845 (ClinicalTrials.gov)	December 2015	8/12/2015	Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis	Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis	Granulomatosis With Polyangiitis (Wegener's Granulomatosis)	Drug: Rituximab;Other: Placebo	Hospital for Special Surgery, New York	Genentech, Inc.;Roche Pharma AG	Terminated	18 Years	N/A	All	3	Phase 4	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2015-001807-29-FR (EUCTR)	09/06/2015	23/07/2015	Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis	Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis : a predictive factor of clinical outcome? (MONITUX) - A multicentric study - MONITUX	Granulomatosis with polyangiitis Microscopic polyangiitis MedDRA version: 18.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]	Trade Name: Rituximab Product Name: Rituximab	CHU de Saint-Etienne	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 4	France
17	NCT02198248 (ClinicalTrials.gov)	October 2014	18/7/2014	Low-dose Glucocorticoid Vasculitis Induction Study	Low-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control Trial	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis	Drug: Rituximab;Drug: Glucocorticoids	Chiba University	National Hospital Organization Chiba East Hospital	Active, not recruiting	20 Years	N/A	All	140	Phase 4	Japan
18	JPRN-UMIN000012409	2014/06/26	04/12/2013	An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis	An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM	Granulomatosis With Polyangiitis (Wegener's) Microscopic Polyangiitis	Experimental: Rituximab Maintenance. Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper. Active Comparator: Azathioprine Maintenance. Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation). Azathioprine withdrawn at month 27.	University of Miyazaki Hospital	The European Vasculitis SocietyVasculitis Clinical Research Consortium	Complete: follow-up complete	18years-old	Not applicable	Male and Female	190	Phase 3	Japan,North America,South America,Australia,Europe
19	NCT02169219 (ClinicalTrials.gov)	June 2014	19/6/2014	Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis	Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis	Granulomatosis With Polyangiitis;Microscopic Polyangiitis	Drug: Glucocorticoids;Drug: Rituximab	Massachusetts General Hospital	Genentech, Inc.	Completed	18 Years	85 Years	All	20	Phase 4	United States
20	NCT01750697 (ClinicalTrials.gov)	May 23, 2013	13/12/2012	A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis	A Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis	Granulomatosis With Polyangiitis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	2 Years	17 Years	All	25	Phase 2	United States;Canada;France;Germany;Italy;Serbia;Turkey;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	NCT01697267 (ClinicalTrials.gov)	April 2013	31/8/2012	Rituximab Vasculitis Maintenance Study	An International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated Vasculitis	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis	Biological: Rituximab;Drug: Azathioprine	Cambridge University Hospitals NHS Foundation Trust	Arthritis Research UK;Roche Pharma AG;Genentech, Inc.;University of Pennsylvania	Completed	15 Years	N/A	All	188	Phase 3	United States;Australia;Canada;Czechia;Ireland;Italy;Japan;New Zealand;Sweden;United Kingdom;Czech Republic
22	EUCTR2012-002062-13-DE (EUCTR)	14/03/2013	13/09/2012	A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis	A Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis	granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: MabThera® Product Code: RO0452294/V01 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Code: RO0452294/V02 INN or Proposed INN: RITUXIMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	25	Phase 2	Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom
23	EUCTR2012-002062-13-IT (EUCTR)	28/01/2013	11/01/2013	A PHASE IIA, INTERNATIONAL, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF 4 x 375 mg/m2 INTRAVENOUS RITUXIMAB IN PEDIATRIC PATIENTS WITH SEVERE GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S) OR MICROSCOPIC POLYANGIITIS	A PHASE IIA, INTERNATIONAL, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF 4 x 375 mg/m2 INTRAVENOUS RITUXIMAB IN PEDIATRIC PATIENTS WITH SEVERE GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S) OR MICROSCOPIC POLYANGIITIS	granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis MedDRA version: 14.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB	F. HOFFMANN - LA ROCHE LTD.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25	Phase 2A	United States;Turkey;United Kingdom;Italy
24	EUCTR2012-002062-13-GB (EUCTR)	18/01/2013	23/08/2012	A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis	A Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis	granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: MabThera® Product Code: RO0452294/V01 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Code: RO0452294/V02 INN or Proposed INN: RITUXIMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	25	Phase 2	United States;Serbia;France;Canada;Turkey;Germany;Italy;United Kingdom
25	NCT01731561 (ClinicalTrials.gov)	November 16, 2012	12/10/2012	Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis	MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis II	Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Renal Limited Forms	Drug: Rituximab (Arm B);Drug: Rituximab (Arm A)	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	All	166	Phase 3	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT01613599 (ClinicalTrials.gov)	June 20, 2012	4/6/2012	An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis	Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab	Granulomatosis With Polyangiitis;Microscopic Polyangiitis	Drug: Rituximab	Genentech, Inc.	NULL	Completed	18 Years	N/A	All	100		United States
27	NCT00748644 (ClinicalTrials.gov)	October 2008	5/9/2008	Efficacy Study of Two Treatments in the Remission of Vasculitis	MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis	Wegener Granulomatosis;Microscopic Polyangiitis	Drug: Rituximab;Drug: Azathioprine	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	75 Years	All	117	Phase 3	France
28	EUCTR2016-001121-14-IE (EUCTR)		21/12/2016	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
29	EUCTR2016-001121-14-FR (EUCTR)		22/06/2018	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
30	EUCTR2016-001121-14-DE (EUCTR)		23/12/2016	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine	Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 21.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02807103 (ClinicalTrials.gov)	December 5, 2016	20/5/2016	Rituximab in Eosinophilic Granulomatosis With Polyangiitis	Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind Study	Eosinophilic Granulomatosis With Polyangiitis (EGPA)	Drug: Rituximab;Drug: Placebo-rituximab;Drug: Cyclophosphamide;Drug: Placebo-cyclophosphamide	Assistance Publique - Hôpitaux de Paris	French Vasculitis Study Group	Recruiting	18 Years	N/A	All	108	Phase 3	France
2	EUCTR2016-000275-25-FR (EUCTR)	21/03/2016	13/04/2016	Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS	Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS	Patients with a diagnosis of EGPA with newly-diagnosed disease or with a relapsing disease at the time of screening MedDRA version: 19.0;Level: PT;Classification code 10048594;Term: Allergic granulomatous angiitis;System Organ Class: 10021428 - Immune system disorders	Trade Name: RITUXIMAB Product Name: RITUXIMAB INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: CYCLOPHOSPHAMIDE Product Name: CYCLOPHOSPHAMIDE INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: MESNA Product Name: MESNA INN or Proposed INN: mesna Other descriptive name: MESNA	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 3	France
3	NCT00424749 (ClinicalTrials.gov)	June 2007	19/1/2007	Rituxan in Churg Strauss Syndrome With Renal Involvement	A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement	Churg-Strauss Syndrome	Drug: Rituximab;Drug: Prednisone	Fernando Fervenza	Genentech, Inc.;Biogen;National Center for Research Resources (NCRR)	Terminated	18 Years	N/A	All	4	Phase 2	United States
4	NCT00307593 (ClinicalTrials.gov)	May 2004	24/3/2006	RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides	Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies	Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis	Drug: Infliximab;Drug: Rituximab	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	Both	20	N/A	France

