:Rituximab    (DrugBank: Rituximab)

47 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
66IgA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3
296胆道閉鎖症1
300IgG4関連疾患2
331特発性多中心性キャッスルマン病5

11. 重症筋無力症 [臨床試験数:226,薬物数:172(DrugBank:45),標的遺伝子数:43,標的パスウェイ数:118
Searched query = "Myasthenia", "MG"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
7 / 226 trials found
No.TrialIDDate_
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1NCT02950155October 16, 201628/10/2016A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia GravisA 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 GravisDrug: Rituximab;Drug: Sodium Chloride solutionFredrik PiehlNULLActive, not recruiting18 YearsN/AAll47Phase 3Sweden
2EUCTR2015-005749-30-SE23/06/201628/04/2016A clinical trial investigating the effect and safety of the drug rituximab in patients with new onset myasthenia gravis, an autoimmune condition affecting muscle strenghtA 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: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3Sweden
3JPRN-UMIN0000165642015/03/1323/02/2015Rituximab for intractable myasthenia gravis myasthenia gravisrituximabTokushima University HospitalNULLPending15years-old80years-oldMale and Female1Not selectedJapan
4NCT02110706May 20147/4/2014BeatMG: Phase II Trial of Rituximab In Myasthenia GravisB Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia GravisMyasthenia GravisDrug: Rituximab;Drug: PlaceboYale UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed21 Years90 YearsAll52Phase 2United States
5JPRN-UMIN0000120892013/10/1523/10/2013Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical studyTreatment 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 gravisAdministration 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 MedicineNULLComplete: follow-up complete20years-old80years-oldMale and Female5Not selectedJapan
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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6NCT00774462January 200816/10/2008Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia GravisFORCE: Rituximab (CD 20+-B Cell-depleting Monoclonal Antibody) for the Treatment of Refractory Inflammatory Myopathies With Specific Antibodies and Refractory Myasthenia GravisMyositis;Myasthenia GravisDrug: RituximabAssistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France;Roche Pharma AGCompleted18 Years80 YearsBoth30Phase 2France
7NCT00619671April 200414/1/2008A Pilot Trial of Rituxan in Refractory Myasthenia GravisPhase 1-2 Pilot Study of Rituximab (Rituxan) in Refractory Myasthenia Gravis.Refractory Myasthenia GravisDrug: Rituximab (Rituxan)University of VermontGenentech, Inc.Completed18 Years80 YearsBoth10Phase 1/Phase 2United States

13. 多発性硬化症/視神経脊髄炎 [臨床試験数:3,050,薬物数:2,147(DrugBank:348),標的遺伝子数:244,標的パスウェイ数:228
Searched query = "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
41 / 3,050 trials found
No.TrialIDDate_
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1NCT04640818November 30, 202018/11/2020Safety and Efficacy of Cladribine Therapy After Anti CD20 TherapySafety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot StudyMultiple SclerosisDrug: Cladribine Oral Tablet;Drug: Rituximab;Drug: OcrelizumabClaudio GobbiMerck AG SwitzerlandNot yet recruiting18 Years80 YearsAll45Switzerland
2NCT04578639November 2, 202022/9/2020Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS DiseaseOcrelizumab VErsus Rituximab Off-Label at the Onset of RelapsingRelapsing Remitting Multiple SclerosisDrug: Rituximab;Drug: OcrelizumabHaukeland University HospitalUniversity Hospital, Akershus;Oslo University Hospital;Helse Stavanger HF;St. Olavs Hospital;University Hospital of North NorwayRecruiting18 Years60 YearsAll211Phase 3Norway
3NCT04480307June 17, 202010/7/2020Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple SclerosisA 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 SclerosisDrug: temelimab 18 mg/kg;Drug: temelimab 36 mg/kg;Drug: temelimab 54 mg/kg;Drug: PlaceboGeNeuro Innovation SASNULLRecruiting18 Years55 YearsAll40Phase 2Sweden
4EUCTR2019-004822-15-SE18/05/202017/01/2020A Clinical Trial Examining the Effects of Temelimab Following Rituximab Treatment in Patients with Multiple SclerosisA 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: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem 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 SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Sweden
5NCT03829566November 20191/2/2019Autologous Transplant To End NMO Spectrum DisorderAutologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica;Devic's Disease;NMO Spectrum DisorderDrug: Rituximab;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLWithdrawn18 Years65 YearsAll0Phase 2/Phase 3United States
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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6NCT04121403October 16, 201923/9/2019Norwegian 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 StudyRelapsing Multiple Sclerosis;Multiple SclerosisBiological: Rituximab;Drug: CladribineOslo University HospitalUniversity 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 HospitalRecruiting18 Years65 YearsAll264Phase 3Norway
7ChiCTR19000257442019-09-012019-09-07Clinical effectiveness and safety of Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trialClinical 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 HospitalNULLRecruiting1870Both1:30;2:30;China
8EUCTR2019-001505-24-NO25/07/201928/05/2019A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple SclerosisNorwegian 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 Level: PT 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 HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
264 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noNorway
9EUCTR2018-000721-31-SE04/07/201824/04/2018A 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Sweden
10NCT03979456July 4, 20183/6/2019RItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MSRItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MS. A Randomized Trial of Long-term Dosage of Rituximab in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: RituximabKarolinska InstitutetNULLRecruiting20 Years52 YearsAll200Phase 3Sweden
No.TrialIDDate_
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11EUCTR2017-000426-35-AT17/04/201812/03/2018The 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 trialEfficacy 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: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem 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 NeurologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2Austria
12NCT03315923December 1, 201717/10/2017Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis PatientsComparison 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 AcetateSecondary Progressive Multiple SclerosisDrug: Rituximab;Drug: Glatiramer AcetateIsfahan University of Medical SciencesNULLCompleted18 Years55 YearsAll84Phase 2/Phase 3Iran, Islamic Republic of
13EUCTR2017-002634-24-SE29/09/201706/07/2017MultipleMS – 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 InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Sweden
14EUCTR2016-003587-39-SE22/05/201723/03/2017This 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 InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3700Phase 4Sweden
15NCT03193866February 1, 201720/4/2017COMparison 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 SclerosisRelapsing-remitting Multiple SclerosisDrug: RituximabKarolinska InstitutetPatient-Centered Outcomes Research Institute;Kaiser Foundation Research InstituteActive, not recruiting18 YearsN/AAll3526Sweden
No.TrialIDDate_
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16NCT02980042January 1, 20179/11/2016Tolerability and Safety of Switching From Rituximab to Ocrelizumab in Patients With Relapsing Forms of Multiple SclerosisEvaluating the Tolerability and Safety Profile of Switching From Rituximab to Ocrelizumab: A Real World Evaluation of Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: RituximabUniversity of Colorado, DenverNULLCompleted18 Years65 YearsAll200Phase 3United States
17NCT02746744May 201618/4/2016RItuximab 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-RemittingDrug: Rituximab;Drug: Dimethyl fumarate;Drug: Sodium Chloride solutionAnders SvenningssonNULLActive, not recruiting18 Years50 YearsAll200Phase 3Sweden
18EUCTR2015-004116-38-SE18/12/201520/10/2015A 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Sweden
19NCT02545959November 30, 20157/9/2015Intrathecal Rituximab in Progressive Multiple SclerosisIntrathecal Rituximab in Progressive Multiple SclerosisMultiple Sclerosis, Chronic Progressive;Nervous System DiseasesDrug: Rituximab IT;Drug: methylprednisolone IV;Drug: Rituximab IVCentre Hospitalier de PAUUniversity Hospital, BordeauxCompleted45 YearsN/AAll10Phase 2France
20NCT03002038September 201521/12/2016Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD PatientsComparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum DisordersNeuromyelitis Optica Spectrum DisorderDrug: Azathioprine;Drug: RituximabIsfahan University of Medical SciencesNULLCompleted18 Years50 YearsAll86Phase 2/Phase 3Iran, Islamic Republic of
No.TrialIDDate_
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21EUCTR2014-005493-11-FR31/08/201515/03/2018Study 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 PauNULLNot Recruiting Female: yes
Male: yes
12 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance
22JPRN-UMIN0000172172015/04/2121/04/2015An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis opticaAn open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica - RIN-2 Neuromyelitis opticaRituximab intravenous infusionClinical Research Center, Utano National Hospital, National Hospital OrganizationZenyaku Kogyo Co., Ltd.Complete: follow-up complete16years-old80years-oldMale and Female40Phase 2,3Japan
23EUCTR2013-002378-26-SE13/11/201415/08/2013Switch 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 lymphocytesSwitch 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: 16.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mabthera®
Product Name: Mabthera
Västerbottens Läns LandstingNULLNot RecruitingFemale: yes
Male: yes
74Phase 2Sweden
24NCT02253264November 201429/9/2014A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis PatientsA Phase 1 Open-label Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients With Magnetic Resonance Imaging Evidence of Leptomeningeal EnhancementPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple SclerosisDrug: RituximabJohns Hopkins UniversityNULLCompleted18 YearsN/AAll8Phase 1United States
25ChiCTR-ICR-150071772014-08-302014-05-30A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic NeuritisA Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis Neuromyelitis Optica associated Optic Neuritis1: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 HospitalNULLRecruiting1870Both1:30;2:30;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
26JPRN-UMIN0000134532014/05/1018/03/2014A 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 antibodyA 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 opticaRituximab intravenous infusion
Placebo
Clinical Research Center, NHO Utano National HospitalZenyaku Kogyo Co., Ltd.Complete: follow-up complete16years-old80years-oldMale and Female40Phase 2,3Japan
27NCT04256252April 20142/2/2020Rituximab 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 TrialNeuromyelitis Optica Spectrum DisorderDrug: RituximabTang-Du HospitalNULLCompleted16 Years75 YearsAll108Phase 4NULL
28EUCTR2012-004436-36-DK19/04/201322/04/2013Effect of rituximab in secondary progressive multiple sclerosisA prospective pilotstudy of immunological and radiological effects of intrathecal rituximab in patients with secondary progressive multiple sclerosis Multiple Sclerosis
MedDRA version: 14.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem 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 HospitalNULLNot RecruitingFemale: yes
Male: yes
15Phase 2Denmark
29NCT02040116February 201314/1/2014Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune DiseasesStudy Evaluating Rapid Infusion Rituximab in Patients With Autoimmune DiseasesMultiple SclerosisDrug: Rituximab InfusionWake Forest University Health SciencesNULLCompleted18 Years80 YearsAll19Phase 4United States
30EUCTR2012-000721-53-SE07/12/201216/10/2012An extension trial of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosisITT-PMS ExtensionAn extension study of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis - ITT-PMS Ext Secondary progressive multiple sclerosis
MedDRA version: 14.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem 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, SwedenNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31JPRN-UMIN0000094212012/06/2828/11/2012Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children neuromyelitis optica (NMO), opsoclonus-myoclonus syndrome (OMS)administration of rituximabDepartment of Pediatrics, Kobe Universtiy Graduate School of MedicineNULLRecruitingNot applicable18years-oldMale and Female10Not appl1cableJapan
32NCT01569451February 201230/3/2012Comparison of Rituximab Induction Therapy Followed by Glatiramer AcetateA Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Rituximab;Drug: Glatiramer Acetate;Other: PlaceboUniversity of Colorado, DenverRocky Mountain MS Research Group, LLCCompleted18 Years55 YearsAll53Phase 2United States
33EUCTR2010-023021-38-SE23/02/201126/11/2010Switch 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-MSSwitch 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: 12.1Level: LLTClassification code 10028245Term: Multiple sclerosis
Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Västerbottens läns landstingNULLNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
34NCT01212094September 201029/9/2010Double 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 SclerosisDrug: Rituximab;Other: normal salineNational Institute of Neurological Disorders and Stroke (NINDS)NULLTerminated18 Years65 YearsAll44Phase 1/Phase 2United States
35NCT01719159November 200925/10/2012Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple SclerosisIntrathecal Therapy With Monoclonal Antibodies in Progressive Multiple SclerosisProgressive Multiple SclerosisDrug: RituximabAnders SvenningssonVästerbotten County Council, SwedenCompleted18 Years65 YearsBoth23Phase 2Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT00787722October 10, 200931/10/2008Hematopoietic Stem Cell Transplant in Devic's DiseaseTrial of High Dose Immunosuppressive Therapy With Hematopoietic Stem Cell Support in Devic's DiseaseDevic's DiseaseProcedure: Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Drug: G-CSF;Drug: rATG;Drug: Mesna;Drug: Rituximab;Drug: MethylprednisoloneNorthwestern UniversityNULLCompleted16 Years65 YearsAll13Phase 1/Phase 2United States
37EUCTR2008-002626-11-SE02/07/200924/04/2009Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosisIntrathecal 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: 14.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Trade Name: Mabthera
Other descriptive name: RITUXIMAB
Dept of NeurologyNULLNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
38NCT00097188December 200418/11/2004A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple SclerosisA 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 SclerosisMultiple SclerosisDrug: rituximabGenentech, Inc.NULLCompleted18 Years55 YearsBoth104Phase 2United States
39NCT00087529June 20049/7/2004A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple SclerosisA 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 SclerosisMultiple SclerosisDrug: placebo;Drug: rituximabGenentech, Inc.NULLCompleted18 Years65 YearsAll439Phase 2/Phase 3Canada;United States
40NCT00501748January 200412/7/2007Safety and Tolerability of Rituximab in Neuromyelitis OpticaOpen Label Study of Safety and Tolerability of Rituximab in Neuromyelitis Optica, Recurrent Transverse Myelitis and Recurrent Bilateral Simultaneous Optic NeuritisNeuromyelitis OpticaDrug: RituximabUniversity of California, San FranciscoGenentech, Inc.Completed12 Years86 YearsBoth20Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2008-005773-35-IT15/01/2013AUTOLOUGUS 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 SMAUTOLOUGUS 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: 15.1Level: LLTClassification code 10028053Term: MSSystem 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 PADOVANULLNAFemale: yes
Male: yes
Phase 1Italy

