DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
11	重症筋無力症	2
13	多発性硬化症／視神経脊髄炎	6
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	1
25	進行性多巣性白質脳症	2
26	HTLV-1関連脊髄症	3
35	天疱瘡	2
38	スティーヴンス・ジョンソン症候群	1
39	中毒性表皮壊死症	1
40	高安動脈炎	1
41	巨細胞性動脈炎	10
43	顕微鏡的多発血管炎	2
44	多発血管炎性肉芽腫症	2
45	好酸球性多発血管炎性肉芽腫症	1
46	悪性関節リウマチ	59
49	全身性エリテマトーデス	8
50	皮膚筋炎／多発性筋炎	10
51	全身性強皮症	3
56	ベーチェット病	2
60	再生不良性貧血	1
61	自己免疫性溶血性貧血	2
63	特発性血小板減少性紫斑病	1
64	血栓性血小板減少性紫斑病	1
65	原発性免疫不全症候群	2
66	IgA腎症	11
75	クッシング病	1
81	先天性副腎皮質酵素欠損症	6
84	サルコイドーシス	7
85	特発性間質性肺炎	2
95	自己免疫性肝炎	4
96	クローン病	5
97	潰瘍性大腸炎	14
113	筋ジストロフィー	2
145	ウエスト症候群	7
162	類天疱瘡（後天性表皮水疱症を含む。）	2
222	一次性ネフローゼ症候群	13
269	化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群	1
271	強直性脊椎炎	1
296	胆道閉鎖症	1
299	嚢胞性線維症	1
300	IgG4関連疾患	2

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000007671	2012/04/01	09/04/2012	Randomized comparative study on efficacy and safety of reduced-dose steroid combined with tacrolimus vs conventional-dose steroid in late- or elderly-onset myasthenia gravis patients		Myasthenia gravis	Administration of prednisolone 35 mg/day with tacrolimus 3mg a day Administration of prednisolone 50 mg/day	Department of Neurology, Chiba University Graduate School of Medicine	NULL	Recruiting	50years-old	Not applicable	Male and Female	40	Not applicable	Japan
2	JPRN-UMIN000007679	2012/04/01	09/04/2012	Randomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patients		Myasthenia gravis	Administration of tacrolimus 3 mg/day Administration of prednisolone 5 mg/day anticholinesterases	Department of Neurology, Chiba University Graduate School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	60	Not selected	Japan

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03368664 (ClinicalTrials.gov)	October 24, 2017	2/11/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis	Drug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonist	Genzyme, a Sanofi Company	NULL	Active, not recruiting	10 Years	17 Years	All	50	Phase 3	Austria;Belgium;Bulgaria;Czechia;France;Germany;Greece;Italy;Netherlands;Poland;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Norway;Switzerland
2	JPRN-UMIN000010094	2013/08/01	01/04/2013	A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis optica		neuromyelitis optica	4.8mg/kg Sivelestat Sodium will administered constantly for 5 days in combination with 3 days intravenous methyl-prednisolone administration to sero-positive neuromyelitis optica patients who relapsed within 72 hours before starting treatment.	Tohoku University Hospital	NULL	Complete: follow-up complete	20years-old	55years-old	Male and Female	10	Phase 1;Phase 2	Japan
3	EUCTR2009-013884-21-PL (EUCTR)	20/05/2010	13/01/2010	A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)	A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)	Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: PEG-liposomal Prednisolone Sodium Phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Trade Name: Solu-Medrol INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Enceladus Pharmaceuticals BV	NULL	Not Recruiting			Female: yes Male: yes	90		Germany;Belgium;Poland
4	NCT01039103 (ClinicalTrials.gov)	December 2009	20/12/2009	Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)	A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Relapsing-remitting Multiple Sclerosis or in Patients With Clinically Isolated Syndrome (CIS)	Acute Exacerbation of Remitting Relapsing Multiple Sclerosis;Clinically Isolated Syndrome	Drug: PEG-liposomal prednisolone sodium phosphate;Drug: Methylprednisolone	Galapagos NV	NULL	Terminated	18 Years	65 Years	Both	15	Phase 2	Belgium;Germany;Poland
5	EUCTR2009-013884-21-DE (EUCTR)	18/11/2009	09/09/2009	A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)	A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)	Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: PEG-liposomal Prednisolone Sodium Phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Trade Name: Solu-Medrol INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Enceladus Pharmaceuticals BV	NULL	Not Recruiting			Female: yes Male: yes	90		Poland;Belgium;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2009-013884-21-BE (EUCTR)	13/11/2009	10/09/2009	A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)	A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)	Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Product Name: PEG-liposomal Prednisolone Sodium Phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Trade Name: Solu-Medrol INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Poland;Belgium;Germany

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2004-002783-24-GB (EUCTR)	25/05/2006	31/03/2006	Prednisolone versus Dexamethasone in Chronic inflammatory demyelinating polyradiculoneuropathy Trial; PREDICT-trial - PREDICT trial	Prednisolone versus Dexamethasone in Chronic inflammatory demyelinating polyradiculoneuropathy Trial; PREDICT-trial - PREDICT trial	Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated disorder. CIDP is characterised by motor and/or sensory symptoms and signs in more than one limb, developing over at least two months. The disease runs a progressive, relapsing-remitting or monophasic course. The diagnosis of CIDP is based on the clinical, electrophysiological, cerebrospinal fluid features and, to a limited degree, on histopathology.	Product Name: dexamethasone Product Code: dexamethasone INN or Proposed INN: Dexamethasone Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone	AMC Medical research BV	NULL	Not Recruiting			Female: yes Male: yes	52		United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2010-020369-26-DE (EUCTR)	29/11/2010	18/08/2010	High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab	High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab	Immune Reconstitution Inflammatory Syndrome MedDRA version: 12.1;Level: PT;Classification code 10054014;Term: Immune reconstitution syndrome	Product Name: methylprednisolone INN or Proposed INN: METHYLPREDNISOLONE Product Name: prednisolone INN or Proposed INN: PREDNISOLONE Product Name: prednisolone INN or Proposed INN: PREDNISOLONE Product Name: prednisolone INN or Proposed INN: PREDNISOLONE Product Name: prednisolone INN or Proposed INN: PREDNISOLONE Product Name: prednisolone INN or Proposed INN: PREDNISOLONE Product Name: prednisolone INN or Proposed INN: PREDNISOLONE	Biogen Idec	NULL	Not Recruiting			Female: yes Male: yes	20		Germany
2	NCT01211665 (ClinicalTrials.gov)	September 2010	29/7/2010	Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)	High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab	Immune Reconstitution Inflammatory Syndrome;Leukoencephalopathy, Progressive Multifocal	Drug: Methylprednisolone;Drug: Prednisolone	Biogen	Elan Pharmaceuticals	Terminated	18 Years	N/A	All	3	Phase 4	United States;Germany

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000024085	2016/09/16	20/09/2016	Phase IIb clinical trial of steroid therapy in patients with HAM(Slow progressor)	HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)	Prednisolone is orally administered at a maximum dose of 0.5mg/kg/day and then tapered to a maintenance dose of 5mg/day. Indistinguishable placebo is orally administered for 24 weeks, and then 5mg/day of prednisolone for the next 24 weeks.	St. Marianna University School of Medicine Hospital	NULL	Recruiting	18years-old	Not applicable	Male and Female	40	Phase 2;Phase 3	Japan
2	JPRN-UMIN000024086	2016/09/16	20/09/2016	Phase IIb clinical trial of steroid therapy in patients with HAM(Non progressor)	HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)	Drugs which possibly affect assessment in the study (e.g. methylprednisolone, prednisolone and other agents targeted to HAM) will be forbidden or limited until Week 48 and periodic evaluation and tests will be performed.	St. Marianna University School of Medicine Hospital	NULL	Recruiting	18years-old	Not applicable	Male and Female	5	Phase 2b	Japan
3	JPRN-UMIN000023798	2016/08/31	31/08/2016	Phase IIb clinical trial of steroid therapy in patients with HAM	HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)	Following to administrate Methylprednisolone 1000mg/day intravenously slowly for consecutive three days, Prednisolone is administered orally for a maximum dose in 0.5mg/kg/day, then decreased gradually and terminated. There is a case to maintain the dose of Prednisolone by the degree of a progress of underlying disease. Prednisolone is administered orally for a maximum dose in 0.5mg/kg/day, then decreased gradually and terminated. There is a case to maintain the dose of Prednisolone by the degree of a progress of underlying disease.	St. Marianna University School of Medicine Hospital	NULL	Recruiting	18years-old	Not applicable	Male and Female	8	Phase 2;Phase 3	Japan

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02613910 (ClinicalTrials.gov)	December 23, 2015	23/11/2015	Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris	OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris	Pemphigus	Drug: Ofatumumab;Drug: Acetaminophen/paracetamol;Drug: Antihistamine (cetirizine or equivalent);Drug: Prednisone/Prednisolone	GlaxoSmithKline	NULL	Terminated	N/A	N/A	All	1	Phase 3	United States
2	NCT00626678 (ClinicalTrials.gov)	January 2008	21/2/2008	Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone	A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone	Pemphigus Vulgaris	Drug: Azathioprine;Drug: Prednisone;Drug: Placebo	Tehran University of Medical Sciences	NULL	Completed	10 Years	75 Years	Both	48	Phase 2	Iran, Islamic Republic of

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-jRCTs061180044	01/06/2017	12/03/2019	Multicenter Open-trial of Steroid pulse therapy for SJS/TEN	Multicenter Open-trial of Steroid pulse therapy for SJS/TEN - MOSST Study	Stevens-Johnson syndrome and Toxic epidermal necrolysis	1. infusion of methylprednisolone at 500~1000 mg/d (0.9% N/S in 3 hour) for 3 consecutive days. 2. Oral predonisolone (0.5 mg/kg/d) was initiated on the day following the last dose of methylprednisolone, and prednisolone was subsequently tapered within 2 weeks. If the ocular involvement score is more than 2, dose of oral predonisolone (1 mg/kg/d) is recommended.	Morita Eishin	NULL	Not Recruiting	>= 20age old	<= 90age old	Both	20	Phase 2	Taiwan;Germany;Japan

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-jRCTs061180044	01/06/2017	12/03/2019	Multicenter Open-trial of Steroid pulse therapy for SJS/TEN	Multicenter Open-trial of Steroid pulse therapy for SJS/TEN - MOSST Study	Stevens-Johnson syndrome and Toxic epidermal necrolysis	1. infusion of methylprednisolone at 500~1000 mg/d (0.9% N/S in 3 hour) for 3 consecutive days. 2. Oral predonisolone (0.5 mg/kg/d) was initiated on the day following the last dose of methylprednisolone, and prednisolone was subsequently tapered within 2 weeks. If the ocular involvement score is more than 2, dose of oral predonisolone (1 mg/kg/d) is recommended.	Morita Eishin	NULL	Not Recruiting	>= 20age old	<= 90age old	Both	20	Phase 2	Taiwan;Germany;Japan

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04161898 (ClinicalTrials.gov)	February 4, 2020	12/11/2019	A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-Takayasu)	Takayasu Arteritis (TAK)	Drug: Upadacitinib;Drug: Placebo for Upadacitinib;Drug: Prednisolone	AbbVie	NULL	Recruiting	18 Years	N/A	All	56	Phase 3	Japan;Korea, Republic of

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2017-003978-13-DK (EUCTR)	17/09/2019	25/02/2019	A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA	Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Denmark;Australia;Netherlands;Germany;Japan;New Zealand
2	EUCTR2017-003978-13-FR (EUCTR)	22/08/2019	19/04/2019	A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA	Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolone 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
3	EUCTR2017-003978-13-GR (EUCTR)	26/07/2019	18/03/2019	A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: SELECT GCA	Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
4	EUCTR2017-003978-13-PT (EUCTR)	08/07/2019	14/03/2019	A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA	Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	Portugal;United States;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
5	EUCTR2017-003978-13-AT (EUCTR)	15/05/2019	05/03/2019	A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA	Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2017-003978-13-BE (EUCTR)	15/05/2019	01/05/2019	A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA	Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
7	EUCTR2017-003978-13-DE (EUCTR)	14/05/2019	05/03/2019	A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA	Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
8	EUCTR2017-003978-13-HU (EUCTR)	08/05/2019	25/03/2019	A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA	Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
9	NCT03765788 (ClinicalTrials.gov)	January 30, 2019	3/12/2018	A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis	A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab (AIN457) in Patients With Giant Cell Arteritis (TitAIN)	Giant Cell Arteritis	Biological: Secukinumab 300 mg, s.c.;Drug: Prednisolone;Drug: Placebo to match Secukinumab, s.c.	Novartis Pharmaceuticals	NULL	Active, not recruiting	50 Years	N/A	All	52	Phase 2	Germany
10	EUCTR2011-005090-22-GB (EUCTR)	28/02/2012	17/01/2012	A study of the effectiveness and safety of delayed release prednisone in patients with newly diagnosed Giant Cell Arteritis	A study of efficacy and safety of delayed release prednisone in newly diagnosed cases of Giant Cell Arteritis - Efficacy and safety of delayed release prednisone in GCA	Giant Cell Arteritis MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Trade Name: Lodotra Product Name: Lodotra (delayed release prednisolone) INN or Proposed INN: Prednisolone Other descriptive name: 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione	Southend Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-003978-13-DK
(EUCTR)

17/09/2019

25/02/2019

A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA

Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 3

United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Denmark;Australia;Netherlands;Germany;Japan;New Zealand

EUCTR2017-003978-13-FR
(EUCTR)

22/08/2019

19/04/2019

A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 3

United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand

EUCTR2017-003978-13-GR
(EUCTR)

26/07/2019

18/03/2019

A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: SELECT GCA

Giant Cell Arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 3

United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand

EUCTR2017-003978-13-PT
(EUCTR)

08/07/2019

14/03/2019

A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 3

Portugal;United States;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand

EUCTR2017-003978-13-AT
(EUCTR)

15/05/2019

05/03/2019

A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 3

United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-003978-13-BE
(EUCTR)

15/05/2019

01/05/2019

A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 3

United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand

EUCTR2017-003978-13-DE
(EUCTR)

14/05/2019

05/03/2019

A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 3

United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand

EUCTR2017-003978-13-HU
(EUCTR)

08/05/2019

25/03/2019

A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 3

United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand

NCT03765788
(ClinicalTrials.gov)

January 30, 2019

3/12/2018

A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis

A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab (AIN457) in Patients With Giant Cell Arteritis (TitAIN)

Giant Cell Arteritis

Biological: Secukinumab 300 mg, s.c.;Drug: Prednisolone;Drug: Placebo to match Secukinumab, s.c.