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2020-002507-19-NL (EUCTR)	07/09/2020	03/09/2020	Research into administration of lower dosed rituximab with an injection	Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial - RTX-SC	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: rituximab Trade Name: Rixathon Product Name: rituximab	Sint Maartenskliniek	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36	Phase 4	Netherlands
2	EUCTR2019-002810-37-PL (EUCTR)	16/06/2020	11/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany
3	EUCTR2019-002810-37-BG (EUCTR)	15/06/2020	28/04/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany
4	EUCTR2019-002810-37-LT (EUCTR)	17/04/2020	03/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany
5	NCT04268771 (ClinicalTrials.gov)	April 8, 2020	31/1/2020	A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products	A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis	Biological: Experimental: Arm A: DRL_RI;Biological: Arm B: Rituxan®/Mabthera®	Dr. Reddy's Laboratories Limited	PPD	Recruiting	18 Years	N/A	All	140	Phase 3	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2019-002810-37-HU (EUCTR)	09/03/2020	20/01/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary
7	EUCTR2019-001754-25-NL (EUCTR)	25/11/2019	25/11/2019	Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment	Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch)	rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel, Benepali, Erelzi Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab INN or Proposed INN: ETANERCEPT INN or Proposed INN: RITUXIMAB INN or Proposed INN: ABATACEPT INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB INN or Proposed INN: SARILUMAB	Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 4	Netherlands
8	EUCTR2018-003877-91-DE (EUCTR)	13/06/2019	26/02/2019	B cell therapy followed by T cell therapy to achieve immune tolerance in rheumatoid arthritis with ACPA antiboidies (TOLERA): an unblinded clinical trial in one centre with random assignment to treatment groups in adult patients who failed methotrexate therapy	Sequential B cell/T cell therapy to re-induce humoral immune tolerance in ACPA-positive Rheumatoid Arthritis (TOLERA): a prospective randomized controlled open-label single-centre clinical trial in adult subjects with active ACPA-positive Rheumatoid Arthritis failing Methotrexate - TOLERA	Active rheumatoid arthritis with ACPA antibodies failing methotrexate MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	INN or Proposed INN: RITUXIMAB Trade Name: Orencia INN or Proposed INN: ABATACEPT	Universitätsklinikum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Germany
9	EUCTR2017-004079-30-PT (EUCTR)	09/08/2018	29/06/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	207	Phase 3	Portugal;Belgium;Spain;Italy
10	EUCTR2018-002368-18-ES (EUCTR)	25/07/2018	25/07/2018	Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load	Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load	1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.2. breast and lung cancer undertreated by chemotherapy3. HIV4. Haematopoietic progenitor cell transplantation (TCPH). MedDRA version: 20.0;Level: PT;Classification code 10006187;Term: Breast cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 20.0;Classification code 10058467;Term: Lung neoplasm malignant;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1;Classification code 10020161;Term: HIV infection;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Fendrix suspension for injection Product Name: Fendrix Product Code: Fendrix INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). Other descriptive name: HEPATITIS B VACCINE (RDNA) Trade Name: HBVAXPRO 5 micrograms/0.5 ml Product Name: HBVAXPRO® 40 micrograms Product Code: HBVAXPRO® 40 micrograms INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA) Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)	FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	740	Phase 4	Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2017-004079-30-ES (EUCTR)	10/07/2018	21/03/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rhuematoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	207	Phase 3	Portugal;Belgium;Spain;Italy
12	EUCTR2017-004079-30-BE (EUCTR)	19/02/2018	19/02/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	219	Phase 3	Portugal;Spain;Belgium;Italy
13	EUCTR2013-005543-90-EE (EUCTR)	07/08/2017	02/06/2017	This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 Biosimilar to Rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
14	EUCTR2014-005368-13-IT (EUCTR)	10/05/2017	16/02/2018	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB	ARCHIGEN BIOTECH LIMITED	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
15	EUCTR2014-005368-13-DE (EUCTR)	22/11/2016	04/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2016-002908-15-NL (EUCTR)	08/11/2016	23/08/2016	REDO study: Research into the effects of lower doses rituximab in patients with rheumatoid arthritis	REDO study: RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO	Rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Sint Maartenskliniek	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 4	Netherlands
17	EUCTR2014-005368-13-ES (EUCTR)	23/09/2016	15/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
18	EUCTR2014-005368-13-HU (EUCTR)	19/09/2016	11/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy
19	EUCTR2014-005368-13-CZ (EUCTR)	13/09/2016	13/09/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
20	EUCTR2012-002535-28-NL (EUCTR)	13/09/2016	01/09/2016	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 19.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Product Code: L01X CO2 Trade Name: RoActemra Product Name: RoActemra Product Code: L04AC07	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	144	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	NCT02792699 (ClinicalTrials.gov)	May 17, 2016	25/4/2016	Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab	A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: ABP 798;Drug: Rituximab (US);Drug: Rituximab (EU)	Amgen	NULL	Completed	18 Years	80 Years	All	311	Phase 3	United States;Bulgaria;Estonia;Germany;Hungary;Poland;Canada
22	NCT03355872 (ClinicalTrials.gov)	February 2016	22/11/2017	A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs	A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs	Rheumatoid Arthritis	Drug: HLX01	Shanghai Henlius Biotech	NULL	Completed	18 Years	65 Years	All	194	Phase 1;Phase 2	NULL
23	EUCTR2012-003876-38-PL (EUCTR)	10/11/2015	16/11/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
24	EUCTR2015-000581-58-CZ (EUCTR)	14/10/2015	16/06/2015	A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra INN or Proposed INN: tocilizumabum Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Revmatologicky ustav Praha	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	Czech Republic
25	EUCTR2012-003876-38-HU (EUCTR)	28/07/2015	22/05/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	EUCTR2012-002535-28-ES (EUCTR)	22/07/2015	10/07/2015	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Portugal;Belgium;Spain;Netherlands;Italy;United Kingdom
27	EUCTR2012-003876-38-DE (EUCTR)	21/07/2015	29/04/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
28	NCT02514772 (ClinicalTrials.gov)	July 2015	30/7/2015	GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®	A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®	Rheumatoid Arthritis	Biological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ®	Sandoz	Hexal AG	Completed	18 Years	N/A	All	107	Phase 3	United States;Germany;Hungary;Poland
29	EUCTR2010-021184-32-BG (EUCTR)	27/05/2015	14/04/2015	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 1;Phase 2	United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
30	EUCTR2010-021184-32-PL (EUCTR)	21/04/2015	06/02/2015	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 1;Phase 2	United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2010-021184-32-GB (EUCTR)	25/03/2015	12/06/2015	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 1;Phase 2	United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
32	NCT02304354 (ClinicalTrials.gov)	March 9, 2015	4/11/2014	Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)	Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)	Rheumatoid Arthritis	Drug: Rituximab	University Hospital, Tours	NULL	Active, not recruiting	18 Years	N/A	All	70	Phase 3	France
33	EUCTR2014-003255-54-CZ (EUCTR)	21/01/2015	24/10/2014	A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid Arthritis	A Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RGB-03 INN or Proposed INN: RITUXIMAB Trade Name: MabThera INN or Proposed INN: RITUXIMAB	Gedeon Richter Plc	NULL	Not Recruiting			Female: yes Male: yes	142	Phase 1;Phase 3	Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany
34	EUCTR2012-002535-28-IT (EUCTR)	16/01/2015	04/11/2014	Not applicable	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180		Portugal;Belgium;United Kingdom;Italy
35	EUCTR2010-021184-32-HU (EUCTR)	09/01/2015	27/10/2014	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 1;Phase 2	United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2013-005543-90-BG (EUCTR)	06/01/2015	22/10/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
37	NCT02371096 (ClinicalTrials.gov)	January 2015	5/2/2015	Comparative Pharmacokinetic Trial of RGB-03 and MabThera		Rheumatoid Arthritis	Drug: MabThera (rituximab);Drug: RGB-03	Gedeon Richter Plc.	NULL	Not yet recruiting	18 Years	75 Years	Both		Phase 1	NULL
38	EUCTR2014-003529-16-GB (EUCTR)	16/12/2014	22/06/2015	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP): A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	219	Phase 3	United Kingdom
39	EUCTR2013-005543-90-DE (EUCTR)	19/11/2014	16/06/2014	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: RITUXIMAB Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
40	EUCTR2014-000859-91-FR (EUCTR)	03/10/2014	18/06/2015	Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde.	Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde. - LYRITUX	Cette étude portera donc sur une population de patients atteints de polyarthrite rhumatoïde (PR) actives et ayant présenté un échec ou une contre-indication à au moins un anti-TNFa, et n’ayant jamais reçu de rituximab. MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MABTHERA INN or Proposed INN: RITUXIMAB	CHRU de TOURS	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2013-004555-21-GR (EUCTR)	22/09/2014	21/03/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
42	EUCTR2013-005543-90-PL (EUCTR)	09/09/2014	11/07/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
43	EUCTR2013-005543-90-HU (EUCTR)	26/08/2014	13/05/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany
44	EUCTR2013-002622-23-NL (EUCTR)	24/06/2014	17/02/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500 INN or Proposed INN: Rituximab	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
45	EUCTR2012-002535-28-PT (EUCTR)	06/06/2014	25/02/2014	Not applicable	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2012-002535-28-BE (EUCTR)	28/04/2014	28/03/2014	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
47	EUCTR2013-004555-21-SK (EUCTR)	07/04/2014	23/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
48	EUCTR2013-004555-21-AT (EUCTR)	07/04/2014	02/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of
49	EUCTR2013-004555-21-HU (EUCTR)	02/04/2014	23/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Korea, Republic of;Bosnia and Herzegovina;Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Latvia;Germany
50	EUCTR2013-004555-21-DE (EUCTR)	31/03/2014	17/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	EUCTR2013-004555-21-PT (EUCTR)	24/03/2014	07/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
52	EUCTR2012-003194-25-HR (EUCTR)	17/03/2014	03/09/2014	Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Mabion S.A.	NULL	Not Recruiting			Female: yes Male: yes	863	Phase 3	Serbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia
53	EUCTR2013-004555-21-LV (EUCTR)	03/03/2014	02/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Korea, Republic of;Bosnia and Herzegovina
54	EUCTR2012-003223-38-DE (EUCTR)	01/07/2013	08/04/2013	Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.	EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04	RHEUMATOID ARTHRITIS MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	157	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
55	EUCTR2012-003223-38-GB (EUCTR)	14/05/2013	12/02/2013	Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.	EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04	RHEUMATOID ARTHRITIS MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	157	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	NCT01873443 (ClinicalTrials.gov)	May 2013	22/5/2013	Long-Term Efficacy and Safety of CT-P10 in Patients With RA	An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1	Rheumatoid Arthritis	Drug: Rituximab, MTX, folic acid	Celltrion	NULL	Completed	18 Years	75 Years	Both	87	Phase 1	Korea, Republic of
57	NCT02468791 (ClinicalTrials.gov)	May 2013	9/6/2015	MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis	A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Rituximab	Mabion SA	NULL	Completed	18 Years	80 Years	All	709	Phase 3	Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine
58	EUCTR2011-002894-48-NO (EUCTR)	11/04/2013	06/09/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
59	EUCTR2011-002896-40-PL (EUCTR)	29/03/2013	11/02/2013	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01	RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195		United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
60	EUCTR2012-003223-38-ES (EUCTR)	27/02/2013	04/03/2013	Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.	EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04	RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	157		United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	EUCTR2011-002894-48-BG (EUCTR)	06/02/2013	20/11/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
62	EUCTR2012-003194-25-LT (EUCTR)	04/02/2013	24/09/2012	Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MabionCD20 INN or Proposed INN: Rituximab Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB	Mabion S.A.	NULL	Not Recruiting			Female: yes Male: yes	863		Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia
63	EUCTR2011-002894-48-DE (EUCTR)	25/01/2013	24/07/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	459		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
64	EUCTR2012-002535-28-GB (EUCTR)	21/01/2013	14/12/2012	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActemra Product Name: RoActemra	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
65	EUCTR2011-002894-48-ES (EUCTR)	18/01/2013	29/10/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 INN or Proposed INN: Not applicable Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	NCT01759030 (ClinicalTrials.gov)	December 2012	20/12/2012	Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis	Double Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor Therapies	Rheumatoid Arthritis	Drug: Rituximab	Biocad	NULL	Completed	18 Years	80 Years	All	181	Phase 3	Belarus;India;Russian Federation;Ukraine;Colombia
67	EUCTR2011-002894-48-GR (EUCTR)	16/11/2012	19/10/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300		United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
68	EUCTR2011-002894-48-PT (EUCTR)	09/11/2012	09/12/2011	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 INN or Proposed INN: No Active Name Specified Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
69	EUCTR2011-002896-40-DE (EUCTR)	23/10/2012	02/07/2012	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01	RHEUMATOID ARTHRITIS MedDRA version: 16.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US	NULL	Not Recruiting			Female: yes Male: yes	195		United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
70	EUCTR2011-002894-48-HU (EUCTR)	16/10/2012	16/08/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	459		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	EUCTR2011-002894-48-EE (EUCTR)	08/10/2012	08/12/2011	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300		United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
72	EUCTR2011-002894-48-GB (EUCTR)	14/09/2012	06/12/2011	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
73	EUCTR2011-002894-48-NL (EUCTR)	10/09/2012	14/12/2011	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	459		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
74	NCT01682512 (ClinicalTrials.gov)	September 5, 2012	10/8/2012	Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis	Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial.	Arthritis, Rheumatoid	Drug: BI 695500;Drug: Rituxan®;Drug: MabThera®	Boehringer Ingelheim	NULL	Terminated	18 Years	80 Years	All	294	Phase 3	United States;Argentina;Belgium;Bulgaria;Canada;Chile;Germany;Greece;Hungary;Ireland;Mexico;Netherlands;Poland;Portugal;Spain;Ukraine;United Kingdom;Brazil;Estonia;France;Guatemala;Italy;New Zealand;Norway;Peru;Russian Federation;Serbia;South Africa;Sweden
75	NCT01643928 (ClinicalTrials.gov)	August 16, 2012	6/7/2012	Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)	EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS	Rheumatoid Arthritis	Biological: Rituximab-Pfizer (PF-05280586) x 3 courses;Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses;Biological: Rituximab-US + Rituximab-Pfizer x 2 Courses	Pfizer	NULL	Completed	18 Years	N/A	All	185	N/A	United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Switzerland;Ukraine
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	EUCTR2011-002896-40-GB (EUCTR)	14/08/2012	11/06/2012	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	United States;Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Israel;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
77	EUCTR2011-002894-48-BE (EUCTR)	02/08/2012	18/07/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	459	Phase 1;Phase 3	Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
78	EUCTR2011-005021-48-NL (EUCTR)	07/06/2012	05/06/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
79	EUCTR2011-005021-48-CZ (EUCTR)	23/05/2012	15/02/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
80	EUCTR2011-005021-48-ES (EUCTR)	14/05/2012	21/02/2012	A study to investigate and compare the efficacy, safety, tolerability andpharmacodynamic (biochemical and physiological effects of the drug) ofTL011 and MabThera® (rituximab) in patients with severe, activerheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallelgroupstudy to evaluate the efficacy, safety, tolerability andpharmacodynamic profiles of TL011 infusions compared with MabThera®(rituximab) in subjects with severe, active rheumatoid arthritis treatedwith methotrexate (MTX) - ALTO	Sujetos adultos con artritis reumatoide (AR) activa de grado severo tratados con MTX MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg Concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	EUCTR2012-000139-21-AT (EUCTR)	14/05/2012	23/04/2012	Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB	Medizinische Universität Wien, Universitätsklinik für Innere Medizin III	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Czech Republic;Slovakia;Austria;Russian Federation;Switzerland
82	EUCTR2011-005021-48-BG (EUCTR)	09/05/2012	20/04/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
83	EUCTR2011-005021-48-HU (EUCTR)	04/05/2012	15/02/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
84	EUCTR2011-005021-48-PL (EUCTR)	10/04/2012	14/03/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of
85	EUCTR2011-004171-36-ES (EUCTR)	30/03/2012	30/01/2012	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Not Recruiting			Female: yes Male: yes	616		Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	EUCTR2011-004171-36-PL (EUCTR)	29/03/2012	22/02/2012	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	616		Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
87	EUCTR2010-021184-32-EE (EUCTR)	23/03/2012	08/03/2012	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	164		Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Germany
88	NCT01526057 (ClinicalTrials.gov)	March 20, 2012	1/2/2012	A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES	Rheumatoid Arthritis	Biological: PF-05280586;Biological: MabThera;Biological: Rituxan	Pfizer	NULL	Completed	18 Years	N/A	All	220	Phase 2	United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Taiwan
89	EUCTR2011-006001-10-IT (EUCTR)	19/03/2012	14/03/2012	Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response	Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response -	Rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MABTHERAEV 1FL 50ML 500MG INN or Proposed INN: RITUXIMAB Other descriptive name: NA Trade Name: MABTHERAEV 1FL 50ML 500MG INN or Proposed INN: RITUXIMAB Other descriptive name: NA	A.O. UNIVERSITARIA INTEGRATA DI VERONA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	48		Italy
90	EUCTR2011-004171-36-GB (EUCTR)	24/02/2012	15/12/2011	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	616		Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	EUCTR2011-004171-36-HU (EUCTR)	23/02/2012	16/12/2011	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	616		Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
92	EUCTR2011-004171-36-CZ (EUCTR)	15/02/2012	30/11/2011	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
93	NCT01534884 (ClinicalTrials.gov)	February 2012	8/2/2012	Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis	Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: rituximab	Celltrion	NULL	Completed	18 Years	75 Years	Both	154	Phase 1	Korea, Republic of
94	NCT01613027 (ClinicalTrials.gov)	February 2012	25/5/2012	An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis	A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)	Rheumatoid Arthritis	Biological: Rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	135	N/A	Greece
95	NCT01592292 (ClinicalTrials.gov)	November 2011	11/4/2012	An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy	A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent	Rheumatoid Arthritis	Drug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: Infliximab	Hoffmann-La Roche	NULL	Completed	20 Years	N/A	All	90	N/A	Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
96	NCT01641952 (ClinicalTrials.gov)	October 2011	13/7/2012	An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent	Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program	Rheumatoid Arthritis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	505	N/A	Romania
97	EUCTR2010-021184-32-IT (EUCTR)	03/08/2011	02/02/2011	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany
98	NCT01295151 (ClinicalTrials.gov)	August 2011	11/2/2011	SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.	Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug	Rheumatoid Arthritis	Drug: Etanercept;Drug: Abatacept;Biological: Rituximab;Drug: Adalimumab;Drug: Certolizumab Pegol;Drug: Infliximab;Drug: Golimumab	Julia Brown	NULL	Completed	18 Years	N/A	Both	122	Phase 4	United Kingdom
99	NCT01382940 (ClinicalTrials.gov)	July 26, 2011	24/6/2011	A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis	A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: rituximab;Drug: methotrexate;Drug: methylprednisolone;Drug: acetaminophen;Drug: antihistamine	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	351	Phase 4	United States
100	NCT01390441 (ClinicalTrials.gov)	July 2011	7/7/2011	A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)	A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Biological: MK-8808;Biological: MabThera® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Loratadine	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	65 Years	All	100	Phase 1	Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
101	EUCTR2010-021184-32-BE (EUCTR)	08/06/2011	14/04/2011	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti- TNF therapies	Refractory rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the US Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
102	EUCTR2010-023880-17-GB (EUCTR)	31/03/2011	25/02/2011	SWITCH Clinical Trial for Patients with Rheumatoid Arthritis who have failed an initial TNF-blocking drug	SWITCH: Randomised-controlled trial of switching to alternative tumour-necrosis factor (TNF)-blocking drugs or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-blocking drug. - SWITCH	Rheumatoid arthritis in patients who have failed to respond to an initial TNF-blocking drug MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	477	Phase 4	United Kingdom
103	NCT01332994 (ClinicalTrials.gov)	March 2011	18/3/2011	A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis	Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI)	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	519	Phase 3	Germany
104	EUCTR2010-020499-50-GB (EUCTR)	07/02/2011	31/12/2010	Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.	Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.	rheumatoid arthritis MedDRA version: 13;Level: PT;Classification code 10039073;Term: rheumatoid arthritis	Trade Name: MabThera Product Name: rituximab	South Tees Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	46	Phase 4	United Kingdom
105	NCT01765374 (ClinicalTrials.gov)	February 2011	12/5/2011	Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis	Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis	Rheumatoid Arthritis	Device: ESAOTE MyLab60;Drug: Rituximab	University Hospital, Rouen	NULL	Completed	18 Years	N/A	Both	30	Phase 4	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	EUCTR2010-022049-88-DE (EUCTR)	05/01/2011	11/11/2010	Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI	Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI	Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra 20 mg/ml Concentrate for solution for infusion Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: Tocilizumab Trade Name: Mabthera 500 mg Concentrate for solution for infusion Product Name: Rituximab Product Code: RO045-2294 INN or Proposed INN: RITUXIMAB	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes			Germany
107	NCT01274182 (ClinicalTrials.gov)	January 2011	10/1/2011	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.	Rheumatoid Arthritis	Biological: GP2013;Biological: MabThera;Biological: Rituxan	Sandoz	Novartis Pharmaceuticals	Completed	18 Years	N/A	All	312	Phase 1;Phase 2	United States;Argentina;Austria;Belgium;Brazil;Estonia;France;Germany;Hungary;India;Italy;Romania;Spain;Turkey
108	EUCTR2010-021184-32-DE (EUCTR)	30/11/2010	30/08/2010	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
109	EUCTR2010-021184-32-AT (EUCTR)	11/11/2010	19/10/2010	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	288	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
110	EUCTR2010-021184-32-FR (EUCTR)	28/10/2010	13/09/2010	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or two anti- TNF therapies	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or two anti- TNF therapies	Refractory rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	France;Hungary;Estonia;Poland;Belgium;Spain;Austria;Bulgaria;Germany;United Kingdom;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	NCT01244958 (ClinicalTrials.gov)	August 2010	28/9/2010	Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis	Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis - a Multicenter Randomised Double-blind Clinical Trial	Rheumatoid Arthritis	Biological: Rituximab;Drug: Placebo	Frank Behrens	NULL	Completed	18 Years	75 Years	Both	156	Phase 3	Germany
112	NCT01593332 (ClinicalTrials.gov)	July 2010	7/1/2012	Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis		DMARD Resistant Rheumatoid Arthritis	Drug: Rituximab	Mashhad University of Medical Sciences	Roche Pharma AG	Completed	19 Years	75 Years	Both	44	Phase 4	Iran, Islamic Republic of
113	EUCTR2009-015950-39-DE (EUCTR)	12/05/2010	28/12/2009	Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritis	Addition of Rituximab to Leflunomide in patients with active rheumatoid arthritis - AMARA	Active rheumatoid arthritis (RA) Patients who have had an inadequate response to disease modifying anti-rheumatic drugs (not more than 3 DMARDs including leflunomide, not more than one anti-TNF failure) and currently have active disease despite at least 3-month treatment with leflunomide. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera® Product Name: Rituximab INN or Proposed INN: RITUXIMAB	Johann Wolfgang Goethe-Universität Frankfurt/M.	NULL	Not Recruiting			Female: yes Male: yes			Germany
114	NCT01117129 (ClinicalTrials.gov)	April 2010	4/5/2010	A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)	Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: placebo;Drug: methotrexate;Drug: rituximab [Mabthera/Rituxan]	Hoffmann-La Roche	NULL	Terminated	18 Years	75 Years	Both	2	Phase 4	Spain
115	NCT01021735 (ClinicalTrials.gov)	April 2010	27/11/2009	Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy	Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy	Rheumatoid Arthritis	Drug: etanercept or adalimumab;Drug: Rituximab	University of Glasgow	Arthritis Research Campaign;NHS Lothian;NHS Grampian;NHS Tayside;NHS Borders;NHS Fife	Completed	18 Years	N/A	Both	302	Phase 4	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
116	EUCTR2009-016789-10-NL (EUCTR)	19/02/2010	17/11/2009	Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab	Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab	To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy	Trade Name: Focetria Trade Name: Pandemrix,	Div KIR AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
117	NCT01071798 (ClinicalTrials.gov)	January 2010	18/2/2010	An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis	A Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine Care	Rheumatoid Arthritis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1653	N/A	Germany;United States
118	NCT02731560 (ClinicalTrials.gov)	January 2010	6/3/2016	Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)	Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: Rituximab	Prof. Abid Z. Farooqi	Aga Khan University;Fatima Memorial Hospital;Fauji Foundation Hospital, Rawalpindi	Completed	18 Years	80 Years	Both	74	Phase 4	NULL
119	EUCTR2009-011268-13-GB (EUCTR)	31/12/2009	15/03/2010	Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study	Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera Product Name: Rituximab Trade Name: Enbrel Product Name: Etanercept Trade Name: Humira Product Name: Adalimumab	NHS Greater Glasgow and Clyde	University of Glasgow	Not Recruiting			Female: yes Male: yes			United Kingdom
120	NCT01000441 (ClinicalTrials.gov)	December 2009	22/10/2009	Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis	Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: infliximab, etanercept, adalimumab;Drug: abatacept, rituximab or tocilizumab	University Hospital, Strasbourg, France	NULL	Recruiting	18 Years	N/A	Both	300	Phase 4	France;Monaco
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	NCT00844714 (ClinicalTrials.gov)	November 2009	12/2/2009	Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy	Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy	Endothelial Function;Rheumatoid Arthritis;Inflammation	Drug: Rituxan	University of California, San Francisco	Genentech, Inc.	Completed	18 Years	N/A	All	20	N/A	United States
122	EUCTR2008-005450-20-BE (EUCTR)	29/10/2009	01/10/2009	The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)	The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)	Rheumatoid arthritis MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade (infliximab) INN or Proposed INN: INFLIXIMAB Other descriptive name: remicade Trade Name: Humira (adalimumab) INN or Proposed INN: ADALIMUMAB Trade Name: Enbrel (etanercept) INN or Proposed INN: ETANERCEPT Other descriptive name: Enbrel Trade Name: Mabthera (rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: Mabthera Trade Name: Orencia (abatacept) INN or Proposed INN: ABATACEPT Other descriptive name: Orencia	Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	261		Belgium
123	NCT01075477 (ClinicalTrials.gov)	September 2009	24/2/2010	An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)	Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines	Rheumatoid Arthritis	Drug: rituximab [Mabthera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	151	N/A	Finland;United States
124	EUCTR2008-005525-11-GR (EUCTR)	20/07/2009	17/11/2009	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
125	EUCTR2009-010955-29-NL (EUCTR)	13/07/2009	27/02/2009	Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.	Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.	Pre-clinical RA patients with a high risk on developing the disease.	Trade Name: MabThera 500 mg (10mg/ml) INN or Proposed INN: Rituximab	Division of Clinically Immunology and Rheumatology, AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
126	EUCTR2008-002381-55-ES (EUCTR)	16/06/2009	01/08/2008	Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.	Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.	Pacientes con artritis reumatoide (AR) activa refractarios a uno o más fármacos antiTNF (definido por un DAS28>3,2). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MABTHERA 500 mg concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB	ROCHE FARMA, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Spain
127	EUCTR2008-005525-11-DE (EUCTR)	24/04/2009	09/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81		United Kingdom;Germany;Netherlands;France;Spain
128	EUCTR2008-005525-11-NL (EUCTR)	31/03/2009	12/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81		France;Spain;Germany;Netherlands;United Kingdom
129	NCT00845832 (ClinicalTrials.gov)	March 2009	17/2/2009	A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate	A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate	Rheumatoid Arthritis	Drug: Placebo;Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Terminated	18 Years	65 Years	All	24	Phase 2	France;Germany;Greece;Netherlands;Poland;Spain;Switzerland;United Kingdom;Belgium;Sweden
130	EUCTR2008-005525-11-FR (EUCTR)	06/02/2009	13/03/2009	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Code: RO452294/V02 INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533/F01 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	81		United Kingdom;Germany;Netherlands;France;Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	EUCTR2008-005525-11-ES (EUCTR)	29/01/2009	09/12/2008	Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Artritis reumatoideRheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MABTHERA 500 mg concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	81		United Kingdom;Germany;Netherlands;France;Spain
132	EUCTR2008-005525-11-GB (EUCTR)	29/12/2008	16/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis		F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
133	EUCTR2007-001585-33-DE (EUCTR)	19/08/2008	14/04/2008	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Netherlands;Latvia;Germany
134	NCT00147966 (ClinicalTrials.gov)	June 2008	2/9/2005	Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)	Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial Biopsies	Rheumatoid Arthritis	Drug: rituximab	University of California, San Diego	Genentech, Inc.	Completed	18 Years	75 Years	All	24	Phase 2	United States
135	EUCTR2007-003647-75-FR (EUCTR)	01/04/2008	07/02/2008	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Finland;United Kingdom;Netherlands;France;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
136	NCT02622503 (ClinicalTrials.gov)	April 2008	2/12/2015	A Study on Rheumatoid Arthritis Patients Treated With Rituximab	Retrospective Data Collection on Rheumatoid Arthritis (RA) Patients Treated With Rituximab in Finland.	Rheumatoid Arthritis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	N/A	N/A	Both	81	N/A	Finland
137	NCT01000610 (ClinicalTrials.gov)	March 17, 2008	21/10/2009	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate	An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	18	Phase 4	Tunisia
138	EUCTR2007-003623-20-ES (EUCTR)	12/03/2008	04/02/2008	Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).	Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).	Se estudiaran los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: RITUXIMAB	Dr. Juan D. Cañete Crespillo, Hospital Clínic de Barcelona	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Spain
139	NCT00664521 (ClinicalTrials.gov)	March 2008	21/4/2008	Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)	A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.	Rheumatoid Arthritis	Biological: Rituximab;Drug: Atacicept;Drug: Placebo matched to atacicept	Merck KGaA	NULL	Completed	18 Years	N/A	All	27	Phase 2	France;Netherlands;Sweden;United Kingdom;Finland
140	EUCTR2007-001585-33-GR (EUCTR)	26/02/2008	09/08/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman- La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
141	EUCTR2007-003647-75-GB (EUCTR)	15/02/2008	10/12/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis		Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	France;Finland;Netherlands;United Kingdom;Sweden
142	EUCTR2007-003647-75-NL (EUCTR)	07/02/2008	29/11/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Sweden;France;Finland;United Kingdom;Netherlands
143	EUCTR2007-003647-75-SE (EUCTR)	06/02/2008	04/12/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: MabThera 500 mg (10 mg/ml) concentrate for solution for infusion Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Finland;United Kingdom;Netherlands;France;Sweden
144	EUCTR2007-003647-75-FI (EUCTR)	31/01/2008	19/12/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Finland;United Kingdom;Netherlands;France;Sweden
145	NCT00963703 (ClinicalTrials.gov)	December 2007	20/8/2009	Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis	Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes	Rheumatoid Arthritis	Drug: Rituximab	University of Manitoba	Hoffmann-La Roche	Completed	18 Years	N/A	Both	15	N/A	Canada
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	NCT00580229 (ClinicalTrials.gov)	December 2007	18/12/2007	A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.	A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: prednisone	University of South Florida	NULL	Completed	18 Years	80 Years	All	50	Phase 2;Phase 3	United States
147	NCT00576433 (ClinicalTrials.gov)	December 2007	18/12/2007	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.	An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor	Rheumatoid Arthritis	Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	Both	60	Phase 4	Russian Federation
148	EUCTR2007-001585-33-ES (EUCTR)	15/11/2007	13/09/2007	Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE	Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE	Artritis reumatoide (AR)Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
149	EUCTR2007-001585-33-LT (EUCTR)	13/11/2007	05/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
150	NCT00578305 (ClinicalTrials.gov)	November 2007	19/12/2007	A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate	A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid Arthritis	Biological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folate	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	185	Phase 3	Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
151	EUCTR2007-001585-33-DK (EUCTR)	26/10/2007	12/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
152	NCT00502853 (ClinicalTrials.gov)	October 25, 2007	17/7/2007	A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.	Pilot Study to Evaluate the Effect of Mabthera in Combination With MTX in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	75 Years	All	10	Phase 4	Italy
153	EUCTR2007-001585-33-EE (EUCTR)	10/10/2007	18/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
154	EUCTR2007-001585-33-FR (EUCTR)	09/10/2007	23/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180		Germany;Netherlands;Denmark;Estonia;France;Spain;Greece;Latvia;Lithuania
155	NCT00934648 (ClinicalTrials.gov)	October 2007	6/7/2009	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate	An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	15	Phase 4	Morocco
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
156	NCT02699892 (ClinicalTrials.gov)	October 2007	25/2/2016	Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis	Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	130	N/A	Serbia
157	EUCTR2007-001585-33-NL (EUCTR)	20/09/2007	09/08/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Latvia;Netherlands
158	EUCTR2006-005640-81-GB (EUCTR)	04/09/2007	27/07/2007	A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA	A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA	Rheumatoid arthritis		University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United Kingdom
159	EUCTR2007-001585-33-CZ (EUCTR)	22/08/2007	04/09/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	France;Estonia;Czech Republic;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
160	EUCTR2007-001754-11-IT (EUCTR)	03/08/2007	02/07/2007	Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND	Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Mabthera INN or Proposed INN: Rituximab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes			Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	EUCTR2007-001585-33-LV (EUCTR)	26/07/2007	30/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
162	NCT00502840 (ClinicalTrials.gov)	July 23, 2007	17/7/2007	A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.	An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	75 Years	All	193	Phase 3	Germany
163	NCT00504777 (ClinicalTrials.gov)	July 2007	19/7/2007	A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.	An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	36	Phase 4	Taiwan
164	EUCTR2006-006746-33-DE (EUCTR)	28/06/2007	12/03/2007	Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR	Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR	Rheumatoid arthritis MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	240		Germany
165	NCT00462345 (ClinicalTrials.gov)	June 2007	18/4/2007	A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.	An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies	Rheumatoid Arthritis	Drug: rituximab;Drug: Methotrexate;Drug: Corticosteroid or NSAID;Dietary Supplement: Folate	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	40	Phase 4	Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	NCT00578565 (ClinicalTrials.gov)	May 2007	19/12/2007	Rituximab in Rheumatoid Arthritis Lung Disease	Rituximab for the Treatment of Rheumatoid Arthritis-Associated Interstitial Pneumonia: A Pilot Study	Rheumatoid Arthritis;Interstitial Pneumonia	Drug: Rituximab	Eric Matteson	Genentech, Inc.;National Center for Research Resources (NCRR)	Completed	18 Years	80 Years	All	10	Phase 3	United States
167	NCT00425932 (ClinicalTrials.gov)	February 2007	22/1/2007	Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis	Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Rituximab	Gaylis, Norman B., M.D.	Oklahoma Medical Research Foundation;Genentech, Inc.	Completed	18 Years	80 Years	Both	60	Phase 2	United States
168	NCT00443651 (ClinicalTrials.gov)	January 2007	2/3/2007	A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis	An Open-Label, Prospective Study of the Safety of Rituximab in Combination With Other Disease-Modifying Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Rituximab;Drug: Anti-inflammatory drugs	Genentech, Inc.	Biogen	Completed	18 Years	80 Years	All	578	Phase 3	United States
169	NCT00424502 (ClinicalTrials.gov)	January 2007	18/1/2007	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.	An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	20	Phase 4	Hungary
170	EUCTR2006-005386-19-BE (EUCTR)	19/12/2006	03/11/2006	Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini	Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini	Rheumatoid arthritis refractory to TNF blockers patients MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera	Cliniques Universitaires Saint-Luc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Belgium
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
171	EUCTR2005-003632-22-ES (EUCTR)	22/11/2006	20/03/2012	A study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with rheumatoid arthritis.	An open-label, exploratory study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with active rheumatoid arthritis	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3		Spain
172	NCT02079532 (ClinicalTrials.gov)	November 2006	4/3/2014	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor	An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent	Rheumatoid Arthritis	Drug: rituximab [MabThera]	Hoffmann-La Roche	NULL	Completed	18 Years	75 Years	All	302	Phase 3	Germany
173	NCT00396812 (ClinicalTrials.gov)	November 2006	6/11/2006	Rituximab for the Treatment of Early Rheumatoid Arthritis (RA)	An Open Label, Single Arm, Single Center, Phase I/II Trial of Rituximab (a Monoclonal Antibody to CD20) for the Treatment of Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Rituximab	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence	Terminated	18 Years	N/A	All	4	Phase 1;Phase 2	United States
174	EUCTR2006-004673-98-HU (EUCTR)	16/10/2006	08/09/2006	Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker	Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker	To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.	Trade Name: MabThera 500 mg concentrate for solution for infusion	Roche (Hungary) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20		Hungary
175	EUCTR2005-002396-33-HU (EUCTR)	26/09/2006	07/07/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
176	EUCTR2006-001000-37-DE (EUCTR)	19/09/2006	16/06/2006	Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST	Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST	Rheumatoid arthritis MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	300		Germany
177	EUCTR2005-002396-33-SK (EUCTR)	14/09/2006	15/06/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Finland;United Kingdom;Germany;Slovakia;Spain;Italy
178	NCT01126541 (ClinicalTrials.gov)	September 2006	18/5/2010	SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy	A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)	Rheumatoid Arthritis	Drug: rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	224	Phase 3	France
179	NCT02006706 (ClinicalTrials.gov)	August 10, 2006	5/12/2013	A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy	An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	15	Phase 3	Serbia
180	NCT01272908 (ClinicalTrials.gov)	July 18, 2006	7/1/2011	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)	Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)	Rheumatoid Arthritis	Drug: rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	120	Phase 3	Canada;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
181	NCT00555542 (ClinicalTrials.gov)	July 2006	7/11/2007	An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis	B Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell Subsets	Rheumatoid Arthritis	Drug: rituximab	Chinese University of Hong Kong	NULL	Completed	21 Years	70 Years	Both	10	Phase 2	China
182	EUCTR2006-000854-32-AT (EUCTR)	29/05/2006	19/05/2006	Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers	Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers	Rheumatoid Arthritis	Trade Name: Rituximab - MabThera Product Name: Rituximab MabThera Product Code: no	Vienna Medical University	NULL	Not Recruiting			Female: yes Male: yes	20		Austria
183	NCT00298272 (ClinicalTrials.gov)	May 2006	1/3/2006	Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis	A Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Tolerability and Safety of Rituximab When Given in Combination With Methotrexate and Etanercept (Enbrel) or Methotrexate and Adalimumab (Humira) in Subjects With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: IDEC-C2B8 (rituximab);Drug: Placebo;Drug: Methotrexate;Drug: Etanercept;Drug: Adalimumab;Drug: Methylprednisolone;Dietary Supplement: Folate	Biogen	Hoffmann-La Roche;Genentech, Inc.	Terminated	18 Years	65 Years	All	54	Phase 2	United States
184	EUCTR2005-002395-15-DE (EUCTR)	27/04/2006	22/11/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
185	EUCTR2005-002396-33-DE (EUCTR)	27/04/2006	10/11/2005	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
186	EUCTR2005-002392-32-DE (EUCTR)	20/04/2006	29/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500		Slovenia;Ireland;Germany;United Kingdom;Sweden
187	EUCTR2005-002396-33-GB (EUCTR)	28/03/2006	11/05/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis		F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 3	Hungary;Slovakia;Finland;Belgium;Spain;Germany;Italy;United Kingdom
188	EUCTR2005-004582-41-GB (EUCTR)	24/03/2006	27/01/2006	Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA	Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA	Active Rheumatoid Arthritis		University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 4	United Kingdom
189	EUCTR2005-002396-33-FI (EUCTR)	06/03/2006	22/12/2005	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab Product Name: Methotrexate Product Code: Methotrexate	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		United Kingdom;Germany;Spain;Italy;Hungary;Finland;Slovakia
190	EUCTR2005-002395-15-CZ (EUCTR)	27/02/2006	27/02/2006	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
191	EUCTR2005-002395-15-SE (EUCTR)	13/02/2006	12/12/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
192	NCT00422383 (ClinicalTrials.gov)	February 2006	15/1/2007	A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)	A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	378	Phase 3	Australia;Belgium;Brazil;Canada;China;Finland;France;Germany;Hungary;Italy;Netherlands;New Zealand;Slovakia;South Africa;Spain;Taiwan;Thailand;United Kingdom;Switzerland;United States
193	NCT00502996 (ClinicalTrials.gov)	February 2006	17/7/2007	A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.	Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)	Rheumatoid Arthritis	Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	246	Phase 3	Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela
194	NCT00282308 (ClinicalTrials.gov)	January 23, 2006	24/1/2006	A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate	A Phase II, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate	Rheumatoid Arthritis	Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisone;Biological: C. albicans;Biological: Tetanus toxoid adsorbed booster vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: Keyhole limpet hemocyanin	Genentech, Inc.	NULL	Completed	18 Years	65 Years	All	103	Phase 2	United States
195	EUCTR2005-002395-15-GB (EUCTR)	20/01/2006	25/04/2006	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis		F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853	Phase 3	Czech Republic;Finland;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
196	EUCTR2005-002395-15-FI (EUCTR)	09/01/2006	26/10/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab Product Name: Methotrexate Product Code: Methotrexate INN or Proposed INN: methotrexate	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
197	EUCTR2005-002395-15-DK (EUCTR)	06/01/2006	19/06/2007	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853	Phase 3	Czech Republic;Finland;Belgium;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
198	NCT00299104 (ClinicalTrials.gov)	January 2006	2/3/2006	A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis	A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: placebo;Drug: rituximab	Genentech, Inc.	Hoffmann-La Roche	Completed	18 Years	80 Years	All	755	Phase 3	United States
199	NCT00266227 (ClinicalTrials.gov)	January 2006	14/12/2005	A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment With Rituximab in Subjects With Rheumatoid Arthritis Receiving Background Methotrexate	Rheumatoid Arthritis	Drug: placebo;Drug: rituximab;Drug: methotrexate;Drug: folate	Genentech, Inc.	NULL	Completed	18 Years	80 Years	All	559	Phase 3	United States
200	NCT00422942 (ClinicalTrials.gov)	January 2006	15/1/2007	A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)	An Open-label, Exploratory Study of the Pharmacokinetic and Pharmacodynamic Activity of MabThera in Combination With Methotrexate in Synovial Tissue and in Peripheral Blood of Patients With Active Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate	Hoffmann-La Roche	NULL	Terminated	18 Years	80 Years	All	3	Phase 2	Netherlands;Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
201	EUCTR2005-002395-15-BE (EUCTR)	29/12/2005	24/11/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy;Sweden
202	EUCTR2005-002395-15-ES (EUCTR)	29/12/2005	31/10/2005	Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”	Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”	Artritis reumatoide / Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853		Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
203	EUCTR2005-002396-33-ES (EUCTR)	27/12/2005	28/10/2005	Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Artritis Reumatoide (Rheumatoid arthritis)	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
204	EUCTR2005-002396-33-BE (EUCTR)	27/12/2005	24/11/2005	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 3	Hungary;Slovakia;Finland;Spain;Belgium;Germany;United Kingdom;Italy
205	EUCTR2005-002392-32-GB (EUCTR)	07/12/2005	15/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Slovenia;Ireland;Germany;United Kingdom;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
206	EUCTR2005-002395-15-IT (EUCTR)	02/12/2005	02/03/2006	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: METHOTREXATE100CPR 2,5MG INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE25CPR 2,5MG INN or Proposed INN: Methotrexate Trade Name: MabThera INN or Proposed INN: Rituximab	F. Hoffmann - La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;Spain;Czech Republic;Denmark;Germany;United Kingdom;Italy;Sweden
207	EUCTR2005-002396-33-IT (EUCTR)	30/11/2005	01/03/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Mabthera INN or Proposed INN: Rituximab	F. Hoffmann- La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
208	EUCTR2005-002392-32-IE (EUCTR)	23/11/2005	13/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis		F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Slovenia;Ireland;Germany;United Kingdom;Sweden
209	EUCTR2005-002392-32-SE (EUCTR)	12/10/2005	19/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500		Slovenia;Ireland;Germany;United Kingdom;Sweden
210	EUCTR2005-002392-32-SI (EUCTR)	11/10/2005	26/10/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500		Slovenia;Ireland;Germany;United Kingdom;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
211	NCT00299130 (ClinicalTrials.gov)	October 2005	3/3/2006	A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis	A Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Folate;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Placebo;Drug: Rituximab	Genentech, Inc.	Hoffmann-La Roche	Completed	18 Years	80 Years	All	511	Phase 3	United States
212	NCT00466037 (ClinicalTrials.gov)	September 2005	24/4/2007	The Effect of Rituximab on the Humoral Response to Influenza Vaccine	Vaccination Against Influenza in Rheumatoid Arthritis Patients: The Effect of Rituximab on the Humoral Response	Rheumatoid Arthritis	Biological: Influenza vaccine	Tel-Aviv Sourasky Medical Center	NULL	Terminated	18 Years	85 Years	Both	64	N/A	NULL
213	NCT00243412 (ClinicalTrials.gov)	August 2005	21/10/2005	A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate	A Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of Methotrexate	Rheumatoid Arthritis	Drug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: Placebo;Drug: Rituximab	Genentech, Inc.	NULL	Completed	18 Years	65 Years	All	42	Phase 2	United States
214	NCT00503425 (ClinicalTrials.gov)	June 30, 2005	17/7/2007	A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy.	An Open Label Study to Assess the Safety and Effect on Disease Activity of MabThera in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With DMARDs and/or One Anti-TNF Alpha Agent	Rheumatoid Arthritis	Drug: Rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	215	Phase 3	Israel
215	EUCTR2005-000674-43-GB (EUCTR)	06/04/2005	03/10/2005	AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis	AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis	Rheumatoid Arthritis		University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 4	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
216	NCT00854321 (ClinicalTrials.gov)	November 2004	2/3/2009	Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University Hospital	One Centre Follow-up Study on Safety and Efficacy	Rheumatoid Arthritis	Drug: rituximab;Drug: rituximab, observational study amon patients with active RA	Kuopio University Hospital	NULL	Completed	18 Years	N/A	Both	49	N/A	Finland
217	NCT02097745 (ClinicalTrials.gov)	June 2004	20/3/2014	A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies	An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies	Rheumatoid Arthritis	Drug: methotrexate;Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	Biogen	Completed	18 Years	80 Years	All	341	Phase 3	United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom
218	NCT00468377 (ClinicalTrials.gov)	March 2004	30/4/2007	Safety and Efficacy Study of Re-treatment With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFa Therapies	An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies	Arthritis, Rheumatoid	Drug: Rituximab	Hoffmann-La Roche	Genentech, Inc.	Active, not recruiting	18 Years	80 Years	Both	341	Phase 3	United States
219	NCT00074438 (ClinicalTrials.gov)	June 2003	12/12/2003	Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis	Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placebo	Genentech, Inc.	Roche Pharma AG	Completed	18 Years	80 Years	Both	465	Phase 2	United States
220	NCT00468546 (ClinicalTrials.gov)	May 2003	30/4/2007	A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy	A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies	Rheumatoid Arthritis	Drug: MabThera/Rituxan;Drug: Methotrexate;Other: Placebo	Hoffmann-La Roche	Biogen	Completed	18 Years	80 Years	All	520	Phase 3	United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
221	NCT02093026 (ClinicalTrials.gov)	August 2002	19/3/2014	Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)	An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic Acid	Hoffmann-La Roche	Genentech, Inc.	Completed	21 Years	N/A	All	465	Phase 2	United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom
222	NCT02693210 (ClinicalTrials.gov)	February 2001	23/2/2016	A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis	A Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Cyclophosphamide;Drug: Methotrexate;Other: Placebo Cyclophosphamide;Other: Placebo Methotrexate;Other: Placebo Rituximab;Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	21 Years	N/A	Both	161	Phase 2	Australia;Belgium;Canada;Czech Republic;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
223	EUCTR2011-002896-40-ES (EUCTR)		26/06/2012	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES	RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	United States;Taiwan;Spain;Korea, Democratic People's Republic of;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
224	EUCTR2015-002156-27-AT (EUCTR)		30/09/2015	Reduced-dose Rituximab in rheumatoid arthritis patients in remission – theREDOREM study	Prospective controlled study of reduced-dose Rituximab in rheumatoidarthritis patients in low disease activity and remission – the REDOREMstudy	rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera INN or Proposed INN: RITUXIMAB	Medical University of Vienna	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-002507-19-NL
(EUCTR)