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 [臨床試験数:145,薬物数:139(DrugBank:23),標的遺伝子数:12,標的パスウェイ数:21
Searched query = "Chronic inflammatory demyelinating polyneuropathy", "Chronic inflammatory demyelinating poly (radiculo) neuropathy", "Multifocal motor neuropathy", "CIDP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
5 / 145 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
1NCT04480450November 202016/7/2020Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II StudyRituximab in Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II StudyChronic Inflammatory Demyelinating PolyneuropathyDrug: RituximabUniversity of Kansas Medical CenterNULLNot yet recruiting18 YearsN/AAll48Phase 2NULL
2NCT03864185March 28, 201919/2/2019The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 AutoantibodiesThe 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 TrialChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Biological: Rituximab (genetical recombination);Other: PlaceboNagoya UniversityJapan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.Active, not recruiting12 YearsN/AAll25Phase 2Japan
3JPRN-jRCT204118003728/03/201931/01/2019RECIPE TrialThe 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 MasahiroNULLNot Recruiting>= 12age oldNot applicableBoth25Japan
4JPRN-UMIN0000357532019/03/2802/02/2019The 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 TrialThe 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 PolyneuropathyCIDP 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 HospitalZenyaku Kogyo Co., Ltd.Complete: follow-up continuing12years-oldNot applicableMale and Female25Phase 2Japan
5EUCTR2017-005034-36-IT22/05/201804/11/2020Study 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: 20.0Level: LLTClassification code 10072650Term: CIDPSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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 HUMANITASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3Italy

17. 多系統萎縮症 [臨床試験数:107,薬物数:153(DrugBank:48),標的遺伝子数:59,標的パスウェイ数:104
Searched query = "Multiple system atrophy", "MSA-C", "MSA-P", "Olivopontocerebellar atrophy", "OPCA", "Striatonigral degeneration", "Shy-Drager syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 107 trial found
No.TrialIDDate_
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Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
1NCT04004819August 15, 201927/6/2019Rituximab for Multiple System AtrphyRituximab Therapy for the Patients With Multiple Syetem AtrophyMultiple System AtrophyDrug: RituximabFirst Affiliated Hospital of Fujian Medical UniversityNULLRecruiting18 Years80 YearsAll50Phase 2China

19. ライソゾーム病 [臨床試験数:784,薬物数:673(DrugBank:101),標的遺伝子数:68,標的パスウェイ数:184
Searched query = "Lysosomal storage disease", "Lysosomal disease", "Gaucher disease", "Niemann-Pick disease", "Niemann-Pick type C", "GM1-gangliosidosis", "GM1-gangliosidoses", "GM2-gangliosidosis", "GM2-gangliosidoses", "Tay-Sachs disease", "Sandhoff disease", "Krabbe disease", "Metachromatic leukodystrophy", "Multiple-sulfatase deficiency", "Farber disease", "Mucopolysaccharidosis type I", "Mucopolysaccharidosis I", "MPS I", "Hurler syndrome", "Scheie syndrome", "Mucopolysaccharidosis type II", "Mucopolysaccharidosis II", "MPS II", "Hunter syndrome", "Mucopolysaccharidosis type III", "Mucopolysaccharidosis III", "MPS III", "Sanfilippo syndrome", "Mucopolysaccharidosis type IV", "Mucopolysaccharidosis IV", "MPS IV", "MPS IVA", "Morquio syndrome", "Morquio A syndrome", "Mucopolysaccharidosis type VI", "Mucopolysaccharidosis VI", "MPS VI", "Maroteaux-Lamy syndrome", "Mucopolysaccharidosis type VII", "Mucopolysaccharidosis VII", "MPS VII", "Sly syndrome", "Mucopolysaccharidosis type IX", "Mucopolysaccharidosis IX", "MPS IX", "Hyaluronidase deficiency", "Sialidosis", "Galactosialidosis", "Mucolipidosis II", "Mucolipidosis type II", "I-cell disease", "Mucolipidosis III", "Mucolipidosis type III", "Alpha-Mannosidosis", "Alpha-Mannosidase Deficiency", "Beta-Mannosidosis", "Beta-Mannosidase Deficiency", "Fucosidosis", "Aspartylglucosaminuria", "Schindler disease", "Kanzaki disease", "Pompe disease", "Acid lipase deficiency", "Wolman disease", "Cholesterol ester storage disease", "Danon disease", "Free sialic acid storage disease", "Salla disease", "Ceroid lipofuscinosis", "Fabry disease", "Cystinosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 784 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT03952637August 19, 201915/5/2019A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human <=-Galactosidase in Type I and Type II GM1 GangliosidosisA Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 GangliosidosisLysosomal Diseases;Gangliosidosis;GM1Biological: 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 examNational Human Genome Research Institute (NHGRI)Axovant Sciences, Inc.Recruiting6 Months12 YearsAll45Phase 1/Phase 2United States
2EUCTR2017-002430-23-IT14/03/201809/03/2020Gene therapy study with autologous hemapoietic stem cells for patients affected by MPSIHA 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: 20.1Level: PTClassification code 10056886Term: Mucopolysaccharidosis ISystem 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 RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6Phase 1Italy

35. 天疱瘡 [臨床試験数:87,薬物数:114(DrugBank:37),標的遺伝子数:17,標的パスウェイ数:158
Searched query = "Pemphigus"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
23 / 87 trials found
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
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agemin
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1NCT04400994June 20, 202027/4/2020IVIG With Rituximab vs Rituximab as First Line Treatment of PemphigusThe Use of IVIG in Combination With Rituximab VS Rituximab as the First Line Treatment of PemphigusPemphigusDrug: Rituximab;Other: IVIgThe University of Hong KongNULLRecruiting18 Years70 YearsAll20Phase 2Hong Kong
2NCT03790293December 20198/10/2018Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 TrialClinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial With Medico-economic Evaluation of the Treatment.Autoimmune DiseasesDrug: Rituximab;Drug: corticosteroids'therapyUniversity Hospital, RouenNULLUnknown status18 Years80 YearsAll90Phase 3NULL
3ChiCTR18000203822019-01-012018-12-27Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigusEfficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus PemphigusGroup 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 UniversityNULLRecruiting1880BothGroup 1:14;Group 2:14;Group 3:14;China
4EUCTR2018-001417-32-FR13/07/201811/06/2018Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3Long-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: 20.0Level: LLTClassification code 10006567Term: Bullous pemphigoidSystem 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 RouenNULLNot RecruitingFemale: yes
Male: yes
77Phase 3France
5JPRN-jRCTs03118040511/05/201722/03/2019Rituximab therapy for refractory pemphigusSafety evaluation study about rituximab therapy for refractory pemphigus Refactory Pemphigus
Other disease of skin or skin tissue
Infuse rituximab 1000mg/body twice biweekly.Funakoshi TakeruNULLRecruiting>= 20age old<= 80age oldBoth20N/AJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-UMIN0000260042017/05/0808/03/2017Safety evaluation study about rituximab therapy for refractory pemphigus pemphigusInfuse rituximab 1000mg/body twice biweeklyKeio University, School of MedicineNULLRecruiting20years-old80years-oldMale and Female10Not appl1cableJapan
7JPRN-UMIN0000242652016/10/0404/10/2016Open-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 pemphigusOpen-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 pemphigusRituximab (genetic recombination)Department of Dermatology,Keio University School of MedicineHOKKAIDO UNIVERSITY HOSPITALOKAYAMA UNIVERSITY HOSPITALKURUME UNIVERSITY HOSPITALComplete: follow-up complete20years-old80years-oldMale and Female10Phase 2Japan
8NCT02383589May 26, 20154/3/2015A 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 VulgarisPemphigus VulgarisDrug: Mycophenolate Mofetil Placebo;Drug: Mycophenolate Mofetil;Drug: Rituximab;Drug: Rituximab PlaceboHoffmann-La RocheGenentech, Inc.Completed18 Years75 YearsAll135Phase 3United States;Argentina;Australia;Brazil;Canada;France;Germany;Israel;Italy;Spain;Turkey;Ukraine
9EUCTR2014-000382-41-FR02/04/201524/06/2015A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA 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 LtdNULLNot Recruiting Female: yes
Male: yes
124 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
10EUCTR2014-000382-41-IT12/03/201502/02/2015A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA 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: 17.1Level: LLTClassification code 10052802Term: Pemphigus vulgarisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
124Phase 3United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
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Inclusion_
agemin
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agemax
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Target_
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PhaseCountries
11EUCTR2014-000382-41-ES09/03/201522/12/2014A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA 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 LtdNULLNot Recruiting Female: yes
Male: yes
124 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
12EUCTR2014-000382-41-DE06/03/201509/12/2014A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Patients With Pemphigus VulgarisA 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 LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
13JPRN-UMIN0000154512014/11/1325/10/2014Exploratory 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, PemphigoidRituximab 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 MedicineHokkaido University, Kurume University, Okayama University, Kawasaki Medical SchoolComplete: follow-up complete20years-old80years-oldMale and Female20Phase 1,2Japan
14JPRN-jRCTs03118022001/05/201415/03/2019Rituximab treatment of blistering diseaseTreatment of refractory autoimmuno blistering disease with rituximab Pemphigus vulgaris, paraneoplastic pemphigus, bullous pemphigoidInfusion of rituximab (1000mg) intravenously. Approximately two weeks after the first dose, a second dose of rituximab is administered in a similar manner.Kanaoka MiwaMichiko AiharaNot Recruiting>= 20age old< 80age oldBoth10N/AJapan
15NCT01974518November 20134/10/2013Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe PemphigusA PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUSPemphigusDrug: Rituximab and Cyclophosphamide IVUprety ShraddhaPostgraduate Institute of Medical Education and ResearchActive, not recruiting18 YearsN/ABoth20Phase 3India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01299857June 201117/2/2011Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by RituximabEVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMABPemphigusDrug: RituximabUniversity Hospital, RouenNULLCompleted18 YearsN/ABoth22Phase 3France
17JPRN-UMIN0000044282010/11/0101/11/2010Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita. pemphigus, bullous pemphigoid, epidermolysis bullosa acquisitaRituximabResearch group of rare intractable dermatologial disorderNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Phase 2Japan
18NCT01338103January 201017/4/2011Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via CylexTreatment 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 TestPemphigusDrug: RituximabRabin Medical CenterLeumit Health ServicesRecruiting18 Years70 YearsBoth10N/AIsrael
19NCT00784589July 20093/11/2008Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With PemphigusComparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With PemphigusPemphigus DiseaseDrug: General Corticotherapy;Drug: RituximabUniversity Hospital, RouenNULLCompleted18 Years80 YearsAll90Phase 3France
20NCT00960713June 200916/7/2009The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune DisordersThe RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune DisordersPemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;CryoglobulinemiaDrug: Rituximab (MABTHERA® or RITUXAN®).University Hospital, ToulouseNULLCompleted18 YearsN/ABoth35N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2008-005266-31-FR06/02/200913/03/2009COMPARAISON 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 IIICOMPARAISON 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: 9.1Level: LLTClassification code 10006567Term: Bullous pemphigoid
Trade Name: mabthéra
Product Name: mathéra
Trade Name: Prednisone
Product Name: CORTANCYL 20 mg
CHU-Hôpitaux de RouenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
22NCT00656656January 20087/4/2008Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for PemphigusCombined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and RituximabPemphigusDrug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus AzathioprineUniversity of LuebeckNULLCompleted18 YearsN/AAll23Phase 2Germany
23EUCTR2007-005711-26-IT15/11/200705/02/2008An 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 - NDAn 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: 9.1Level: LLTClassification code 10034280Term: Pemphigus
Trade Name: MABTHERA
INN or Proposed INN: Rituximab
ISTITUTO DERMOPATICO IMMACOLATANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy

36. 表皮水疱症 [臨床試験数:147,薬物数:170(DrugBank:40),標的遺伝子数:32,標的パスウェイ数:113
Searched query = "Epidermolysis bullosa", "EBS", "JEB", "DDEB", "RDEB", "Kindler syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 147 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN0000044282010/11/0101/11/2010Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita. pemphigus, bullous pemphigoid, epidermolysis bullosa acquisitaRituximabResearch group of rare intractable dermatologial disorderNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Phase 2Japan

41. 巨細胞性動脈炎 [臨床試験数:108,薬物数:111(DrugBank:32),標的遺伝子数:33,標的パスウェイ数:121
Searched query = "Giant cell arteritis", "Temporal arteritis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 108 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003964-30-GB22/10/202031/07/2020Biologics 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: 21.1Level: PTClassification code 10047115Term: VasculitisSystem 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 TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2United Kingdom

42. 結節性多発動脈炎 [臨床試験数:14,薬物数:27(DrugBank:16),標的遺伝子数:26,標的パスウェイ数:102
Searched query = "Polyarteritis nodosa", "PAN"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 14 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003964-30-GB22/10/202031/07/2020Biologics 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: 21.1Level: PTClassification code 10047115Term: VasculitisSystem 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 TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2United Kingdom

43. 顕微鏡的多発血管炎 [臨床試験数:85,薬物数:80(DrugBank:19),標的遺伝子数:13,標的パスウェイ数:85
Searched query = "Microscopic polyangiitis", "MPA"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
36 / 85 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03920722September 201918/2/2019Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic PolyangiitisEfficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic PolyangiitisMicroscopic Polyangiitis (MPA)Drug: Rituximab;Drug: placeboAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupNot yet recruiting18 YearsN/AAll106Phase 3France
2EUCTR2018-000637-12-FR29/03/201931/01/2019Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitisEfficacy 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)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
106 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance
3EUCTR2016-001121-14-NO06/10/201707/02/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden
4EUCTR2016-001121-14-NL15/06/201718/01/2017A 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: 19.1Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
5EUCTR2016-001121-14-BE08/05/201706/02/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-001121-14-HU24/04/201723/01/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
7EUCTR2016-001121-14-DK07/04/201701/02/2017A 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: 20.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
8EUCTR2016-001121-14-GB06/04/201723/12/2016A 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: 20.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Sweden
9EUCTR2016-001121-14-ES21/03/201720/01/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
10EUCTR2016-001121-14-CZ20/03/201712/01/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-001121-14-AT13/02/201710/01/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
12EUCTR2016-001121-14-SE13/02/201721/12/2016A 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: 20.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
13NCT02115997July 6, 201514/4/2014A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic PolyangitisWegener's Granulomatosis or Microscopic PolyangiitisDrug: Methylprednisolone;Drug: Prednisone;Drug: RituximabHoffmann-La RocheNULLRecruiting18 YearsN/AAll30Phase 4India
14EUCTR2015-001807-29-FR09/06/201523/07/2015Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitisPharmacokinetic 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: 18.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem 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-EtienneNULLNot RecruitingFemale: yes
Male: yes
50Phase 4France
15EUCTR2012-001102-14-CZ15/04/201503/01/2013RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitisAn 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: 18.0Level: LLTClassification code 10047889Term: Wegeners granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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 TrustNULLNot RecruitingFemale: yes
Male: yes
190Phase 3Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2012-001102-14-IE10/10/201414/08/2014RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitisAn 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: 18.0Level: LLTClassification code 10047889Term: Wegeners granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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 , IrelandNULLNot RecruitingFemale: yes
Male: yes
190Phase 3Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Sweden
17NCT02198248October 201418/7/2014Low-dose Glucocorticoid Vasculitis Induction StudyLow-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control TrialAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener GranulomatosisDrug: Rituximab;Drug: GlucocorticoidsChiba UniversityNational Hospital Organization Chiba East HospitalActive, not recruiting20 YearsN/AAll140Phase 4Japan
18EUCTR2012-001102-14-IT12/09/201418/12/2013RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitisAn 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: 16.1Level: LLTClassification code 10047889Term: Wegeners granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.1Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.1Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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 TrustNULLNot RecruitingFemale: yes
Male: yes
190Phase 3Spain;Ireland;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
19JPRN-UMIN0000124092014/06/2604/12/2013An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitisAn 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 PolyangiitisExperimental: 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 HospitalThe European Vasculitis SocietyVasculitis Clinical Research ConsortiumComplete: follow-up complete18years-oldNot applicableMale and Female190Phase 3Japan,North America,South America,Australia,Europe
20NCT02169219June 201419/6/2014Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated VasculitisShort-Course Glucocorticoids and Rituximab in ANCA-Associated VasculitisGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: Glucocorticoids;Drug: RituximabMassachusetts General HospitalGenentech, Inc.Completed18 Years85 YearsAll20Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2012-001102-14-ES21/06/201316/05/2013RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitisAn 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: 16.0Level: LLTClassification code 10047889Term: Wegeners granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.0Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.0Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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 TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190New Zealand;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;Sweden
22NCT01750697May 23, 201313/12/2012A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisA 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 PolyangiitisGranulomatosis With PolyangiitisDrug: RituximabHoffmann-La RocheNULLCompleted2 Years17 YearsAll25Phase 2United States;Canada;France;Germany;Italy;Serbia;Turkey;United Kingdom
23NCT01697267April 201331/8/2012Rituximab Vasculitis Maintenance StudyAn International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated VasculitisAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener GranulomatosisBiological: Rituximab;Drug: AzathioprineCambridge University Hospitals NHS Foundation TrustArthritis Research UK;Roche Pharma AG;Genentech, Inc.;University of PennsylvaniaCompleted15 YearsN/AAll188Phase 3United States;Australia;Canada;Czechia;Ireland;Italy;Japan;New Zealand;Sweden;United Kingdom;Czech Republic
24EUCTR2012-002062-13-DE14/03/201313/09/2012A 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 polyangiitisA 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: 19.0Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
25Phase 2Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom
25EUCTR2012-002062-13-IT28/01/201311/01/2013A 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 POLYANGIITISA 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: 14.1Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.1Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Turkey;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2012-002062-13-GB18/01/201323/08/2012A 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 polyangiitisA 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: 19.0Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
25Phase 2United States;Serbia;France;Canada;Turkey;Germany;Italy;United Kingdom
27NCT01731561November 16, 201212/10/2012Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated VasculitisMAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis IIGranulomatosis With Polyangiitis;Microscopic Polyangiitis;Renal Limited FormsDrug: Rituximab (Arm B);Drug: Rituximab (Arm A)Assistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll166Phase 3France
28NCT01613599June 20, 20124/6/2012An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisProspective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With RituximabGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: RituximabGenentech, Inc.NULLCompleted18 YearsN/AAll100United States
29NCT00748644October 20085/9/2008Efficacy Study of Two Treatments in the Remission of VasculitisMAINtenance of Remission Using RITuximab in Systemic ANCA-associated VasculitisWegener Granulomatosis;Microscopic PolyangiitisDrug: Rituximab;Drug: AzathioprineAssistance Publique - Hôpitaux de ParisNULLCompleted18 Years75 YearsAll117Phase 3France
30EUCTR2005-003610-15-CZ29/08/200623/02/2006An 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. - RITUXVASAn 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: RituximabAddenbrooke's Hospital, Cambridge University Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66United Kingdom;Czech Republic;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00104299January 200524/2/2005Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic PolyangiitisRituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)Vasculitis;Wegener's Granulomatosis;Microscopic PolyangiitisDrug: Rituximab plus cyclophosphamide placebo (rituximab group);Drug: Cyclophosphamide plus rituximab placebo (control group);Drug: Azathioprine;Drug: Methylprednisolone (or other glucocorticoid);Drug: PrednisoneNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Genentech, Inc.Completed15 YearsN/AAll197Phase 2/Phase 3United States;Netherlands
32NCT00307593May 200424/3/2006RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing VasculitidesInfliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant TherapiesWegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic PolyangiitisDrug: Infliximab;Drug: RituximabAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/ABoth20N/AFrance
33EUCTR2012-001102-14-GB07/09/2012RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitisAn 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 System Organ Class: 10047065 - Vascular disorders
MedDRA version: 15.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 15.0 Level: PT 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 TrustNULLNot Recruiting Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSpain;Ireland;Austria;Italy;United Kingdom;Czech Republic;Canada;Switzerland;Mexico;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
34EUCTR2016-001121-14-FR22/06/2018A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
35EUCTR2016-001121-14-IE21/12/2016A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-001121-14-DE23/12/2016A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