Novartis Pharmaceuticals

NULL

Active, not recruiting

50 Years

N/A

All

Phase 2

Germany

EUCTR2011-005090-22-GB
(EUCTR)

28/02/2012

17/01/2012

A study of the effectiveness and safety of delayed release prednisone in patients with newly diagnosed Giant Cell Arteritis

A study of efficacy and safety of delayed release prednisone in newly diagnosed cases of Giant Cell Arteritis - Efficacy and safety of delayed release prednisone in GCA

Giant Cell Arteritis
MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Trade Name: Lodotra
Product Name: Lodotra (delayed release prednisolone)
INN or Proposed INN: Prednisolone
Other descriptive name: 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione

Southend Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00753103 (ClinicalTrials.gov)	January 2003	15/9/2008	Anti-Cytokine Therapy for Vasculitis	Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis	Wegener's Granulomatosis;Renal Limited Vasculitis;Microscopic Polyangiitis	Biological: Infliximab;Drug: Cyclophosphamide;Drug: Prednisolone;Drug: Azathioprine;Procedure: Plasma exchange;Drug: Mycophenolate mofetil;Drug: Methylprednisolone	University Hospital Birmingham NHS Foundation Trust	NULL	Completed	18 Years	N/A	Both	37	Phase 2	United Kingdom
2	NCT01408836 (ClinicalTrials.gov)	March 1995	2/8/2011	Plasma Exchange for Renal Vasculitis	Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis	Wegener's Granulomatosis;Microscopic Polyangiitis	Procedure: Plasma exchange;Drug: Intravenous methyl prednisolone;Drug: Methyl prednisolone	Cambridge University Hospitals NHS Foundation Trust	University Hospital Birmingham;Imperial College London;London North West Healthcare NHS Trust;University Hospitals, Leicester;Lund University Hospital;University Medical Centre Groningen;Fundacio Clinic;Helsinki University	Terminated	18 Years	80 Years	Both	150	Phase 2;Phase 3	United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00753103
(ClinicalTrials.gov)

January 2003

15/9/2008

Anti-Cytokine Therapy for Vasculitis

Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis

Wegener's Granulomatosis;Renal Limited Vasculitis;Microscopic Polyangiitis

Biological: Infliximab;Drug: Cyclophosphamide;Drug: Prednisolone;Drug: Azathioprine;Procedure: Plasma exchange;Drug: Mycophenolate mofetil;Drug: Methylprednisolone

University Hospital Birmingham NHS Foundation Trust

NULL

Completed

18 Years

N/A

Both

Phase 2

United Kingdom

NCT01408836
(ClinicalTrials.gov)

March 1995

2/8/2011

Plasma Exchange for Renal Vasculitis

Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis

Wegener's Granulomatosis;Microscopic Polyangiitis

Procedure: Plasma exchange;Drug: Intravenous methyl prednisolone;Drug: Methyl prednisolone

Cambridge University Hospitals NHS Foundation Trust

University Hospital Birmingham;Imperial College London;London North West Healthcare NHS Trust;University Hospitals, Leicester;Lund University Hospital;University Medical Centre Groningen;Fundacio Clinic;Helsinki University

Terminated

18 Years

80 Years

Both

150

Phase 2;Phase 3

United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03967925 (ClinicalTrials.gov)	February 1, 2019	18/1/2019	Rituximab and Belimumab Combination Therapy in PR3 Vasculitis	A Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated Vasculitis	ANCA Associated Vasculitis;Granulomatosis With Polyangiitis	Drug: Belimumab;Drug: Rituximab;Drug: Prednisolone	Rachel Jones	GlaxoSmithKline;Medical Research Council;Imperial College London;University College, London;Newcastle University;University of Glasgow;University of Cambridge	Recruiting	18 Years	N/A	All	30	Phase 2	United Kingdom
2	NCT03298061 (ClinicalTrials.gov)	April 14, 2015	27/9/2017	Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921	Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy)	Churg-Strauss Syndrome	Drug: Mepolizumab;Drug: Prednisolone	GlaxoSmithKline	NULL	Active, not recruiting	18 Years	N/A	All	104	Phase 3	United States;Belgium;Canada;France;Germany;Japan;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03967925
(ClinicalTrials.gov)

February 1, 2019

18/1/2019

Rituximab and Belimumab Combination Therapy in PR3 Vasculitis

A Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated Vasculitis

ANCA Associated Vasculitis;Granulomatosis With Polyangiitis

Drug: Belimumab;Drug: Rituximab;Drug: Prednisolone

Rachel Jones

GlaxoSmithKline;Medical Research Council;Imperial College London;University College, London;Newcastle University;University of Glasgow;University of Cambridge

Recruiting

18 Years

N/A

All

Phase 2

United Kingdom

NCT03298061
(ClinicalTrials.gov)

April 14, 2015

27/9/2017

Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921

Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy)

Churg-Strauss Syndrome

Drug: Mepolizumab;Drug: Prednisolone

GlaxoSmithKline

NULL

Active, not recruiting

18 Years

N/A

All

104

Phase 3

United States;Belgium;Canada;France;Germany;Japan;United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03298061 (ClinicalTrials.gov)	April 14, 2015	27/9/2017	Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921	Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy)	Churg-Strauss Syndrome	Drug: Mepolizumab;Drug: Prednisolone	GlaxoSmithKline	NULL	Active, not recruiting	18 Years	N/A	All	104	Phase 3	United States;Belgium;Canada;France;Germany;Japan;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03298061
(ClinicalTrials.gov)

April 14, 2015

27/9/2017

Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921

Churg-Strauss Syndrome

Drug: Mepolizumab;Drug: Prednisolone

GlaxoSmithKline

NULL

Active, not recruiting

18 Years

N/A

All

104

Phase 3

United States;Belgium;Canada;France;Germany;Japan;United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03368235 (ClinicalTrials.gov)	January 18, 2018	3/11/2017	Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 Compared to Prednisolone 20 mg in Patients With Active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: AZD9567;Drug: Prednisolone	AstraZeneca	NULL	Completed	18 Years	80 Years	All	21	Phase 2	Netherlands;Sweden;Denmark
2	EUCTR2017-000838-64-NL (EUCTR)	10/11/2017	13/06/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: AZD9567 monohydrate INN or Proposed INN: AZD9567 Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: Prednisolone	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
3	EUCTR2017-000838-64-SE (EUCTR)	11/09/2017	19/05/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: AZD9567 Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: -	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
4	EUCTR2017-000838-64-DK (EUCTR)	25/08/2017	13/06/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: -	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
5	EUCTR2011-004720-35-NL (EUCTR)	22/03/2017	22/02/2017	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) 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]	Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE INN or Proposed INN: METHOTREXATE INN or Proposed INN: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE INN or Proposed INN: PREDNISOLONE	The Karolinska Institute, ClinTRID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Norway;Iceland;Netherlands;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2015-002729-21-PT (EUCTR)	12/09/2016	27/04/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria	Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Portugal;Hungary;Slovakia;Finland;Germany
7	NCT02930343 (ClinicalTrials.gov)	September 2016	13/9/2016	Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy	Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine	Jawaharlal Institute of Postgraduate Medical Education & Research	NULL	Completed	18 Years	65 Years	All	136	Phase 3	India
8	NCT02585258 (ClinicalTrials.gov)	June 30, 2016	20/10/2015	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis	RheumatoId Arthritis	Drug: Prednisolone;Other: Placebo	VU University Medical Center	European Commission	Active, not recruiting	65 Years	N/A	All	500	Phase 4	Germany;Hungary;Italy;Netherlands;Portugal;Romania;Slovakia;Finland
9	EUCTR2015-002729-21-FI (EUCTR)	21/06/2016	30/03/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria	Rheumatoid artritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 4	Portugal;Hungary;Slovakia;Finland;Germany
10	EUCTR2015-002729-21-HU (EUCTR)	04/05/2016	11/02/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria	Rheumatoid artritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Hungary;Slovakia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT02760316 (ClinicalTrials.gov)	May 2, 2016	25/4/2016	A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567.	A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control	Rheumatoid Arthritis	Drug: AZD9567 10 mg;Drug: AZD9567 20 mg;Drug: AZD9567 40 mg;Drug: AZD9567 80 mg;Drug: Prednisolone 20 mg;Drug: AZD9567 125 mg;Drug: AZD9567 155 mg;Drug: Prednisolone 5 mg;Drug: Prednisolone 40 mg	AstraZeneca	NULL	Completed	18 Years	55 Years	All	64	Phase 1	Germany;United Kingdom
12	EUCTR2015-002729-21-DE (EUCTR)	25/04/2016	02/02/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - GLORIA	Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 4	Portugal;Hungary;Slovakia;Finland;Germany
13	EUCTR2015-002924-17-BE (EUCTR)	24/02/2016	27/01/2016	A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis	A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis	Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Nanocort INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE Trade Name: Depo Medrol Product Name: Depo Medrol	Sun Pharma Global FZE	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Belgium;Netherlands
14	NCT02644499 (ClinicalTrials.gov)	December 31, 2015	30/12/2015	Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis	Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid	Jawaharlal Institute of Postgraduate Medical Education & Research	NULL	Completed	18 Years	N/A	All	186	Phase 4	India
15	NCT03172325 (ClinicalTrials.gov)	November 18, 2015	24/5/2017	Study to Demonstrate Non-Inferiority Efficacy and Safety of CinnoRA® Produced by CinnaGen Company Versus Humira® for Treatment of Active Rheumatoid Arthritis	A Phase III, Randomized, Two-armed, Double-blind (Patient and Assessor Blinded), Parallel Active Controlled Non-Inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety of Two Disease-modifying Anti Rheumatic Drugs CinnoRA® (Produced by CinnaGen Company) Versus Humira® for Treatment of Active Rheumatoid Arthritis	Active Rheumatoid Arthritis	Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Prednisolone	Cinnagen	NULL	Completed	18 Years	75 Years	All	136	Phase 3	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT02512575 (ClinicalTrials.gov)	November 18, 2015	6/7/2015	A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.	A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects.	Safety;Tolerability;Pharmacokinetics;Pharmacodynamics;Healthy Subjects;Rheumatoid Arthritis	Drug: AZD9567 Monohydrat;Drug: Placebo oral suspension/ Placebo capsule;Drug: Prednisolone	AstraZeneca	NULL	Completed	18 Years	55 Years	Male	72	Phase 1	Germany
17	EUCTR2015-002924-17-NL (EUCTR)	12/11/2015	06/10/2015	A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis	A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis	Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Sun Pharma Global FZE	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Belgium;Netherlands
18	NCT02466581 (ClinicalTrials.gov)	February 3, 2015	29/5/2015	Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity	A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity	Rheumatoid Arthritis	Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone;Biological: Cimzia;Biological: Orencia;Biological: RoActemra	Karolinska Institutet	NULL	Active, not recruiting	18 Years	N/A	All	25	Phase 4	Sweden
19	NCT02000336 (ClinicalTrials.gov)	January 2014	19/11/2013	Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis	Comparison of the Efficacy and Safety of Two Different Starting Dosages of Prednisolone in Early Active Rheumatoid Arthritis: a Randomized, Placebo Controlled Trial	Progression of Rheumatoid Arthritis	Drug: Prednisolone;Drug: Placebo	Prof. Dr. rer. nat. H.J. Trampisch	Ruhr University of Bochum	Completed	18 Years	N/A	All	395	Phase 3	Germany
20	EUCTR2012-004074-25-DE (EUCTR)	30/10/2013	29/07/2013	Comparison of the effectiveness and safety of two different starting dosages of cortisone, compared to each other and to placebo, in early active rheumatoid arthritis	Comparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA	Early rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 10mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 10mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 20mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 20mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon	Ruhr-Universität Bochum	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	JPRN-UMIN000010126	2013/02/25	26/02/2013	Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease	Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD	Interstitial lung disease related to rheumatoid arthritis	In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on. In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases.	Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	34	Not applicable	Japan
22	EUCTR2011-002392-41-BG (EUCTR)	09/04/2012	07/02/2012	A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.	A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Z102 Product Code: Z102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® Product Name: Prednisone INN or Proposed INN: PREDNISONE	Zalicus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria
23	EUCTR2011-002392-41-HU (EUCTR)	28/03/2012	16/12/2011	A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.	A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Z102 Product Code: Z102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® Product Name: Prednisone INN or Proposed INN: PREDNISONE	Zalicus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria
24	NCT01612377 (ClinicalTrials.gov)	March 2012	22/2/2012	Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis	A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Prednisolone-Dipyridamole;Drug: Prednisone;Drug: prednisone	Zalicus	NULL	Terminated	18 Years	N/A	Both	18	Phase 2	Serbia
25	NCT01395251 (ClinicalTrials.gov)	February 2012	12/7/2011	Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis	Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Prednisolone	Rheumazentrum Ruhrgebiet	NULL	Completed	18 Years	N/A	Both	130	Phase 2;Phase 3	Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	EUCTR2011-002633-19-DE (EUCTR)	21/12/2011	02/08/2011	Prednisolone test for patients with an inflammatory joint disease	Diagnostic value of oral prednisolone test for rheumatoid arthritis - RZR12011-TryCort	rheumatoid arthritis MedDRA version: 14.0;Level: LLT;Classification code 10062719;Term: Seronegative rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Product Name: Paracetamol INN or Proposed INN: PARACETAMOL	Rheumazentrum Ruhrgebiet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Germany
27	EUCTR2011-000436-28-PL (EUCTR)	07/12/2011	20/06/2011	A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.	A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE	Zalicus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation
28	EUCTR2011-000436-28-BG (EUCTR)	07/10/2011	06/10/2011	A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.	A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE	Zalicus, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 2	United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria
29	EUCTR2011-000436-28-HU (EUCTR)	02/08/2011	10/08/2011	A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.	A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE	Zalicus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria
30	NCT01369745 (ClinicalTrials.gov)	June 2011	7/6/2011	A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis	A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Prednisolone;Drug: dipyridamole;Drug: Prednisone;Drug: Z102;Other: placebo	Zalicus	NULL	Completed	18 Years	N/A	All	294	Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2009-015740-42-DE (EUCTR)	12/05/2010	12/01/2010	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Metex 2,5mg INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Metex 2,5mg	Universitätsklinkum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 3	Germany
32	EUCTR2007-003508-36-GB (EUCTR)	02/07/2008	29/02/2008	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis		Nitec Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	Hungary;Germany;United Kingdom
33	EUCTR2007-004399-38-LT (EUCTR)	26/06/2008	23/04/2008	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		United Kingdom;Estonia;Lithuania
34	EUCTR2007-003508-36-HU (EUCTR)	17/06/2008	18/02/2008	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Lodotra® INN or Proposed INN: Prednisone	Nitec Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	350		Hungary;Germany;United Kingdom
35	EUCTR2007-003508-36-DE (EUCTR)	25/04/2008	28/03/2008	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	INN or Proposed INN: Prednisone	Nitec Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	350		Hungary;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2007-004399-38-EE (EUCTR)	18/04/2008	29/02/2008	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		United Kingdom;Estonia;Lithuania
37	EUCTR2007-003069-42-LT (EUCTR)	01/04/2008	05/02/2008	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;United Kingdom;Estonia;Lithuania
38	EUCTR2007-003069-42-HU (EUCTR)	27/03/2008	18/09/2007	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;United Kingdom;Estonia;Lithuania
39	EUCTR2007-004399-38-GB (EUCTR)	03/03/2008	20/03/2008	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Dipyridamole INN or Proposed INN: Prednisolone Product Code: CRx-102 INN or Proposed INN: Dipyridamole INN or Proposed INN: Prednisolone	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		United Kingdom;Estonia;Lithuania
40	EUCTR2007-006729-28-GB (EUCTR)	25/01/2008	04/12/2007	Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA	Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA	The objective of this study is to compare the efficacy of equivalent doses of IM triamcinolone acetonide and oral prednisolone in controlling a symptomatic flare in patients with established RA. MedDRA version: 9.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up	Trade Name: Kenalog Product Name: Triamcinolone acetonide INN or Proposed INN: TRIAMCINOLONE ACETONIDE Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE	Trafford NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	58		United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2007-003069-42-GB (EUCTR)	24/01/2008	15/08/2007	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;United Kingdom;Estonia;Lithuania
42	EUCTR2007-003069-42-EE (EUCTR)	31/10/2007	10/08/2007	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;United Kingdom;Estonia;Lithuania
43	NCT00551707 (ClinicalTrials.gov)	October 2007	29/10/2007	Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: CRx-102 (2.7/180);Drug: prednisolone;Drug: dipyridamole;Drug: placebo;Drug: CRx-102 (2.7/360)	Zalicus	NULL	Completed	18 Years	N/A	All	51	Phase 2	United States;Argentina;Canada;Estonia;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa
44	EUCTR2007-001190-28-GB (EUCTR)	09/05/2007	17/04/2007	Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT	Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Methotrexate Product Code: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: Sulfasalazine Product Code: Sulfasalazine INN or Proposed INN: SULFASALAZINE Product Name: Hydroxychloroquine Product Code: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Product Name: Ciclosporin Product Code: Ciclosporin INN or Proposed INN: Ciclosporin Product Name: Leflunomide Product Code: Leflunomide INN or Proposed INN: Leflunomide Product Name: Sodium aurothiomalate (intramuscular gold) Product Code: Sodium aurothiomalate (intramuscular gold) INN or Proposed INN: Sodium aurothiomalate Product Name: methylprednisolone Product Code: methylprednisolone INN or Proposed INN: Methylprednisolone Product Name: Prednisolone Product Code: Predniso	King's College London	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 4	United Kingdom
45	NCT00443430 (ClinicalTrials.gov)	May 2007	2/3/2007	Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis	Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA)	Juvenile Chronic Polyarthritis;Juvenile Idiopathic Arthritis;Juvenile Rheumatoid Arthritis	Drug: methotrexate;Drug: methotrexate - etanercept - prednisolone arm	Seattle Children's Hospital	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Amgen	Completed	2 Years	17 Years	All	85	Phase 4	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2004-001930-18-EE (EUCTR)	17/04/2006	19/01/2006	A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA	A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA	RHEUMATOID ARTHRITIS	Trade Name: Persantin 100 mg and Product Name: N/A Product Code: CRx-102 INN or Proposed INN: prednisolone & dipyridamole	CombinatoRx, Inc	NULL	Not Recruiting			Female: yes Male: yes	60		Estonia
47	EUCTR2004-004995-35-DK (EUCTR)	10/04/2006	20/09/2005	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Czech Republic;Germany;United Kingdom;Denmark;Italy
48	EUCTR2004-004995-35-GB (EUCTR)	24/02/2006	16/03/2005	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Trade Name: Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Czech Republic;Austria;Denmark;Germany;Italy;United Kingdom
49	NCT00379990 (ClinicalTrials.gov)	January 2006	21/9/2006	A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.	A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects.	Arthritis, Rheumatoid	Drug: GW274150;Drug: Prednisolone;Other: Placebo	GlaxoSmithKline	NULL	Completed	18 Years	N/A	Both	48	Phase 2	Serbia;United Kingdom
50	EUCTR2005-000902-30-GB (EUCTR)	09/12/2005	05/08/2005	A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients	A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients	Rheumatoid arthritis		GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 4	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	EUCTR2004-004995-35-IT (EUCTR)	08/11/2005	02/02/2007	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD	Evaluate the difference in ACR-20 response between rheumatoid arthritis subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 8 weeks of treatment. MedDRA version: 6.1;Level: PT;Classification code 10039073	INN or Proposed INN: Paroxetine INN or Proposed INN: Paroxetine Trade Name: Prednisolene tablets BP 1 mg INN or Proposed INN: Prednisolone	COMBINATORX, INC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	220	Phase 2	Czech Republic;Germany;United Kingdom;Denmark;Italy
52	EUCTR2004-004995-35-AT (EUCTR)	16/10/2005	09/11/2005	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Trade Name: Paroxetine Hydrochloride tablets 10 & 20 mg and Prednisolone 1 mg BP Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Czech Republic;Denmark;Austria;Germany;Italy;United Kingdom
53	NCT00241982 (ClinicalTrials.gov)	October 2005	18/10/2005	Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis	Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: long-circulating liposomal prednisolone	Radboud University	Utrecht University	Completed	18 Years	N/A	Both	22	Phase 2	Netherlands
54	EUCTR2004-005115-29-DE (EUCTR)	14/09/2005	16/05/2006	A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship	A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship	Rheumatoid arthritis	Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: Overencapsulated Prednisolone Tablets INN or Proposed INN: Prednisolone	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	77		United Kingdom;Germany
55	EUCTR2005-001977-82-GB (EUCTR)	09/09/2005	14/07/2005	A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects	A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects	Rheumatoid arthritis		GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	EUCTR2004-004995-35-CZ (EUCTR)	30/08/2005	30/08/2005	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Trade Name: Prednisolone Tablets BP 1 mg Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Germany;United Kingdom;Czech Republic;Denmark;Italy
57	EUCTR2004-004995-35-DE (EUCTR)	14/07/2005	17/03/2005	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine Product Name: N/A Product Code: CRX-139 INN or Proposed INN: Prednisolone Product Name: N/A Product Code: CRX-139 INN or Proposed INN: paroxetine	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Czech Republic;United Kingdom;Germany;Denmark;Italy
58	NCT00134693 (ClinicalTrials.gov)	June 21, 2005	24/8/2005	A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis	A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship	Arthritis, Rheumatoid	Drug: Prednisolone;Drug: SB-681323	GlaxoSmithKline	NULL	Completed	18 Years	N/A	All	77	Phase 2	Australia;France;Germany;Russian Federation;United Kingdom
59	NCT00908089 (ClinicalTrials.gov)	March 2003	22/5/2009	TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis	Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab;Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo	Helsinki University	Seinajoki Central Hospital;Oulu University Hospital;Jyväskylä Central Hospital;Kuopio University Hospital;Satakunta Central Hospital;University of Turku;Rheumatism Foundation Hospital;Orton Invalid Foundation;South Karelia central hospital;Lappi Central Hospital;Central Hospital of Kanta-Hame	Active, not recruiting	18 Years	60 Years	Both	100	Phase 4	Finland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03368235
(ClinicalTrials.gov)