07/09/2020

03/09/2020

Research into administration of lower dosed rituximab with an injection

Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial - RTX-SC

rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: rituximab
Trade Name: Rixathon
Product Name: rituximab

Sint Maartenskliniek

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

EUCTR2019-002810-37-PL
(EUCTR)

16/06/2020

11/03/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 100mg
INN or Proposed INN: RITUXIMAB
Trade Name: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany

EUCTR2019-002810-37-BG
(EUCTR)

15/06/2020

28/04/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany

EUCTR2019-002810-37-LT
(EUCTR)

17/04/2020

03/03/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany

NCT04268771
(ClinicalTrials.gov)

April 8, 2020

31/1/2020

A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products

A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Rheumatoid Arthritis

Biological: Experimental: Arm A: DRL_RI;Biological: Arm B: Rituxan®/Mabthera®

Dr. Reddy's Laboratories Limited

PPD

Recruiting

18 Years

N/A

All

140

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002810-37-HU
(EUCTR)

09/03/2020

20/01/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary

EUCTR2019-001754-25-NL
(EUCTR)

25/11/2019

Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment

Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch)

rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel, Benepali, Erelzi
Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: RITUXIMAB
INN or Proposed INN: ABATACEPT
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
INN or Proposed INN: SARILUMAB

Reade

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

EUCTR2018-003877-91-DE
(EUCTR)

13/06/2019

26/02/2019

B cell therapy followed by T cell therapy to achieve immune tolerance in rheumatoid arthritis with ACPA antiboidies (TOLERA): an unblinded clinical trial in one centre with random assignment to treatment groups in adult patients who failed methotrexate therapy

Sequential B cell/T cell therapy to re-induce humoral immune tolerance in ACPA-positive Rheumatoid Arthritis (TOLERA): a prospective randomized controlled open-label single-centre clinical trial in adult subjects with active ACPA-positive Rheumatoid Arthritis failing Methotrexate - TOLERA

Active rheumatoid arthritis with ACPA antibodies failing methotrexate
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

INN or Proposed INN: RITUXIMAB
Trade Name: Orencia
INN or Proposed INN: ABATACEPT

Universitätsklinikum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

EUCTR2017-004079-30-PT
(EUCTR)

09/08/2018

29/06/2018

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU

Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: Rituximab
Other descriptive name: Rituximab
Trade Name: RoActmera
Product Name: RoActmera
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB SC
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

207

Phase 3

Portugal;Belgium;Spain;Italy

EUCTR2018-002368-18-ES
(EUCTR)

25/07/2018

Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load

1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.2. breast and lung cancer undertreated by chemotherapy3. HIV4. Haematopoietic progenitor cell transplantation (TCPH).
MedDRA version: 20.0;Level: PT;Classification code 10006187;Term: Breast cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 20.0;Classification code 10058467;Term: Lung neoplasm malignant;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.1;Classification code 10020161;Term: HIV infection;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Fendrix suspension for injection
Product Name: Fendrix
Product Code: Fendrix
INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Other descriptive name: HEPATITIS B VACCINE (RDNA)
Trade Name: HBVAXPRO 5 micrograms/0.5 ml
Product Name: HBVAXPRO® 40 micrograms
Product Code: HBVAXPRO® 40 micrograms
INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)

FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

740

Phase 4

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-004079-30-ES
(EUCTR)

10/07/2018

21/03/2018

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

Rhuematoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: Rituximab
Other descriptive name: Rituximab
Trade Name: RoActmera
Product Name: RoActmera
Trade Name: Enbrel
Product Name: Enbrel

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

207

Phase 3

Portugal;Belgium;Spain;Italy

EUCTR2017-004079-30-BE
(EUCTR)

19/02/2018

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

219

Phase 3

Portugal;Spain;Belgium;Italy

EUCTR2013-005543-90-EE
(EUCTR)

07/08/2017

02/06/2017

This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 Biosimilar to Rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

EUCTR2014-005368-13-IT
(EUCTR)

10/05/2017

16/02/2018

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SAIT101 (rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB

ARCHIGEN BIOTECH LIMITED

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

EUCTR2014-005368-13-DE
(EUCTR)

22/11/2016

04/07/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Product Name: SAIT101 (proposed rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB

Archigen Biotech Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-002908-15-NL
(EUCTR)

08/11/2016

23/08/2016

REDO study: Research into the effects of lower doses rituximab in patients with rheumatoid arthritis

REDO study: RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO

Rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Sint Maartenskliniek

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 4

Netherlands

EUCTR2014-005368-13-ES
(EUCTR)

23/09/2016

15/07/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SAIT101 (rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

EUCTR2014-005368-13-HU
(EUCTR)

19/09/2016

11/07/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy

EUCTR2014-005368-13-CZ
(EUCTR)

13/09/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

EUCTR2012-002535-28-NL
(EUCTR)

13/09/2016

01/09/2016

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Rheumatoid Arthritis
MedDRA version: 19.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
Product Code: L01X CO2
Trade Name: RoActemra
Product Name: RoActemra
Product Code: L04AC07

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

144

Phase 4

Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02792699
(ClinicalTrials.gov)

May 17, 2016

25/4/2016

Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: ABP 798;Drug: Rituximab (US);Drug: Rituximab (EU)

Amgen

NULL

Completed

18 Years

80 Years

All

311

Phase 3

United States;Bulgaria;Estonia;Germany;Hungary;Poland;Canada

NCT03355872
(ClinicalTrials.gov)

February 2016

22/11/2017

A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs

Rheumatoid Arthritis

Drug: HLX01

Shanghai Henlius Biotech

NULL

Completed

18 Years

65 Years

All

194

Phase 1;Phase 2

NULL

EUCTR2012-003876-38-PL
(EUCTR)

10/11/2015

16/11/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT

Rheumatoid Arthritis
MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

EUCTR2015-000581-58-CZ
(EUCTR)

14/10/2015

16/06/2015

A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action

A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
INN or Proposed INN: tocilizumabum
Other descriptive name: TOCILIZUMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB

Revmatologicky ustav Praha

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic

EUCTR2012-003876-38-HU
(EUCTR)

28/07/2015

22/05/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

Rheumatoid Arthritis
MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-002535-28-ES
(EUCTR)

22/07/2015

10/07/2015

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Rheumatoid Arthritis
MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 4

Portugal;Belgium;Spain;Netherlands;Italy;United Kingdom

EUCTR2012-003876-38-DE
(EUCTR)

21/07/2015

29/04/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

Rheumatoid Arthritis
MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

NCT02514772
(ClinicalTrials.gov)

July 2015

30/7/2015

GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

Rheumatoid Arthritis

Biological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ®

Sandoz

Hexal AG

Completed

18 Years

N/A

All

107

Phase 3

United States;Germany;Hungary;Poland

EUCTR2010-021184-32-BG
(EUCTR)

27/05/2015

14/04/2015

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies

Refractory rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: NA
Product Code: GP2013
INN or Proposed INN: rituximab
Other descriptive name: NA
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 1;Phase 2

United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

EUCTR2010-021184-32-PL
(EUCTR)

21/04/2015

06/02/2015

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 1;Phase 2

United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-021184-32-GB
(EUCTR)

25/03/2015

12/06/2015

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Refractory rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 1;Phase 2

United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

NCT02304354
(ClinicalTrials.gov)

March 9, 2015

4/11/2014

Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)

Rheumatoid Arthritis

Drug: Rituximab

University Hospital, Tours

NULL

Active, not recruiting

18 Years

N/A

All

Phase 3

France

EUCTR2014-003255-54-CZ
(EUCTR)

21/01/2015

24/10/2014

A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid Arthritis

A Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients

Rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: RGB-03
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB

Gedeon Richter Plc

NULL

Not Recruiting

Female: yes
Male: yes

142

Phase 1;Phase 3

Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany

EUCTR2012-002535-28-IT
(EUCTR)

16/01/2015

04/11/2014

Not applicable

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Rheumatoid Arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Portugal;Belgium;United Kingdom;Italy

EUCTR2010-021184-32-HU
(EUCTR)

09/01/2015

27/10/2014

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Refractory rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 1;Phase 2

United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-005543-90-BG
(EUCTR)

06/01/2015

22/10/2014

This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 - Biosimilar to rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

NCT02371096
(ClinicalTrials.gov)

January 2015

5/2/2015

Comparative Pharmacokinetic Trial of RGB-03 and MabThera

Rheumatoid Arthritis

Drug: MabThera (rituximab);Drug: RGB-03

Gedeon Richter Plc.

NULL

Not yet recruiting

18 Years

75 Years

Both

Phase 1

NULL

EUCTR2014-003529-16-GB
(EUCTR)

16/12/2014

22/06/2015

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

Stratification of Biologic Therapies for RA by Pathobiology (STRAP): A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP

Trade Name: MabThera
Product Name: MabThera
Trade Name: RoActmera
Product Name: RoActmera
Trade Name: Enbrel
Product Name: Enbrel

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

219

Phase 3

United Kingdom

EUCTR2013-005543-90-DE
(EUCTR)

19/11/2014

16/06/2014

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Product Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: RITUXIMAB
Other descriptive name: ABP 798 - Biosimilar to rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

EUCTR2014-000859-91-FR
(EUCTR)

03/10/2014

18/06/2015

Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde.

Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde. - LYRITUX

Cette étude portera donc sur une population de patients atteints de polyarthrite rhumatoïde (PR) actives et ayant présenté un échec ou une contre-indication à au moins un anti-TNFa, et n’ayant jamais reçu de rituximab.
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MABTHERA
INN or Proposed INN: RITUXIMAB

CHRU de TOURS

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-004555-21-GR
(EUCTR)

22/09/2014

21/03/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina

EUCTR2013-005543-90-PL
(EUCTR)

09/09/2014

11/07/2014

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

EUCTR2013-005543-90-HU
(EUCTR)

26/08/2014

13/05/2014

This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany

EUCTR2013-002622-23-NL
(EUCTR)

24/06/2014

17/02/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: Bi 695500
INN or Proposed INN: Rituximab

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

EUCTR2012-002535-28-PT
(EUCTR)

06/06/2014

25/02/2014

Not applicable

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 4

Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-002535-28-BE
(EUCTR)

28/04/2014

28/03/2014

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 4

Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom

EUCTR2013-004555-21-SK
(EUCTR)

07/04/2014

23/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina

EUCTR2013-004555-21-AT
(EUCTR)

07/04/2014

02/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of

EUCTR2013-004555-21-HU
(EUCTR)

02/04/2014

23/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 18.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Korea, Republic of;Bosnia and Herzegovina;Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Latvia;Germany

EUCTR2013-004555-21-DE
(EUCTR)

31/03/2014

17/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

CELLTRION, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-004555-21-PT
(EUCTR)

24/03/2014

07/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina

EUCTR2012-003194-25-HR
(EUCTR)

17/03/2014

03/09/2014

Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Mabion S.A.

NULL

Not Recruiting

Female: yes
Male: yes

863

Phase 3

Serbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia

EUCTR2013-004555-21-LV
(EUCTR)

03/03/2014

02/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Korea, Republic of;Bosnia and Herzegovina

EUCTR2012-003223-38-DE
(EUCTR)

01/07/2013

08/04/2013

Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04

RHEUMATOID ARTHRITIS
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Rituximab-Pfizer
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

157

Phase 2

United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

EUCTR2012-003223-38-GB
(EUCTR)

14/05/2013

12/02/2013

Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04

RHEUMATOID ARTHRITIS
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

157

Phase 2

United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01873443
(ClinicalTrials.gov)

May 2013

22/5/2013

Long-Term Efficacy and Safety of CT-P10 in Patients With RA

An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1

Rheumatoid Arthritis

Drug: Rituximab, MTX, folic acid

Celltrion

NULL

Completed

18 Years

75 Years

Both

Phase 1

Korea, Republic of

NCT02468791
(ClinicalTrials.gov)

May 2013

9/6/2015

MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab

Mabion SA

NULL

Completed

18 Years

80 Years

All

709

Phase 3

Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine

EUCTR2011-002894-48-NO
(EUCTR)

11/04/2013

06/09/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden

EUCTR2011-002896-40-PL
(EUCTR)

29/03/2013

11/02/2013

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01

RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

EUCTR2012-003223-38-ES
(EUCTR)

27/02/2013

04/03/2013

Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

157

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-002894-48-BG
(EUCTR)

06/02/2013

20/11/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden

EUCTR2012-003194-25-LT
(EUCTR)

04/02/2013

24/09/2012

Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MabionCD20
INN or Proposed INN: Rituximab
Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB

Mabion S.A.

NULL

Not Recruiting

Female: yes
Male: yes

863

Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia

EUCTR2011-002894-48-DE
(EUCTR)

25/01/2013

24/07/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

EUCTR2012-002535-28-GB
(EUCTR)

21/01/2013

14/12/2012

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Trade Name: MabThera
Product Name: MabThera
Trade Name: RoActemra
Product Name: RoActemra

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 4

Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom

EUCTR2011-002894-48-ES
(EUCTR)

18/01/2013

29/10/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Product Code: BI 695500
INN or Proposed INN: Not applicable
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01759030
(ClinicalTrials.gov)

December 2012

20/12/2012

Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis

Double Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor Therapies

Rheumatoid Arthritis

Drug: Rituximab

Biocad

NULL

Completed

18 Years

80 Years

All

181

Phase 3

Belarus;India;Russian Federation;Ukraine;Colombia

EUCTR2011-002894-48-GR
(EUCTR)

16/11/2012

19/10/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden

EUCTR2011-002894-48-PT
(EUCTR)

09/11/2012

09/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695500
INN or Proposed INN: No Active Name Specified
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden

EUCTR2011-002896-40-DE
(EUCTR)

23/10/2012

02/07/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 16.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US

NULL

Not Recruiting

Female: yes
Male: yes

195

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

EUCTR2011-002894-48-HU
(EUCTR)

16/10/2012

16/08/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-002894-48-EE
(EUCTR)

08/10/2012

08/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

EUCTR2011-002894-48-GB
(EUCTR)

14/09/2012

06/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

EUCTR2011-002894-48-NL
(EUCTR)

10/09/2012

14/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

NCT01682512
(ClinicalTrials.gov)

September 5, 2012

10/8/2012

Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis

Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial.

Arthritis, Rheumatoid

Drug: BI 695500;Drug: Rituxan®;Drug: MabThera®

Boehringer Ingelheim

NULL

Terminated

18 Years

80 Years

All

294

Phase 3

United States;Argentina;Belgium;Bulgaria;Canada;Chile;Germany;Greece;Hungary;Ireland;Mexico;Netherlands;Poland;Portugal;Spain;Ukraine;United Kingdom;Brazil;Estonia;France;Guatemala;Italy;New Zealand;Norway;Peru;Russian Federation;Serbia;South Africa;Sweden

NCT01643928
(ClinicalTrials.gov)

August 16, 2012

6/7/2012

Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS

Rheumatoid Arthritis

Biological: Rituximab-Pfizer (PF-05280586) x 3 courses;Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses;Biological: Rituximab-US + Rituximab-Pfizer x 2 Courses

Pfizer

NULL

Completed

18 Years

N/A

All

185

N/A

United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Switzerland;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-002896-40-GB
(EUCTR)

14/08/2012

11/06/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

195

Phase 2

United States;Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Israel;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

EUCTR2011-002894-48-BE
(EUCTR)

02/08/2012

18/07/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

Phase 1;Phase 3

EUCTR2011-005021-48-NL
(EUCTR)

07/06/2012

05/06/2012

A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)

A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO

adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland

EUCTR2011-005021-48-CZ
(EUCTR)

23/05/2012

15/02/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands

EUCTR2011-005021-48-ES
(EUCTR)

14/05/2012

21/02/2012

A study to investigate and compare the efficacy, safety, tolerability andpharmacodynamic (biochemical and physiological effects of the drug) ofTL011 and MabThera® (rituximab) in patients with severe, activerheumatoid arthritis treated with methotrexate (MTX)

A multicenter, double-blind, randomized, active controlled, parallelgroupstudy to evaluate the efficacy, safety, tolerability andpharmacodynamic profiles of TL011 infusions compared with MabThera®(rituximab) in subjects with severe, active rheumatoid arthritis treatedwith methotrexate (MTX) - ALTO

Sujetos adultos con artritis reumatoide (AR) activa de grado severo tratados con MTX
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg Concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-000139-21-AT
(EUCTR)

14/05/2012

23/04/2012

Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action

A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Other descriptive name: TOCILIZUMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Other descriptive name: TOCILIZUMAB

Medizinische Universität Wien, Universitätsklinik für Innere Medizin III

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic;Slovakia;Austria;Russian Federation;Switzerland

EUCTR2011-005021-48-BG
(EUCTR)

09/05/2012

20/04/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands

EUCTR2011-005021-48-HU
(EUCTR)

04/05/2012

15/02/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland

EUCTR2011-005021-48-PL
(EUCTR)

10/04/2012

14/03/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of

EUCTR2011-004171-36-ES
(EUCTR)

30/03/2012

30/01/2012

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: SAIT101
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Trade Name: MabThera®
Product Name: MabThera®
INN or Proposed INN: RITUXIMAB

Samsung Electronics Co. Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

616

Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-004171-36-PL
(EUCTR)

29/03/2012

22/02/2012

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

EUCTR2010-021184-32-EE
(EUCTR)

23/03/2012

08/03/2012

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

164

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Germany

NCT01526057
(ClinicalTrials.gov)

March 20, 2012

1/2/2012

A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)

Rheumatoid Arthritis

Biological: PF-05280586;Biological: MabThera;Biological: Rituxan

Pfizer

NULL

Completed

18 Years

N/A

All

220

Phase 2

United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Taiwan

EUCTR2011-006001-10-IT
(EUCTR)

19/03/2012

14/03/2012

Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response

Rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MABTHERA*EV 1FL 50ML 500MG
INN or Proposed INN: RITUXIMAB
Other descriptive name: NA
Trade Name: MABTHERA*EV 1FL 50ML 500MG
INN or Proposed INN: RITUXIMAB
Other descriptive name: NA

A.O. UNIVERSITARIA INTEGRATA DI VERONA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

EUCTR2011-004171-36-GB
(EUCTR)

24/02/2012

15/12/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-004171-36-HU
(EUCTR)

23/02/2012

16/12/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

EUCTR2011-004171-36-CZ
(EUCTR)

15/02/2012

30/11/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Samsung Electronics Co. Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

NCT01534884
(ClinicalTrials.gov)

February 2012

8/2/2012

Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: rituximab

Celltrion

NULL

Completed

18 Years

75 Years

Both

154

Phase 1

Korea, Republic of

NCT01613027
(ClinicalTrials.gov)

February 2012

25/5/2012

An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis

A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)

Rheumatoid Arthritis

Biological: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

135

N/A

Greece

NCT01592292
(ClinicalTrials.gov)

November 2011

11/4/2012

An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent

Rheumatoid Arthritis

Drug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: Infliximab

Hoffmann-La Roche

NULL

Completed

20 Years

N/A

All

N/A

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01641952
(ClinicalTrials.gov)

October 2011

13/7/2012

An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

505

N/A

Romania

EUCTR2010-021184-32-IT
(EUCTR)

03/08/2011

02/02/2011

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Refractory rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

164

Phase 2

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany

NCT01295151
(ClinicalTrials.gov)

August 2011

11/2/2011

SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.

Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug

Rheumatoid Arthritis

Drug: Etanercept;Drug: Abatacept;Biological: Rituximab;Drug: Adalimumab;Drug: Certolizumab Pegol;Drug: Infliximab;Drug: Golimumab

Julia Brown

NULL

Completed

18 Years

N/A

Both

122

Phase 4

United Kingdom

NCT01382940
(ClinicalTrials.gov)

July 26, 2011

24/6/2011

A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis

A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: rituximab;Drug: methotrexate;Drug: methylprednisolone;Drug: acetaminophen;Drug: antihistamine

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

351

Phase 4

United States

100

NCT01390441
(ClinicalTrials.gov)

July 2011

7/7/2011

A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)

A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Biological: MK-8808;Biological: MabThera® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Loratadine

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

65 Years

All

100

Phase 1

Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

101

EUCTR2010-021184-32-BE
(EUCTR)

08/06/2011

14/04/2011

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the US
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

164

Phase 2

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

102

EUCTR2010-023880-17-GB
(EUCTR)

31/03/2011

25/02/2011

SWITCH Clinical Trial for Patients with Rheumatoid Arthritis who have failed an initial TNF-blocking drug

SWITCH: Randomised-controlled trial of switching to alternative tumour-necrosis factor (TNF)-blocking drugs or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-blocking drug. - SWITCH

Rheumatoid arthritis in patients who have failed to respond to an initial TNF-blocking drug
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

477

Phase 4

United Kingdom

103

NCT01332994
(ClinicalTrials.gov)

March 2011

18/3/2011

A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis

Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI)

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

519

Phase 3

Germany

104

EUCTR2010-020499-50-GB
(EUCTR)

07/02/2011

31/12/2010

Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.

rheumatoid arthritis
MedDRA version: 13;Level: PT;Classification code 10039073;Term: rheumatoid arthritis

Trade Name: MabThera
Product Name: rituximab

South Tees Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

105

NCT01765374
(ClinicalTrials.gov)

February 2011

12/5/2011

Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

Rheumatoid Arthritis

Device: ESAOTE MyLab60;Drug: Rituximab

University Hospital, Rouen

NULL

Completed

18 Years

N/A

Both

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

EUCTR2010-022049-88-DE
(EUCTR)

05/01/2011

11/11/2010

Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI

Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: RoActemra 20 mg/ml Concentrate for solution for infusion
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
Trade Name: Mabthera 500 mg Concentrate for solution for infusion
Product Name: Rituximab
Product Code: RO045-2294
INN or Proposed INN: RITUXIMAB

Roche Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany

107

NCT01274182
(ClinicalTrials.gov)

January 2011

10/1/2011

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.

Rheumatoid Arthritis

Biological: GP2013;Biological: MabThera;Biological: Rituxan

Sandoz

Novartis Pharmaceuticals

Completed

18 Years

N/A

All

312

Phase 1;Phase 2

United States;Argentina;Austria;Belgium;Brazil;Estonia;France;Germany;Hungary;India;Italy;Romania;Spain;Turkey

108

EUCTR2010-021184-32-DE
(EUCTR)

30/11/2010

30/08/2010

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Refractory rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

164

Phase 2

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

109

EUCTR2010-021184-32-AT
(EUCTR)

11/11/2010

19/10/2010

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Refractory rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

288

Phase 2

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

110

EUCTR2010-021184-32-FR
(EUCTR)

28/10/2010

13/09/2010

Refractory rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

164

Phase 2

France;Hungary;Estonia;Poland;Belgium;Spain;Austria;Bulgaria;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

NCT01244958
(ClinicalTrials.gov)

August 2010

28/9/2010

Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis

Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis - a Multicenter Randomised Double-blind Clinical Trial

Rheumatoid Arthritis

Biological: Rituximab;Drug: Placebo

Frank Behrens

NULL

Completed

18 Years

75 Years

Both

156

Phase 3

Germany

112

NCT01593332
(ClinicalTrials.gov)

July 2010

7/1/2012

Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis

DMARD Resistant Rheumatoid Arthritis

Drug: Rituximab

Mashhad University of Medical Sciences

Roche Pharma AG

Completed

19 Years

75 Years

Both

Phase 4

Iran, Islamic Republic of

113

EUCTR2009-015950-39-DE
(EUCTR)

12/05/2010

28/12/2009

Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritis

Addition of Rituximab to Leflunomide in patients with active rheumatoid arthritis - AMARA

Active rheumatoid arthritis (RA) Patients who have had an inadequate response to disease modifying anti-rheumatic drugs (not more than 3 DMARDs including leflunomide, not more than one anti-TNF failure) and currently have active disease despite at least 3-month treatment with leflunomide. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera®
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB

Johann Wolfgang Goethe-Universität Frankfurt/M.

NULL

Not Recruiting

Female: yes
Male: yes

Germany

114

NCT01117129
(ClinicalTrials.gov)

April 2010

4/5/2010

A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)

Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: placebo;Drug: methotrexate;Drug: rituximab [Mabthera/Rituxan]

Hoffmann-La Roche

NULL

Terminated

18 Years

75 Years

Both

Phase 4

Spain

115

NCT01021735
(ClinicalTrials.gov)

April 2010

27/11/2009

Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy

Rheumatoid Arthritis

Drug: etanercept or adalimumab;Drug: Rituximab

University of Glasgow

Arthritis Research Campaign;NHS Lothian;NHS Grampian;NHS Tayside;NHS Borders;NHS Fife

Completed

18 Years

N/A

Both

302

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

116

EUCTR2009-016789-10-NL
(EUCTR)

19/02/2010

17/11/2009

Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab

To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy

Trade Name: Focetria
Trade Name: Pandemrix,

Div KIR AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

117

NCT01071798
(ClinicalTrials.gov)

January 2010

18/2/2010

An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis

A Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine Care

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1653

N/A

Germany;United States

118

NCT02731560
(ClinicalTrials.gov)

January 2010

6/3/2016

Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)

Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Rituximab

Prof. Abid Z. Farooqi

Aga Khan University;Fatima Memorial Hospital;Fauji Foundation Hospital, Rawalpindi

Completed

18 Years

80 Years

Both

Phase 4

NULL

119

EUCTR2009-011268-13-GB
(EUCTR)

31/12/2009

15/03/2010

Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study

Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera
Product Name: Rituximab
Trade Name: Enbrel
Product Name: Etanercept
Trade Name: Humira
Product Name: Adalimumab

NHS Greater Glasgow and Clyde

University of Glasgow

Not Recruiting

Female: yes
Male: yes

United Kingdom

120

NCT01000441
(ClinicalTrials.gov)

December 2009

22/10/2009

Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: infliximab, etanercept, adalimumab;Drug: abatacept, rituximab or tocilizumab

University Hospital, Strasbourg, France

NULL

Recruiting

18 Years

N/A

Both

300

Phase 4

France;Monaco

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

121

NCT00844714
(ClinicalTrials.gov)

November 2009

12/2/2009

Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy

Endothelial Function;Rheumatoid Arthritis;Inflammation

Drug: Rituxan

University of California, San Francisco

Genentech, Inc.

Completed

18 Years

N/A

All

N/A

United States

122

EUCTR2008-005450-20-BE
(EUCTR)

29/10/2009

01/10/2009

The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)

Rheumatoid arthritis
MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade (infliximab)
INN or Proposed INN: INFLIXIMAB
Other descriptive name: remicade
Trade Name: Humira (adalimumab)
INN or Proposed INN: ADALIMUMAB
Trade Name: Enbrel (etanercept)
INN or Proposed INN: ETANERCEPT
Other descriptive name: Enbrel
Trade Name: Mabthera (rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: Mabthera
Trade Name: Orencia (abatacept)
INN or Proposed INN: ABATACEPT
Other descriptive name: Orencia

Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

261

Belgium

123

NCT01075477
(ClinicalTrials.gov)

September 2009

24/2/2010

An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)

Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines

Rheumatoid Arthritis

Drug: rituximab [Mabthera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

151

N/A

Finland;United States

124

EUCTR2008-005525-11-GR
(EUCTR)

20/07/2009

17/11/2009

A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Greece;Spain;Netherlands;Germany;United Kingdom

125

EUCTR2009-010955-29-NL
(EUCTR)

13/07/2009

27/02/2009

Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.

Pre-clinical RA patients with a high risk on developing the disease.

Trade Name: MabThera 500 mg (10mg/ml)
INN or Proposed INN: Rituximab

Division of Clinically Immunology and Rheumatology, AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

126

EUCTR2008-002381-55-ES
(EUCTR)

16/06/2009

01/08/2008

Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.

Pacientes con artritis reumatoide (AR) activa refractarios a uno o más fármacos antiTNF (definido por un DAS28>3,2).
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MABTHERA 500 mg concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB

ROCHE FARMA, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Spain

127

EUCTR2008-005525-11-DE
(EUCTR)

24/04/2009

09/12/2008

A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

128

EUCTR2008-005525-11-NL
(EUCTR)

31/03/2009

12/12/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

France;Spain;Germany;Netherlands;United Kingdom

129

NCT00845832
(ClinicalTrials.gov)

March 2009

17/2/2009

A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate

A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate

Rheumatoid Arthritis

Drug: Placebo;Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Terminated

18 Years

65 Years

All

Phase 2

France;Germany;Greece;Netherlands;Poland;Spain;Switzerland;United Kingdom;Belgium;Sweden

130

EUCTR2008-005525-11-FR
(EUCTR)

06/02/2009

13/03/2009

A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera
Product Code: RO452294/V02
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533/F01
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

EUCTR2008-005525-11-ES
(EUCTR)

29/01/2009

09/12/2008

Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Artritis reumatoideRheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MABTHERA 500 mg concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

132

EUCTR2008-005525-11-GB
(EUCTR)

29/12/2008

16/12/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Greece;Spain;Netherlands;Germany;United Kingdom

133

EUCTR2007-001585-33-DE
(EUCTR)

19/08/2008

14/04/2008

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Netherlands;Latvia;Germany

134

NCT00147966
(ClinicalTrials.gov)

June 2008

2/9/2005

Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)

Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial Biopsies

Rheumatoid Arthritis

Drug: rituximab

University of California, San Diego

Genentech, Inc.

Completed

18 Years

75 Years

All

Phase 2

United States

135

EUCTR2007-003647-75-FR
(EUCTR)

01/04/2008

07/02/2008

A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Netherlands;France;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

136

NCT02622503
(ClinicalTrials.gov)

April 2008

2/12/2015

A Study on Rheumatoid Arthritis Patients Treated With Rituximab

Retrospective Data Collection on Rheumatoid Arthritis (RA) Patients Treated With Rituximab in Finland.

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

N/A

Both

N/A

Finland

137

NCT01000610
(ClinicalTrials.gov)

March 17, 2008

21/10/2009

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Tunisia

138

EUCTR2007-003623-20-ES
(EUCTR)

12/03/2008

04/02/2008

Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).

Se estudiaran los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB

Dr. Juan D. Cañete Crespillo, Hospital Clínic de Barcelona

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

139

NCT00664521
(ClinicalTrials.gov)

March 2008

21/4/2008

Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)

A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.

Rheumatoid Arthritis

Biological: Rituximab;Drug: Atacicept;Drug: Placebo matched to atacicept

Merck KGaA

NULL

Completed

18 Years

N/A

All

Phase 2

France;Netherlands;Sweden;United Kingdom;Finland

140

EUCTR2007-001585-33-GR
(EUCTR)

26/02/2008

09/08/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman- La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

141

EUCTR2007-003647-75-GB
(EUCTR)

15/02/2008

10/12/2007

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Finland;Netherlands;United Kingdom;Sweden

142

EUCTR2007-003647-75-NL
(EUCTR)

07/02/2008

29/11/2007

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Sweden;France;Finland;United Kingdom;Netherlands

143

EUCTR2007-003647-75-SE
(EUCTR)

06/02/2008

04/12/2007

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: MabThera 500 mg (10 mg/ml) concentrate for solution for infusion
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Netherlands;France;Sweden

144

EUCTR2007-003647-75-FI
(EUCTR)

31/01/2008

19/12/2007

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Netherlands;France;Sweden

145

NCT00963703
(ClinicalTrials.gov)

December 2007

20/8/2009

Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes

Rheumatoid Arthritis

Drug: Rituximab

University of Manitoba

Hoffmann-La Roche

Completed

18 Years

N/A

Both

N/A

Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

NCT00580229
(ClinicalTrials.gov)

December 2007

18/12/2007

A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: prednisone

University of South Florida

NULL

Completed

18 Years

80 Years

All

Phase 2;Phase 3

United States

147

NCT00576433
(ClinicalTrials.gov)

December 2007

18/12/2007

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor

Rheumatoid Arthritis

Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

Both

Phase 4

Russian Federation

148

EUCTR2007-001585-33-ES
(EUCTR)

15/11/2007

13/09/2007

Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE

Artritis reumatoide (AR)Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

149

EUCTR2007-001585-33-LT
(EUCTR)

13/11/2007

05/07/2007

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE

Rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

150

NCT00578305
(ClinicalTrials.gov)

November 2007

19/12/2007

A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Biological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folate

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

185

Phase 3

Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

151

EUCTR2007-001585-33-DK
(EUCTR)

26/10/2007

12/07/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

152

NCT00502853
(ClinicalTrials.gov)

October 25, 2007

17/7/2007

A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.