44. 多発血管炎性肉芽腫症 [臨床試験数:84,薬物数:88(DrugBank:22),標的遺伝子数:13,標的パスウェイ数:37
Searched query = "Wegener granulomatosis", "Multiple vasculitis granulomatous disease", "Granulomatosis with polyangiitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
30 / 84 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03967925February 1, 201918/1/2019Rituximab and Belimumab Combination Therapy in PR3 VasculitisA Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated VasculitisANCA Associated Vasculitis;Granulomatosis With PolyangiitisDrug: Belimumab;Drug: Rituximab;Drug: PrednisoloneRachel JonesGlaxoSmithKline;Medical Research Council;Imperial College London;University College, London;Newcastle University;University of Glasgow;University of CambridgeRecruiting18 YearsN/AAll30Phase 2United Kingdom
2NCT03164473March 7, 201822/5/2017Maintenance 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 TrialEosinophilic Granulomatosis With PolyangiitisDrug: Rituximab;Drug: Azathioprine;Drug: Placebo-rituximab;Drug: Placebo-azathioprineAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupRecruiting18 YearsN/AAll98Phase 4France
3EUCTR2016-001121-14-NO06/10/201707/02/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden
4EUCTR2016-001121-14-NL15/06/201718/01/2017A 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: 19.1Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
5EUCTR2016-001121-14-BE08/05/201706/02/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-001121-14-HU24/04/201723/01/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
7EUCTR2016-001121-14-DK07/04/201701/02/2017A 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: 20.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
8EUCTR2016-001121-14-GB06/04/201723/12/2016A 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: 20.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Sweden
9EUCTR2016-001121-14-ES21/03/201720/01/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
10EUCTR2016-001121-14-CZ20/03/201712/01/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-001121-14-SE13/02/201721/12/2016A 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: 20.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
12EUCTR2016-001121-14-AT13/02/201710/01/2017A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
13NCT02807103December 5, 201620/5/2016Rituximab in Eosinophilic Granulomatosis With PolyangiitisEvaluation 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 StudyEosinophilic Granulomatosis With Polyangiitis (EGPA)Drug: Rituximab;Drug: Placebo-rituximab;Drug: Cyclophosphamide;Drug: Placebo-cyclophosphamideAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupRecruiting18 YearsN/AAll108Phase 3France
14EUCTR2016-000275-25-FR21/03/201613/04/2016Evaluation 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. - REOVASEvaluation 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: 19.0Level: PTClassification code 10048594Term: Allergic granulomatous angiitisSystem 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)NULLNot RecruitingFemale: yes
Male: yes
108Phase 3France
15NCT02626845December 20158/12/2015Rituximab for the Otolaryngologic Manifestations of Granulomatosis With PolyangiitisRituximab for the Otolaryngologic Manifestations of Granulomatosis With PolyangiitisGranulomatosis With Polyangiitis (Wegener's Granulomatosis)Drug: Rituximab;Other: PlaceboHospital for Special Surgery, New YorkGenentech, Inc.;Roche Pharma AGTerminated18 YearsN/AAll3Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2015-001807-29-FR09/06/201523/07/2015Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitisPharmacokinetic 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: 18.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem 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-EtienneNULLNot RecruitingFemale: yes
Male: yes
50Phase 4France
17NCT02198248October 201418/7/2014Low-dose Glucocorticoid Vasculitis Induction StudyLow-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control TrialAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener GranulomatosisDrug: Rituximab;Drug: GlucocorticoidsChiba UniversityNational Hospital Organization Chiba East HospitalActive, not recruiting20 YearsN/AAll140Phase 4Japan
18JPRN-UMIN0000124092014/06/2604/12/2013An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitisAn 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 PolyangiitisExperimental: 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 HospitalThe European Vasculitis SocietyVasculitis Clinical Research ConsortiumComplete: follow-up complete18years-oldNot applicableMale and Female190Phase 3Japan,North America,South America,Australia,Europe
19NCT02169219June 201419/6/2014Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated VasculitisShort-Course Glucocorticoids and Rituximab in ANCA-Associated VasculitisGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: Glucocorticoids;Drug: RituximabMassachusetts General HospitalGenentech, Inc.Completed18 Years85 YearsAll20Phase 4United States
20NCT01750697May 23, 201313/12/2012A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisA 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 PolyangiitisGranulomatosis With PolyangiitisDrug: RituximabHoffmann-La RocheNULLCompleted2 Years17 YearsAll25Phase 2United States;Canada;France;Germany;Italy;Serbia;Turkey;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01697267April 201331/8/2012Rituximab Vasculitis Maintenance StudyAn International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated VasculitisAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener GranulomatosisBiological: Rituximab;Drug: AzathioprineCambridge University Hospitals NHS Foundation TrustArthritis Research UK;Roche Pharma AG;Genentech, Inc.;University of PennsylvaniaCompleted15 YearsN/AAll188Phase 3United States;Australia;Canada;Czechia;Ireland;Italy;Japan;New Zealand;Sweden;United Kingdom;Czech Republic
22EUCTR2012-002062-13-DE14/03/201313/09/2012A 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 polyangiitisA 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: 19.0Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
25Phase 2Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom
23EUCTR2012-002062-13-IT28/01/201311/01/2013A 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 POLYANGIITISA 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: 14.1Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.1Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Turkey;United Kingdom;Italy
24EUCTR2012-002062-13-GB18/01/201323/08/2012A 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 polyangiitisA 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: 19.0Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
25Phase 2United States;Serbia;France;Canada;Turkey;Germany;Italy;United Kingdom
25NCT01731561November 16, 201212/10/2012Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated VasculitisMAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis IIGranulomatosis With Polyangiitis;Microscopic Polyangiitis;Renal Limited FormsDrug: Rituximab (Arm B);Drug: Rituximab (Arm A)Assistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll166Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01613599June 20, 20124/6/2012An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisProspective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With RituximabGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: RituximabGenentech, Inc.NULLCompleted18 YearsN/AAll100United States
27NCT00748644October 20085/9/2008Efficacy Study of Two Treatments in the Remission of VasculitisMAINtenance of Remission Using RITuximab in Systemic ANCA-associated VasculitisWegener Granulomatosis;Microscopic PolyangiitisDrug: Rituximab;Drug: AzathioprineAssistance Publique - Hôpitaux de ParisNULLCompleted18 Years75 YearsAll117Phase 3France
28EUCTR2016-001121-14-IE21/12/2016A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
29EUCTR2016-001121-14-DE23/12/2016A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
30EUCTR2016-001121-14-FR22/06/2018A 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 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT 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.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

45. 好酸球性多発血管炎性肉芽腫症 [臨床試験数:27,薬物数:41(DrugBank:18),標的遺伝子数:18,標的パスウェイ数:98
Searched query = "Eosinophilic granulomatosis with Polyangiitis", "EGPA", "Eosinophilic multiple vasculitis granulomatous disease", "Allergic granulomatous angiitis", "Churg-Strauss syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
4 / 27 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02807103December 5, 201620/5/2016Rituximab in Eosinophilic Granulomatosis With PolyangiitisEvaluation 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 StudyEosinophilic Granulomatosis With Polyangiitis (EGPA)Drug: Rituximab;Drug: Placebo-rituximab;Drug: Cyclophosphamide;Drug: Placebo-cyclophosphamideAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupRecruiting18 YearsN/AAll108Phase 3France
2EUCTR2016-000275-25-FR21/03/201613/04/2016Evaluation 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. - REOVASEvaluation 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: 19.0Level: PTClassification code 10048594Term: Allergic granulomatous angiitisSystem 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)NULLNot RecruitingFemale: yes
Male: yes
108Phase 3France
3NCT00424749June 200719/1/2007Rituxan in Churg Strauss Syndrome With Renal InvolvementA Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal InvolvementChurg-Strauss SyndromeDrug: Rituximab;Drug: PrednisoneFernando FervenzaGenentech, Inc.;Biogen;National Center for Research Resources (NCRR)Terminated18 YearsN/AAll4Phase 2United States
4NCT00307593May 200424/3/2006RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing VasculitidesInfliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant TherapiesWegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic PolyangiitisDrug: Infliximab;Drug: RituximabAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/ABoth20N/AFrance