January 18, 2018

3/11/2017

Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 Compared to Prednisolone 20 mg in Patients With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: AZD9567;Drug: Prednisolone

AstraZeneca

NULL

Completed

18 Years

80 Years

All

Phase 2

Netherlands;Sweden;Denmark

EUCTR2017-000838-64-NL
(EUCTR)

10/11/2017

13/06/2017

An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Code: AZD9567 monohydrate
INN or Proposed INN: AZD9567
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: Prednisolone

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

EUCTR2017-000838-64-SE
(EUCTR)

11/09/2017

19/05/2017

An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)

Product Name: AZD9567
Product Code: AZD9567 monohydrate
INN or Proposed INN: N/A
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: -

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

EUCTR2017-000838-64-DK
(EUCTR)

25/08/2017

13/06/2017

An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)

Product Code: AZD9567 monohydrate
INN or Proposed INN: N/A
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: -

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

EUCTR2011-004720-35-NL
(EUCTR)

22/03/2017

22/02/2017

A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.

Rheumatoid arthritis (RA)
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]

Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
INN or Proposed INN: PREDNISOLONE

The Karolinska Institute, ClinTRID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Finland;Denmark;Norway;Iceland;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-002729-21-PT
(EUCTR)

12/09/2016

27/04/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria

Rheumatoid artritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

NCT02930343
(ClinicalTrials.gov)

September 2016

13/9/2016

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine

Jawaharlal Institute of Postgraduate Medical Education & Research

NULL

Completed

18 Years

65 Years

All

136

Phase 3

India

NCT02585258
(ClinicalTrials.gov)

June 30, 2016

20/10/2015

The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study

The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis

RheumatoId Arthritis

Drug: Prednisolone;Other: Placebo

VU University Medical Center

European Commission

Active, not recruiting

65 Years

N/A

All

500

Phase 4

Germany;Hungary;Italy;Netherlands;Portugal;Romania;Slovakia;Finland

EUCTR2015-002729-21-FI
(EUCTR)

21/06/2016

30/03/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

Rheumatoid artritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

EUCTR2015-002729-21-HU
(EUCTR)

04/05/2016

11/02/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

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

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Hungary;Slovakia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02760316
(ClinicalTrials.gov)

May 2, 2016

25/4/2016

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567.

A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control

Rheumatoid Arthritis

Drug: AZD9567 10 mg;Drug: AZD9567 20 mg;Drug: AZD9567 40 mg;Drug: AZD9567 80 mg;Drug: Prednisolone 20 mg;Drug: AZD9567 125 mg;Drug: AZD9567 155 mg;Drug: Prednisolone 5 mg;Drug: Prednisolone 40 mg

AstraZeneca

NULL

Completed

18 Years

55 Years

All

Phase 1

Germany;United Kingdom

EUCTR2015-002729-21-DE
(EUCTR)

25/04/2016

02/02/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

EUCTR2015-002924-17-BE
(EUCTR)

24/02/2016

27/01/2016

A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis

A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis

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

Product Name: Nanocort
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE
Trade Name: Depo Medrol
Product Name: Depo Medrol

Sun Pharma Global FZE

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 3

Belgium;Netherlands

NCT02644499
(ClinicalTrials.gov)

December 31, 2015

30/12/2015

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid

Jawaharlal Institute of Postgraduate Medical Education & Research

NULL

Completed

18 Years

N/A

All

186

Phase 4

India

NCT03172325
(ClinicalTrials.gov)

November 18, 2015

24/5/2017

Study to Demonstrate Non-Inferiority Efficacy and Safety of CinnoRA® Produced by CinnaGen Company Versus Humira® for Treatment of Active Rheumatoid Arthritis

A Phase III, Randomized, Two-armed, Double-blind (Patient and Assessor Blinded), Parallel Active Controlled Non-Inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety of Two Disease-modifying Anti Rheumatic Drugs CinnoRA® (Produced by CinnaGen Company) Versus Humira® for Treatment of Active Rheumatoid Arthritis

Active Rheumatoid Arthritis

Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Prednisolone

Cinnagen

NULL

Completed

18 Years

75 Years

All

136

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02512575
(ClinicalTrials.gov)

November 18, 2015

6/7/2015

A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.

A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects.

Safety;Tolerability;Pharmacokinetics;Pharmacodynamics;Healthy Subjects;Rheumatoid Arthritis

Drug: AZD9567 Monohydrat;Drug: Placebo oral suspension/ Placebo capsule;Drug: Prednisolone

AstraZeneca

NULL

Completed

18 Years

55 Years

Male

Phase 1

Germany

EUCTR2015-002924-17-NL
(EUCTR)

12/11/2015

06/10/2015

A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis

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

Sun Pharma Global FZE

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 3

Belgium;Netherlands

NCT02466581
(ClinicalTrials.gov)

February 3, 2015

29/5/2015

Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity

A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity

Rheumatoid Arthritis

Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone;Biological: Cimzia;Biological: Orencia;Biological: RoActemra

Karolinska Institutet

NULL

Active, not recruiting

18 Years

N/A

All

Phase 4

Sweden

NCT02000336
(ClinicalTrials.gov)

January 2014

19/11/2013

Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis

Comparison of the Efficacy and Safety of Two Different Starting Dosages of Prednisolone in Early Active Rheumatoid Arthritis: a Randomized, Placebo Controlled Trial

Progression of Rheumatoid Arthritis

Drug: Prednisolone;Drug: Placebo

Prof. Dr. rer. nat. H.J. Trampisch

Ruhr University of Bochum

Completed

18 Years

N/A

All

395

Phase 3

Germany

EUCTR2012-004074-25-DE
(EUCTR)

30/10/2013

29/07/2013

Comparison of the effectiveness and safety of two different starting dosages of cortisone, compared to each other and to placebo, in early active rheumatoid arthritis

Comparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA

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

Trade Name: PredniHEXAL® 5mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL® 5mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL® 10mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 10mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL® 20mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 20mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon

Ruhr-Universität Bochum

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-UMIN000010126

2013/02/25

26/02/2013

Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease

Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD

Interstitial lung disease related to rheumatoid arthritis

In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on.
In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases.

Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not applicable

Japan

EUCTR2011-002392-41-BG
(EUCTR)

09/04/2012

07/02/2012

A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.

A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Treatment of patients with moderate to severe rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Z102
Product Code: Z102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
Product Name: Prednisone
INN or Proposed INN: PREDNISONE

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria

EUCTR2011-002392-41-HU
(EUCTR)

28/03/2012

16/12/2011

A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.