Pilot Study to Evaluate the Effect of Mabthera in Combination With MTX in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

All

Phase 4

Italy

153

EUCTR2007-001585-33-EE
(EUCTR)

10/10/2007

18/07/2007

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

154

EUCTR2007-001585-33-FR
(EUCTR)

09/10/2007

23/07/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Germany;Netherlands;Denmark;Estonia;France;Spain;Greece;Latvia;Lithuania

155

NCT00934648
(ClinicalTrials.gov)

October 2007

6/7/2009

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Morocco

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

156

NCT02699892
(ClinicalTrials.gov)

October 2007

25/2/2016

Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis

Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

130

N/A

Serbia

157

EUCTR2007-001585-33-NL
(EUCTR)

20/09/2007

09/08/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Latvia;Netherlands

158

EUCTR2006-005640-81-GB
(EUCTR)

04/09/2007

27/07/2007

A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA

Rheumatoid arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United Kingdom

159

EUCTR2007-001585-33-CZ
(EUCTR)

22/08/2007

04/09/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

France;Estonia;Czech Republic;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

160

EUCTR2007-001754-11-IT
(EUCTR)

03/08/2007

02/07/2007

Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Mabthera
INN or Proposed INN: Rituximab

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

EUCTR2007-001585-33-LV
(EUCTR)

26/07/2007

30/07/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

162

NCT00502840
(ClinicalTrials.gov)

July 23, 2007

17/7/2007

A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

All

193

Phase 3

Germany

163

NCT00504777
(ClinicalTrials.gov)

July 2007

19/7/2007

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Taiwan

164

EUCTR2006-006746-33-DE
(EUCTR)

28/06/2007

12/03/2007

Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR

Rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

Roche Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

240

Germany

165

NCT00462345
(ClinicalTrials.gov)

June 2007

18/4/2007

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies

Rheumatoid Arthritis

Drug: rituximab;Drug: Methotrexate;Drug: Corticosteroid or NSAID;Dietary Supplement: Folate

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

Phase 4

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

NCT00578565
(ClinicalTrials.gov)

May 2007

19/12/2007

Rituximab in Rheumatoid Arthritis Lung Disease

Rituximab for the Treatment of Rheumatoid Arthritis-Associated Interstitial Pneumonia: A Pilot Study

Rheumatoid Arthritis;Interstitial Pneumonia

Drug: Rituximab

Eric Matteson

Genentech, Inc.;National Center for Research Resources (NCRR)

Completed

18 Years

80 Years

All

Phase 3

United States

167

NCT00425932
(ClinicalTrials.gov)

February 2007

22/1/2007

Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis

Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Rituximab

Gaylis, Norman B., M.D.

Oklahoma Medical Research Foundation;Genentech, Inc.

Completed

18 Years

80 Years

Both

Phase 2

United States

168

NCT00443651
(ClinicalTrials.gov)

January 2007

2/3/2007

A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis

An Open-Label, Prospective Study of the Safety of Rituximab in Combination With Other Disease-Modifying Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab;Drug: Anti-inflammatory drugs

Genentech, Inc.

Biogen

Completed

18 Years

80 Years

All

578

Phase 3

United States

169

NCT00424502
(ClinicalTrials.gov)

January 2007

18/1/2007

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Hungary

170

EUCTR2006-005386-19-BE
(EUCTR)

19/12/2006

03/11/2006

Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini

Rheumatoid arthritis refractory to TNF blockers patients
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera

Cliniques Universitaires Saint-Luc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

171

EUCTR2005-003632-22-ES
(EUCTR)

22/11/2006

20/03/2012

A study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with rheumatoid arthritis.

An open-label, exploratory study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with active rheumatoid arthritis

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

172

NCT02079532
(ClinicalTrials.gov)

November 2006

4/3/2014

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent

Rheumatoid Arthritis

Drug: rituximab [MabThera]

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

All

302

Phase 3

Germany

173

NCT00396812
(ClinicalTrials.gov)

November 2006

6/11/2006

Rituximab for the Treatment of Early Rheumatoid Arthritis (RA)

An Open Label, Single Arm, Single Center, Phase I/II Trial of Rituximab (a Monoclonal Antibody to CD20) for the Treatment of Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab

National Institute of Allergy and Infectious Diseases (NIAID)

Autoimmunity Centers of Excellence

Terminated

18 Years

N/A

All

Phase 1;Phase 2

United States

174

EUCTR2006-004673-98-HU
(EUCTR)

16/10/2006

08/09/2006

Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker

To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.

Trade Name: MabThera 500 mg concentrate for solution for infusion

Roche (Hungary) Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary

175

EUCTR2005-002396-33-HU
(EUCTR)

26/09/2006

07/07/2006

A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

176

EUCTR2006-001000-37-DE
(EUCTR)

19/09/2006

16/06/2006

Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST

Rheumatoid arthritis
MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

Roche Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

300

Germany

177

EUCTR2005-002396-33-SK
(EUCTR)

14/09/2006

15/06/2006

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Finland;United Kingdom;Germany;Slovakia;Spain;Italy

178

NCT01126541
(ClinicalTrials.gov)

September 2006

18/5/2010

SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy

A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)

Rheumatoid Arthritis

Drug: rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

224

Phase 3

France

179

NCT02006706
(ClinicalTrials.gov)

August 10, 2006

5/12/2013

A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

Phase 3

Serbia

180

NCT01272908
(ClinicalTrials.gov)

July 18, 2006

7/1/2011

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)

Rheumatoid Arthritis

Drug: rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

120

Phase 3

Canada;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

181

NCT00555542
(ClinicalTrials.gov)

July 2006

7/11/2007

An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis

B Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell Subsets

Rheumatoid Arthritis

Drug: rituximab

Chinese University of Hong Kong

NULL

Completed

21 Years

70 Years

Both

Phase 2

China

182

EUCTR2006-000854-32-AT
(EUCTR)

29/05/2006

19/05/2006

Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers

Rheumatoid Arthritis

Trade Name: Rituximab - MabThera
Product Name: Rituximab MabThera
Product Code: no

Vienna Medical University

NULL

Not Recruiting

Female: yes
Male: yes

Austria

183

NCT00298272
(ClinicalTrials.gov)

May 2006

1/3/2006

Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis

A Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Tolerability and Safety of Rituximab When Given in Combination With Methotrexate and Etanercept (Enbrel) or Methotrexate and Adalimumab (Humira) in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: IDEC-C2B8 (rituximab);Drug: Placebo;Drug: Methotrexate;Drug: Etanercept;Drug: Adalimumab;Drug: Methylprednisolone;Dietary Supplement: Folate

Biogen

Hoffmann-La Roche;Genentech, Inc.

Terminated

18 Years

65 Years

All

Phase 2

United States

184

EUCTR2005-002395-15-DE
(EUCTR)

27/04/2006

22/11/2005

A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.

Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

185

EUCTR2005-002396-33-DE
(EUCTR)

27/04/2006

10/11/2005

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

186

EUCTR2005-002392-32-DE
(EUCTR)

20/04/2006

29/09/2005

A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.

Active rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Slovenia;Ireland;Germany;United Kingdom;Sweden

187

EUCTR2005-002396-33-GB
(EUCTR)

28/03/2006

11/05/2006

Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 3

Hungary;Slovakia;Finland;Belgium;Spain;Germany;Italy;United Kingdom

188

EUCTR2005-004582-41-GB
(EUCTR)

24/03/2006

27/01/2006

Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA

Active Rheumatoid Arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

189

EUCTR2005-002396-33-FI
(EUCTR)

06/03/2006

22/12/2005

Rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
Product Name: Methotrexate
Product Code: Methotrexate

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

United Kingdom;Germany;Spain;Italy;Hungary;Finland;Slovakia

190

EUCTR2005-002395-15-CZ
(EUCTR)

27/02/2006

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

191

EUCTR2005-002395-15-SE
(EUCTR)

13/02/2006

12/12/2005

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

192

NCT00422383
(ClinicalTrials.gov)

February 2006

15/1/2007

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

378

Phase 3

Australia;Belgium;Brazil;Canada;China;Finland;France;Germany;Hungary;Italy;Netherlands;New Zealand;Slovakia;South Africa;Spain;Taiwan;Thailand;United Kingdom;Switzerland;United States

193

NCT00502996
(ClinicalTrials.gov)

February 2006

17/7/2007

A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)

Rheumatoid Arthritis

Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

246

Phase 3

Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela

194

NCT00282308
(ClinicalTrials.gov)

January 23, 2006

24/1/2006

A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

A Phase II, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

Rheumatoid Arthritis

Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisone;Biological: C. albicans;Biological: Tetanus toxoid adsorbed booster vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: Keyhole limpet hemocyanin

Genentech, Inc.

NULL

Completed

18 Years

65 Years

All

103

Phase 2

United States

195

EUCTR2005-002395-15-GB
(EUCTR)

20/01/2006

25/04/2006

Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Phase 3

Czech Republic;Finland;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

196

EUCTR2005-002395-15-FI
(EUCTR)

09/01/2006

26/10/2005

Rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
Product Name: Methotrexate
Product Code: Methotrexate
INN or Proposed INN: methotrexate

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

197

EUCTR2005-002395-15-DK
(EUCTR)

06/01/2006

19/06/2007

Rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Phase 3

Czech Republic;Finland;Belgium;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

198

NCT00299104
(ClinicalTrials.gov)

January 2006

2/3/2006

A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: placebo;Drug: rituximab

Genentech, Inc.

Hoffmann-La Roche

Completed

18 Years

80 Years

All

755

Phase 3

United States

199

NCT00266227
(ClinicalTrials.gov)

January 2006

14/12/2005

A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment With Rituximab in Subjects With Rheumatoid Arthritis Receiving Background Methotrexate

Rheumatoid Arthritis

Drug: placebo;Drug: rituximab;Drug: methotrexate;Drug: folate

Genentech, Inc.

NULL

Completed

18 Years

80 Years

All

559

Phase 3

United States

200

NCT00422942
(ClinicalTrials.gov)

January 2006

15/1/2007

A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)

An Open-label, Exploratory Study of the Pharmacokinetic and Pharmacodynamic Activity of MabThera in Combination With Methotrexate in Synovial Tissue and in Peripheral Blood of Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Terminated

18 Years

80 Years

All

Phase 2

Netherlands;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

201

EUCTR2005-002395-15-BE
(EUCTR)

29/12/2005

24/11/2005

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy;Sweden

202

EUCTR2005-002395-15-ES
(EUCTR)

29/12/2005

31/10/2005

Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”

Artritis reumatoide / Rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

203

EUCTR2005-002396-33-ES
(EUCTR)

27/12/2005

28/10/2005

Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.

Artritis Reumatoide (Rheumatoid arthritis)

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

204

EUCTR2005-002396-33-BE
(EUCTR)

27/12/2005

24/11/2005

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 3

Hungary;Slovakia;Finland;Spain;Belgium;Germany;United Kingdom;Italy

205

EUCTR2005-002392-32-GB
(EUCTR)

07/12/2005

15/09/2005

Active rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Slovenia;Ireland;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

206

EUCTR2005-002395-15-IT
(EUCTR)

02/12/2005

02/03/2006

Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: METHOTREXATE*100CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*25CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: MabThera
INN or Proposed INN: Rituximab

F. Hoffmann - La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;Spain;Czech Republic;Denmark;Germany;United Kingdom;Italy;Sweden

207

EUCTR2005-002396-33-IT
(EUCTR)

30/11/2005

01/03/2006

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Mabthera
INN or Proposed INN: Rituximab

F. Hoffmann- La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

208

EUCTR2005-002392-32-IE
(EUCTR)

23/11/2005

13/09/2005

Active rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Slovenia;Ireland;Germany;United Kingdom;Sweden

209

EUCTR2005-002392-32-SE
(EUCTR)

12/10/2005

19/09/2005

Active rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Slovenia;Ireland;Germany;United Kingdom;Sweden

210

EUCTR2005-002392-32-SI
(EUCTR)

11/10/2005

26/10/2005

Active rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Slovenia;Ireland;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

211

NCT00299130
(ClinicalTrials.gov)

October 2005

3/3/2006

A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis

A Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Folate;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Placebo;Drug: Rituximab

Genentech, Inc.

Hoffmann-La Roche

Completed

18 Years

80 Years

All

511

Phase 3

United States

212

NCT00466037
(ClinicalTrials.gov)

September 2005

24/4/2007

The Effect of Rituximab on the Humoral Response to Influenza Vaccine

Vaccination Against Influenza in Rheumatoid Arthritis Patients: The Effect of Rituximab on the Humoral Response

Rheumatoid Arthritis

Biological: Influenza vaccine

Tel-Aviv Sourasky Medical Center

NULL

Terminated

18 Years

85 Years

Both

N/A

NULL

213

NCT00243412
(ClinicalTrials.gov)

August 2005

21/10/2005

A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate

A Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of Methotrexate

Rheumatoid Arthritis

Drug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: Placebo;Drug: Rituximab

Genentech, Inc.

NULL

Completed

18 Years

65 Years

All

Phase 2

United States

214

NCT00503425
(ClinicalTrials.gov)

June 30, 2005

17/7/2007

A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy.

An Open Label Study to Assess the Safety and Effect on Disease Activity of MabThera in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With DMARDs and/or One Anti-TNF Alpha Agent

Rheumatoid Arthritis

Drug: Rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

215

Phase 3

Israel

215

EUCTR2005-000674-43-GB
(EUCTR)

06/04/2005

03/10/2005

AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis

Rheumatoid Arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

216

NCT00854321
(ClinicalTrials.gov)

November 2004

2/3/2009

Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University Hospital

One Centre Follow-up Study on Safety and Efficacy

Rheumatoid Arthritis

Drug: rituximab;Drug: rituximab, observational study amon patients with active RA

Kuopio University Hospital

NULL

Completed

18 Years

N/A

Both

N/A

Finland

217

NCT02097745
(ClinicalTrials.gov)

June 2004

20/3/2014

A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies

Rheumatoid Arthritis

Drug: methotrexate;Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

Biogen

Completed

18 Years

80 Years

All

341

Phase 3

United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom

218

NCT00468377
(ClinicalTrials.gov)

March 2004

30/4/2007

Safety and Efficacy Study of Re-treatment With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFa Therapies

Arthritis, Rheumatoid

Drug: Rituximab

Hoffmann-La Roche

Genentech, Inc.

Active, not recruiting

18 Years

80 Years

Both

341

Phase 3

United States

219

NCT00074438
(ClinicalTrials.gov)

June 2003

12/12/2003

Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placebo

Genentech, Inc.

Roche Pharma AG

Completed

18 Years

80 Years

Both

465

Phase 2

United States

220

NCT00468546
(ClinicalTrials.gov)

May 2003

30/4/2007

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies

Rheumatoid Arthritis

Drug: MabThera/Rituxan;Drug: Methotrexate;Other: Placebo

Hoffmann-La Roche

Biogen

Completed

18 Years

80 Years

All

520

Phase 3

United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

221

NCT02093026
(ClinicalTrials.gov)

August 2002

19/3/2014

Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)

An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic Acid

Hoffmann-La Roche

Genentech, Inc.

Completed

21 Years

N/A

All

465

Phase 2

United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom

222

NCT02693210
(ClinicalTrials.gov)

February 2001

23/2/2016

A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis

A Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Cyclophosphamide;Drug: Methotrexate;Other: Placebo Cyclophosphamide;Other: Placebo Methotrexate;Other: Placebo Rituximab;Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

21 Years

N/A

Both

161

Phase 2

Australia;Belgium;Canada;Czech Republic;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom

223

EUCTR2011-002896-40-ES
(EUCTR)

26/06/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

195

Phase 2

United States;Taiwan;Spain;Korea, Democratic People's Republic of;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

224

EUCTR2015-002156-27-AT
(EUCTR)

30/09/2015

Reduced-dose Rituximab in rheumatoid arthritis patients in remission – theREDOREM study

Prospective controlled study of reduced-dose Rituximab in rheumatoidarthritis patients in low disease activity and remission – the REDOREMstudy

rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
INN or Proposed INN: RITUXIMAB