46. 悪性関節リウマチ [臨床試験数:4,183,薬物数:2,538(DrugBank:401),標的遺伝子数:183,標的パスウェイ数:219
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
224 / 4,183 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002507-19-NL07/09/202003/09/2020Research into administration of lower dosed rituximab with an injectionComparison 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: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 MaartenskliniekNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 4Netherlands
2EUCTR2019-002810-37-PL16/06/202011/03/2020A 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: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany
3EUCTR2019-002810-37-BG15/06/202028/04/2020A 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: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany
4EUCTR2019-002810-37-LT17/04/202003/03/2020A 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: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany
5NCT04268771April 8, 202031/1/2020A Phase III Transition Study of DRL Rituximab to Reference Medicinal ProductsA 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 ArthritisBiological: Experimental: Arm A: DRL_RI;Biological: Arm B: Rituxan®/Mabthera®Dr. Reddy's Laboratories LimitedPPDRecruiting18 YearsN/AAll140Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-002810-37-HU09/03/202020/01/2020A 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: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary
7EUCTR2019-001754-25-NL25/11/201925/11/2019Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatmentUsing 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
ReadeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 4Netherlands
8EUCTR2018-003877-91-DE13/06/201926/02/2019B 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 therapySequential 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: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 ErlangenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Germany
9EUCTR2017-004079-30-PT09/08/201829/06/2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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: 20.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
207Phase 3Portugal;Belgium;Spain;Italy
10EUCTR2018-002368-18-ES25/07/201825/07/2018Phase 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 loadPhase 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: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 20.0Level: PTClassification code 10058467Term: Lung neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0Level: PTClassification code 10063581Term: Stem cell transplantSystem 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
740Phase 4Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-004079-30-ES10/07/201821/03/2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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: 20.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
207Phase 3Portugal;Belgium;Spain;Italy
12EUCTR2017-004079-30-BE19/02/201819/02/2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
219 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;Spain;Belgium;Italy
13EUCTR2013-005543-90-EE07/08/201702/06/2017This 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: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
14EUCTR2014-005368-13-IT10/05/201716/02/2018A 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: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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 LIMITEDNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
15EUCTR2014-005368-13-DE22/11/201604/07/2016A 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: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2016-002908-15-NL08/11/201623/08/2016REDO study: Research into the effects of lower doses rituximab in patients with rheumatoid arthritisREDO 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 MaartenskliniekNULLNot Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesNetherlands
17EUCTR2014-005368-13-ES23/09/201615/07/2016A 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: 19.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
18EUCTR2014-005368-13-HU19/09/201611/07/2016A 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: 19.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy
19EUCTR2012-002535-28-NL13/09/201601/09/2016A 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: 19.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 4Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
20EUCTR2014-005368-13-CZ13/09/201613/09/2016A 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: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
282Phase 1;Phase 3United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02792699May 17, 201625/4/2016Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to RituximabA Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid ArthritisArthritis, RheumatoidDrug: ABP 798;Drug: Rituximab (US);Drug: Rituximab (EU)AmgenNULLCompleted18 Years80 YearsAll311Phase 3United States;Bulgaria;Estonia;Germany;Hungary;Poland;Canada
22NCT03355872February 201622/11/2017A 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 DMARDsA 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 DMARDsRheumatoid ArthritisDrug: HLX01Shanghai Henlius BiotechNULLCompleted18 Years65 YearsAll194Phase 1/Phase 2NULL
23EUCTR2012-003876-38-PL10/11/201516/11/2015Clinical 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 pastA 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: 19.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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)NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Poland;Germany
24EUCTR2015-000581-58-CZ14/10/201516/06/2015A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of ActionA 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 PrahaNULLNot RecruitingFemale: yes
Male: yes
40Phase 4Czech Republic
25EUCTR2012-003876-38-HU28/07/201522/05/2015Clinical 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 pastA 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: 18.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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)NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2012-002535-28-ES22/07/201510/07/2015A 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: 18.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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)NULLNot RecruitingFemale: yes
Male: yes
180Phase 4Portugal;Belgium;Spain;Netherlands;Italy;United Kingdom
27EUCTR2012-003876-38-DE21/07/201529/04/2015Clinical 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 pastA 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: 19.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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)NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Poland;Germany
28NCT02514772July 201530/7/2015GP2013 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 ArthritisBiological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ®SandozHexal AGCompleted18 YearsN/AAll107Phase 3United States;Germany;Hungary;Poland
29EUCTR2010-021184-32-BG27/05/201514/04/2015GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA 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: 18.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 AGNULLNot RecruitingFemale: yes
Male: yes
124Phase 1;Phase 2United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
30EUCTR2010-021184-32-PL21/04/201506/02/2015GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA 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: 18.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 AGNULLNot RecruitingFemale: yes
Male: yes
124Phase 1;Phase 2United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2010-021184-32-GB25/03/201512/06/2015GP2013 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 AGNULLNot Recruiting Female: yes
Male: yes
124 Human pharmacology (Phase 1): yes Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
32NCT02304354March 9, 20154/11/2014Relationship 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 ArthritisDrug: RituximabUniversity Hospital, ToursNULLActive, not recruiting18 YearsN/AAll70Phase 3France
33EUCTR2014-003255-54-CZ21/01/201524/10/2014A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid ArthritisA 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: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 PlcNULLNot RecruitingFemale: yes
Male: yes
142Phase 1;Phase 3Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany
34EUCTR2012-002535-28-IT16/01/201504/11/2014Not applicableA 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: 17.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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 LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Portugal;Belgium;United Kingdom;Italy
35EUCTR2010-021184-32-HU09/01/201527/10/2014GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA 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: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 AGNULLNot RecruitingFemale: yes
Male: yes
124Phase 1;Phase 2United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2013-005543-90-BG06/01/201522/10/2014This 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: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
37NCT02371096January 20155/2/2015Comparative Pharmacokinetic Trial of RGB-03 and MabTheraRheumatoid ArthritisDrug: MabThera (rituximab);Drug: RGB-03Gedeon Richter Plc.NULLNot yet recruiting18 Years75 YearsBothPhase 1NULL
38EUCTR2014-003529-16-GB16/12/201422/06/2015Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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: 20.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
219Phase 3United Kingdom
39EUCTR2013-005543-90-DE19/11/201416/06/2014This 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: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
40EUCTR2014-000859-91-FR03/10/201418/06/2015Relation 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: 18.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 TOURSNULLNot RecruitingFemale: yes
Male: yes
100Phase 4France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2013-004555-21-GR22/09/201421/03/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA 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: 16.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;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
42EUCTR2013-005543-90-PL09/09/201411/07/2014This 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: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
43EUCTR2013-005543-90-HU26/08/201413/05/2014This 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: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 1;Phase 3United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany
44EUCTR2013-002622-23-NL24/06/201417/02/2014Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trialSafety 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: 16.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 16.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
250United 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
45EUCTR2012-002535-28-PT06/06/201425/02/2014Not applicableA 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: 20.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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 LondonNULLNot RecruitingFemale: yes
Male: yes
160Phase 4Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2012-002535-28-BE28/04/201428/03/2014A 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-RAA 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)NULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesPortugal;Spain;Belgium;Netherlands;Italy;United Kingdom
47EUCTR2013-004555-21-AT07/04/201402/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA 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: 19.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of
48EUCTR2013-004555-21-SK07/04/201423/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA 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: 16.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;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
49EUCTR2013-004555-21-HU02/04/201423/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA 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: 18.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Korea, 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
50EUCTR2013-004555-21-DE31/03/201417/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA 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: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
361Phase 3Portugal;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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2013-004555-21-PT24/03/201407/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA 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: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
52EUCTR2012-003194-25-HR17/03/201403/09/2014Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid ArthritisRandomized, 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.NULLNot Recruiting Female: yes
Male: yes
863 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia
53EUCTR2013-004555-21-LV03/03/201402/01/2014This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid ArthritisA 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: 16.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem 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.NULLNot RecruitingFemale: yes
Male: yes
361Phase 3Portugal;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
54EUCTR2012-003223-38-DE01/07/201308/04/2013Rheumatoid 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: 17.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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 10017NULLNot RecruitingFemale: yes
Male: yes
157Phase 2United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
55EUCTR2012-003223-38-GB14/05/201312/02/2013Rheumatoid 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 10017NULLNot Recruiting Female: yes
Male: yes
157 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT02468791May 20139/6/2015MabionCD20® Compared to MabThera® in Patients With Rheumatoid ArthritisA Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: RituximabMabion SANULLCompleted18 Years80 YearsAll709Phase 3Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine
57NCT01873443May 201322/5/2013Long-Term Efficacy and Safety of CT-P10 in Patients With RAAn 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 1.1Rheumatoid ArthritisDrug: Rituximab, MTX, folic acidCelltrionNULLCompleted18 Years75 YearsBoth87Phase 1Korea, Republic of
58EUCTR2011-002894-48-NO11/04/201306/09/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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: 14.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United 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
59EUCTR2011-002896-40-PL29/03/201311/02/2013A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA 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: 14.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
60EUCTR2012-003223-38-ES27/02/201304/03/2013Rheumatoid 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: 14.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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 10017NULLNot RecruitingFemale: yes
Male: yes
157United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2011-002894-48-BG06/02/201320/11/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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: 17.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
300Serbia;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
62EUCTR2012-003194-25-LT04/02/201324/09/2012Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid ArthritisRandomized, 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: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
863Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia
63EUCTR2011-002894-48-DE25/01/201324/07/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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: 18.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
459Serbia;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
64EUCTR2012-002535-28-GB21/01/201314/12/2012A 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-RAA 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: 20.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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)NULLNot RecruitingFemale: yes
Male: yes
160Phase 4Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
65EUCTR2011-002894-48-ES18/01/201329/10/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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: 14.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
300United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT01759030December 201220/12/2012Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid ArthritisDouble 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 TherapiesRheumatoid ArthritisDrug: RituximabBiocadNULLCompleted18 Years80 YearsAll181Phase 3Belarus;India;Russian Federation;Ukraine;Colombia
67EUCTR2011-002894-48-GR16/11/201219/10/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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: 14.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United 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
68EUCTR2011-002894-48-PT09/11/201209/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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: 15.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 15.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
300United 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
69EUCTR2011-002896-40-DE23/10/201202/07/2012A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA 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: 16.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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 USNULLNot RecruitingFemale: yes
Male: yes
195United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
70EUCTR2011-002894-48-HU16/10/201216/08/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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: 17.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
459Serbia;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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2011-002894-48-EE08/10/201208/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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: 14.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United 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
72EUCTR2011-002894-48-GB14/09/201206/12/2011Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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 GmbHNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): yes Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;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
73EUCTR2011-002894-48-NL10/09/201214/12/2011Efficacy, 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: 17.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
459Serbia;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
74NCT01682512September 5, 201210/8/2012Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid ArthritisEfficacy, 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, RheumatoidDrug: BI 695500;Drug: Rituxan®;Drug: MabThera®Boehringer IngelheimNULLTerminated18 Years80 YearsAll294Phase 3United 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
75NCT01643928August 16, 20126/7/2012Rheumatoid 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 TRIALSRheumatoid ArthritisBiological: Rituximab-Pfizer (PF-05280586) x 3 courses;Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses;Biological: Rituximab-US + Rituximab-Pfizer x 2 CoursesPfizerNULLCompleted18 YearsN/AAll185N/AUnited States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Switzerland;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2011-002896-40-GB14/08/201211/06/2012A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA 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 10017NULLNot Recruiting Female: yes
Male: yes
195 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited 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
77EUCTR2011-002894-48-BE02/08/201218/07/2012Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trialEfficacy, 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: 17.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
MedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
459Phase 1;Phase 3Serbia;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
78EUCTR2011-005021-48-NL07/06/201205/06/2012A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
79EUCTR2011-005021-48-CZ23/05/201215/02/2012A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
80EUCTR2011-005021-48-ES14/05/201221/02/2012A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2012-000139-21-AT14/05/201223/04/2012Multi-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 IIINULLNot RecruitingFemale: yes
Male: yes
Phase 4Czech Republic;Slovakia;Austria;Russian Federation;Switzerland
82EUCTR2011-005021-48-BG09/05/201220/04/2012A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
83EUCTR2011-005021-48-HU04/05/201215/02/2012A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
84EUCTR2011-005021-48-PL10/04/201214/03/2012A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 IndustriesNULLNot RecruitingFemale: yes
Male: yes
544Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of
85EUCTR2011-004171-36-ES30/03/201230/01/2012A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
616Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2011-004171-36-PL29/03/201222/02/2012A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
616Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
87EUCTR2010-021184-32-EE23/03/201208/03/2012GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA 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: 18.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Germany
88NCT01526057March 20, 20121/2/2012A 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 THERAPIESRheumatoid ArthritisBiological: PF-05280586;Biological: MabThera;Biological: RituxanPfizerNULLCompleted18 YearsN/AAll220Phase 2United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Taiwan
89EUCTR2011-006001-10-IT19/03/201214/03/2012Efficacy 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 responseEfficacy 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: 14.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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 VERONANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Italy
90EUCTR2011-004171-36-GB24/02/201215/12/2011A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
616Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2011-004171-36-HU23/02/201216/12/2011A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
616Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
92EUCTR2011-004171-36-CZ15/02/201230/11/2011A 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: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
616Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
93NCT01534884February 20128/2/2012Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid ArthritisPhase 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 ArthritisRheumatoid ArthritisBiological: rituximabCelltrionNULLCompleted18 Years75 YearsBoth154Phase 1Korea, Republic of
94NCT01613027February 201225/5/2012An Observational Study of MabThera in Participants With Severe Active Rheumatoid ArthritisA 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 ArthritisBiological: RituximabHoffmann-La RocheNULLCompleted18 YearsN/AAll135N/AGreece
95NCT01592292November 201111/4/2012An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha TherapyA 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 AgentRheumatoid ArthritisDrug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: InfliximabHoffmann-La RocheNULLCompleted20 YearsN/AAll90N/AKorea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT01641952October 201113/7/2012An 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) AgentNon-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 ProgramRheumatoid ArthritisDrug: RituximabHoffmann-La RocheNULLCompleted18 YearsN/AAll505N/ARomania
97EUCTR2010-021184-32-IT03/08/201102/02/2011GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA 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: 16.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany
98NCT01295151August 201111/2/2011SWITCH 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 DrugRheumatoid ArthritisDrug: Etanercept;Drug: Abatacept;Biological: Rituximab;Drug: Adalimumab;Drug: Certolizumab Pegol;Drug: Infliximab;Drug: GolimumabJulia BrownNULLCompleted18 YearsN/ABoth122Phase 4United Kingdom
99NCT01382940July 26, 201124/6/2011A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid ArthritisA Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: rituximab;Drug: methotrexate;Drug: methylprednisolone;Drug: acetaminophen;Drug: antihistamineHoffmann-La RocheNULLCompleted18 YearsN/AAll351Phase 4United States
100NCT01390441July 20117/7/2011A 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 ArthritisBiological: MK-8808;Biological: MabThera® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: LoratadineMerck Sharp & Dohme Corp.NULLTerminated18 Years65 YearsAll100Phase 1Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2010-021184-32-BE08/06/201114/04/2011GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA 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: 16.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
102EUCTR2010-023880-17-GB31/03/201125/02/2011SWITCH Clinical Trial for Patients with Rheumatoid Arthritis who have failed an initial TNF-blocking drugSWITCH: 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 LeedsNULLNot Recruiting Female: yes
Male: yes
477 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited Kingdom
103NCT01332994March 201118/3/2011A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid ArthritisEfficacy 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 ArthritisDrug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll519Phase 3Germany
104EUCTR2010-020499-50-GB07/02/201131/12/2010Changes 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: 13Level: PTClassification code 10039073Term: rheumatoid arthritis
Trade Name: MabThera
Product Name: rituximab
South Tees Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
46Phase 4United Kingdom
105NCT01765374February 201112/5/2011Study of Sonographic Efficacy of Rituximab in Rheumatoid ArthritisStudy of Sonographic Efficacy of Rituximab in Rheumatoid ArthritisRheumatoid ArthritisDevice: ESAOTE MyLab60;Drug: RituximabUniversity Hospital, RouenNULLCompleted18 YearsN/ABoth30Phase 4France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2010-022049-88-DE05/01/201111/11/2010Efficacy 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) - MIRAIEfficacy 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 AGNULLNot RecruitingFemale: yes
Male: yes
Germany
107NCT01274182January 201110/1/2011GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA 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 ArthritisBiological: GP2013;Biological: MabThera;Biological: RituxanSandozNovartis PharmaceuticalsCompleted18 YearsN/AAll312Phase 1/Phase 2United States;Argentina;Austria;Belgium;Brazil;Estonia;France;Germany;Hungary;India;Italy;Romania;Spain;Turkey
108EUCTR2010-021184-32-DE30/11/201030/08/2010GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA 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: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
109EUCTR2010-021184-32-AT11/11/201019/10/2010GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard TherapyA 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 AGNULLNot RecruitingFemale: yes
Male: yes
288Phase 2Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
110EUCTR2010-021184-32-FR28/10/201013/09/2010A 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 therapiesA 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: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Hexal AGNULLNot RecruitingFemale: yes
Male: yes
164Phase 2France;Hungary;Estonia;Poland;Belgium;Spain;Austria;Bulgaria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT01244958August 201028/9/2010Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid ArthritisAddition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis - a Multicenter Randomised Double-blind Clinical TrialRheumatoid ArthritisBiological: Rituximab;Drug: PlaceboFrank BehrensNULLCompleted18 Years75 YearsBoth156Phase 3Germany
112NCT01593332July 20107/1/2012Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid ArthritisDMARD Resistant Rheumatoid ArthritisDrug: RituximabMashhad University of Medical SciencesRoche Pharma AGCompleted19 Years75 YearsBoth44Phase 4Iran, Islamic Republic of
113EUCTR2009-015950-39-DE12/05/201028/12/2009Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritisAddition 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
Germany
114NCT01021735April 201027/11/2009Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic TherapyOptimal Management of Rheumatoid Arthritis Patients Requiring Biologic TherapyRheumatoid ArthritisDrug: etanercept or adalimumab;Drug: RituximabUniversity of GlasgowArthritis Research Campaign;NHS Lothian;NHS Grampian;NHS Tayside;NHS Borders;NHS FifeCompleted18 YearsN/ABoth302Phase 4United Kingdom
115NCT01117129April 20104/5/2010A 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 ArthritisDrug: rituximab [MabThera/Rituxan];Drug: placebo;Drug: methotrexate;Drug: rituximab [Mabthera/Rituxan]Hoffmann-La RocheNULLTerminated18 Years75 YearsBoth2Phase 4Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2009-016789-10-NL19/02/201017/11/2009Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximabEfficacy 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 therapyTrade Name: Focetria
Trade Name: Pandemrix,
Div KIR AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
117NCT02731560January 20106/3/2016Rituximab (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 ArthritisDrug: RituximabProf. Abid Z. FarooqiAga Khan University;Fatima Memorial Hospital;Fauji Foundation Hospital, RawalpindiCompleted18 Years80 YearsBoth74Phase 4NULL
118NCT01071798January 201018/2/2010An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid ArthritisA 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 CareRheumatoid ArthritisDrug: RituximabHoffmann-La RocheNULLCompleted18 YearsN/AAll1653N/AGermany;United States
119EUCTR2009-011268-13-GB31/12/200915/03/2010Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT studyOptimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study Rheumatoid Arthritis
MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 ClydeUniversity of GlasgowNot RecruitingFemale: yes
Male: yes
United Kingdom
120NCT01000441December 200922/10/2009Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid ArthritisRotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid ArthritisRheumatoid ArthritisDrug: infliximab, etanercept, adalimumab;Drug: abatacept, rituximab or tocilizumabUniversity Hospital, Strasbourg, FranceNULLRecruiting18 YearsN/ABoth300Phase 4France;Monaco
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT00844714November 200912/2/2009Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab TherapyCardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab TherapyEndothelial Function;Rheumatoid Arthritis;InflammationDrug: RituxanUniversity of California, San FranciscoGenentech, Inc.Completed18 YearsN/AAll20N/AUnited States
122EUCTR2008-005450-20-BE29/10/200901/10/2009The 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: 12.0Level: PTClassification code 10039073Term: 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 DiseasesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Belgium
123NCT01075477September 200924/2/2010An 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 GuidelinesRheumatoid ArthritisDrug: rituximab [Mabthera/Rituxan]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth151N/AFinland;United States
124EUCTR2008-005525-11-GR20/07/200917/11/2009A 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: 9.1Level: LLTClassification code 10039073Term: 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 LtdNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Greece;Spain;Netherlands;Germany;United Kingdom
125EUCTR2009-010955-29-NL13/07/200927/02/2009Prevention 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, AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2008-002381-55-ES16/06/200901/08/2008Evaluación 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: 9.1Level: LLTClassification code 10039073Term: 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.NULLNot RecruitingFemale: yes
Male: yes
Spain
127EUCTR2008-005525-11-DE24/04/200909/12/2008A 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: 13.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
81United Kingdom;Germany;Netherlands;France;Spain
128EUCTR2008-005525-11-NL31/03/200912/12/2008A 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: 9.1Level: LLTClassification code 10039073Term: 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 LtdNULLNot RecruitingFemale: yes
Male: yes
81France;Spain;Germany;Netherlands;United Kingdom
129NCT00845832March 200917/2/2009A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to MethotrexateA 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 MethotrexateRheumatoid ArthritisDrug: Placebo;Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLTerminated18 Years65 YearsAll24Phase 2France;Germany;Greece;Netherlands;Poland;Spain;Switzerland;United Kingdom;Belgium;Sweden
130EUCTR2008-005525-11-FR06/02/200913/03/2009A 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: 9.1Level: LLTClassification code 10039073Term: 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81United Kingdom;Germany;Netherlands;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2008-005525-11-ES29/01/200909/12/2008Estudio 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: 9.1Level: LLTClassification code 10039073Term: 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81United Kingdom;Germany;Netherlands;France;Spain
132EUCTR2008-005525-11-GB29/12/200816/12/2008A 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 LtdNULLNot Recruiting Female: yes
Male: yes
81 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Greece;Spain;Netherlands;Germany;United Kingdom
133EUCTR2007-001585-33-DE19/08/200814/04/2008A 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-SCOREA 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Netherlands;Latvia;Germany
134NCT00147966June 20082/9/2005Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial BiopsiesRheumatoid ArthritisDrug: rituximabUniversity of California, San DiegoGenentech, Inc.Completed18 Years75 YearsAll24Phase 2United States
135EUCTR2007-003647-75-FR01/04/200807/02/2008A 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 arthritisA 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: 9.1Level: LLTClassification code 10039073Term: 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 InternationalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Finland;United Kingdom;Netherlands;France;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT02622503April 20082/12/2015A Study on Rheumatoid Arthritis Patients Treated With RituximabRetrospective Data Collection on Rheumatoid Arthritis (RA) Patients Treated With Rituximab in Finland.Rheumatoid ArthritisDrug: RituximabHoffmann-La RocheNULLCompletedN/AN/ABoth81N/AFinland
137NCT01000610March 17, 200821/10/2009A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to MethotrexateAn 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 MethotrexateRheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisoloneHoffmann-La RocheNULLCompleted18 YearsN/AAll18Phase 4Tunisia
138EUCTR2007-003623-20-ES12/03/200804/02/2008Estudio 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Dr. Juan D. Cañete Crespillo, Hospital Clínic de BarcelonaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
139NCT00664521March 200821/4/2008Atacicept 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 ArthritisBiological: Rituximab;Drug: Atacicept;Drug: Placebo matched to ataciceptMerck KGaANULLCompleted18 YearsN/AAll27Phase 2France;Netherlands;Sweden;United Kingdom;Finland
140EUCTR2007-001585-33-GR26/02/200809/08/2007A 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. - SCOREA 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman- La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2007-003647-75-GB15/02/200810/12/2007A 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 arthritisA 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 - GenevaNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Finland;Netherlands;United Kingdom;Sweden
142EUCTR2007-003647-75-NL07/02/200829/11/2007A 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 arthritisA 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: 9.1Level: LLTClassification code 10039073Term: 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 InternationalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Sweden;France;Finland;United Kingdom;Netherlands
143EUCTR2007-003647-75-SE06/02/200804/12/2007A 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 arthritisA 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: 9.1Level: LLTClassification code 10039073Term: 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Finland;United Kingdom;Netherlands;France;Sweden
144EUCTR2007-003647-75-FI31/01/200819/12/2007A 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 arthritisA 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: 9.1Level: LLTClassification code 10039073Term: 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Finland;United Kingdom;Netherlands;France;Sweden
145NCT00963703December 200720/8/2009Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid ArthritisTreatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial OutcomesRheumatoid ArthritisDrug: RituximabUniversity of ManitobaHoffmann-La RocheCompleted18 YearsN/ABoth15N/ACanada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT00576433December 200718/12/2007A 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 InhibitorRheumatoid ArthritisDrug: Methotrexate;Drug: rituximab [MabThera/Rituxan]Hoffmann-La RocheNULLCompleted18 Years80 YearsBoth60Phase 4Russian Federation
147NCT00580229December 200718/12/2007A 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 ArthritisDrug: prednisoneUniversity of South FloridaNULLCompleted18 Years80 YearsAll50Phase 2/Phase 3United States
148EUCTR2007-001585-33-ES15/11/200713/09/2007Estudio 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. - SCOREEstudio 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
149EUCTR2007-001585-33-LT13/11/200705/07/2007A 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. SCOREA 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
150NCT00578305November 200719/12/2007A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to MethotrexateA 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 MethotrexateRheumatoid ArthritisBiological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folateHoffmann-La RocheNULLCompleted18 Years80 YearsAll185Phase 3Argentina;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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2007-001585-33-DK26/10/200712/07/2007A 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. - SCOREA 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
152NCT00502853October 25, 200717/7/2007A 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 ArthritisDrug: rituximab [MabThera/Rituxan];Drug: MethotrexateHoffmann-La RocheNULLCompleted18 Years75 YearsAll10Phase 4Italy
153EUCTR2007-001585-33-EE10/10/200718/07/2007A 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. SCOREA 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
154EUCTR2007-001585-33-FR09/10/200723/07/2007A 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. - SCOREA 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Germany;Netherlands;Denmark;Estonia;France;Spain;Greece;Latvia;Lithuania
155NCT00934648October 20076/7/2009A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to MethotrexateAn 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 MethotrexateRheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: methotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll15Phase 4Morocco
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT02699892October 200725/2/2016Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid ArthritisPost Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid ArthritisRheumatoid ArthritisDrug: RituximabHoffmann-La RocheNULLCompleted18 Years80 YearsAll130N/ASerbia
157EUCTR2007-001585-33-NL20/09/200709/08/2007A 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. - SCOREA 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Latvia;Netherlands
158EUCTR2006-005640-81-GB04/09/200727/07/2007A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRAA PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA Rheumatoid arthritisUniversity of LeedsNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited Kingdom
159EUCTR2007-001585-33-CZ22/08/200704/09/2007A 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. - SCOREA 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Estonia;Czech Republic;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
160EUCTR2007-001754-11-IT03/08/200702/07/2007Pilot 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. - NDPilot 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: Mabthera
INN or Proposed INN: Rituximab
ROCHENULLNot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2007-001585-33-LV26/07/200730/07/2007A 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-SCOREA 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
162NCT00502840July 23, 200717/7/2007A 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 ArthritisDrug: rituximab [MabThera/Rituxan]Hoffmann-La RocheNULLCompleted18 Years75 YearsAll193Phase 3Germany
163NCT00504777July 200719/7/2007A 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 ArthritisDrug: rituximab [MabThera/Rituxan];Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll36Phase 4Taiwan
164EUCTR2006-006746-33-DE28/06/200712/03/2007Re-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 IRRe-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: 9.1Level: PTClassification code 10039073Term: 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 AGNULLNot RecruitingFemale: yes
Male: yes
240Germany
165NCT00462345June 200718/4/2007A 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 TherapiesRheumatoid ArthritisDrug: rituximab;Drug: Methotrexate;Drug: Corticosteroid or NSAID;Dietary Supplement: FolateHoffmann-La RocheNULLCompleted18 Years80 YearsAll40Phase 4Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT00578565May 200719/12/2007Rituximab in Rheumatoid Arthritis Lung DiseaseRituximab for the Treatment of Rheumatoid Arthritis-Associated Interstitial Pneumonia: A Pilot StudyRheumatoid Arthritis;Interstitial PneumoniaDrug: RituximabEric MattesonGenentech, Inc.;National Center for Research Resources (NCRR)Completed18 Years80 YearsAll10Phase 3United States
167NCT00425932February 200722/1/2007Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid ArthritisImpact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid ArthritisRheumatoid ArthritisBiological: RituximabGaylis, Norman B., M.D.Oklahoma Medical Research Foundation;Genentech, Inc.Completed18 Years80 YearsBoth60Phase 2United States
168NCT00443651January 20072/3/2007A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid ArthritisAn Open-Label, Prospective Study of the Safety of Rituximab in Combination With Other Disease-Modifying Anti-Rheumatic Drugs in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Rituximab;Drug: Anti-inflammatory drugsGenentech, Inc.BiogenCompleted18 Years80 YearsAll578Phase 3United States
169NCT00424502January 200718/1/2007A 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 ArthritisDrug: rituximab [MabThera/Rituxan];Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll20Phase 4Hungary
170EUCTR2006-005386-19-BE19/12/200603/11/2006Cytokines 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 / miniCytokines 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: 8.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera Cliniques Universitaires Saint-LucNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2005-003632-22-ES22/11/200620/03/2012A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3Spain
172NCT00396812November 20066/11/2006Rituximab 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 ArthritisRheumatoid ArthritisDrug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceTerminated18 YearsN/AAll4Phase 1/Phase 2United States
173NCT02079532November 20064/3/2014A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF InhibitorAn 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 AgentRheumatoid ArthritisDrug: rituximab [MabThera]Hoffmann-La RocheNULLCompleted18 Years75 YearsAll302Phase 3Germany
174EUCTR2006-004673-98-HU16/10/200608/09/2006Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blockerEfficacy 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 infusionRoche (Hungary) Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Hungary
175EUCTR2005-002396-33-HU26/09/200607/07/2006A 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 arthritisTrade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2006-001000-37-DE19/09/200616/06/2006Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRSTEfficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST Rheumatoid arthritis
MedDRA version: 8.1Level: PTClassification code 10039073Term: 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 AGNULLNot RecruitingFemale: yes
Male: yes
300Germany
177EUCTR2005-002396-33-SK14/09/200615/06/2006A 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 arthritisTrade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Hungary;Finland;United Kingdom;Germany;Slovakia;Spain;Italy
178NCT01126541September 200618/5/2010SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa TherapyA 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 ArthritisDrug: rituximabHoffmann-La RocheNULLCompleted18 YearsN/AAll224Phase 3France
179NCT02006706August 10, 20065/12/2013A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD TherapyAn 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 FailureRheumatoid ArthritisDrug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisoloneHoffmann-La RocheNULLCompleted18 Years80 YearsAll15Phase 3Serbia
180NCT01272908July 18, 20067/1/2011A 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 ArthritisDrug: rituximabHoffmann-La RocheNULLCompleted18 Years80 YearsAll120Phase 3Canada;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT00555542July 20067/11/2007An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid ArthritisB Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell SubsetsRheumatoid ArthritisDrug: rituximabChinese University of Hong KongNULLCompleted21 Years70 YearsBoth10Phase 2China
182EUCTR2006-000854-32-AT29/05/200619/05/2006Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-BlockersRituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers Rheumatoid ArthritisTrade Name: Rituximab - MabThera
Product Name: Rituximab MabThera
Product Code: no
Vienna Medical UniversityNULLNot RecruitingFemale: yes
Male: yes
20Austria
183NCT00298272May 20061/3/2006Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisBiological: IDEC-C2B8 (rituximab);Drug: Placebo;Drug: Methotrexate;Drug: Etanercept;Drug: Adalimumab;Drug: Methylprednisolone;Dietary Supplement: FolateBiogenHoffmann-La Roche;Genentech, Inc.Terminated18 Years65 YearsAll54Phase 2United States
184EUCTR2005-002396-33-DE27/04/200610/11/2005A 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 arthritisTrade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
185EUCTR2005-002395-15-DE27/04/200622/11/2005A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2005-002392-32-DE20/04/200629/09/2005A 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 arthritisTrade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
500Slovenia;Ireland;Germany;United Kingdom;Sweden
187EUCTR2005-002396-33-GB28/03/200611/05/2006A 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 arthritisF. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
375 Human pharmacology (Phase 1): Therapeut1c exploratory (Phase 2): Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4):Hungary;Slovakia;Finland;Belgium;Spain;Germany;Italy;United Kingdom
188EUCTR2005-004582-41-GB24/03/200627/01/2006 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 ArthritisUniversity of LeedsNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited Kingdom
189EUCTR2005-002396-33-FI06/03/200622/12/2005A 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 arthritisTrade 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.NULLNot RecruitingFemale: yes
Male: yes
375United Kingdom;Germany;Spain;Italy;Hungary;Finland;Slovakia
190EUCTR2005-002395-15-CZ27/02/200627/02/2006A 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2005-002395-15-SE13/02/200612/12/2005A 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
192NCT00422383February 200615/1/2007A 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 ArthritisDrug: rituximab [MabThera/Rituxan]Hoffmann-La RocheNULLCompleted18 YearsN/AAll378Phase 3Australia;Belgium;Brazil;Canada;China;Finland;France;Germany;Hungary;Italy;Netherlands;New Zealand;Slovakia;South Africa;Spain;Taiwan;Thailand;United Kingdom;Switzerland;United States
193NCT00502996February 200617/7/2007A 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 ArthritisDrug: Methotrexate;Drug: rituximab [MabThera/Rituxan]Hoffmann-La RocheNULLCompleted18 YearsN/AAll246Phase 3Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela
194NCT00282308January 23, 200624/1/2006A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background MethotrexateA 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 MethotrexateRheumatoid ArthritisDrug: Rituximab;Drug: Methotrexate;Drug: Methylprednisone;Biological: C. albicans;Biological: Tetanus toxoid adsorbed booster vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: Keyhole limpet hemocyaninGenentech, Inc.NULLCompleted18 Years65 YearsAll103Phase 2United States
195EUCTR2005-002395-15-GB20/01/200625/04/2006A 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 arthritisF. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
853 Human pharmacology (Phase 1): Therapeut1c exploratory (Phase 2): Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4):Czech Republic;Finland;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2005-002395-15-FI09/01/200626/10/2005A 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 arthritisTrade 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.NULLNot RecruitingFemale: yes
Male: yes
853Phase 3Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
197EUCTR2005-002395-15-DK06/01/200619/06/2007A 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 arthritisProduct Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
853Phase 3Czech Republic;Finland;Belgium;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
198NCT00422942January 200615/1/2007A 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 ArthritisDrug: rituximab [MabThera/Rituxan];Drug: MethotrexateHoffmann-La RocheNULLTerminated18 Years80 YearsAll3Phase 2Netherlands;Spain
199NCT00266227January 200614/12/2005A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background MethotrexateA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment With Rituximab in Subjects With Rheumatoid Arthritis Receiving Background MethotrexateRheumatoid ArthritisDrug: placebo;Drug: rituximab;Drug: methotrexate;Drug: folateGenentech, Inc.NULLCompleted18 Years80 YearsAll559Phase 3United States
200NCT00299104January 20062/3/2006A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: placebo;Drug: rituximabGenentech, Inc.Hoffmann-La RocheCompleted18 Years80 YearsAll755Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2005-002395-15-ES29/12/200531/10/2005Estudio 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 arthritisTrade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
853Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
202EUCTR2005-002395-15-BE29/12/200524/11/2005A 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: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Czech Republic;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy;Sweden
203EUCTR2005-002396-33-BE27/12/200524/11/2005A 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 arthritisTrade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Phase 3Hungary;Slovakia;Finland;Spain;Belgium;Germany;United Kingdom;Italy
204EUCTR2005-002396-33-ES27/12/200528/10/2005Estudio 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.NULLNot RecruitingFemale: yes
Male: yes
375Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
205EUCTR2005-002392-32-GB07/12/200515/09/2005A 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 arthritisProduct Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
500Phase 3Slovenia;Ireland;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2005-002395-15-IT02/12/200502/03/2006A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Finland;Spain;Czech Republic;Denmark;Germany;United Kingdom;Italy;Sweden
207EUCTR2005-002396-33-IT30/11/200501/03/2006A 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: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
375Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
208EUCTR2005-002392-32-IE23/11/200513/09/2005A 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 arthritisF. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
500 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSlovenia;Ireland;Germany;United Kingdom;Sweden
209EUCTR2005-002392-32-SE12/10/200519/09/2005A 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 arthritisProduct Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
500Slovenia;Ireland;Germany;United Kingdom;Sweden
210EUCTR2005-002392-32-SI11/10/200526/10/2005A 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 arthritisProduct Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
500Slovenia;Ireland;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT00299130October 20053/3/2006A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: Folate;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Placebo;Drug: RituximabGenentech, Inc.Hoffmann-La RocheCompleted18 Years80 YearsAll511Phase 3United States
212NCT00466037September 200524/4/2007The Effect of Rituximab on the Humoral Response to Influenza VaccineVaccination Against Influenza in Rheumatoid Arthritis Patients: The Effect of Rituximab on the Humoral ResponseRheumatoid ArthritisBiological: Influenza vaccineTel-Aviv Sourasky Medical CenterNULLTerminated18 Years85 YearsBoth64N/ANULL
213NCT00243412August 200521/10/2005A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving MethotrexateA 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 MethotrexateRheumatoid ArthritisDrug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: Placebo;Drug: RituximabGenentech, Inc.NULLCompleted18 Years65 YearsAll42Phase 2United States
214NCT00503425June 30, 200517/7/2007A 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 AgentRheumatoid ArthritisDrug: Rituximab [MabThera/Rituxan]Hoffmann-La RocheNULLCompleted18 YearsN/AAll215Phase 3Israel
215EUCTR2005-000674-43-GB06/04/200503/10/2005 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 ArthritisUniversity of LeedsNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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agemin
Inclusion_
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PhaseCountries
216NCT00854321November 20042/3/2009Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University HospitalOne Centre Follow-up Study on Safety and EfficacyRheumatoid ArthritisDrug: rituximab;Drug: rituximab, observational study amon patients with active RAKuopio University HospitalNULLCompleted18 YearsN/ABoth49N/AFinland
217NCT02097745June 200420/3/2014A 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 TherapiesAn 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 TherapiesRheumatoid ArthritisDrug: methotrexate;Drug: rituximab [MabThera/Rituxan]Hoffmann-La RocheBiogenCompleted18 Years80 YearsAll341Phase 3United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom
218NCT00468377March 200430/4/2007Safety and Efficacy Study of Re-treatment With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFa TherapiesAn 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 TherapiesArthritis, RheumatoidDrug: RituximabHoffmann-La RocheGenentech, Inc.Active, not recruiting18 Years80 YearsBoth341Phase 3United States
219NCT00074438June 200312/12/2003Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid ArthritisRandomized, 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 ArthritisRheumatoid ArthritisDrug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placeboGenentech, Inc.Roche Pharma AGCompleted18 Years80 YearsBoth465Phase 2United States
220NCT00468546May 200330/4/2007A 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 TherapyA 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 TherapiesRheumatoid ArthritisDrug: MabThera/Rituxan;Drug: Methotrexate;Other: PlaceboHoffmann-La RocheBiogenCompleted18 Years80 YearsAll520Phase 3United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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agemin
Inclusion_
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PhaseCountries
221NCT02093026August 200219/3/2014Extension 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 ArthritisRheumatoid ArthritisDrug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic AcidHoffmann-La RocheGenentech, Inc.Completed21 YearsN/AAll465Phase 2United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom
222NCT02693210February 200123/2/2016A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: Cyclophosphamide;Drug: Methotrexate;Other: Placebo Cyclophosphamide;Other: Placebo Methotrexate;Other: Placebo Rituximab;Drug: RituximabHoffmann-La RocheNULLCompleted21 YearsN/ABoth161Phase 2Australia;Belgium;Canada;Czech Republic;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
223EUCTR2015-002156-27-AT30/09/2015Reduced-dose Rituximab in rheumatoid arthritis patients in remission – theREDOREM studyProspective 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 ViennaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Austria
224EUCTR2011-002896-40-ES26/06/2012A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritisA 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: 14.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem 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 10017NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United 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