A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Product Name: Z102
Product Code: Z102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
Product Name: Prednisone
INN or Proposed INN: PREDNISONE

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria

NCT01612377
(ClinicalTrials.gov)

March 2012

22/2/2012

Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis

A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Prednisolone-Dipyridamole;Drug: Prednisone;Drug: prednisone

Zalicus

NULL

Terminated

18 Years

N/A

Both

Phase 2

Serbia

NCT01395251
(ClinicalTrials.gov)

February 2012

12/7/2011

Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis

Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Prednisolone

Rheumazentrum Ruhrgebiet

NULL

Completed

18 Years

N/A

Both

130

Phase 2;Phase 3

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-002633-19-DE
(EUCTR)

21/12/2011

02/08/2011

Prednisolone test for patients with an inflammatory joint disease

Diagnostic value of oral prednisolone test for rheumatoid arthritis - RZR12011-TryCort

rheumatoid arthritis
MedDRA version: 14.0;Level: LLT;Classification code 10062719;Term: Seronegative rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Product Name: Paracetamol
INN or Proposed INN: PARACETAMOL

Rheumazentrum Ruhrgebiet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

EUCTR2011-000436-28-PL
(EUCTR)

07/12/2011

20/06/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Product Name: Z102
Product Code: Z102
INN or Proposed INN: Z102 (Prednisolone and Dipyridamole).
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
Product Code: Dipyridamole
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
INN or Proposed INN: PREDNISONE

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation

EUCTR2011-000436-28-BG
(EUCTR)

07/10/2011

06/10/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

Zalicus, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria

EUCTR2011-000436-28-HU
(EUCTR)

02/08/2011

10/08/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria

NCT01369745
(ClinicalTrials.gov)

June 2011

7/6/2011

A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Prednisolone;Drug: dipyridamole;Drug: Prednisone;Drug: Z102;Other: placebo

Zalicus

NULL

Completed

18 Years

N/A

All

294

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2009-015740-42-DE
(EUCTR)

12/05/2010

12/01/2010

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO

Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Prednisolon
Product Code: Prednisolon
INN or Proposed INN: PREDNISOLONE
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Azathioprin
Other descriptive name: AZATHIOPRINE
Trade Name: Immunosporin
Product Name: Immunosporin
INN or Proposed INN: CICLOSPORIN
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: GOLIMUMAB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Product Name: Quensyl
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Trade Name: REMICADE
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Lantarel
Product Name: Lantarel
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Lantarel
Trade Name: Arava
Product Name: Arava
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Metex 2,5mg
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Metex 2,5mg

Universitätsklinkum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Germany

EUCTR2007-003508-36-GB
(EUCTR)

02/07/2008

29/02/2008

A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2

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

Nitec Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

Hungary;Germany;United Kingdom

EUCTR2007-004399-38-LT
(EUCTR)

26/06/2008

23/04/2008

A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

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

Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

United Kingdom;Estonia;Lithuania

EUCTR2007-003508-36-HU
(EUCTR)

17/06/2008

18/02/2008

A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2

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

Trade Name: Lodotra®
INN or Proposed INN: Prednisone

Nitec Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

350

Hungary;Germany;United Kingdom

EUCTR2007-003508-36-DE
(EUCTR)

25/04/2008

28/03/2008

A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2

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

INN or Proposed INN: Prednisone

Nitec Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

350

Hungary;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-004399-38-EE
(EUCTR)

18/04/2008

29/02/2008

A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

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

Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

United Kingdom;Estonia;Lithuania

EUCTR2007-003069-42-LT
(EUCTR)

01/04/2008

05/02/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)

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

Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;United Kingdom;Estonia;Lithuania

EUCTR2007-003069-42-HU
(EUCTR)

27/03/2008

18/09/2007

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)

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

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;United Kingdom;Estonia;Lithuania

EUCTR2007-004399-38-GB
(EUCTR)

03/03/2008

20/03/2008

A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

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

Product Code: CRx-102
INN or Proposed INN: Dipyridamole
INN or Proposed INN: Prednisolone
Product Code: CRx-102
INN or Proposed INN: Dipyridamole
INN or Proposed INN: Prednisolone

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

United Kingdom;Estonia;Lithuania

EUCTR2007-006729-28-GB
(EUCTR)

25/01/2008

04/12/2007

Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA

The objective of this study is to compare the efficacy of equivalent doses of IM triamcinolone acetonide and oral prednisolone in controlling a symptomatic flare in patients with established RA.
MedDRA version: 9.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up

Trade Name: Kenalog
Product Name: Triamcinolone acetonide
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE

Trafford NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-003069-42-GB
(EUCTR)

24/01/2008

15/08/2007

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)

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

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;United Kingdom;Estonia;Lithuania

EUCTR2007-003069-42-EE
(EUCTR)

31/10/2007

10/08/2007

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)

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

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;United Kingdom;Estonia;Lithuania

NCT00551707
(ClinicalTrials.gov)

October 2007

29/10/2007

Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: CRx-102 (2.7/180);Drug: prednisolone;Drug: dipyridamole;Drug: placebo;Drug: CRx-102 (2.7/360)

Zalicus

NULL

Completed

18 Years

N/A

All

Phase 2

United States;Argentina;Canada;Estonia;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa

EUCTR2007-001190-28-GB
(EUCTR)

09/05/2007

17/04/2007

Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT

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

Product Name: Methotrexate
Product Code: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: Sulfasalazine
Product Code: Sulfasalazine
INN or Proposed INN: SULFASALAZINE
Product Name: Hydroxychloroquine
Product Code: Hydroxychloroquine
INN or Proposed INN: Hydroxychloroquine
Product Name: Ciclosporin
Product Code: Ciclosporin
INN or Proposed INN: Ciclosporin
Product Name: Leflunomide
Product Code: Leflunomide
INN or Proposed INN: Leflunomide
Product Name: Sodium aurothiomalate (intramuscular gold)
Product Code: Sodium aurothiomalate (intramuscular gold)
INN or Proposed INN: Sodium aurothiomalate
Product Name: methylprednisolone
Product Code: methylprednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Prednisolone
Product Code: Predniso

King's College London

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 4

United Kingdom

NCT00443430
(ClinicalTrials.gov)

May 2007

2/3/2007

Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis

Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA)

Juvenile Chronic Polyarthritis;Juvenile Idiopathic Arthritis;Juvenile Rheumatoid Arthritis

Drug: methotrexate;Drug: methotrexate - etanercept - prednisolone arm

Seattle Children's Hospital

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Amgen

Completed

2 Years

17 Years

All

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2004-001930-18-EE
(EUCTR)

17/04/2006

19/01/2006

A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA

RHEUMATOID ARTHRITIS

Trade Name: Persantin 100 mg and
Product Name: N/A
Product Code: CRx-102
INN or Proposed INN: prednisolone & dipyridamole

CombinatoRx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Estonia

EUCTR2004-004995-35-DK
(EUCTR)

10/04/2006

20/09/2005

A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA

ACTIVE RHEUMATOID ARTHRITIS

Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Czech Republic;Germany;United Kingdom;Denmark;Italy

EUCTR2004-004995-35-GB
(EUCTR)

24/02/2006

16/03/2005

ACTIVE RHEUMATOID ARTHRITIS

Trade Name: Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Czech Republic;Austria;Denmark;Germany;Italy;United Kingdom

NCT00379990
(ClinicalTrials.gov)

January 2006

21/9/2006

A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.

A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects.

Arthritis, Rheumatoid

Drug: GW274150;Drug: Prednisolone;Other: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

N/A

Both

Phase 2

Serbia;United Kingdom

EUCTR2005-000902-30-GB
(EUCTR)

09/12/2005

05/08/2005

A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients

Rheumatoid arthritis

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2004-004995-35-IT
(EUCTR)

08/11/2005

02/02/2007

Evaluate the difference in ACR-20 response between rheumatoid arthritis subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 8 weeks of treatment.
MedDRA version: 6.1;Level: PT;Classification code 10039073

INN or Proposed INN: Paroxetine
INN or Proposed INN: Paroxetine
Trade Name: Prednisolene tablets BP 1 mg
INN or Proposed INN: Prednisolone

COMBINATORX, INC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 2

Czech Republic;Germany;United Kingdom;Denmark;Italy

EUCTR2004-004995-35-AT
(EUCTR)

16/10/2005

09/11/2005

ACTIVE RHEUMATOID ARTHRITIS

Trade Name: Paroxetine Hydrochloride tablets 10 & 20 mg and Prednisolone 1 mg BP
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Czech Republic;Denmark;Austria;Germany;Italy;United Kingdom

NCT00241982
(ClinicalTrials.gov)

October 2005

18/10/2005

Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: long-circulating liposomal prednisolone

Radboud University

Utrecht University

Completed

18 Years

N/A

Both

Phase 2

Netherlands

EUCTR2004-005115-29-DE
(EUCTR)

14/09/2005

16/05/2006

A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship

Rheumatoid arthritis

Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: Overencapsulated Prednisolone Tablets
INN or Proposed INN: Prednisolone

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Germany

EUCTR2005-001977-82-GB
(EUCTR)

09/09/2005

14/07/2005

A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects

Rheumatoid arthritis

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2004-004995-35-CZ
(EUCTR)

30/08/2005

ACTIVE RHEUMATOID ARTHRITIS

Trade Name: Prednisolone Tablets BP 1 mg
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Germany;United Kingdom;Czech Republic;Denmark;Italy

EUCTR2004-004995-35-DE
(EUCTR)

14/07/2005

17/03/2005

ACTIVE RHEUMATOID ARTHRITIS

Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine
Product Name: N/A
Product Code: CRX-139
INN or Proposed INN: Prednisolone
Product Name: N/A
Product Code: CRX-139
INN or Proposed INN: paroxetine

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Czech Republic;United Kingdom;Germany;Denmark;Italy

NCT00134693
(ClinicalTrials.gov)

June 21, 2005

24/8/2005

A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis

A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship

Arthritis, Rheumatoid

Drug: Prednisolone;Drug: SB-681323

GlaxoSmithKline

NULL

Completed

18 Years

N/A

All

Phase 2

Australia;France;Germany;Russian Federation;United Kingdom

NCT00908089
(ClinicalTrials.gov)

March 2003

22/5/2009

TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis

Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab;Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo

Helsinki University

Seinajoki Central Hospital;Oulu University Hospital;Jyväskylä Central Hospital;Kuopio University Hospital;Satakunta Central Hospital;University of Turku;Rheumatism Foundation Hospital;Orton Invalid Foundation;South Karelia central hospital;Lappi Central Hospital;Central Hospital of Kanta-Hame

Active, not recruiting

18 Years

60 Years

Both

100

Phase 4

Finland

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-jRCTs011190011	13/03/2020	13/03/2020	Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus	Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus - Sibelius Study	Systemic lupus erythematosus Systemic lupus erhythematosus;D008180	Subjects who have met the entry criteria will be randomly to one of the two treatment groups based on a computer-generated randomization schedule as follows: 1) BEL group and 2) CS increased group using standard CS therapy (CS group) . 1. Subjects in BEL group will receive BEL 200 mg weekly SC on Day 0, and then every 7 days through week 24 or BEL 10mg/kg IV on Day 0, 14, 28 and every 1 month. 2. Subjects in CS group will receive prednisolone (All subjects will start treatment with MMF oral 1g/day In both groups, if subjects are not on treatment with HCQ, their drug will be started at a dose individually adjusted on basis of the patient's height (from 200 to 400mg/day). In the BEL group, the baseline dose of CS	Atsumi Tatsuya	NULL	Recruiting	>= 18age old	Not applicable	Both	48	Phase 4	Japan
2	NCT01773616 (ClinicalTrials.gov)	April 2015	1/11/2012	Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis	Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis	Systemic Lupus Erythematosus, Lupus Nephritis	Drug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisolone	Imperial College London	Karolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study Group	Terminated	12 Years	75 Years	All	24	Phase 3	United Kingdom
3	NCT01085097 (ClinicalTrials.gov)	July 2010	4/3/2010	Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Nephritis	A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids)	Lupus Nephritis	Drug: laquinimod;Drug: Mycophenolate Mofetil;Drug: prednisolone/prednisone;Drug: Placebo	Teva Pharmaceutical Industries	NULL	Completed	18 Years	75 Years	Both	47	Phase 2	United States;Canada;France;Russian Federation;United Kingdom
4	NCT00430677 (ClinicalTrials.gov)	June 2007	1/2/2007	Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis	A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: Corticosteroids (prednisone or prednisolone);Drug: Abatacept;Drug: Mycophenolate mofetil (MMF)	Bristol-Myers Squibb	NULL	Terminated	18 Years	N/A	All	423	Phase 2;Phase 3	United States;Argentina;Australia;Belgium;Brazil;Canada;China;France;Hong Kong;India;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Japan;Philippines;Puerto Rico
5	JPRN-UMIN000000639	2007/03/01	16/03/2007	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus		Systemic lupus erythematosus	IDEC-C2B8 plus oral prednisolone(tapering) 1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183). Placebo plus oral prednisolone(tapering) 1000 mg of placebo day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).	Zenyaku Kogyo Co., Ltd.	NULL	Complete: follow-up complete	16years-old	75years-old	Male and Female	150	Phase 2;Phase 3	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	JPRN-C000000159	2006/03/01	01/04/2006	Mizolibin for systemic lupus erythematosus in children(JSRDC10)		systematic lupus erythematosus	Methylprednisolone+mizoribine+prednisolone	Japanese Study Group of Renal Disease in Children(JSRDC)	NULL	Complete: follow-up complete	2years-old	18years-old	Male and Female	30	Not selected	Japan
7	JPRN-C000000378	1995/03/01	01/04/2006	A combination of methylprednisoloneand prednisolone and a combination of Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04)		systematic lupus erythematosus	Methylprednisolone+prednisolone Methylprednisolone+prednisolone+mizoribine	Japanese Study Group of Renal Disease in Children(JSRDC)	NULL	Complete: follow-up complete	2years-old	18years-old	Male and Female	60	Not selected	Japan
8	EUCTR2005-003957-28-BE (EUCTR)		24/10/2006	Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile systemic lupus erythematosus nephritis: oral cyclophosphamide versus high dose intravenous cyclophosphamide versus intermediate dose intravenous cyclophosphamide - PRINTO JSLE Trial	Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile systemic lupus erythematosus nephritis: oral cyclophosphamide versus high dose intravenous cyclophosphamide versus intermediate dose intravenous cyclophosphamide - PRINTO JSLE Trial	Systemic lupus erythematosus nephritis	Product Name: Azathioprine INN or Proposed INN: Azathioprine Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone sodium succinate Product Name: Prednisolone INN or Proposed INN: Methylprednisolone Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide	University Hospital Gent	NULL	NA			Female: yes Male: yes	216	Phase 3	Belgium;Denmark;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-jRCTs011190011

13/03/2020

Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus

Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus - Sibelius Study

Systemic lupus erythematosus
Systemic lupus erhythematosus;D008180

Subjects who have met the entry criteria will be randomly to one of the two treatment groups based on a computer-generated randomization schedule as follows: 1) BEL group and 2) CS increased group using standard CS therapy (CS group) .