Medical University of Vienna

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04127747 (ClinicalTrials.gov)	August 18, 2020	14/10/2019	Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus Erythematosus	A Multicenter, Randomized Controlled Clinical Study About Efficacy and Safety of Standard Dose and Individualized Dose of Rituximab in Maintaining Remission in Patients With Moderate to Severe Systemic Lupus Erythematosus	Autoimmune Diseases	Drug: Standard dose of rituximab;Drug: Individualized dose of rituximab	Second Affiliated Hospital, School of Medicine, Zhejiang University	NULL	Recruiting	18 Years	65 Years	All	110	Phase 4	China
2	NCT03747159 (ClinicalTrials.gov)	October 1, 2018	12/10/2018	Synergetic B-cell Immunomodulation in SLE - 2nd Study.	A Randomized Trial to Investigate the Reset of Humoral Autoimmunity by Combining Belimumab With Rituximab in Severe Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: Belimumab Injection	Leiden University Medical Center	Dutch Kidney Foundation;GlaxoSmithKline	Recruiting	18 Years	N/A	All	30	Phase 2	Netherlands
3	EUCTR2018-001392-21-NL (EUCTR)	25/09/2018	25/09/2018	Synergetic B-cell immunomodulation in SLE – 2nd study	A randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus	systemic lupus erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 21.1;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: belimumab or benlysta Trade Name: anti-CD20 B cell depletion with Truxima Product Name: truxima	Leiden University Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2;Phase 3	Netherlands
4	NCT03312907 (ClinicalTrials.gov)	March 1, 2018	13/10/2017	A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid Taper	GlaxoSmithKline	NULL	Active, not recruiting	18 Years	N/A	All	292	Phase 3	United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain
5	EUCTR2016-003050-32-NL (EUCTR)	16/02/2018	24/10/2017	A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;Netherlands;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2016-003050-32-DE (EUCTR)	09/01/2018	21/06/2017	A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo- Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of
7	EUCTR2016-003050-32-ES (EUCTR)	05/12/2017	01/12/2017	A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE).	Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA	GlaxoSmithKline, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of
8	NCT03054259 (ClinicalTrials.gov)	September 21, 2017	17/1/2017	Rituximab Objective Outcome Measures Trial in SLE	A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus	Systemic Lupus Erythematosus Arthritis	Drug: Rituximab;Drug: Methylprednisolone;Drug: Normal Saline	University of Leeds	NULL	Recruiting	18 Years	99 Years	All	30	Phase 2	United Kingdom
9	NCT01773616 (ClinicalTrials.gov)	April 2015	1/11/2012	Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis	Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis	Systemic Lupus Erythematosus, Lupus Nephritis	Drug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisolone	Imperial College London	Karolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study Group	Terminated	12 Years	75 Years	All	24	Phase 3	United Kingdom
10	JPRN-UMIN000000763	2007/05/01	05/07/2007	Phase II study of rituximab in patients with severe systemic lupus erythematosus		Systemic lupus erythematosus	1000 mg of rituximab on days 1, 15, 169 and 183	Zenyaku Kogyo Co., Ltd.	NULL	Complete: follow-up complete	16years-old	75years-old	Male and Female	30	Phase 2	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	JPRN-UMIN000000639	2007/03/01	16/03/2007	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus		Systemic lupus erythematosus	IDEC-C2B8 plus oral prednisolone(tapering) 1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183). Placebo plus oral prednisolone(tapering) 1000 mg of placebo day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).	Zenyaku Kogyo Co., Ltd.	NULL	Complete: follow-up complete	16years-old	75years-old	Male and Female	150	Phase 2;Phase 3	Japan
12	NCT00381810 (ClinicalTrials.gov)	June 22, 2006	26/9/2006	A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus	An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g	Lupus Erythematosus, Systemic	Drug: Rituximab;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Diphenhydramine	Genentech, Inc.	NULL	Terminated	16 Years	75 Years	All	31	Phase 3	United States
13	NCT00556192 (ClinicalTrials.gov)	June 2006	8/11/2007	Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus	Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy Restore Peripheral B Cell Abnormalities in Systemic Lupus Erythematosus(SLE)?	Systemic Lupus Erythematosus	Drug: rituximab	Chinese University of Hong Kong	NULL	Completed	18 Years	70 Years	Both	20	Phase 2	China
14	NCT00278538 (ClinicalTrials.gov)	September 23, 2005	15/1/2006	Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus	Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II Trial	Systemic Lupus Erythematosus	Biological: Hematopoietic stem cell transplantation	Northwestern University	NULL	Completed	15 Years	60 Years	All	32	Phase 2	United States
15	NCT00230035 (ClinicalTrials.gov)	September 2005	28/9/2005	Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST)	A Randomized, Open Label, Phase II Multicenter Study of Non-Myeloablative Autologous Transplantation With Auto-CD34+HPC Versus Currently Available Immunosuppressive/Immunomodulatory Therapy for Treatment of Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Procedure: Leukapheresis;Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT);Procedure: Autologous CD34+HPC transplantation (HSCT);Procedure: Plasmapheresis;Drug: Rabbit anti-thymocyte globulin;Drug: Methylprednisolone;Drug: Growth colony stimulating factor (G-CSF);Drug: Corticosteroids;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Intravenous immunoglobulin;Drug: Methotrexate;Drug: Rituximab;Drug: Leflunomide	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Withdrawn	18 Years	60 Years	Both	0	Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT00137969 (ClinicalTrials.gov)	May 10, 2005	26/8/2005	A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus	Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: Rituximab;Drug: Placebo;Drug: Prednisone;Drug: Acetaminophen;Drug: Diphenhydramine	Genentech, Inc.	NULL	Completed	16 Years	75 Years	All	262	Phase 2;Phase 3	United States;Canada
17	NCT00076752 (ClinicalTrials.gov)	January 30, 2004	2/2/2004	Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus	A Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: fludarabine phosphate;Drug: cyclophosphamide;Biological: Rituxan (rituximab);Biological: filgrastim;Drug: methylprednisolone;Other: immunologic technique;Other: laboratory biomarker analysis;Procedure: autologous hematopoietic stem cell transplantation;Drug: Diphenhydramine;Drug: Mesna	National Cancer Institute (NCI)	NULL	Completed	15 Years	40 Years	All	9	Phase 2	United States
18	NCT00293072 (ClinicalTrials.gov)	March 2002	16/2/2006	Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis	Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy	Systemic Lupus Erythematosus;ANCA Associated Vasculitis	Drug: Rituximab	Cambridge University Hospitals NHS Foundation Trust	Roche Pharma AG	Completed	18 Years	70 Years	Both	20	Phase 2	United Kingdom
19	NCT00036491 (ClinicalTrials.gov)	January 2001	10/5/2002	Anti-CD20 in Systemic Lupus Erythematosus	An Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: Rituximab	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence	Completed	18 Years	70 Years	All	24	Phase 1;Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000018376	2015/07/22	22/07/2015	Efficacy and safety of rituximab for patients with severe rheumatic disease	Efficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic disease	Childhood-onset severe rheumatic disease(systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome)	1) Induction Therapy rituximab 375mg/m2 (max500mg) 1-4 times/1-2 weeks 2) Maintenance Therapy rituximab 375mg/m2 (max500mg) 1 times/6-12 months	Yokohama City University Hospital Department of Pediatrics	NULL	Complete: follow-up complete	2years-old	Not applicable	Male and Female	20	Not selected	Japan
2	EUCTR2012-003633-42-GB (EUCTR)	18/10/2013	22/08/2013	A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseases	A randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD	A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Cyclophosphamide Injection 1g Product Name: Cyclophosphamide Injection 1g INN or Proposed INN: Cyclophosphamide	Royal Brompton and Harefield NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			United Kingdom
3	EUCTR2006-000078-65-GB (EUCTR)	08/12/2008	07/12/2010	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis	Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis MedDRA version: 8.1;Level: LLT;Classification code 10036102;Term: Polymyositis	Trade Name: Mabthera Product Name: Mabthera	Karolinska University Hospital	NULL	Not Recruiting			Female: yes Male: yes	202	Phase 2	Czech Republic;United Kingdom;Sweden
4	EUCTR2006-000078-65-CZ (EUCTR)	12/11/2007	18/10/2007	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM)	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM)	Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis. MedDRA version: 9.1;Level: LLT;Classification code 10036102;Term: Polymyositis	Trade Name: Mabthera Product Code: Mabthera	Karolinska University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	202		United Kingdom;Czech Republic;Sweden
5	EUCTR2006-000078-65-SE (EUCTR)	17/01/2007	02/11/2006	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis	Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis MedDRA version: 8.1;Level: LLT;Classification code 10036102;Term: Polymyositis	Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: Rituximab	Karolinska University Hospital	NULL	Not Recruiting			Female: yes Male: yes	202		United Kingdom;Czech Republic;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT00106184 (ClinicalTrials.gov)	March 2006	21/3/2005	Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)	Rituximab Therapy in Refractory Adult and Juvenile Idiopathic Inflammatory Myopathy (IIM)	Myositis;Dermatomyositis;Polymyositis;Juvenile Dermatomyositis	Drug: Rituximab;Drug: Placebo	University of Pittsburgh	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Genentech, Inc.;Biogen	Completed	5 Years	N/A	All	200	Phase 2	United States;Canada;Czech Republic;Sweden;United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03844061 (ClinicalTrials.gov)	July 29, 2019	31/1/2019	Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis	A Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis	Systemic Sclerosis	Drug: Belimumab;Drug: Rituximab;Other: Placebo Subcutaneous Injection;Other: Placebo Infusion;Drug: MMF	Hospital for Special Surgery, New York	GlaxoSmithKline	Recruiting	18 Years	80 Years	All	30	Phase 2	United States
2	NCT03630211 (ClinicalTrials.gov)	July 31, 2018	7/8/2018	Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis	Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc)	Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary Hypertension	Drug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body Irradiation	Paul Szabolcs	NULL	Recruiting	16 Years	70 Years	All	8	Phase 2	United States
3	NCT03593902 (ClinicalTrials.gov)	May 17, 2018	28/6/2018	Cardiac Safe Transplants for Systemic Sclerosis	Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction	Systemic Sclerosis;Scleroderma	Drug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells	Northwestern University	NULL	Terminated	18 Years	65 Years	All	9	Phase 2;Phase 3	United States
4	NCT04274257 (ClinicalTrials.gov)	December 4, 2017	13/2/2020	A Study of the Efficacy and Safety of Rituximab in Participants With Systemic Sclerosis	Double-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic Sclerosis	Scleroderma, Systemic;Skin Sclerosis;Lung Fibrosis;Autoimmune Diseases;Collagen Diseases	Drug: Double-Blind Placebo;Drug: Double-Blind Rituximab	Tokyo University	Japan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.	Completed	20 Years	80 Years	All	56	Phase 2;Phase 3	Japan
5	JPRN-UMIN000018376	2015/07/22	22/07/2015	Efficacy and safety of rituximab for patients with severe rheumatic disease	Efficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic disease	Childhood-onset severe rheumatic disease(systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome)	1) Induction Therapy rituximab 375mg/m2 (max500mg) 1-4 times/1-2 weeks 2) Maintenance Therapy rituximab 375mg/m2 (max500mg) 1 times/6-12 months	Yokohama City University Hospital Department of Pediatrics	NULL	Complete: follow-up complete	2years-old	Not applicable	Male and Female	20	Not selected	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT01862926 (ClinicalTrials.gov)	November 2014	22/5/2013	Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD	A Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung Disease	Interstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue Disease	Drug: Rituximab;Drug: Cyclophosphamide	Royal Brompton & Harefield NHS Foundation Trust	Imperial College London;University of East Anglia;University College London Hospitals	Active, not recruiting	18 Years	80 Years	All	116	Phase 2;Phase 3	United Kingdom
7	EUCTR2012-003633-42-GB (EUCTR)	18/10/2013	22/08/2013	A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseases	A randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD	A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Cyclophosphamide Injection 1g Product Name: Cyclophosphamide Injection 1g INN or Proposed INN: Cyclophosphamide	Royal Brompton and Harefield NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			United Kingdom
8	EUCTR2012-004955-35-IT (EUCTR)	29/07/2013	30/05/2013	A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with Rituximab: evaluation of the effectiveness of B-cell depletion therapy”	A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with Rituximab: evaluation of the effectiveness of B-cell depletion therapy”	SYSTEMIC SCLEROSIS MedDRA version: 16.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Mabthera	POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
9	NCT01748084 (ClinicalTrials.gov)	April 9, 2013	10/12/2012	Rituximab in Systemic Sclerosis	Evaluation of Rituximab in Systemic Sclerosis Associated Polyarthritis	Systemic Sclerosis	Drug: Rituximab;Drug: Placebo (NaCl)	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	80 Years	All	22	Phase 2;Phase 3	France
10	JPRN-jRCTs031180373	14/05/2012	18/03/2019	Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis	Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis - Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis	Interstitial lung disease secondary to systemic sclerosis	Rituximab 375mg/m2 once a week/4 times	Yoshizaki Ayumi	Sato Shinichi	Recruiting	>= 20age old	< 80age old	Both	60	Phase 2	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	JPRN-UMIN000007702	2012/04/26	24/04/2012	Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis		Interstitial lung disease secondary to systemic sclerosis	Rituximab(+) 30weeks 375mg/m2 once a week 4 times	Department of Dermatology, University of Tokyo	NULL	Recruiting	20years-old	80years-old	Male and Female	20	Not selected	Japan
12	NCT01086540 (ClinicalTrials.gov)	June 24, 2011	11/3/2010	Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)	A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)	Systemic Sclerosis-Associated PAH	Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.	Completed	18 Years	75 Years	All	57	Phase 2	United States
13	NCT01309997 (ClinicalTrials.gov)	March 2011	1/3/2011	Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease	A Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell Transplantation	Graft Versus Host Disease;Systemic Scleroderma	Drug: imatinib mesylate;Biological: rituximab	Lee, Stephanie	National Cancer Institute (NCI)	Completed	2 Years	N/A	All	72	Phase 2	United States
14	NCT01047072 (ClinicalTrials.gov)	January 2010	11/1/2010	Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis	Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis	Systemic Scleroderma	Drug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	National Cancer Institute (NCI)	Withdrawn	18 Years	65 Years	Both	0	Phase 2	United States
15	NCT00936546 (ClinicalTrials.gov)	June 2009	9/7/2009	A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy	A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy	Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)	Drug: Rituximab	University Hospital, Ghent	NULL	Active, not recruiting	18 Years	N/A	Both	10	Phase 2	Belgium
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2008-007180-16-NL (EUCTR)	13/05/2009	24/11/2008	INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA - RItuximab In Scleroderma ( RITIS)	INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA - RItuximab In Scleroderma ( RITIS)	systemic sclerosis MedDRA version: 9.1;Level: PT;Classification code 10039710;Term: Scleroderma	Trade Name: Rituximab Product Name: Mabthera	LUMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
17	NCT00379431 (ClinicalTrials.gov)	November 2006	20/9/2006	A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab	A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab	Early and Severe Systemic Sclerosis	Drug: Administration of rituximab and methylprednisolone	University Hospital, Ghent	NULL	Active, not recruiting	18 Years	N/A	Both	40	Phase 2	Belgium
18	EUCTR2006-003836-31-BE (EUCTR)	06/09/2006	02/08/2006	A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab	A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab	systemic sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis	Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab	University Hospital Gent	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Belgium

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2015-000400-26-GB (EUCTR)	17/03/2017	14/12/2016	A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome	A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome.	Primary Sjogrens disease MedDRA version: 19.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
2	NCT02631538 (ClinicalTrials.gov)	February 17, 2016	14/12/2015	Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome	A Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's Syndrome	Sjogren's Syndrome	Drug: Belimumab;Drug: Rituximab;Drug: Placebo belimumab;Drug: Placebo rituximab	GlaxoSmithKline	NULL	Completed	18 Years	N/A	All	86	Phase 2	Argentina;Canada;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom
3	EUCTR2015-000400-26-IT (EUCTR)	18/01/2016	10/11/2020	A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndrome	A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. - NA	Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML Product Name: MABTHERA Product Code: [NA] INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO Product Name: BENLYSTA Product Code: [na] INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: SOLU-MEDROL Product Code: [na] INN or Proposed INN: METILPREDNISOLONE Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [na] INN or Proposed INN: PARACETAMOLO Trade Name: XYZAL - 20 COMPRESSE RI	GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
4	EUCTR2015-000400-26-NO (EUCTR)	08/01/2016	23/09/2015	A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome	A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome.	Primary Sjogrens disease MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;Canada;Argentina;Spain;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden
5	EUCTR2015-000400-26-NL (EUCTR)	28/12/2015	08/12/2015	A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome	A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome.	Primary Sjogrens disease MedDRA version: 18.1;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;Canada;Argentina;Spain;Norway;Germany;Netherlands;United Kingdom;Italy;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2015-000400-26-SE (EUCTR)	15/12/2015	08/09/2015	A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome	A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome.	Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
7	EUCTR2015-000400-26-DE (EUCTR)	03/12/2015	01/10/2015	A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome	A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome.	Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
8	EUCTR2015-000400-26-FR (EUCTR)	01/12/2015	24/02/2017	A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome	A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome.	Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;Canada;Argentina;Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;Norway
9	NCT02495129 (ClinicalTrials.gov)	December 2015	8/7/2015	Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome	A Three-part, Partially Open Label and Double-blind, Randomized Study to Assess the Pharmacodynamic Effects, Safety, Tolerability and Preliminary Efficacy of VAY736 in Patients With Primary Sjögren's Syndrome Using [Zr-89]-Rituximab PET/CT	Primary Sjögren's Syndrome	Drug: VAY736 lower dose;Drug: VAY736 higher dose	Novartis Pharmaceuticals	NULL	Withdrawn	N/A	N/A	All	0	Phase 1;Phase 2	Netherlands
10	EUCTR2015-000400-26-ES (EUCTR)	19/11/2015	05/10/2015	A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndrome	A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome.	Primary Sjogrens disease MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA	GlaxoSmithKline, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	JPRN-UMIN000018376	2015/07/22	22/07/2015	Efficacy and safety of rituximab for patients with severe rheumatic disease	Efficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic disease	Childhood-onset severe rheumatic disease(systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome)	1) Induction Therapy rituximab 375mg/m2 (max500mg) 1-4 times/1-2 weeks 2) Maintenance Therapy rituximab 375mg/m2 (max500mg) 1 times/6-12 months	Yokohama City University Hospital Department of Pediatrics	NULL	Complete: follow-up complete	2years-old	Not applicable	Male and Female	20	Not selected	Japan
12	EUCTR2010-021430-64-GB (EUCTR)	03/12/2010	04/11/2010	A clinical trial to show whether there is an improvment in symptoms after the administration of rituximab in patients with primary Sjögren’s syndrome.	A randomised double blind placebo controlled clinical trial of anti B-cell therapy in patients with primary Sjögren’s syndrome. - TRACTISS (Rituximab / Placebo in Sjogren's Syndrome) Version 1.0	Primary Sjögren’s syndrome (PSS). MedDRA version: 14.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera (rituximab) Product Name: MabThera (Rituximab) Product Code: N/A INN or Proposed INN: Rituximab Other descriptive name: Rituxan (US, Canada, Japan), MabThera (rest of world)	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	110		United Kingdom
13	NCT00426543 (ClinicalTrials.gov)	January 2007	23/1/2007	Effect of B-cell Depletion in Patients With Primary Sjögren's Syndrome	Phase 1 Study of B-cell Depletion With Rituximab on Oral, Ocular and General Disease Manifestations in Patients With Primary Sjögren's Syndrome	Primary Sjögren's Syndrome;Xerostomia;Hyposalivation;Keratoconjunctivitis Sicca;Fatigue	Drug: MabThera (rituximab);Drug: Rituximab, Mabthera	University of Copenhagen	Rigshospitalet, Denmark	Completed	18 Years	70 Years	Female	21	Phase 2	Denmark
14	NCT00363350 (ClinicalTrials.gov)	August 2006	10/8/2006	Rituximab Treatment in Sjogren's Syndrome	Rituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled Trial	Sjogren's Syndrome	Drug: rituximab (anti-CD20)	University Medical Centre Groningen	Hoffmann-La Roche	Completed	18 Years	85 Years	Both	30	Phase 1;Phase 2	Netherlands
15	NCT00101829 (ClinicalTrials.gov)	April 2004	13/1/2005	Anti-CD20 Antibody Therapy for Sjogren's Syndrome	An Open-Label, One Arm, Phase I Safety Study of Anti-CD20 Antibody (Rituximab, Rituxan) Therapy in the Treatment of Primary Sjogren's Syndrome	Sjogren's Syndrome	Drug: Rituximab	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence	Completed	18 Years	75 Years	All	12	Phase 1	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03579875 (ClinicalTrials.gov)	November 13, 2018	25/5/2018	T Cell Receptor a/ß TCD HCT in Patients With Fanconi Anemia	T Cell Receptor Alpha/Beta T Cell Depleted (a/ß TCD) Hematopoietic Cell Transplantation in Patients With Fanconi Anemia (FA)	Fanconi Anemia;Severe Aplastic Anemia;Myelodysplastic Syndromes	Drug: Total Body Irradiation (TBI) (Plan 1);Drug: Cyclophosphamide (CY) (Plan 1);Drug: Fludarabine (FLU);Drug: Methylprednisolone (MP);Device: Donor mobilized PBSC infusion;Drug: G-CSF;Drug: Cyclophosphamide (CY) (Plan 2);Drug: Rituximab;Drug: Busulfan	Masonic Cancer Center, University of Minnesota	NULL	Recruiting	N/A	65 Years	All	48	Phase 2	United States
2	NCT02960646 (ClinicalTrials.gov)	January 18, 2017	8/11/2016	Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies	Phase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical Transplantation	Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome;Aplastic Anemia;Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Lymphoblastic Lymphoma;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Plasma Cell Myeloma;Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma;Recurrent Hodgkin Lymphoma;Recurrent Non-Hodgkin Lymphoma;Recurrent Plasma Cell Myeloma;Therapy-Related Myelodysplastic Syndrome	Drug: Cyclophosphamide;Biological: Filgrastim;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Biological: Rituximab;Drug: Tacrolimus;Radiation: Total-Body Irradiation	M.D. Anderson Cancer Center	National Cancer Institute (NCI)	Recruiting	18 Years	65 Years	All	12	Phase 1	United States
3	NCT01408342 (ClinicalTrials.gov)	July 2011	29/7/2011	Alemtuzumab and Rituximab in Aplastic Anemia	Low-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic Anemia	Aplastic Anemia	Drug: Alemtuzumab and Rituximab	Hospital Universitario Dr. Jose E. Gonzalez	NULL	Withdrawn	12 Months	N/A	Both	0	N/A	Mexico
4	NCT00229619 (ClinicalTrials.gov)	September 2005	29/9/2005	Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia	A Pilot Study of Recombinant Humanized Anti- Cluster of Differentiation Antigen 20 (Anti-CD20) Antibody (Rituximab) in Patients With Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia	Anemia, Aplastic;Red-Cell Aplasia, Pure;Anemia, Diamond-Blackfan	Drug: Rituximab	National Heart, Lung, and Blood Institute (NHLBI)	NULL	Completed	2 Years	N/A	All	11	Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2011-004835-30-FI (EUCTR)	10/07/2013	17/06/2013	Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy.	Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5	Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04]	Trade Name: Levact INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE Trade Name: MabThera INN or Proposed INN: RITUXIMAB	Department of Medicine, Haugesund Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50		Finland;Norway
2	EUCTR2011-004835-30-DK (EUCTR)	17/01/2013	30/11/2012	Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy.	Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5	Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04]	Trade Name: Levact INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE Trade Name: MabThera INN or Proposed INN: RITUXIMAB	Department of Medicine, Haugesund Hospital	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	Finland;Denmark;Norway
3	NCT02689986 (ClinicalTrials.gov)	January 2013	16/2/2016	Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease	The CAD5 Study::Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicenter Trial on the Safety and Efficacy of Bendamustine and Rituximab Combination Therapy	Cold Agglutinin Disease;Autoimmune Hemolytic Anemia	Drug: Bendamustine, Rituximab	Helse Fonna	NULL	Completed	18 Years	N/A	All	43	Phase 2	Denmark;Finland;Norway
4	EUCTR2011-004835-30-NO (EUCTR)	23/10/2012	29/08/2012	Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy.	Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5	Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04]	Trade Name: Levact INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE Trade Name: MabThera INN or Proposed INN: RITUXIMAB	Department of Medicine, Haugesund Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50		Norway
5	NCT01181154 (ClinicalTrials.gov)	March 3, 2011	12/8/2010	Rituximab in Auto-Immune Hemolytic Anemia	Rituximab in Adult's Warm Auto-Immune Hemolytic Anemia : a Phase III, Double-bind, Randomised Placebo-controlled Trial	Warm Autoimmune Hemolytic Anemia	Drug: rituximab (Mabthera®);Drug: Placebo	Assistance Publique - Hôpitaux de Paris	Hoffmann-La Roche	Completed	18 Years	N/A	All	32	Phase 3	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT00960713 (ClinicalTrials.gov)	June 2009	16/7/2009	The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders	The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders	Pemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;Cryoglobulinemia	Drug: Rituximab (MABTHERA® or RITUXAN®).	University Hospital, Toulouse	NULL	Completed	18 Years	N/A	Both	35	N/A	France
7	NCT01345708 (ClinicalTrials.gov)	January 2009	28/4/2011	A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia	A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia	Autoimmune Hemolytic Disease (Cold Type) (Warm Type)	Drug: prednisone, low dose rituximab	Fondazione Ospedale	University Hospital, Udine, Italy	Completed	18 Years	N/A	Both	23	Phase 2	Italy
8	EUCTR2008-006713-25-IT (EUCTR)	23/09/2008	16/01/2009	A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND	A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND	ANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHE	INN or Proposed INN: Rituximab	OSPEDALE MAGGIORE DI MILANO (IRCCS)	NULL	Not Recruiting			Female: yes Male: yes			Italy
9	NCT00373594 (ClinicalTrials.gov)	June 2005	7/9/2006	Therapy for Chronic Cold Agglutinin Disease	Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicentre Study on the Safety and Efficacy of Rituximab in Combination With Fludarabine.	Cold Agglutinin Disease	Drug: Rituximab;Drug: Fludarabine	University of Bergen	NULL	Completed	18 Years	90 Years	Both	30	Phase 2	Norway;Russian Federation
10	NCT01134432 (ClinicalTrials.gov)	March 2005	28/5/2010	Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia	Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.	Anemia, Hemolytic, Autoimmune	Drug: prednisolone + mabthera;Drug: Prednisolone	Copenhagen University Hospital at Herlev	NULL	Completed	18 Years	N/A	Both	65	Phase 3	Denmark