49. 全身性エリテマトーデス [臨床試験数:827,薬物数:638(DrugBank:168),標的遺伝子数:108,標的パスウェイ数:191
Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
19 / 827 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
1NCT04127747August 18, 202014/10/2019Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus ErythematosusA 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 ErythematosusAutoimmune DiseasesDrug: Standard dose of rituximab;Drug: Individualized dose of rituximabSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruiting18 Years65 YearsAll110Phase 4China
2NCT03747159October 1, 201812/10/2018Synergetic 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 ErythematosusLupus Erythematosus, SystemicDrug: Belimumab InjectionLeiden University Medical CenterDutch Kidney Foundation;GlaxoSmithKlineRecruiting18 YearsN/AAll30Phase 2Netherlands
3EUCTR2018-001392-21-NL25/09/201825/09/2018Synergetic B-cell immunomodulation in SLE – 2nd studyA randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus systemic lupus erythematosus
MedDRA version: 21.1Level: LLTClassification code 10042947Term: Systemic lupus erythematosus syndSystem Organ Class: 100000004859
MedDRA version: 20.0Level: LLTClassification code 10029142Term: Nephritis systemic lupus erythematosusSystem Organ Class: 100000004857
MedDRA version: 21.1Level: LLTClassification code 10042948Term: Systemic lupus erythematosus syndrome aggravatedSystem 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 CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2;Phase 3Netherlands
4NCT03312907March 1, 201813/10/2017A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVEA 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 ErythematosusDrug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid TaperGlaxoSmithKlineNULLActive, not recruiting18 YearsN/AAll292Phase 3United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain
5EUCTR2016-003050-32-NL16/02/201824/10/2017 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-BELIEVEA 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 LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;Netherlands;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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PhaseCountries
6EUCTR2016-003050-32-DE09/01/201821/06/2017 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 LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of
7EUCTR2016-003050-32-ES05/12/201701/12/2017A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVEA 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of
8NCT03054259September 21, 201717/1/2017Rituximab Objective Outcome Measures Trial in SLEA Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus ErythematosusSystemic Lupus Erythematosus ArthritisDrug: Rituximab;Drug: Methylprednisolone;Drug: Normal SalineUniversity of LeedsNULLRecruiting18 Years99 YearsAll30Phase 2United Kingdom
9NCT01773616April 20151/11/2012Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus NephritisPhase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus NephritisSystemic Lupus Erythematosus, Lupus NephritisDrug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisoloneImperial College LondonKarolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study GroupTerminated12 Years75 YearsAll24Phase 3United Kingdom
10JPRN-UMIN0000007632007/05/0105/07/2007Phase II study of rituximab in patients with severe systemic lupus erythematosus Systemic lupus erythematosus1000 mg of rituximab on days 1, 15, 169 and 183Zenyaku Kogyo Co., Ltd.NULLComplete: follow-up complete16years-old75years-oldMale and Female30Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
11JPRN-UMIN0000006392007/03/0116/03/2007A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus Systemic lupus erythematosusIDEC-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.NULLComplete: follow-up complete16years-old75years-oldMale and Female150Phase 2/3Japan
12NCT00381810June 22, 200626/9/2006A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus ErythematosusAn 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 U2971gLupus Erythematosus, SystemicDrug: Rituximab;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: DiphenhydramineGenentech, Inc.NULLTerminated16 Years75 YearsAll31Phase 3United States
13NCT00556192June 20068/11/2007Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus ErythematosusCan Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy Restore Peripheral B Cell Abnormalities in Systemic Lupus Erythematosus(SLE)?Systemic Lupus ErythematosusDrug: rituximabChinese University of Hong KongNULLCompleted18 Years70 YearsBoth20Phase 2China
14NCT00278538September 23, 200515/1/2006Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus ErythematosusCyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II TrialSystemic Lupus ErythematosusBiological: Hematopoietic stem cell transplantationNorthwestern UniversityNULLCompleted15 Years60 YearsAll32Phase 2United States
15NCT00230035September 200528/9/2005Lupus 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 ErythematosusSystemic Lupus ErythematosusProcedure: 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: LeflunomideNational Institute of Allergy and Infectious Diseases (NIAID)NULLWithdrawn18 Years60 YearsBoth0Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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Inclusion_
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size
PhaseCountries
16NCT00137969May 10, 200526/8/2005A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus ErythematosusRandomized, 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 ErythematosusLupus Erythematosus, SystemicDrug: Rituximab;Drug: Placebo;Drug: Prednisone;Drug: Acetaminophen;Drug: DiphenhydramineGenentech, Inc.NULLCompleted16 Years75 YearsAll262Phase 2/Phase 3United States;Canada
17NCT00076752January 30, 20042/2/2004Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus ErythematosusA Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: 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: MesnaNational Cancer Institute (NCI)NULLCompleted15 Years40 YearsAll9Phase 2United States
18NCT00293072March 200216/2/2006Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and VasculitisPilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional TherapySystemic Lupus Erythematosus;ANCA Associated VasculitisDrug: RituximabCambridge University Hospitals NHS Foundation TrustRoche Pharma AGCompleted18 Years70 YearsBoth20Phase 2United Kingdom
19NCT00036491January 200110/5/2002Anti-CD20 in Systemic Lupus ErythematosusAn Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceCompleted18 Years70 YearsAll24Phase 1/Phase 2United States