1. Subjects in BEL group will receive BEL 200 mg weekly SC on Day 0, and then every 7 days through week 24 or BEL 10mg/kg IV on Day 0, 14, 28 and every 1 month.
2. Subjects in CS group will receive prednisolone (All subjects will start treatment with MMF oral 1g/day
In both groups, if subjects are not on treatment with HCQ, their drug will be started at a dose individually adjusted on basis of the patient's height (from 200 to 400mg/day).
In the BEL group, the baseline dose of CS

Atsumi Tatsuya

NULL

Recruiting

>= 18age old

Not applicable

Both

Phase 4

Japan

NCT01773616
(ClinicalTrials.gov)

April 2015

1/11/2012

Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis

Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis

Systemic Lupus Erythematosus, Lupus Nephritis

Drug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisolone

Imperial College London

Karolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study Group

Terminated

12 Years

75 Years

All

Phase 3

United Kingdom

NCT01085097
(ClinicalTrials.gov)

July 2010

4/3/2010

Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Nephritis

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids)

Lupus Nephritis

Drug: laquinimod;Drug: Mycophenolate Mofetil;Drug: prednisolone/prednisone;Drug: Placebo

Teva Pharmaceutical Industries

NULL

Completed

18 Years

75 Years

Both

Phase 2

United States;Canada;France;Russian Federation;United Kingdom

NCT00430677
(ClinicalTrials.gov)

June 2007

1/2/2007

Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Corticosteroids (prednisone or prednisolone);Drug: Abatacept;Drug: Mycophenolate mofetil (MMF)

Bristol-Myers Squibb

NULL

Terminated

18 Years

N/A

All

423

Phase 2;Phase 3

United States;Argentina;Australia;Belgium;Brazil;Canada;China;France;Hong Kong;India;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Japan;Philippines;Puerto Rico

JPRN-UMIN000000639

2007/03/01

16/03/2007

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus

Systemic lupus erythematosus

IDEC-C2B8 plus oral prednisolone(tapering)
1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).
Placebo plus oral prednisolone(tapering)
1000 mg of placebo day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).

Zenyaku Kogyo Co., Ltd.

NULL

Complete: follow-up complete

16years-old

75years-old

Male and Female

150

Phase 2;Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-C000000159

2006/03/01

01/04/2006

Mizolibin for systemic lupus erythematosus in children(JSRDC10)

systematic lupus erythematosus

Methylprednisolone+mizoribine+prednisolone

Japanese Study Group of Renal Disease in Children(JSRDC)

NULL

Complete: follow-up complete

2years-old

18years-old

Male and Female

Not selected

Japan

JPRN-C000000378

1995/03/01

01/04/2006

A combination of methylprednisoloneand prednisolone and a combination of Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04)

systematic lupus erythematosus

Methylprednisolone+prednisolone
Methylprednisolone+prednisolone+mizoribine

Japanese Study Group of Renal Disease in Children(JSRDC)

NULL

Complete: follow-up complete

2years-old

18years-old

Male and Female

Not selected

Japan

EUCTR2005-003957-28-BE
(EUCTR)

24/10/2006

Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile systemic lupus erythematosus nephritis: oral cyclophosphamide versus high dose intravenous cyclophosphamide versus intermediate dose intravenous cyclophosphamide - PRINTO JSLE Trial

Systemic lupus erythematosus nephritis

Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone sodium succinate
Product Name: Prednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide

University Hospital Gent

NULL

Female: yes
Male: yes

216

Phase 3

Belgium;Denmark;Italy

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000032193	2018/04/11	13/04/2018	Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial	Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial - Combination therapy of corticosteroid and tacrolimus for anti-MDA5 antibody-positive DM-ILD	anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung disease	Patients without poor prognostic factors: combination therapy of corticosteroid (prednisolone) and tacrolimus for 12 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day (Maximum dose of prednisolone is 60mg/body/day). Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more in the study period (12 months). Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml. For patients with poor prognostic factors, attending physician can chose any treatments (e.g. corticosteroid, immunosuppressant, IVIG). The patients were followed up for 12 months.	Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine	NULL	Recruiting	20years-old	80years-old	Male and Female	40	Not selected	Japan
2	JPRN-UMIN000032022	2018/04/01	01/04/2018	Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial	Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial - Corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for anti-ARS antibody-positive PM/DM-ILD	anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung disease	Arm 1: corticosteroid (prednisolone) monotherapy for 24 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.) Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month). Arm 2: combination therapy of corticosteroid (prednisolone) and tacrolimus for 24 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.) Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month). Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml.	Hamamatsu University School of Medicine	NULL	Recruiting	20years-old	80years-old	Male and Female	66	Not selected	Japan
3	JPRN-UMIN000015469	2014/10/20	18/10/2014	Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease	Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease - Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILD	polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease	arm1: tacrolimus and predonisolon therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Taclorimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml. arm2: cyclosporine and predonisolone therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Cyclosporine is administered orally at initial dose of 3 mg/kg/day (twice daily before meal) and adjusted over time to maintain a whole-blood trough level of 100 - 150 ng/ml.	Second Division, Department of Internal medicine, Hamamatsu University School of Medicine	NULL	Complete: follow-up complete	18years-old	75years-old	Male and Female	50	Not selected	Japan
4	ChiCTR-TRC-13003178	2013-05-01	2013-01-03	Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study	Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study	Polymyositis/Dermatomyositis	group1-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg / d, then reduce 2.5mg every two weeks to 5mg/d, maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group1-predinsone+MTX group:MTX 10-20mgQw×24w; MTX 7.5-10mgQw×48w, the usage of prednisone is the same as in the control group.;group1-predinsone+LEF group:LEF 20mg/d×24w; LEF 10mg/d×48w, the usage of prednisone is the same as in the control group.;group2-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg/d, then reduce 2.5mg every two weeks to 5mg/d,maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group2-predinsone+CTX group:CTX iv 0.8-1.0g/4w×24w; CTX iv 0.8-1.0g/12w×48w, the usage of prednisone is the same as in the control group.;group2-predinsone+MTX group:MMF 1.5-2.0g /d×24w; MMF 0.75-1g/d×48w, the usage of prednisone is the same as in the control group.;	Department of rheumatology, China-Japan Friendship hospital	NULL	Recruiting	18	70	Both	group1-predinsone group(control group):94;group1-predinsone+MTX group:94;group1-predinsone+LEF group:94;group2-predinsone group(control group):94;group2-predinsone+CTX group:94;group2-predinsone+MTX group:94;		China
5	JPRN-UMIN000001866	2009/04/01	10/04/2009	Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis	Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis - Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis	Dermatomyositis or polymyositis with interstitial pneumonia	(1)The patients are initially treated with methylprednisolone (m-PSL) pulse (1000 mg daily for three days) followed by oral prednisolone (1mg/kg daily). (2)Continuous intravenous CyA (2 mg/kg daily for initial dose) is started following m-PSL pulse therapy, and the dosage will be adjusted to a level of 200-300ng/ml.	Department of Neurology and Rheumatology, Shinshu University School of Medicine	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	10	Not selected	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2005-003956-37-GB (EUCTR)	18/06/2008	20/03/2008	Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate	Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate	Juvenile Dermatomyositis at onset	Trade Name: treatment defined only by active substance Product Name: prednisone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methylprednisolone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methotrexate Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methotrexate Product Code: not available INN or Proposed INN: not availa	Istituto Giannina Gaslini	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	132	Phase 3	United Kingdom;Netherlands;Belgium;Italy;Sweden
7	JPRN-JMA-IIA00012	20/07/2007	05/07/2007	Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus	An open-label clinical trial of the combination treatment of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial pneumonitis, with comparison against corticosteroid-treated historical controls	Interstitial pneumonitis associated with polymyositis/dermatomyositis	Intervention type:DRUG. Intervention1:Tacrolimus, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg..	IMPPACT study central office	Hokkaido University Hospital, Tsukuba University Hospital, Chiba University Hospital, The University of Tokyo Hospital, Tokyo Medical and Dental University Hospital, International Medical Center of Japan, Juntendo University Hospital, Keio University Hospital, Osaka Minami Medical Center, Tokushima University Hospital, Nagasaki University Hospital of Medicine and Dentistry	Completed	>=16 YEARS	<75 YEARS	BOTH	20		Japan
8	NCT00504348 (ClinicalTrials.gov)	July 2007	19/7/2007	Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus	An Open-label Clinical Trial of the Combination Treatment of Tacrolimus and Corticosteroid in Polymyositis/Dermatomyositis Patients With Interstitial Pneumonitis, With Comparison Against Corticosteroid-treated Historical Controls	Interstitial Pneumonitis;Polymyositis;Dermatomyositis	Drug: Tacrolimus	Tokyo Medical and Dental University	Japan Medical Association;Astellas Pharma Inc	Completed	16 Years	74 Years	All	25	Phase 2;Phase 3	Japan
9	EUCTR2005-003956-37-BE (EUCTR)	13/11/2006	25/10/2006	Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial	Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial	Juvenile Dermatomyositis at onset	Product Name: Prednisolone INN or Proposed INN: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone sodium succinate Product Name: Cyclosporine INN or Proposed INN: Cyclosporine A Product Name: Cyclosporine INN or Proposed INN: Cyclosporine A Product Name: Methotrexate INN or Proposed INN: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate	University Hospital Gent	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 3	United Kingdom;Netherlands;Belgium;Italy;Sweden
10	NCT00004357 (ClinicalTrials.gov)	September 1997	18/10/1999	Absorption of Corticosteroids in Children With Juvenile Dermatomyositis	Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis	Vasculitis, Hypersensitivity;Connective Tissue Diseases;Dermatomyositis;Vasculitis	Drug: Methylprednisolone;Drug: Prednisolone	Northwestern University	Ann & Robert H Lurie Children's Hospital of Chicago	Completed	4 Years	21 Years	Both	6	Phase 2	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-UMIN000032193

2018/04/11

13/04/2018

Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial

anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung disease

Patients without poor prognostic factors:
combination therapy of corticosteroid (prednisolone) and tacrolimus for 12 months

Initial dose of oral prednisolone is 0.7 - 1mg/kg/day (Maximum dose of prednisolone is 60mg/body/day). Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity.
After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more in the study period (12 months).

Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml.

For patients with poor prognostic factors, attending physician can chose any treatments (e.g. corticosteroid, immunosuppressant, IVIG). The patients were followed up for 12 months.

Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine

NULL

Recruiting

20years-old

80years-old

Male and Female

Not selected

Japan

JPRN-UMIN000032022

2018/04/01

01/04/2018

Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial - Corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for anti-ARS antibody-positive PM/DM-ILD

anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung disease

Arm 1: corticosteroid (prednisolone) monotherapy for 24 months

Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.)
Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity.
After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month).
Arm 2: combination therapy of corticosteroid (prednisolone) and tacrolimus for 24 months

Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.)
Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity.
After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month).

Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml.

Hamamatsu University School of Medicine

NULL

Recruiting

20years-old

80years-old

Male and Female

Not selected

Japan

JPRN-UMIN000015469

2014/10/20

18/10/2014

Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease

Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease - Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILD

polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease

arm1: tacrolimus and predonisolon therapy for 52 weeks

Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more.

Taclorimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml.
arm2: cyclosporine and predonisolone therapy for 52 weeks

Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more.

Cyclosporine is administered orally at initial dose of 3 mg/kg/day (twice daily before meal) and adjusted over time to maintain a whole-blood trough level of 100 - 150 ng/ml.

Second Division, Department of Internal medicine, Hamamatsu University School of Medicine

NULL

Complete: follow-up complete

18years-old

75years-old

Male and Female

Not selected

Japan

ChiCTR-TRC-13003178

2013-05-01

2013-01-03

Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study

Polymyositis/Dermatomyositis

group1-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg / d, then reduce 2.5mg every two weeks to 5mg/d, maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group1-predinsone+MTX group:MTX 10-20mgQw×24w; MTX 7.5-10mgQw×48w, the usage of prednisone is the same as in the control group.;group1-predinsone+LEF group:LEF 20mg/d×24w; LEF 10mg/d×48w, the usage of prednisone is the same as in the control group.;group2-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg/d, then reduce 2.5mg every two weeks to 5mg/d,maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group2-predinsone+CTX group:CTX iv 0.8-1.0g/4w×24w; CTX iv 0.8-1.0g/12w×48w, the usage of prednisone is the same as in the control group.;group2-predinsone+MTX group:MMF 1.5-2.0g /d×24w; MMF 0.75-1g/d×48w, the usage of prednisone is the same as in the control group.;

Department of rheumatology, China-Japan Friendship hospital

NULL

Recruiting

Both

group1-predinsone group(control group):94;group1-predinsone+MTX group:94;group1-predinsone+LEF group:94;group2-predinsone group(control group):94;group2-predinsone+CTX group:94;group2-predinsone+MTX group:94;

China

JPRN-UMIN000001866

2009/04/01

10/04/2009

Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis

Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis - Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis

Dermatomyositis or polymyositis with interstitial pneumonia

(1)The patients are initially treated with methylprednisolone (m-PSL) pulse (1000 mg daily for three days) followed by oral prednisolone (1mg/kg daily).
(2)Continuous intravenous CyA (2 mg/kg daily for initial dose) is started following m-PSL pulse therapy, and the dosage will be adjusted to a level of 200-300ng/ml.

Department of Neurology and Rheumatology, Shinshu University School of Medicine

NULL

Complete: follow-up complete

16years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2005-003956-37-GB
(EUCTR)

18/06/2008

20/03/2008

Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate

Juvenile Dermatomyositis at onset

Trade Name: treatment defined only by active substance
Product Name: prednisone
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: methylprednisolone
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: cyclosporine A
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: cyclosporine A
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: methotrexate
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: methotrexate
Product Code: not available
INN or Proposed INN: not availa

Istituto Giannina Gaslini

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

132

Phase 3

United Kingdom;Netherlands;Belgium;Italy;Sweden

JPRN-JMA-IIA00012

20/07/2007

05/07/2007

Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus

An open-label clinical trial of the combination treatment of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial pneumonitis, with comparison against corticosteroid-treated historical controls

Interstitial pneumonitis associated with polymyositis/dermatomyositis

Intervention type:DRUG. Intervention1:Tacrolimus, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg..