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	ChiCTR2000035408	2020-08-20	2020-08-10	A randomized controlled study for rituximab in first-line treatment of newly diagnosed immune thrombocytopenia	Study of rituximab in first-line treatment of newly diagnosed immune thrombocytopenia	Idiopathic Thrombocytopenic Purpura	Standard dose group:Rituximab (Hanrikang) 375mg/m2, 4 times a week (day 8, 15, 22, 29).;Low-dose group:Rituximab (Hanrikang) 100mg/ time once a week, administered 4 times (day 8, 15, 22 and 29).;Dexamethasone control group:high-dose dexamethasone (HD-DXM), 40mg/d, iv for 4 days (day 1 to day 4), every 15 days, 2 to 4 cycles, until CR or the end of the study.;	Henan Cancer Hospital	NULL	Recruiting	18	65	Both	Standard dose group:20;Low-dose group:20;Dexamethasone control group:20;	Phase 4	China
2	NCT04518475 (ClinicalTrials.gov)	August 10, 2020	12/8/2020	Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults	A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients	Primary Immune Thrombocytopenia (ITP)	Drug: eltrombopag combining rituximab;Drug: eltrombopag	Institute of Hematology & Blood Diseases Hospital	The Second Affiliated Hospital of Kunming Medical University;Henan Cancer Hospital;Tianjin Medical University Second Hospital;The First Affiliated Hospital of Xiamen University;Nantong University	Recruiting	18 Years	60 Years	All	224	Phase 4	China
3	ChiCTR2000030603	2020-05-01	2020-03-08	Clinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopenia	Clinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopenia	Primary Immune Thrombocytopenia	The short -course glucocorticoid group:treat with glucocorticoid;The eltrombopag group:treat with eltrombopag;The rituximab group:treat with rituximab;Splenectomy group:treat with splenectomy;The azathioprine group:treat with azathioprine;The cyclosporine group:treat with cyclosporine;	The Second Affiliated Hospital of Kunming Medical University	NULL	Pending	18	75	Both	The short -course glucocorticoid group:65;The eltrombopag group:65;The rituximab group:65;Splenectomy group:65;The azathioprine group:65;The cyclosporine group:65;	Phase 4	China
4	ChiCTR1900027748	2019-12-01	2019-11-25	Clinical study of rituximab in the treatment of refractory immune thrombocytopenia	Clinical study of rituximab in the treatment of refractory immune thrombocytopenia	Primary Immune Thrombocytopenia	Case series:Treating with rituximab (hanlikan);	Department of Hematology, the Second Affiliated Hospital of Kunming Medical University	NULL	Pending			Both	Case series:60;	Phase 4	China
5	NCT03443570 (ClinicalTrials.gov)	March 1, 2018	18/2/2018	Rituximab Combining Bortezomib Versus Rituximab in Management of ITP	A Multicenter Prospective Randomized Study of Rituximab Combined With Bortezomib Versus Rituximab in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)	Immune Thrombocytopenia;Purpura, Thrombocytopenic, Idiopathic	Drug: Rituximab;Drug: Bortezomib	Shandong University	The Affiliated Hospital of Qingdao University;Yantai Yuhuangding Hospital	Not yet recruiting	18 Years	75 Years	All	200	Phase 3	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2015-005276-14-DK (EUCTR)	08/12/2016	19/10/2016	Maintenance treatment With rituximab in ITP	Prolonging the response by low-dose Rituximab maintenance therapy in immune thrombocytopenia: a randomized placebo-controlled trial- the PROLONG trial. - PROLONG-trial	Immune thrombocytopenia MedDRA version: 20.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]		Sykehuset Østfold HF	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 3	France;United States;Denmark;Norway;Tunisia;United Kingdom
7	NCT01734057 (ClinicalTrials.gov)	July 2012	21/11/2012	Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)	A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)	Purpura;Idiopathic Thrombocytopenic Purpura	Drug: recombinant human thrombopoietin (rhTPO); rituximab;Drug: Dexamethasone	Shandong University	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences;Anhui Medical University;The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital;Shenzhen Second People's Hospital;China Medical University, China;Zhejiang Provincial Hospital of TCM	Withdrawn	18 Years	75 Years	Both	0	Phase 3	China
8	JPRN-JMA-IIA00070	31/10/2011	12/08/2011	R-ITP: Clinical Evaluation of Rituximab in Primary Immune Thrombocytopenia	R-ITP: Clinical Evaluation of Rituximab in Primary Immune Thrombocytopenia	Idiopathic Thrombocytopenic Purpura	Intervention type:DRUG. Intervention1:rituximab, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP.	Keio University School of Medicine , Yoshitaka miyakawa	NULL	Completed	>=20 YEARS	No Limit	BOTH	24	Phase 3	Japan
9	NCT01525836 (ClinicalTrials.gov)	May 2011	31/1/2012	rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP	Recombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP.	Purpura;Idiopathic Thrombocytopenic Purpura	Drug: rituximab; recombinant human thrombopoietin (rhTPO);Drug: Rituximab	Shandong University	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences;The First Affiliated Hospital of Anhui Medical University;The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital;Shenzhen Second People's Hospital;First Hospital of China Medical University	Completed	18 Years	72 Years	Both	123	Phase 3	China
10	NCT03258866 (ClinicalTrials.gov)	January 1, 2010	18/8/2017	The Study of Different Dose Rituximab in the Treatment of ITP	The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia	Purpura, Thrombocytopenic, Idiopathic;Immune Thrombocytopenia	Drug: Rituximab	Shandong University	NULL	Completed	10 Years	70 Years	All	62	Phase 4	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT01506414 (ClinicalTrials.gov)	June 2009	16/11/2011	Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP)	A Multicentre Investigation of Recombinant Human Thrombopoietin (Rh-TPO) Combine With Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)	Purpura;Idiopathic Thrombocytopenic Purpura	Drug: rhTPO in combination with Rituximab	Ming Hou	Peking Union Medical College Hospital;Chinese Academy of Medical Sciences;First Affiliated Hospital, Sun Yat-Sen University;West China Hospital;Shandong Provincial Hospital;Wuhan Union Hospital, China;Zhejiang University	Completed	16 Years	75 Years	Both	91	Phase 3	China
12	EUCTR2005-005918-20-FR (EUCTR)	23/12/2008	23/10/2008	Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP study	Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP study	Immune thrombocytopenic purpura (ITP) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Trade Name: MabThera Product Name: MabThera Other descriptive name: RITUXIMAB	Rikshospitalet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	110	Phase 3	United Kingdom;France;Sweden
13	NCT00749112 (ClinicalTrials.gov)	August 2008	8/9/2008	Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias	Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias	Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune	Drug: Alemtuzumab, Rituximab	Hospital Universitario Dr. Jose E. Gonzalez	NULL	Completed	16 Years	N/A	Both	19	Phase 2;Phase 3	Mexico
14	NCT00475423 (ClinicalTrials.gov)	May 2007	17/5/2007	A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.	An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura.	Idiopathic Thrombocytopenic Purpura	Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	122	Phase 2	Australia
15	NCT00770562 (ClinicalTrials.gov)	July 2005	9/10/2008	A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)	A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombocytopenic Purpura	Idiopathic Thrombocytopenic Purpura	Drug: rituximab;Drug: Dexamethasone	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	103	Phase 3	Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2005-000859-15-IT (EUCTR)	14/04/2005	20/06/2005	Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults.	Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults.	Front-line treatment of adult ITP MedDRA version: 6.1;Level: PT;Classification code 10021245	Trade Name: Mabthera INN or Proposed INN: Rituximab Trade Name: Mabthera INN or Proposed INN: Rituximab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes			Italy
17	NCT01713855 (ClinicalTrials.gov)	October 2004	18/10/2012	Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura	Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)	Idiopathic Thrombocytopenic Purpura;Immune Thrombocytopenic Purpura	Biological: Inactivated Trivalent Influenza vaccine	Neufeld, Ellis J, MD, PhD	Terrana ITP Research Fund	Completed	18 Months	18 Years	Both	10	N/A	United States
18	NCT00909077 (ClinicalTrials.gov)	August 2004	26/5/2009	The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)	A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)	Idiopathic Thrombocytopenic Purpura	Drug: Dexamethasone;Drug: Dexamethasone and Rituximab	Copenhagen University Hospital at Herlev	NULL	Completed	18 Years	N/A	All	155	Phase 3	Denmark
19	NCT00161564 (ClinicalTrials.gov)	February 2004	8/9/2005	A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone	A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine,and Prednisone) in Subjects With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment	Idiopathic Thrombocytopenic Purpura (ITP)	Drug: Rituximab	Weill Medical College of Cornell University	Genentech, Inc.	Withdrawn	12 Years	N/A	All	0	Phase 2	United States
20	NCT01713738 (ClinicalTrials.gov)	May 2003	18/10/2012	Clinical Trial of Rituximab in Children and Adolescents With Chronic Idiopathic Thrombocytopenic Purpura (ITP)	Open Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)in Children and Adolescents	Idiopathic Thrombocytopenic Purpura (ITP);Immune Thrombocytopenic Purpura (ITP)	Drug: rituximab	Neufeld, Ellis J, MD, PhD	Genentech, Inc.;Biogen Idec;Glaser Pediatric Research Network;Terrana ITP Research Fund	Completed	18 Months	18 Years	Both	36	Phase 1;Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04588194 (ClinicalTrials.gov)	November 1, 2020	30/1/2020	Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia	Romiplostim in Combination With Low-dose Rituximab and High-dose Dexamethasone as Frontline Treatment for Immune Thrombocytopenia	Immune Thrombocytopenia;Thrombotic Thrombocytopenic Purpura	Drug: Romiplostim;Drug: Rituximab;Drug: Dexamethasone	David Gomez Almaguer	NULL	Recruiting	16 Years	90 Years	All	12	Phase 2	Mexico
2	NCT04074187 (ClinicalTrials.gov)	October 21, 2019	14/8/2019	A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)	An Open-label Multicenter Trial to Study the Efficacy and Safety of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura	Thrombotic Thrombocytopenic Purpura	Drug: Caplacizumab (ALX-0081);Drug: Plasma exchange (PE);Drug: Corticosteroid treatment (Methylprednisolone or prednisolone);Drug: Immunosuppressive treatment (eg, rituximab)	Sanofi	NULL	Recruiting	18 Years	N/A	All	18	Phase 2;Phase 3	Japan
3	EUCTR2017-001117-86-GB (EUCTR)	25/07/2017	18/05/2018	Elective rituximab in TTP	A phase IV, prospective, randomised single-blind UK multicentre non-inferiority trial of low-dose versus standard dose rituximab for prevention of relapses in acquired TTP - Elective rituximab in TTP	Acquired thrombotic thrombocytopenic purpura;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Mabthera Product Name: Mabthera	University College London	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	52	Phase 4	United Kingdom
4	JPRN-JMA-IIA00160	20/01/2014	16/01/2014	Investigator Initiated Clinical Trial of Rituximab for Thrombotic Thrombocytopenic Purpura	Investigator Initiated Clinical Trial of Rituximab for Thrombotic Thrombocytopenic Purpura	Thrombotic Thrombocytopenic Purpura	Intervention type:DRUG. Intervention1:Rituximab, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:1st cycle Initiate infusion at a rate of 50 mg/hr. In the absence of adverse events such as allergic reaction or infusion reaction, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr. Subsequent cycles If patients did not experience or experience grade 2 or less severe adverse events such as allergic reaction or infusion reaction during previous cycles, initiate infusion at a rate of 100 mg/hr and increase infusion rate by 100 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr. If patients experience grade 3 or more severe adverse events such as allergic reaction or infusion reaction during previous cycles, initiate infusion at a rate of 50 mg/hr and increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr..	Saitama Medical University , Department of General Internal Medicine, Yoshitaka Miyakawa	NULL	Completed	>=20 YEARS	<=79 YEARS	BOTH	8	Phase 2	Japan
5	ChiCTR-ONRC-13003194	2013-07-01	2013-04-18	The multicetre clinical study of the diagnosis,treatment and prognosis evaluation in thrombotic thrombocytopenic purpura.	The multicetre clinical study of the diagnosis,treatment and prognosis evaluation in thrombotic thrombocytopenic purpura.	Thrombotic Thrombocytopenic Purpura	experimental group:rituximab;Control group:No intervention;	The First Affiliated Hospital Of Soochow University	NULL	Recruiting	8	75	Both	experimental group:70;Control group:30;	I (Phase 1 study)	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT01554514 (ClinicalTrials.gov)	August 2012	8/3/2012	Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura	Adjuvant Low Dose Rituximab for Acquired TTP With Severe ADAMTS13 Deficiency	Thrombotic Thrombocytopenic Purpura	Biological: rituximab	Washington University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)	Completed	18 Years	N/A	All	19	Phase 2	United States
7	NCT00907751 (ClinicalTrials.gov)	May 2010	22/5/2009	Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura	Association of Rituximab to Plasma Exchange in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura	Thrombotic Thrombocytopenic Purpura	Drug: rituximab	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	Both	12	Phase 2	France
8	EUCTR2010-018794-38-IT (EUCTR)	23/02/2010	26/07/2010	EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP	EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP	THROMBOTIC THROMBOCYTOPENIC PURPURA MedDRA version: 9.1;Level: LLT;Classification code 10037562	Trade Name: MABTHERA INN or Proposed INN: Rituximab	FONDAZIONE IRCCS CA` GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
9	NCT00799773 (ClinicalTrials.gov)	April 2009	26/11/2008	Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)	STAR - Study of TTP and Rituximab, A Randomized Clinical Trial	Thrombotic Thrombocytopenic Purpura	Drug: Rituximab;Procedure: Plasma exchange;Drug: Corticosteroids	New England Research Institutes	National Heart, Lung, and Blood Institute (NHLBI);Genentech, Inc.	Terminated	12 Years	N/A	All	3	Phase 3	United States
10	NCT00531089 (ClinicalTrials.gov)	December 2007	17/9/2007	Rituximab in Patients With Relapsed or Refractory TTP-HUS	A Phase II Study Evaluating the Efficacy of Rituximab in the Management of Patients With Relapsed/Refractory Thrombotic Thrombocytopenic Purpura (TTP) - Hemolytic Uremic Syndrome (HUS)	Thrombotic Thrombocytopenic Purpura;Hemolytic Uremic Syndrome	Drug: Rituximab	Hamilton Health Sciences Corporation	Canadian Apheresis Group;Hoffmann-La Roche;McMaster University	Recruiting	18 Years	N/A	Both	60	Phase 2	Canada
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT00937131 (ClinicalTrials.gov)	March 2006	9/7/2009	The Use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura (TTP)	A Study to Assess the Safety, Efficacy and Tolerability of Rituximab (Mabthera) in Combination With Plasma Exchange (PEX) in Patients With Acute Thrombotic Thrombocytopenic Purpura (TTP)	Thrombotic Thrombocytopenic Purpura (TTP)	Drug: Rituximab	University College, London	NULL	Active, not recruiting	18 Years	65 Years	Both	40	Phase 2	United Kingdom
12	EUCTR2005-002274-30-GB (EUCTR)	14/12/2005	04/11/2005	A Study to assess the safety, efficacy and tolerability of Rituximab(Mabthera) in combination with Plasma Exchange in patients with Acute Thrombotic Thrombocytopenia Purpura. - The use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura.	A Study to assess the safety, efficacy and tolerability of Rituximab(Mabthera) in combination with Plasma Exchange in patients with Acute Thrombotic Thrombocytopenia Purpura. - The use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura.	Thrombotic Thrombocytopenia Purpura		University College London	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United Kingdom
13	NCT00251277 (ClinicalTrials.gov)	November 2005	7/11/2005	Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura	Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura	Thrombotic Thrombocytopenic Purpura	Drug: Rituximab	Weill Medical College of Cornell University	Genentech, Inc.	Withdrawn	17 Years	N/A	Both	0	Phase 1;Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2018-003842-18-IT (EUCTR)	08/01/2019	19/11/2018	Gene therapy study using a frozen formulation of OTL-103 in patients with Wiskott-Aldrich Syndrome (WAS)	A Single Arm, Open Label Clinical Study of Haematopoietic Stem Cell Gene Therapy with Cryopreserved Autologous CD34+ Cells Transduced with Lentiviral Vector encoding WAS cDNA in Subjects with Wiskott-Aldrich Syndrome (WAS). - Clinical study using cryopreserved OTL-103 for treatment of WAS.	Wiskott-Aldrich Syndrome MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: OTL-103 Dispersion for Infusion Product Code: OTL-103 INN or Proposed INN: Other hematological Agents Other descriptive name: Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human Wiskott Aldrich Syndrome (WAS) cDNA sequence Trade Name: Busilvex INN or Proposed INN: BUSULFAN Other descriptive name: NA Trade Name: Fludarabina Accord INN or Proposed INN: FLUDARABINE Other descriptive name: NA Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: NA Trade Name: Mozobil, INN or Proposed INN: plerixafor Other descriptive name: PLERIXAFOR Trade Name: MYELOSTIM Product Name: granulocyte colony stimulating factor (G-CSF) INN or Proposed INN:	Orchard Therapeutics Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	6	Phase 3	Italy
2	JPRN-UMIN000030806	2018/01/17	15/01/2018	A phase I/II clinical trial of hematopoietic stem cell gene therapy for Wiskott-Aldrich Syndrome		Wiskott-Aldrich syndrome	WASP cDNA-transduced autologous hematopoietic stem cells are administered to patients affected by WAS after the administration of rituximab and preconditioning chemotherapy including Fludarabine and Busulfan. 1. Rituximab (day-22) 375 mg/m2 2. Preconditioning chemotherapy Fludarabine 30mg/m2 x 2 (day-3, day-2) Busulfan cumulative target AUC 48000 ng/mL*h (day-3 to -1, every 6 hours) 3. Infusion of WASP cDNA-transduced CD34 positive HSC 5 x 10^6/kg (at least 3 x 10^6/kg)	National Center for Child Heath and Development	NULL	Recruiting	Not applicable	Not applicable	Male	3	Phase 1;Phase 2	Japan
3	NCT02789397 (ClinicalTrials.gov)	May 2, 2016	16/5/2016	Treatment of Granulomatous and Lymphocytic Interstitial Lung Disease in Patients With Common Variable Immunodeficiency	Clinical Trial to Assess the Efficacy of Rituximab and Azathioprine in the Treatment of Granulomatous and Lymphocytic Interstitial Lung Disease (GLILD) in Adult Patients With Common Variable Immunodeficiency (CVID)	Granulomatous and Lymphocytic Interstitial Lung Disease	Drug: Rituximab (RTX) and Azathioprine (AZA);Drug: Placebos	Medical College of Wisconsin	NULL	Withdrawn	18 Years	N/A	All	0	Phase 2	NULL
4	EUCTR2009-017346-32-IT (EUCTR)	15/03/2010	26/04/2010	HAEMATOPOIETIC STEM CELL GENE THERAPY	A PHASE I/II CLINICAL TRIAL OF HAEMATOPOIETIC STEM CELL GENE THERAPY FOR THE WISKOTT-ALDRICH SYNDROME - TIGET-WAS	Wiskott-Aldrich Syndrom MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: FLUDARABINA TEVA - 25 MG/ML CONCENTRATO PER SOLUZIONE INIETTABILE O PER INFUSIONE 1 FLACONCINO DI VETRO DA 2 ML Product Name: na Product Code: [na] INN or Proposed INN: FLUDARABINA Other descriptive name: FLUDARABINA Trade Name: MOZOBIL - 20 MG/ML - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) - 24 MG/1.2 ML 1 FLACONCINO Product Name: PLERIXAFOR Product Code: [na] INN or Proposed INN: PLERIXAFOR Other descriptive name: Plerixafor Trade Name: MYELOSTIM - 34 1 FLACONCINO LIOFILIZZATO 33.6 MIU + SIRINGA PRERIEMPITA SOLVENTE 1 ML Product Name: na Product Code: [na] INN or Proposed INN: LENOGRASTIM Trade Name: MABTHERA - 2 FIALE 100 MG 10 ML Product Name: RITUXIMAB Product Code: [na] INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: BUSILVEX - 6 MG/ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO - 10 ML 8 FLACONCINI Product Name: na Product Code: [na]	Orchard Therapeutics (Europe) Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	8	Phase 1;Phase 2	Italy