50. 皮膚筋炎/多発性筋炎 [臨床試験数:157,薬物数:207(DrugBank:76),標的遺伝子数:47,標的パスウェイ数:142
Searched query = "Dermatomyositis", "Polymyositis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
6 / 157 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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agemin
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PhaseCountries
1JPRN-UMIN0000183762015/07/2222/07/2015Efficacy and safety of rituximab for patients with severe rheumatic diseaseEfficacy 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 PediatricsNULLComplete: follow-up complete2years-oldNot applicableMale and Female20Not selectedJapan
2EUCTR2012-003633-42-GB18/10/201322/08/2013A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseasesA 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: 14.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1Level: PTClassification code 10022611Term: Interstitial lung diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1Level: PTClassification code 10027754Term: Mixed connective tissue diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1Level: PTClassification code 10039710Term: SclerodermaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1Level: PTClassification code 10036102Term: PolymyositisSystem 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 TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
3EUCTR2006-000078-65-GB08/12/200807/12/2010Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositisRituximab 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: 8.1Level: LLTClassification code 10036102Term: Polymyositis
Trade Name: Mabthera
Product Name: Mabthera
Karolinska University HospitalNULLNot RecruitingFemale: yes
Male: yes
202Phase 2Czech Republic;United Kingdom;Sweden
4EUCTR2006-000078-65-CZ12/11/200718/10/2007Rituximab 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: 9.1Level: LLTClassification code 10036102Term: Polymyositis
Trade Name: Mabthera
Product Code: Mabthera
Karolinska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
202United Kingdom;Czech Republic;Sweden
5EUCTR2006-000078-65-SE17/01/200702/11/2006Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositisRituximab 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: 8.1Level: LLTClassification code 10036102Term: Polymyositis
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: Rituximab
Karolinska University HospitalNULLNot RecruitingFemale: yes
Male: yes
202United Kingdom;Czech Republic;Sweden
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6NCT00106184March 200621/3/2005Rituximab 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 DermatomyositisDrug: Rituximab;Drug: PlaceboUniversity of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Genentech, Inc.;BiogenCompleted5 YearsN/AAll200Phase 2United States;Canada;Czech Republic;Sweden;United Kingdom