IMPPACT study central office

Hokkaido University Hospital, Tsukuba University Hospital, Chiba University Hospital, The University of Tokyo Hospital, Tokyo Medical and Dental University Hospital, International Medical Center of Japan, Juntendo University Hospital, Keio University Hospital, Osaka Minami Medical Center, Tokushima University Hospital, Nagasaki University Hospital of Medicine and Dentistry

Completed

>=16 YEARS

<75 YEARS

BOTH

Japan

NCT00504348
(ClinicalTrials.gov)

July 2007

19/7/2007

Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus

An Open-label Clinical Trial of the Combination Treatment of Tacrolimus and Corticosteroid in Polymyositis/Dermatomyositis Patients With Interstitial Pneumonitis, With Comparison Against Corticosteroid-treated Historical Controls

Interstitial Pneumonitis;Polymyositis;Dermatomyositis

Drug: Tacrolimus

Tokyo Medical and Dental University

Japan Medical Association;Astellas Pharma Inc

Completed

16 Years

74 Years

All

Phase 2;Phase 3

Japan

EUCTR2005-003956-37-BE
(EUCTR)

13/11/2006

25/10/2006

Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial

Juvenile Dermatomyositis at onset

Product Name: Prednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone sodium succinate
Product Name: Cyclosporine
INN or Proposed INN: Cyclosporine A
Product Name: Cyclosporine
INN or Proposed INN: Cyclosporine A
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate

University Hospital Gent

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 3

United Kingdom;Netherlands;Belgium;Italy;Sweden

NCT00004357
(ClinicalTrials.gov)

September 1997

18/10/1999

Absorption of Corticosteroids in Children With Juvenile Dermatomyositis

Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis

Vasculitis, Hypersensitivity;Connective Tissue Diseases;Dermatomyositis;Vasculitis

Drug: Methylprednisolone;Drug: Prednisolone

Northwestern University

Ann & Robert H Lurie Children's Hospital of Chicago

Completed

4 Years

21 Years

Both

Phase 2

United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03607071 (ClinicalTrials.gov)	May 15, 2018	20/7/2018	Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma	Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study	Myocardial Inflammation	Drug: Prednisolone and taper	Khon Kaen University	NULL	Completed	18 Years	N/A	All	20	Phase 2	Thailand
2	NCT03708718 (ClinicalTrials.gov)	December 21, 2017	8/10/2018	Prednisolone in Early Diffuse Systemic Sclerosis	A Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19)	Systemic Sclerosis	Drug: Prednisolone 5 mg;Drug: Placebo oral capsule; From August 2020 'no additional treatment'	Prof. Ariane herrick	Versus Arthritis	Recruiting	18 Years	N/A	All	72	Phase 2	United Kingdom
3	EUCTR2016-002651-25-GB (EUCTR)	11/07/2017	08/05/2018	A Study of Prednisolone in Patients with Early (within 3 years of onset) Diffuse Cutaneous Scleroderma (Systemic Sclerosis)	A Phase II Randomised Controlled Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis - PRedSS: Prednisolone in Early Diffuse Systemic Sclerosis. Version 1.0	Early diffuse cutaneous systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Prednisolone 5mg Gastro-resistant Tablets Product Name: Prednisolone 5mg Gastro-resistant Tablets INN or Proposed INN: Prednisolone Other descriptive name: Prednisolon;Prednisolona; Prednisoloni; Prednisolonum; Prednizolon;Prednizolonas	Research Governance and Integrity, University of Manchester	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	72	Phase 2	United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03607071
(ClinicalTrials.gov)

May 15, 2018

20/7/2018

Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma

Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study

Myocardial Inflammation

Drug: Prednisolone and taper

Khon Kaen University

NULL

Completed

18 Years

N/A

All

Phase 2

Thailand

NCT03708718
(ClinicalTrials.gov)

December 21, 2017

8/10/2018

Prednisolone in Early Diffuse Systemic Sclerosis

A Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19)

Systemic Sclerosis

Drug: Prednisolone 5 mg;Drug: Placebo oral capsule; From August 2020 'no additional treatment'

Prof. Ariane herrick

Versus Arthritis

Recruiting

18 Years

N/A

All

Phase 2

United Kingdom

EUCTR2016-002651-25-GB
(EUCTR)

11/07/2017

08/05/2018

A Study of Prednisolone in Patients with Early (within 3 years of onset) Diffuse Cutaneous Scleroderma (Systemic Sclerosis)

A Phase II Randomised Controlled Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis - PRedSS: Prednisolone in Early Diffuse Systemic Sclerosis. Version 1.0

Early diffuse cutaneous systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Prednisolone 5mg Gastro-resistant Tablets
Product Name: Prednisolone 5mg Gastro-resistant Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: Prednisolon;Prednisolona; Prednisoloni; Prednisolonum; Prednizolon;Prednizolonas

Research Governance and Integrity, University of Manchester

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000012469	2013/12/02	02/12/2013	Comparison of Adalimumab and Steroid in Intestinal Behcet's disease	Comparison of Adalimumab and Steroid in Intestinal Behcet's disease - Castle Study	Intestinal Behcet's disease	Subcutaneous injection of adalumumab with 160mg at 0 week, 80mg at 2 weeks and 40mg every other week after at 4 weeks continuously. Oral administration of prednisolone with 0.6mg/kg/day during from 1 to 2 weeks, and tapering off until 12 weeks with decreasing dosage 5mg/kg/week approximately	Castle Study Group	NULL	Recruiting	15years-old	Not applicable	Male and Female	50	Not selected	Japan
2	NCT00931957 (ClinicalTrials.gov)	October 2010	30/6/2009	Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease	Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease	Behcet Syndrome;Uveal Disease	Drug: Etanercept, Methotrexate, Prednisolone	Tehran University of Medical Sciences	Wyeth is now a wholly owned subsidiary of Pfizer	Recruiting	16 Years	60 Years	Both	80	N/A	Iran, Islamic Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-UMIN000012469

2013/12/02

02/12/2013

Comparison of Adalimumab and Steroid in Intestinal Behcet's disease

Comparison of Adalimumab and Steroid in Intestinal Behcet's disease - Castle Study

Intestinal Behcet's disease

Subcutaneous injection of adalumumab with 160mg at 0 week, 80mg at 2 weeks and 40mg every other week after at 4 weeks continuously.
Oral administration of prednisolone with 0.6mg/kg/day during from 1 to 2 weeks, and tapering off until 12 weeks with decreasing dosage 5mg/kg/week approximately

Castle Study Group

NULL

Recruiting

15years-old

Not applicable

Male and Female

Not selected

Japan

NCT00931957
(ClinicalTrials.gov)

October 2010

30/6/2009

Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease

Behcet Syndrome;Uveal Disease

Drug: Etanercept, Methotrexate, Prednisolone

Tehran University of Medical Sciences

Wyeth is now a wholly owned subsidiary of Pfizer

Recruiting

16 Years

60 Years

Both

N/A

Iran, Islamic Republic of

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-jRCTs071190032	26/11/2019	21/10/2019	W-JHS AA02	Investigation on the effectiveness of rabbit ATG + cyclosporine + eltrombopag therapy for patients with aplastic anemia - W-JHS AA02	aplastic anemia	1. The administration of rATG; 2.5 mg/kg, iv. daily, day 1 - day 5 + CsA; 5 mg/kg, po. bid (before breakfast and before dinner) +adrenalcorticosteroid (the dose is mentioned after) is started. CsA used is Neoral or generic drug emulsified in the same way with Neoral. A blood level of CsA is measured and the dose which CsA blood level 2 hours after oral administration (C2) reachs 600 - 900 ng/mL is adjusted. The investigator shall reduce the dose of CsA by 25% on this occasion when blood trough level (C0) just before the administration is beyond 250 ng/mL because renal function disorder may occur (2). When serum creatinine level also becomes higher than 150% of baselines, the 25% dose reduction of CsA shall be performed. If C2 did not reach to 600 ng/mL, then dose of CsA is appropriately increased. 2. EPAG; 75 mg, po. daily (before sleep, requires to pass more than at least 2 hours after dinner) is started from day 6. 3. The dose of steroid is as follows: Day 1 - day 5: methylprednisolone 2 mg/kg/day Day 6: Methylprednisolone 1 mg/kg/day Day 8, 10, 12, 14, 16, 18, 20: prednisolone 0.5 mg/kg/day Discontinuation after day 21 4. The administration of CsA and EPAG is continued for 26 weeks. When it passed 26 weeks, further treatment mentioned above is entrusted to the investigator in each medical institution after 27 weeks if patients reached Camitta criteria CR or PR. However, the administration is continued for 52 weeks even if the dose of CsA is reduced. The treatment after 53 weeks is not specified. If patients did not reach CR or PR at 26 weeks, treatment after 27 weeks is entrusted to the investigator in each medical institution (it is not specified in this study).	Nakao Shinji	NULL	Recruiting	>= 18age old	< 80age old	Both	60	Phase 2	Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-jRCTs071190032

26/11/2019

21/10/2019

W-JHS AA02

Investigation on the effectiveness of rabbit ATG + cyclosporine + eltrombopag therapy for patients with aplastic anemia - W-JHS AA02

aplastic anemia

1. The administration of rATG; 2.5 mg/kg, iv. daily, day 1 - day 5 + CsA; 5 mg/kg, po. bid (before breakfast and before dinner) +adrenalcorticosteroid (the dose is mentioned after) is started. CsA used is Neoral or generic drug emulsified in the same way with Neoral. A blood level of CsA is measured and the dose which CsA blood level 2 hours after oral administration (C2) reachs 600 - 900 ng/mL is adjusted. The investigator shall reduce the dose of CsA by 25% on this occasion when blood trough level (C0) just before the administration is beyond 250 ng/mL because renal function disorder may occur (2). When serum creatinine level also becomes higher than 150% of baselines, the 25% dose reduction of CsA shall be performed. If C2 did not reach to 600 ng/mL, then dose of CsA is appropriately increased.
2. EPAG; 75 mg, po. daily (before sleep, requires to pass more than at least 2 hours after dinner) is started from day 6.
3. The dose of steroid is as follows:
Day 1 - day 5: methylprednisolone 2 mg/kg/day
Day 6: Methylprednisolone 1 mg/kg/day
Day 8, 10, 12, 14, 16, 18, 20: prednisolone 0.5 mg/kg/day
Discontinuation after day 21
4. The administration of CsA and EPAG is continued for 26 weeks. When it passed 26 weeks, further treatment mentioned above is entrusted to the investigator in each medical institution after 27 weeks if patients reached Camitta criteria CR or PR. However, the administration is continued for 52 weeks even if the dose of CsA is reduced. The treatment after 53 weeks is not specified. If patients did not reach CR or PR at 26 weeks, treatment after 27 weeks is entrusted to the investigator in each medical institution (it is not specified in this study).

Nakao Shinji

NULL

Recruiting

>= 18age old

< 80age old

Both

Phase 2

Japan

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT01579110 (ClinicalTrials.gov)	April 2012	13/4/2012	Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.	Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.	Anemia;Anemia, Hemolytic;Anemia, Hemolytic, Autoimmune;Hemolysis;Hematologic Diseases;Autoimmune Diseases;Immune System Diseases;Pathologic Processes	Drug: levamisole;Drug: Prednisone	Institute of Hematology & Blood Diseases Hospital	NULL	Active, not recruiting	18 Years	N/A	Both	100	Phase 2	China
2	NCT01134432 (ClinicalTrials.gov)	March 2005	28/5/2010	Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia	Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.	Anemia, Hemolytic, Autoimmune	Drug: prednisolone + mabthera;Drug: Prednisolone	Copenhagen University Hospital at Herlev	NULL	Completed	18 Years	N/A	Both	65	Phase 3	Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01579110
(ClinicalTrials.gov)

April 2012

13/4/2012

Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.

Anemia;Anemia, Hemolytic;Anemia, Hemolytic, Autoimmune;Hemolysis;Hematologic Diseases;Autoimmune Diseases;Immune System Diseases;Pathologic Processes

Drug: levamisole;Drug: Prednisone

Institute of Hematology & Blood Diseases Hospital

NULL

Active, not recruiting

18 Years

N/A

Both

100

Phase 2

China

NCT01134432
(ClinicalTrials.gov)

March 2005

28/5/2010

Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia

Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.

Anemia, Hemolytic, Autoimmune

Drug: prednisolone + mabthera;Drug: Prednisolone

Copenhagen University Hospital at Herlev

NULL

Completed

18 Years

N/A

Both

Phase 3

Denmark

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00451594 (ClinicalTrials.gov)	September 2005	22/3/2007	High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP	A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura	Idiopathic Thrombocytopenic Purpura	Drug: Dexamethasone;Drug: Prednisolone	Cooperative Study Group A for Hematology	NULL	Completed	16 Years	N/A	Both	157	Phase 3	Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00451594
(ClinicalTrials.gov)

September 2005

22/3/2007

High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura

Idiopathic Thrombocytopenic Purpura

Drug: Dexamethasone;Drug: Prednisolone

Cooperative Study Group A for Hematology

NULL

Completed

16 Years

N/A

Both

157

Phase 3

Korea, Republic of

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04074187 (ClinicalTrials.gov)	October 21, 2019	14/8/2019	A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)	An Open-label Multicenter Trial to Study the Efficacy and Safety of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura	Thrombotic Thrombocytopenic Purpura	Drug: Caplacizumab (ALX-0081);Drug: Plasma exchange (PE);Drug: Corticosteroid treatment (Methylprednisolone or prednisolone);Drug: Immunosuppressive treatment (eg, rituximab)	Sanofi	NULL	Recruiting	18 Years	N/A	All	18	Phase 2;Phase 3	Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04074187
(ClinicalTrials.gov)

October 21, 2019

14/8/2019

A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

An Open-label Multicenter Trial to Study the Efficacy and Safety of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura

Thrombotic Thrombocytopenic Purpura

Drug: Caplacizumab (ALX-0081);Drug: Plasma exchange (PE);Drug: Corticosteroid treatment (Methylprednisolone or prednisolone);Drug: Immunosuppressive treatment (eg, rituximab)