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	ChiCTR2000036468	2020-08-25	2020-08-23	A Multicentre, Randomized, Controlled Trial of Rituximab in Treatment of Primary IgA Nephropathy	A Multicentre, Randomized, Controlled Trial of Rituximab in Treatment of Primary IgA Nephropathy	IgAN	Rituximab group:Rituximab+RASi;control group:RASi;	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	NULL	Recruiting	18	75	Both	Rituximab group:58;control group:58;	Phase 4	China
2	NCT04525729 (ClinicalTrials.gov)	July 1, 2020	17/8/2020	Rituximab and RASi in Patients With IgAN	A Multicentre, Randomized, Controlled Study of Rituximab in Treatment of Primary IgA Nephropathy	IgA Nephropathy	Drug: Rituximab;Drug: RAS 2410	CHENNAN	NULL	Recruiting	18 Years	75 Years	All	116	Phase 4	China
3	NCT02571842 (ClinicalTrials.gov)	January 2012	6/10/2015	Rituximab in Recurrent IgA Nephropathy	A Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation Pathology	Recurrent IgA Nephropathy	Drug: Intravenous Rituximab;Drug: ACEI/ARB and corticosteroids	Chulalongkorn University	NULL	Recruiting	18 Years	70 Years	Both	30	Phase 4	Thailand
4	NCT00498368 (ClinicalTrials.gov)	February 2009	9/7/2007	Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy	A Multicenter, Randomized, Prospective, Open-Label Trial of Rituximab in the Treatment of Progressive IgA Nephropathy	IgA Nephropathy	Drug: Intravenous Rituximab;Drug: ACE/ARB;Dietary Supplement: Omega-3 Fatty Acid Fish Oil Supplement	Mayo Clinic	Ohio State University;Stanford University;University of North Carolina, Chapel Hill;Columbia University;Genentech, Inc.;Biogen	Completed	18 Years	70 Years	All	34	Phase 4	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2018-002632-24-FR (EUCTR)	13/11/2018	20/07/2018	to evaluate a triple therapy: plasma exchange, rituximab, intravenous immunoglobulin (IVIg) and corticosteroid administration compared to standard corticosteroid therapy in patients for severe acute exacerbation of idiopathic pulmonary	Therapeutic plasma exchange, rituximab and intravenous immunoglobulins (IVIg) for severe acute exacerbation of idiopathic pulmonary fibrosis admitted in ICU: an open, randomized, controlled trial - EXCHANGE-IFP	severe acute exacerbation of idiopathic pulmonary fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]		ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	France
2	NCT03286556 (ClinicalTrials.gov)	September 4, 2018	12/9/2017	Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis	Study of Therapeutic Plasma Exchange, Rituximab and Intravenous Immunoglobulin for Acute Exacerbations of Idiopathic Pulmonary Fibrosis (STRIVE-IPF)	Idiopathic Pulmonary Fibrosis, Acute Fatal Form	Drug: Autoantibody Reductive Therapy;Drug: Treatment as Usual (TAU)	University of Alabama at Birmingham	National Heart, Lung, and Blood Institute (NHLBI);Brigham and Women's Hospital;Temple University;University of Pittsburgh	Recruiting	40 Years	85 Years	All	51	Phase 2	United States
3	NCT03500731 (ClinicalTrials.gov)	April 19, 2018	30/3/2018	Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure	Lung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow Failure	Idiopathic Pulmonary Fibrosis;Emphysema or COPD	Biological: CD3/CD19 negative hematopoietic stem cells;Drug: Rituximab;Drug: Alemtuzumab;Drug: Fludarabine;Drug: Thiotepa;Drug: G-CSF;Drug: Hydroxyurea	Paul Szabolcs	NULL	Recruiting	18 Years	60 Years	All	8	Phase 1;Phase 2	United States
4	NCT01969409 (ClinicalTrials.gov)	January 2014	17/10/2013	Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis	Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis (ART-IPF)	Ambulatory IPF	Drug: Rituximab;Drug: Placebo	University of Alabama at Birmingham	National Institutes of Health (NIH)	Active, not recruiting	50 Years	85 Years	All	58	Phase 2	United States
5	NCT01524068 (ClinicalTrials.gov)	September 2012	27/1/2012	A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations	A Multicenter, Open-Label, Phase II Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis Exacerbations	Idiopathic Pulmonary Fibrosis	Drug: Standard Steroid Treatment;Drug: The Standard Steroid Treatment, Plasma Exchange and rituximab	University of Pittsburgh	NULL	Withdrawn	18 Years	90 Years	Both	0	Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT01266317 (ClinicalTrials.gov)	March 2011	22/12/2010	Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations	Open-Label, Feasibility Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis Exacerbations	IPF	Drug: Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids	Michael Donahoe	NULL	Completed	18 Years	80 Years	All	9	Phase 1;Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000016320	2014/09/18	24/01/2015	Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease		Pulmonary arterial hypertension associated with connective tissue disease	Weekly rituximab (375mg/m2) infusion for 4 weeks	The University of Tokyo Hospital	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	6	Not selected	Japan
2	NCT01086540 (ClinicalTrials.gov)	June 24, 2011	11/3/2010	Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)	A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)	Systemic Sclerosis-Associated PAH	Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.	Completed	18 Years	75 Years	All	57	Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02376335 (ClinicalTrials.gov)	October 2012	24/2/2015	B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis	B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis	Fatigue;Primary Biliary Cirrhosis	Biological: Rituximab;Other: Placebo	Newcastle-upon-Tyne Hospitals NHS Trust	National Institute for Health Research, United Kingdom;Department of Health, United Kingdom;Newcastle University	Completed	18 Years	N/A	All	71	Phase 2	United Kingdom
2	EUCTR2012-000145-12-GB (EUCTR)	15/08/2012	04/07/2012	Pilot study of Rituximab for the treatment of fatigue in PBC	Rituximab for the Treatment of Fatigue in Primary Biliary Cirrhosis (PBC) - RITPBC Study	Severe fatigue in Primary Biliary Cirrhosis MedDRA version: 18.0;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		The Newcastle upon Tyne Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 2	United Kingdom
3	NCT00364819 (ClinicalTrials.gov)	January 2007	15/8/2006	Initial Study of Rituximab to Treat Primary Biliary Cirrhosis	Effects of Rituximab (Rituxan) on B Cell and AMA Response in Patients With Primary Biliary Cirrhosis	Primary Biliary Cirrhosis	Drug: rituximab	University of California, Davis	Genentech, Inc.	Completed	18 Years	65 Years	Female	6	Phase 1;Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04128176 (ClinicalTrials.gov)	May 25, 2021	12/10/2019	Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid	An Open-Label Study to Evaluate the Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid	Bullous Pemphigoid	Drug: Rituximab combined with Omalizumab	University of California, Davis	NULL	Not yet recruiting	18 Years	90 Years	All	15	Phase 3	United States
2	NCT03295383 (ClinicalTrials.gov)	July 11, 2019	22/9/2017	Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid	Randomized Double Blind Double Dummy Control Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid	Severe Forms of Mucous Membrane Pemphigoid	Drug: Rituximab 1g IV;Drug: Cyclophosphamide 50Mg Oral Tablet;Drug: Placebo of Rituximab;Drug: Placebo Oral Tablet	University Hospital, Rouen	NULL	Recruiting	18 Years	80 Years	All	130	Phase 3	France
3	EUCTR2018-001417-32-FR (EUCTR)	13/07/2018	11/06/2018	Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3	Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3. Immunological, clinical and medicoeconomic evaluation	Patients with Bullous pemphigoid included in RITUXIMAB3 study MedDRA version: 20.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: MABTHERA INN or Proposed INN: RITUXIMAB Trade Name: Prednisone Product Name: CORTANCYL 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: CORTANCYL 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE	CHU-Hôpitaux de Rouen	NULL	Not Recruiting			Female: yes Male: yes	77	Phase 3	France
4	JPRN-UMIN000015451	2014/11/13	25/10/2014	Exploratory research on effectiveness and safety of Rituximab treatment including maintenance administration for steroid intractable autoimmune bullous diseases of the skin.Rtx-BD Trial (Rituximab of Intractable Autoimmune Bullous Disease Trial) 2		Pemphigus, Pemphigoid	Rituximab 375mg/sqm, q1w, 4 doses. Maintenance administration of rituximab is possible if PDA or BPDAI is between 1 and 10 on week 24 to 48	Department of Dermatology,Keio University School of Medicine	Hokkaido University, Kurume University, Okayama University, Kawasaki Medical School	Complete: follow-up complete	20years-old	80years-old	Male and Female	20	Phase 1;Phase 2	Japan
5	JPRN-jRCTs031180220	01/05/2014	15/03/2019	Rituximab treatment of blistering disease	Treatment of refractory autoimmuno blistering disease with rituximab	Pemphigus vulgaris, paraneoplastic pemphigus, bullous pemphigoid	Infusion of rituximab (1000mg) intravenously. Approximately two weeks after the first dose, a second dose of rituximab is administered in a similar manner.	Kanaoka Miwa	Michiko Aihara	Not Recruiting	>= 20age old	< 80age old	Both	10	N/A	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	JPRN-UMIN000004428	2010/11/01	01/11/2010	Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita.		pemphigus, bullous pemphigoid, epidermolysis bullosa acquisita	Rituximab	Research group of rare intractable dermatologial disorder	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Phase 2	Japan
7	EUCTR2008-005266-31-FR (EUCTR)	06/02/2009	13/03/2009	COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab III	COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab III	Pemphogoide bulleuse MedDRA version: 9.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid	Trade Name: mabthéra Product Name: mathéra Trade Name: Prednisone Product Name: CORTANCYL 20 mg	CHU-Hôpitaux de Rouen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
8	NCT00525616 (ClinicalTrials.gov)	December 2008	20/7/2007	Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid	Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.	Bullous Pemphigoid	Drug: Mabthera	University Hospital, Rouen	NULL	Completed	18 Years	80 Years	Both	18	Phase 3	France
9	NCT00584935 (ClinicalTrials.gov)	January 2006	26/12/2007	Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid	Phase I/II Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid	Ocular Cicatricial Pemphigoid	Drug: Rituximab	University of Alabama at Birmingham	Genentech, Inc.;Biogen	Completed	19 Years	N/A	All	3	Phase 1;Phase 2	United States
10	NCT00286325 (ClinicalTrials.gov)	March 2005	1/2/2006	Rituximab in the Treatment of Patients With Bullous Pemphigoid	Rituximab in the Treatment of Patients With Bullous Pemphigoid	Bullous Pemphigoid	Drug: Rituximab	Duke University	Genentech, Inc.	Completed	18 Years	N/A	All	8	Phase 1;Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT01842386 (ClinicalTrials.gov)	April 29, 2014	25/4/2013	Rituximab for Anti-cytokine Autoantibody-Associated Diseases	Rituximab (Anti-CD20) for the Treatment of Subjects With Anticytokine Autoantibody-Associated Diseases	Pulmonary Alveolar Proteinosis (PAP);Severe Mucocutaneous Candidoasis	Drug: Rituximab	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Active, not recruiting	18 Years	N/A	All	7	Phase 1	United States
2	NCT00552461 (ClinicalTrials.gov)	January 2007	31/10/2007	Prospective Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis	Prospective Open-Label Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis	Pulmonary Alveolar Proteinosis;Primary Disease	Drug: rituximab	East Carolina University	Genentech, Inc.	Recruiting	18 Years	N/A	Both	10	Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02525172 (ClinicalTrials.gov)	August 2015	10/8/2015	Immune Modulation Therapy for Pompe Disease	Immune Modulation Therapy for ERT-naïve or ERT-treated Pompe Disease Patients	Pompe Disease	Drug: Rituximab;Drug: intravenous immune globulin;Drug: Bortezomib;Drug: Methotrexate	National Taiwan University Hospital	NULL	Recruiting	N/A	N/A	Both	8	Phase 4	Taiwan
2	NCT00701129 (ClinicalTrials.gov)	October 2009	17/6/2008	An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naive Cross-Reacting Immunologic Material (CRIM[-]) Patients With Infantile-Onset Pompe Disease	An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme®-Naive, CRIM(-) Patients With Infantile-onset Pompe Disease	Pompe Disease;Glycogen Storage Disease Type II	Biological: Alglucosidase Alfa;Drug: Methotrexate;Drug: Rituximab	Genzyme, a Sanofi Company	NULL	Completed	N/A	N/A	All	4	Phase 4	United States;Israel
3	NCT01451879 (ClinicalTrials.gov)	October 2008	15/9/2011	Observational Study for Subjects With Pompe Disease Undergoing Immune Modulation Therapies	Effects of Immunomodulation Therapy on Anti-rhGAA Immune Response in Subjects With Pompe Disease Receiving rhGAA Enzyme Replacement Therapy	Pompe Disease	Drug: Rituximab;Drug: Miglustat	University of Florida	NULL	Completed	N/A	65 Years	All	11	N/A	United States
4	EUCTR2015-000583-34-Outside-EU/EEA (EUCTR)		15/04/2015	Immune Tolerance Induction Study	An Exploratory Study of the Safety and Efficacy of Immune Tolerance Induction (ITI) in Patients with Pompe Disease Who Have Previously Received Myozyme	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 17.1;Level: LLT;Classification code 10036143;Term: Pompe's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]	Product Name: Alglucosidase alfa Product Code: Myozyme® INN or Proposed INN: ALGLUCOSIDASE ALFA Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE MONOHYDRATE Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE Product Name: Rituximab INN or Proposed INN: RITUXIMAB Product Name: Methotrexate INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: METHOTREXATE SODIUM	Genzyme Corporation Inc	NULL	NA			Female: yes Male: yes	9		United States;Israel
5	EUCTR2015-000584-14-Outside-EU/EEA (EUCTR)		15/04/2015	An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naive Cross-Reacting Immunologic Material (CRIM[-]) Patients With Infantile-Onset Pompe Disease	An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naïve CRIM(-) Patients with Infantile-Onset Pompe Disease	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 17.1;Level: LLT;Classification code 10036143;Term: Pompe's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]	Product Name: Myozyme® INN or Proposed INN: ALGLUCOSIDASE ALFA Product Name: Rituximab INN or Proposed INN: RITUXIMAB Product Name: Methotrexate INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: METHOTREXATE SODIUM	Genzyme Corporation Inc	NULL	NA			Female: yes Male: yes	4		United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00432653 (ClinicalTrials.gov)	March 2007	6/2/2007	Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis	Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis	Ankylosing Spondylitis	Drug: rituximab	Charite University, Berlin, Germany	Hoffmann-La Roche	Not yet recruiting	18 Years	65 Years	Both	20	Phase 2;Phase 3	Germany
2	EUCTR2006-002306-64-DE (EUCTR)	28/12/2006	04/10/2006	Open label clinical trial with Rituximab (MabThera ®) in Ankylosing Spondylitis - Extension of open label trial: Re-Treatment of patients who have shown response to first course of Rituximab - Ritux-AS-01	Open label clinical trial with Rituximab (MabThera ®) in Ankylosing Spondylitis - Extension of open label trial: Re-Treatment of patients who have shown response to first course of Rituximab - Ritux-AS-01	Moderate to severe ankylosing spondylitis who have had an inadequate response to or do not tolerate conventional therapy including NSAIDs, DMARDs and TNF alpha inhibitors	Trade Name: Rituximab/ Mabthera Product Name: MabThera Product Code: Ro45-2294 INN or Proposed INN: rituximab	Charité Universitaetsmedizin	NULL	Not Recruiting			Female: yes Male: yes			Germany
3	EUCTR2005-005358-27-GB (EUCTR)	12/07/2006	10/04/2006	Efficacy of Rituximab (Mabthera) in active ankylosing spondylitis: a clinical and magnetic resonance imaging study - Rituximab in AS	Efficacy of Rituximab (Mabthera) in active ankylosing spondylitis: a clinical and magnetic resonance imaging study - Rituximab in AS	Ankylosing spondylitis (AS) is an inflammatory condition primarily affecting the spine. The disease may remain symptomatic and progressive life-long. It is part of the family of spondyloarthropathies which also comprises psoriatic arthritis, reactive arthritis and enteropathic arthritis.		University Hospital of North Staffordshire	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 2	United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03653338 (ClinicalTrials.gov)	August 2, 2018	2/8/2018	T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias	T-Cell Depleted, Alternative Donor Transplant in Pediatric and Adult Patients With Severe Sickle Cell Disease (SCD) and Other Transfusion-Dependent Anemias	Sickle Cell Anemia;Beta-thalassemia Major;Diamond-blackfan Anemia	Biological: CD3/CD19 depleted leukocytes;Biological: CD45RA depleted leukocytes;Drug: Hydroxyurea;Drug: Rituximab;Drug: Alemtuzumab;Drug: Fludarabine;Drug: Thiotepa	Paul Szabolcs	NULL	Recruiting	5 Years	40 Years	All	5	Phase 1;Phase 2	United States
2	NCT00229619 (ClinicalTrials.gov)	September 2005	29/9/2005	Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia	A Pilot Study of Recombinant Humanized Anti- Cluster of Differentiation Antigen 20 (Anti-CD20) Antibody (Rituximab) in Patients With Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia	Anemia, Aplastic;Red-Cell Aplasia, Pure;Anemia, Diamond-Blackfan	Drug: Rituximab	National Heart, Lung, and Blood Institute (NHLBI)	NULL	Completed	2 Years	N/A	All	11	Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03700229 (ClinicalTrials.gov)	October 10, 2018	4/10/2018	Study to Evaluate Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A	An Open-label Phase II Study to Determine the Efficacy and Safety of Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A	Acquired Hemophilia A	Drug: Bortezomib;Drug: Rituximab	Peking Union Medical College Hospital	NULL	Unknown status	18 Years	N/A	All	22	Phase 2	China
2	NCT03384277 (ClinicalTrials.gov)	October 26, 2017	28/11/2017	Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab	A Prospective, Randomized, Multicenter Clinical Trial of Acquired Haemophilia A With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab	Acquired Hemophilia A	Drug: Steroid;Drug: Rituximab;Drug: Cyclophosphamide	Zhang Lei	Qilu Hospital of Shandong University;Tianjin First Central Hospital;The Second Affiliated Hospital of Kunming Medical University;Henan Cancer Hospital	Recruiting	18 Years	80 Years	All	100	Phase 3	China
3	NCT00306670 (ClinicalTrials.gov)	April 2006	23/3/2006	Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia A	A Prospective, Phase II/III Randomized, Mult-institutional Controlled, Open-label, Phase II Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Patients With Acquired Hemophilia A	Hemophilia A	Drug: Rituxan;Drug: prednisone	Georgetown University	Genentech, Inc.	Terminated	18 Years	65 Years	All	2	Phase 2;Phase 3	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02705638 (ClinicalTrials.gov)	April 2016	7/3/2016	Treatment of IgG4-Related Disease With Revlimid and Rituximab	Treatment of IgG4-Related Disease With Revlimid and Rituximab: The TIGR2 Trial	Immunoglobulin G Subclass 4 Related Disease;IgG4-related Disease;Autoimmune Pancreatitis;IgG4-related Sclerosing Cholangitis;Retroperitoneal Fibrosis	Drug: Rituximab;Drug: Lenalidomide	Mayo Clinic	Celgene Corporation	Completed	18 Years	N/A	All	6	Phase 1	United States
2	NCT01584388 (ClinicalTrials.gov)	April 2012	22/4/2012	Rituximab in IgG4-RD: A Phase 1-2 Trial	Rituximab (RTX) for IgG4-related Disease (IgG4-RD): a Prospective,Open-label Trial	Retroperitoneal Fibrosis;Autoimmune Pancreatitis;Sialadenitis;Pseudotumor	Drug: Rituximab	Massachusetts General Hospital	Genentech, Inc.	Completed	18 Years	N/A	All	30	Phase 1;Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04585893 (ClinicalTrials.gov)	October 2020	10/9/2020	Safety and Efficacy of Rituximab for Treatment of Multicentric Castleman Disease in Malawi	LCCC 1950 - Rituximab for Multicentric Castleman Disease in Malawi, A Single-Arm Phase II Safety/Efficacy Trial	Multicentric Castleman Disease	Drug: Rituximab;Drug: Etoposide	UNC Lineberger Comprehensive Cancer Center	Fogarty International Center of the National Institute of Health	Not yet recruiting	18 Years	N/A	All	27	Phase 2	Malawi
2	NCT03864419 (ClinicalTrials.gov)	October 24, 2019	1/3/2019	Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda	A Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With Local Standard-of-Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castleman Disease in Pediatrics and Adults in Uganda	Burkitt Lymphoma;KSHV-associated Multicentric Castleman Disease;Diffuse Large B-Cell Lymphoma	Biological: Rituximab or Rituximab Hyaluronidase Human;Drug: Cyclophosphamide;Drug: Vincristine;Drug: Methotrexate;Drug: Doxorubicin;Drug: Doxorubicin Hydrochloride;Drug: Prednisone;Drug: Etoposide	Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)	Recruiting	2 Years	N/A	All	40	Phase 1	Uganda;United States
3	NCT02228512 (ClinicalTrials.gov)	August 15, 2014	27/8/2014	Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas	Phase I/II Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas (Primary Effusion Lymphoma and Large Cell Lymphoma Arising in KSHV-Associated Multicentric Castleman Disease)	Large Cell Lymphoma Arising in KSHV-associated Multicentric Castleman Disease;Primary Effusion Lymphoma	Drug: Pomalidomide;Drug: Rituximab;Drug: Prednisone;Drug: Etoposide;Drug: Doxorubicin;Drug: Vincristine;Drug: Cyclophosphamide	National Cancer Institute (NCI)	NULL	Withdrawn	18 Years	99 Years	All	0	Phase 1;Phase 2	United States
4	NCT00092222 (ClinicalTrials.gov)	October 28, 2004	21/9/2004	Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity	Targeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease Activity	Lymphoproliferative Disorder;HHV-8;Malignancy;HIV	Drug: Etoposide;Drug: Interferon-alpha;Drug: Rituximab;Drug: Zidovudine;Drug: Liposomal Doxorubicin;Drug: Bortezomib;Drug: Valganciclovir;Drug: Doxorubicin;Drug: Vincristine;Drug: Cyclophosphamide;Drug: Filgrastim (G-CSF);Drug: Prednisone;Drug: Sirolimus;Other: Observation Only	National Cancer Institute (NCI)	NULL	Recruiting	12 Years	N/A	All	72	Phase 2	United States
5	NCT00127569 (ClinicalTrials.gov)	May 2003	4/8/2005	Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy	Multicenter, Phase II Trial Assessing the Efficacy of Rituximab in HIV Infected Patients With Multicentric Castleman Disease Dependent on Chemotherapy (ANRS 117 Study, CastlemaB)	HIV Infections;Giant Lymph Node Hyperplasia	Drug: Rituximab	French National Agency for Research on AIDS and Viral Hepatitis	Hoffmann-La Roche	Terminated	18 Years	N/A	Both	25	Phase 2	NULL