51. 全身性強皮症 [臨床試験数:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210
Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
18 / 466 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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1NCT03844061July 29, 201931/1/2019Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic SclerosisA Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: Belimumab;Drug: Rituximab;Other: Placebo Subcutaneous Injection;Other: Placebo Infusion;Drug: MMFHospital for Special Surgery, New YorkGlaxoSmithKlineRecruiting18 Years80 YearsAll30Phase 2United States
2NCT03630211July 31, 20187/8/2018Autologous Stem Cell Transplantation in Patients With Systemic SclerosisAutologous 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 HypertensionDrug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body IrradiationPaul SzabolcsNULLRecruiting16 Years70 YearsAll8Phase 2United States
3NCT03593902May 17, 201828/6/2018Cardiac Safe Transplants for Systemic SclerosisAutologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac DysfunctionSystemic Sclerosis;SclerodermaDrug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLTerminated18 Years65 YearsAll9Phase 2/Phase 3United States
4NCT04274257December 4, 201713/2/2020A Study of the Efficacy and Safety of Rituximab in Participants With Systemic SclerosisDouble-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic SclerosisScleroderma, Systemic;Skin Sclerosis;Lung Fibrosis;Autoimmune Diseases;Collagen DiseasesDrug: Double-Blind Placebo;Drug: Double-Blind RituximabTokyo UniversityJapan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.Completed20 Years80 YearsAll56Phase 2/Phase 3Japan
5JPRN-UMIN0000183762015/07/2222/07/2015Efficacy and safety of rituximab for patients with severe rheumatic diseaseEfficacy 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 PediatricsNULLComplete: follow-up complete2years-oldNot applicableMale and Female20Not selectedJapan
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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6NCT01862926November 201422/5/2013Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILDA Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung DiseaseInterstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue DiseaseDrug: Rituximab;Drug: CyclophosphamideRoyal Brompton & Harefield NHS Foundation TrustImperial College London;University of East Anglia;University College London HospitalsActive, not recruiting18 Years80 YearsAll116Phase 2/Phase 3United Kingdom
7EUCTR2012-003633-42-GB18/10/201322/08/2013A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseasesA 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: 14.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1Level: PTClassification code 10022611Term: Interstitial lung diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1Level: PTClassification code 10027754Term: Mixed connective tissue diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1Level: PTClassification code 10039710Term: SclerodermaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1Level: PTClassification code 10036102Term: PolymyositisSystem 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 TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
8EUCTR2012-004955-35-IT29/07/201330/05/2013A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with <