Sanofi

NULL

Recruiting

18 Years

N/A

All

Phase 2;Phase 3

Japan

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT01220531 (ClinicalTrials.gov)	September 2010	22/9/2010	Thymus Transplantation Safety-Efficacy	Safety and Efficacy of Thymus Transplantation in Complete DiGeorge Anomaly, IND#9836	Complete DiGeorge Anomaly;DiGeorge Syndrome;DiGeorge Anomaly;Complete DiGeorge Syndrome	Biological: Thymus Tissue for Transplantation;Procedure: Blood Draw;Drug: Rabbit anti-thymocyte globulin;Drug: Cyclosporine;Drug: Tacrolimus;Drug: Methylprednisolone or Prednisolone;Drug: Basiliximab;Drug: Mycophenolate mofetil	M. Louise Markert	National Institutes of Health (NIH);National Institute of Allergy and Infectious Diseases (NIAID);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);Enzyvant Therapeutics GmbH	Available	N/A	N/A	All			United States
2	NCT00579527 (ClinicalTrials.gov)	December 19, 2005	20/12/2007	Phase I/II Thymus Transplantation With Immunosuppression #950	Phase I/II Trial of Thymus Transplantation With Immunosuppression, #950	DiGeorge Anomaly;Complete DiGeorge Anomaly;Complete Atypical DiGeorge Anomaly;Complete DiGeorge Syndrome;Complete Atypical DiGeorge Syndrome	Biological: Cultured Thymus Tissue for Implantation (CTTI);Other: Cultured Thymus Tissue Implantation and Parental Parathyroid Transplantation;Procedure: Blood Draw;Drug: Rabbit anti-thymocyte globulin;Drug: Cyclosporine;Drug: Tacrolimus;Drug: Methylprednisolone or Prednisolone;Drug: Daclizumab;Drug: Mycophenolate mofetil	M. Louise Markert	National Institutes of Health (NIH);National Institute of Allergy and Infectious Diseases (NIAID);Enzyvant Therapeutics GmbH;Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Completed	N/A	N/A	All	14	Phase 1;Phase 2	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01220531
(ClinicalTrials.gov)

September 2010

22/9/2010

Thymus Transplantation Safety-Efficacy

Safety and Efficacy of Thymus Transplantation in Complete DiGeorge Anomaly, IND#9836

Complete DiGeorge Anomaly;DiGeorge Syndrome;DiGeorge Anomaly;Complete DiGeorge Syndrome

Biological: Thymus Tissue for Transplantation;Procedure: Blood Draw;Drug: Rabbit anti-thymocyte globulin;Drug: Cyclosporine;Drug: Tacrolimus;Drug: Methylprednisolone or Prednisolone;Drug: Basiliximab;Drug: Mycophenolate mofetil

M. Louise Markert

National Institutes of Health (NIH);National Institute of Allergy and Infectious Diseases (NIAID);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);Enzyvant Therapeutics GmbH

Available

N/A

All

United States

NCT00579527
(ClinicalTrials.gov)

December 19, 2005

20/12/2007

Phase I/II Thymus Transplantation With Immunosuppression #950

Phase I/II Trial of Thymus Transplantation With Immunosuppression, #950

DiGeorge Anomaly;Complete DiGeorge Anomaly;Complete Atypical DiGeorge Anomaly;Complete DiGeorge Syndrome;Complete Atypical DiGeorge Syndrome

Biological: Cultured Thymus Tissue for Implantation (CTTI);Other: Cultured Thymus Tissue Implantation and Parental Parathyroid Transplantation;Procedure: Blood Draw;Drug: Rabbit anti-thymocyte globulin;Drug: Cyclosporine;Drug: Tacrolimus;Drug: Methylprednisolone or Prednisolone;Drug: Daclizumab;Drug: Mycophenolate mofetil

M. Louise Markert

National Institutes of Health (NIH);National Institute of Allergy and Infectious Diseases (NIAID);Enzyvant Therapeutics GmbH;Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Completed

N/A

All

Phase 1;Phase 2

United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	ChiCTR1900026883	2019-12-01	2019-10-25	A prospective randomized controlled trial of a new method for glucocorticoid intervention in progressive IgA nephropathy	A prospective randomized controlled trial of a new method for glucocorticoid intervention in progressive IgA nephropathy	IgA nephropathy	1:0.5mg/kg.d prednisolone induced remission;2:0.8mg/kg.d prednisolone induced remission ;	Nephrology Department, Hangzhou Hospital of Traditional Chinese Medicine, Zhejiang Province	NULL	Pending	18	72	Both	1:71;2:71;		China
2	JPRN-UMIN000032031	2018/04/01	01/04/2018	The steroid internal use method for patients with IgA nephropathy	The steroid internal use method for patients with IgA nephropathy - The steroid internal use method for patients with IgA nephropathy	IgA nephropathy	Prednisolone 0.5mg/kg/every other day group Prednisolone 0.25mg/kg/everyday group	Juntendo University	NULL	Recruiting	20years-old	100years-old	Male and Female	100	Not selected	Japan
3	NCT02662283 (ClinicalTrials.gov)	May 2016	20/1/2016	Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy	Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy —— A Prospective, Randomized, Controlled, Multi-Center Clinical Trial	IGA Nephropathy	Drug: Prednisolone;Drug: Reh-acteoside	Sun Yat-sen University	NULL	Not yet recruiting	14 Years	70 Years	Both	75	Phase 2;Phase 3	China
4	NCT01451710 (ClinicalTrials.gov)	March 2011	7/10/2011	The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy	The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy	IgA Nephropathy	Drug: Prednisone or Prednisolone	Nanjing University School of Medicine	NULL	Completed	18 Years	65 Years	Both	30	N/A	China
5	EUCTR2009-016003-26-GB (EUCTR)	06/05/2010	17/03/2010	RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic	RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic	Primary Proteinuric Glomeruolnephritis Focal segmental glomeruloscerosis and IgA nephropathy MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders	Trade Name: Myfortic Product Name: Myfortic 360mg Tablets INN or Proposed INN: mycophenolic acid Other descriptive name: mycophenolate sodium Trade Name: Myfortic Product Name: Myfortic 180mg Tablets INN or Proposed INN: mycophenolic sodium Other descriptive name: mycophenolate sodium Product Name: Prednisolone INN or Proposed INN: prednisolone	UHB NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2007-000871-41-DE (EUCTR)	24/01/2008	27/11/2007	Supportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgAN	Supportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgAN	IgA nephropathy (IgAN) as the most common type of glomerulonephritis. MedDRA version: 16.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders	Product Name: Azathioprine INN or Proposed INN: AZATHIOPRINE Product Name: Cyclophosphamid INN or Proposed INN: CYCLOPHOSPHAMIDE Product Name: Prednisolon INN or Proposed INN: PREDNISOLONE Product Name: Methylprednisolon INN or Proposed INN: METHYLPREDNISOLONE Product Name: supportive therapy	RWTH Aachen	NULL	Not Recruiting			Female: yes Male: yes	148		Germany
7	JPRN-UMIN000000593	2006/11/01	05/02/2007	Randomized controlled trial of mizoribine for progressive IgA nephropathy		IgA nephropathy with moderate to severe histological alterations	Methylprednisolone pulse therapy followed by oral prednisolone administration Methylprednisolone pulse therapy followed by oral prednisolone and mizoribine administration	West Japan Study Group for Therapy of IgA Nephropathy	NULL	Complete: follow-up complete	15years-old	60years-old	Male and Female	120	Not selected	Japan
8	JPRN-C000000341	2004/04/01	31/03/2006	Randomised controlled trial of multiple drugs combined therapy for diffuse IgA nephropathy		Refractory IgA nephropathy	Prednisolone and anti-thrombocyte and angiotensin II receptor blocker or angiotensin converting enzyme inhibitor inhibitor mizoribine and Prednisolone and anti thrombocyte and angiotensin II receptor blocker or angiotensin-converting enzyme	Japanese Study Group of Multiple drug therapy for IgAN	NULL	Complete: follow-up complete	16years-old	75years-old	Male and Female	60	Not selected	Japan
9	JPRN-C000000363	2001/08/01	14/05/2007	A combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial prolideration in children:A randomized controlled trial of efficacy and safety		IgA nephropathy in children	prednisolone+mizoribine for 2 years prednisolone+mizoribine+warfarin+dipyridamole for 2 years	The Japanese Pediatric IgA Nephropathy ofTreatment Study Group	NULL	Complete: follow-up complete	2years-old	18years-old	Male and Female	80	Not selected	Japan
10	JPRN-C000000375	1998/08/01	01/04/2006	A combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with nephrotic syndrome and diffuse mesangial proliferation in children.		IgA nephropathy in children	prednisolone+mizoribine+warfarin+dipyridamole for 2 years	The Japanese Pediatric IgA Nephropathy of Treatment Study Group	NULL	Complete: follow-up complete	2years-old	18years-old	Male and Female	20	Not selected	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	JPRN-C000000374	1998/08/01	01/04/2006	A combination of prednisolone, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial proliferation in children.		IgA nephropathy in children	prednisolone+warfarin+dipyridamole for 2 years	The Japanese Pediatric IgA Nephropathy ofTreatment Study Group	NULL	Complete: follow-up complete	2years-old	18years-old	Male and Female	20	Not selected	Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

ChiCTR1900026883

2019-12-01

2019-10-25

A prospective randomized controlled trial of a new method for glucocorticoid intervention in progressive IgA nephropathy

IgA nephropathy

1:0.5mg/kg.d prednisolone induced remission;2:0.8mg/kg.d prednisolone induced remission ;

Nephrology Department, Hangzhou Hospital of Traditional Chinese Medicine, Zhejiang Province

NULL

Pending

Both

1:71;2:71;

China

JPRN-UMIN000032031

2018/04/01

01/04/2018

The steroid internal use method for patients with IgA nephropathy

The steroid internal use method for patients with IgA nephropathy - The steroid internal use method for patients with IgA nephropathy

IgA nephropathy

Prednisolone 0.5mg/kg/every other day group
Prednisolone 0.25mg/kg/everyday group

Juntendo University

NULL

Recruiting

20years-old

100years-old

Male and Female

100

Not selected

Japan

NCT02662283
(ClinicalTrials.gov)

May 2016

20/1/2016

Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy

Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy —— A Prospective, Randomized, Controlled, Multi-Center Clinical Trial

IGA Nephropathy

Drug: Prednisolone;Drug: Reh-acteoside

Sun Yat-sen University

NULL

Not yet recruiting

14 Years

70 Years

Both

Phase 2;Phase 3

China

NCT01451710
(ClinicalTrials.gov)

March 2011

7/10/2011

The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

IgA Nephropathy

Drug: Prednisone or Prednisolone

Nanjing University School of Medicine

NULL

Completed

18 Years

65 Years

Both

N/A

China

EUCTR2009-016003-26-GB
(EUCTR)

06/05/2010

17/03/2010

RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic

Primary Proteinuric Glomeruolnephritis Focal segmental glomeruloscerosis and IgA nephropathy
MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders

Trade Name: Myfortic
Product Name: Myfortic 360mg Tablets
INN or Proposed INN: mycophenolic acid
Other descriptive name: mycophenolate sodium
Trade Name: Myfortic
Product Name: Myfortic 180mg Tablets
INN or Proposed INN: mycophenolic sodium
Other descriptive name: mycophenolate sodium
Product Name: Prednisolone
INN or Proposed INN: prednisolone

UHB NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-000871-41-DE
(EUCTR)

24/01/2008

27/11/2007

Supportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgAN

IgA nephropathy (IgAN) as the most common type of glomerulonephritis.
MedDRA version: 16.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders

Product Name: Azathioprine
INN or Proposed INN: AZATHIOPRINE
Product Name: Cyclophosphamid
INN or Proposed INN: CYCLOPHOSPHAMIDE
Product Name: Prednisolon
INN or Proposed INN: PREDNISOLONE
Product Name: Methylprednisolon
INN or Proposed INN: METHYLPREDNISOLONE
Product Name: supportive therapy

RWTH Aachen

NULL

Not Recruiting

Female: yes
Male: yes

148

Germany

JPRN-UMIN000000593

2006/11/01

05/02/2007

Randomized controlled trial of mizoribine for progressive IgA nephropathy

IgA nephropathy with moderate to severe histological alterations

Methylprednisolone pulse therapy followed by oral prednisolone administration
Methylprednisolone pulse therapy followed by oral prednisolone and mizoribine administration

West Japan Study Group for Therapy of IgA Nephropathy

NULL

Complete: follow-up complete

15years-old

60years-old

Male and Female

120

Not selected

Japan

JPRN-C000000341

2004/04/01

31/03/2006

Randomised controlled trial of multiple drugs combined therapy for diffuse IgA nephropathy

Refractory IgA nephropathy

Prednisolone and anti-thrombocyte and angiotensin II receptor blocker or angiotensin converting enzyme inhibitor
inhibitor
mizoribine and Prednisolone and anti thrombocyte and angiotensin II receptor blocker or angiotensin-converting enzyme

Japanese Study Group of Multiple drug therapy for IgAN

NULL

Complete: follow-up complete

16years-old

75years-old

Male and Female

Not selected

Japan

JPRN-C000000363

2001/08/01

14/05/2007

A combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial prolideration in children:A randomized controlled trial of efficacy and safety

IgA nephropathy in children

prednisolone+mizoribine for 2 years
prednisolone+mizoribine+warfarin+dipyridamole for 2 years

The Japanese Pediatric IgA Nephropathy ofTreatment Study Group

NULL

Complete: follow-up complete

2years-old

18years-old

Male and Female

Not selected

Japan

JPRN-C000000375

1998/08/01

01/04/2006

A combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with nephrotic syndrome and diffuse mesangial proliferation in children.

IgA nephropathy in children

prednisolone+mizoribine+warfarin+dipyridamole for 2 years

The Japanese Pediatric IgA Nephropathy of Treatment Study Group

NULL

Complete: follow-up complete

2years-old

18years-old

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-C000000374

1998/08/01

01/04/2006

A combination of prednisolone, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial proliferation in children.

IgA nephropathy in children

prednisolone+warfarin+dipyridamole for 2 years

The Japanese Pediatric IgA Nephropathy ofTreatment Study Group

NULL

Complete: follow-up complete

2years-old

18years-old

Male and Female

Not selected

Japan

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03111810 (ClinicalTrials.gov)	May 25, 2017	17/3/2017	Targeting Iatrogenic Cushing's Syndrome With 11ß-hydroxysteroid Dehydrogenase Type 1 Inhibition	Targeting Iatrogenic Cushing's Syndrome With 11ß-hydroxysteroid Dehydrogenase Type 1 Inhibition (TICSI)	Iatrogenic Cushing's Disease	Drug: AZD4017 and prednisolone;Drug: Placebo Oral Tablet and prednisolone	University of Oxford	AstraZeneca	Recruiting	18 Years	60 Years	Male	32	Phase 2	United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03111810
(ClinicalTrials.gov)

May 25, 2017

17/3/2017

Targeting Iatrogenic Cushing's Syndrome With 11ß-hydroxysteroid Dehydrogenase Type 1 Inhibition

Targeting Iatrogenic Cushing's Syndrome With 11ß-hydroxysteroid Dehydrogenase Type 1 Inhibition (TICSI)

Iatrogenic Cushing's Disease

Drug: AZD4017 and prednisolone;Drug: Placebo Oral Tablet and prednisolone

University of Oxford

AstraZeneca

Recruiting

18 Years

60 Years

Male

Phase 2

United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2015-000711-40-DK (EUCTR)	08/09/2016	11/07/2016	Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.	A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.	Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000012082;Therapeutic area: Diseases [C] - Hormonal diseases [C19]	Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Trade Name: Hydrocortisone 10mg Tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Dexamethasone 0,1 mg Tablets INN or Proposed INN: DEXAMETHASONE Trade Name: Prednisolone 2,5 mg Tablets INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE Product Name: Hydrocortisone tablet 2.5 mg	Diurnal Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 3	France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
2	NCT03760835 (ClinicalTrials.gov)	August 11, 2016	9/11/2018	Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment	Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment	Congenital Adrenal Hyperplasia	Drug: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone);Drug: Dual release hydrocortisone (plenadren)	Federico II University	NULL	Recruiting	18 Years	N/A	All	150	Phase 4	Italy
3	EUCTR2015-000711-40-NL (EUCTR)	28/04/2016	17/11/2015	Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.	A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.	Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 18.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]	Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Trade Name: Hydrocortisone 20mg Tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Dexamethasone 1,5 mg Tablets INN or Proposed INN: DEXAMETHASONE Trade Name: Prednisolone 5 mg Tablets INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	Diurnal Ltd	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 3	United States;Denmark;Germany;Netherlands;United Kingdom;Sweden
4	EUCTR2015-000711-40-SE (EUCTR)	11/01/2016	13/10/2015	Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.	A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.	Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000012082;Therapeutic area: Diseases [C] - Hormonal diseases [C19]	Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Trade Name: Hydrocortisone 20mg Tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Dexamethasone 2mg Tablets INN or Proposed INN: DEXAMETHASONE Trade Name: Prednisolone 1mg Tablets INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	Diurnal Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 3	France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
5	EUCTR2011-005822-23-SE (EUCTR)	18/11/2014	20/09/2013	A trial comparing continuous subcutaneous hydrocortisone infusion (CSHI) therapy with conventional oral glucocorticoid therapy in patients with Congenital Andrenal Hyperplasia (CAH)	CONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA	Congenital Adrenal Hyperplasia MedDRA version: 14.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]	Trade Name: Solu-Cortef INN or Proposed INN: HYDROCORTISONE SODIUM SUCCINATE Other descriptive name: HYDROCORTISONE SODIUM SUCCINATE INN or Proposed INN: Prednisolone INN or Proposed INN: Hydrocortisone	Haukeland University Hospital	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Norway;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2011-005822-23-NO (EUCTR)	16/10/2012	25/02/2013	A trial comparing continuous subcutaneous hydrocortisone therapy with conventional oral glucocorticoid therapy in congenital adrenal hyperplasia	CONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA	Congenital adrenal hyperplasia (CAH) MedDRA version: 14.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]	Trade Name: Solu-Cortef Trade Name: Cortison Trade Name: Prednisolone	Haukeland University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-000711-40-DK
(EUCTR)

08/09/2016

11/07/2016

Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.

A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.

Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000012082;Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 10mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 0,1 mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 2,5 mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Product Name: Hydrocortisone tablet 2.5 mg

Diurnal Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 3

France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden

NCT03760835
(ClinicalTrials.gov)

August 11, 2016

9/11/2018

Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment

Congenital Adrenal Hyperplasia

Drug: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone);Drug: Dual release hydrocortisone (plenadren)

Federico II University

NULL

Recruiting

18 Years

N/A

All

150

Phase 4

Italy

EUCTR2015-000711-40-NL
(EUCTR)

28/04/2016

17/11/2015

A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.

Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 18.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 20mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 1,5 mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 5 mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

Diurnal Ltd

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 3

United States;Denmark;Germany;Netherlands;United Kingdom;Sweden

EUCTR2015-000711-40-SE
(EUCTR)

11/01/2016

13/10/2015

A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.

Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 20mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 2mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 1mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

Diurnal Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 3

France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden

EUCTR2011-005822-23-SE
(EUCTR)

18/11/2014

20/09/2013

A trial comparing continuous subcutaneous hydrocortisone infusion (CSHI) therapy with conventional oral glucocorticoid therapy in patients with Congenital Andrenal Hyperplasia (CAH)

CONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA

Congenital Adrenal Hyperplasia
MedDRA version: 14.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Trade Name: Solu-Cortef
INN or Proposed INN: HYDROCORTISONE SODIUM SUCCINATE
Other descriptive name: HYDROCORTISONE SODIUM SUCCINATE
INN or Proposed INN: Prednisolone
INN or Proposed INN: Hydrocortisone

Haukeland University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-005822-23-NO
(EUCTR)

16/10/2012

25/02/2013

A trial comparing continuous subcutaneous hydrocortisone therapy with conventional oral glucocorticoid therapy in congenital adrenal hyperplasia

CONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA

Congenital adrenal hyperplasia (CAH)
MedDRA version: 14.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Trade Name: Solu-Cortef
Trade Name: Cortison
Trade Name: Prednisolone

Haukeland University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Norway

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04314193 (ClinicalTrials.gov)	June 1, 2020	24/2/2020	Effectiveness of Methotrexate Versus Prednisolone as First-line Therapy for Pulmonary Sarcoidosis	The PREDMETH Trial: Effectiveness of Methotrexate Versus Prednisolone as First-line Therapy for Pulmonary Sarcoidosis - A Randomized Controlled Trial	Sarcoidosis, Pulmonary	Drug: Methotrexate;Drug: Prednisolone	Erasmus Medical Center	St. Antonius Hospital;Longfonds	Recruiting	18 Years	N/A	All	138	Phase 4	Netherlands
2	NCT03705884 (ClinicalTrials.gov)	January 1, 2018	8/8/2018	PET/MR Imaging In Patients With Cardiac Sarcoidosis	Molecular Imaging in Cardiovascular Disease Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR): Cardiac Sarcoidosis	Cardiac Sarcoidosis	Other: 18F-FDG;Drug: Prednisolone	University of Edinburgh	NULL	Unknown status	40 Years	N/A	All	40	N/A	United Kingdom
3	NCT03324503 (ClinicalTrials.gov)	December 8, 2017	12/10/2017	A Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis	A Multicenter, Open-Label Study to Estimate the Effect Sizes of HRCT Endpoints in Response to GLUCOCORTICOID Induction Therapy in Subjects With Pulmonary Sarcoidosis	Sarcoidosis, Pulmonary	Drug: Glucocorticoid (prednisone or prednisolone)	Celgene	NULL	Completed	18 Years	65 Years	All	8	N/A	United States;Netherlands;United Kingdom
4	JPRN-UMIN000025936	2017/06/12	20/02/2017	Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial		Cardiac sarcoidosis	combination therapy group: Prednisolone; Predonisolone start from 30mg/day and continue same dose for one month. After one month, prednisolone decrease 25mg, 20mg, 15mg, 10mg every 2-4 weeks. Finally, maintenance dose of predonisolone is 7.5mg. Antimicrobial agent; Clarithromycin start from 400mg/day for 24weeks. Doxycycline start 100mg/day for 22 weeks after 2 months of clarithromycin therapy. Prednisolone; Predonisolone start from 30mg/day and continue same dose for one month. After one month, prednisolone decrease 25mg, 20mg, 15mg, 10mg every 2-4 weeks. Finally, maintenance dose of predonisolone is 7.5mg.	National cerebral and cardiovascular center	NULL	Recruiting	20years-old	Not applicable	Male and Female	80	Not selected	Japan
5	NCT03265405 (ClinicalTrials.gov)	April 1, 2017	23/8/2017	Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis	Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis: a Randomized Controlled Trial	Sarcoidosis	Drug: Low dose prednisolone;Drug: Medium dose prednisolone	Postgraduate Institute of Medical Education and Research	NULL	Recruiting	18 Years	65 Years	All	86	Phase 4	India
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	ChiCTR-IOR-15005953	2012-01-01	2015-01-11	The effects of corticosteroid treatment on asymptomatic sarcoidosis	The effects of corticosteroid treatment on asymptomatic sarcoidosis	Sarcoidosis	Corticosteroid-treated group :prednisolone ;Placebo:Placebo;	The First Affiliated Hospital, Guangzhou Medical University	NULL	Completed	18	76	Both	Corticosteroid-treated group :64;Placebo:63;		NULL
7	NCT01245036 (ClinicalTrials.gov)	January 2009	15/11/2010	Efficacy of Antituberculous Therapy in Management of Sarcoidosis	Rifampicin and Isoniazid Along With Prednisolone Compared to Prednisolone Alone in Treatment of Sarcoidosis: a Pilot Randomized Controlled Trial	Sarcoidosis;Tuberculosis	Drug: Antituberculous therapy along with steroids	Postgraduate Institute of Medical Education and Research	NULL	Completed	15 Years	75 Years	Both	100	N/A	India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04314193
(ClinicalTrials.gov)

June 1, 2020

24/2/2020

Effectiveness of Methotrexate Versus Prednisolone as First-line Therapy for Pulmonary Sarcoidosis

The PREDMETH Trial: Effectiveness of Methotrexate Versus Prednisolone as First-line Therapy for Pulmonary Sarcoidosis - A Randomized Controlled Trial

Sarcoidosis, Pulmonary

Drug: Methotrexate;Drug: Prednisolone

Erasmus Medical Center

St. Antonius Hospital;Longfonds

Recruiting

18 Years

N/A

All

138

Phase 4

Netherlands

NCT03705884
(ClinicalTrials.gov)

January 1, 2018

8/8/2018

PET/MR Imaging In Patients With Cardiac Sarcoidosis

Molecular Imaging in Cardiovascular Disease Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR): Cardiac Sarcoidosis

Cardiac Sarcoidosis

Other: 18F-FDG;Drug: Prednisolone

University of Edinburgh

NULL

Unknown status

40 Years

N/A

All

N/A

United Kingdom

NCT03324503
(ClinicalTrials.gov)

December 8, 2017

12/10/2017

A Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis

A Multicenter, Open-Label Study to Estimate the Effect Sizes of HRCT Endpoints in Response to GLUCOCORTICOID Induction Therapy in Subjects With Pulmonary Sarcoidosis

Sarcoidosis, Pulmonary

Drug: Glucocorticoid (prednisone or prednisolone)

Celgene

NULL

Completed

18 Years

65 Years

All

N/A

United States;Netherlands;United Kingdom

JPRN-UMIN000025936

2017/06/12

20/02/2017

Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial

Cardiac sarcoidosis

combination therapy group:
Prednisolone; Predonisolone start from 30mg/day and continue same dose for one month. After one month, prednisolone decrease 25mg, 20mg, 15mg, 10mg every 2-4 weeks. Finally, maintenance dose of predonisolone is 7.5mg.
Antimicrobial agent; Clarithromycin start from 400mg/day for 24weeks. Doxycycline start 100mg/day for 22 weeks after 2 months of clarithromycin therapy.

Prednisolone; Predonisolone start from 30mg/day and continue same dose for one month. After one month, prednisolone decrease 25mg, 20mg, 15mg, 10mg every 2-4 weeks. Finally, maintenance dose of predonisolone is 7.5mg.

National cerebral and cardiovascular center

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not selected

Japan

NCT03265405
(ClinicalTrials.gov)

April 1, 2017

23/8/2017

Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis

Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis: a Randomized Controlled Trial

Sarcoidosis

Drug: Low dose prednisolone;Drug: Medium dose prednisolone

Postgraduate Institute of Medical Education and Research

NULL

Recruiting

18 Years

65 Years

All

Phase 4

India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

ChiCTR-IOR-15005953

2012-01-01

2015-01-11

The effects of corticosteroid treatment on asymptomatic sarcoidosis

Sarcoidosis

Corticosteroid-treated group :prednisolone ;Placebo:Placebo;

The First Affiliated Hospital, Guangzhou Medical University

NULL

Completed

Both

Corticosteroid-treated group :64;Placebo:63;

NULL

NCT01245036
(ClinicalTrials.gov)

January 2009

15/11/2010

Efficacy of Antituberculous Therapy in Management of Sarcoidosis

Rifampicin and Isoniazid Along With Prednisolone Compared to Prednisolone Alone in Treatment of Sarcoidosis: a Pilot Randomized Controlled Trial

Sarcoidosis;Tuberculosis

Drug: Antituberculous therapy along with steroids

Postgraduate Institute of Medical Education and Research

NULL

Completed

15 Years

75 Years

Both

100

N/A

India

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02460588 (ClinicalTrials.gov)	December 2015	16/3/2015	Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis	Cyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized Trial	Idiopathic Pulmonary Fibrosis	Drug: Cyclophosphamide;Drug: Placebo;Drug: Corticosteroid (prednisolone)	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	All	120	Phase 3	France
2	EUCTR2010-023828-24-GB (EUCTR)	09/06/2011	27/04/2011	The effect of Thalidomide on sputum biomarkers in IPF cough. - The effect of Thalidomide on sputum biomarkers in IPF cough	The effect of Thalidomide on sputum biomarkers in IPF cough. - The effect of Thalidomide on sputum biomarkers in IPF cough	Cough in Idiopathic Pulmonary fibrosis.	Trade Name: Thalidomide Pharmion Product Name: Thalidomide Pharmion Trade Name: PREDNISOLONE Product Name: prednisolone	University of Nottingham	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02460588
(ClinicalTrials.gov)

December 2015

16/3/2015

Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Cyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized Trial

Idiopathic Pulmonary Fibrosis

Drug: Cyclophosphamide;Drug: Placebo;Drug: Corticosteroid (prednisolone)

Assistance Publique - Hôpitaux de Paris

NULL

Completed

18 Years

N/A

All

120

Phase 3

France

EUCTR2010-023828-24-GB
(EUCTR)

09/06/2011

27/04/2011

The effect of Thalidomide on sputum biomarkers in IPF cough. - The effect of Thalidomide on sputum biomarkers in IPF cough

Cough in Idiopathic Pulmonary fibrosis.

Trade Name: Thalidomide Pharmion
Product Name: Thalidomide Pharmion
Trade Name: PREDNISOLONE
Product Name: prednisolone

University of Nottingham

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04371718 (ClinicalTrials.gov)	November 2020	29/4/2020	Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)	A Phase II, Randomized, Double-Blind, Placebo Controlled, Trial of JKB-122 as an Adjunct Therapy to Prednisolone and Azathioprine in the Induction of Remission in Autoimmune Hepatitis (AIH)	Autoimmune Hepatitis	Drug: JKB-122;Other: Placebo	TaiwanJ Pharmaceuticals Co., Ltd	NULL	Not yet recruiting	18 Years	65 Years	All	120	Phase 2	NULL
2	EUCTR2016-001038-91-BE (EUCTR)	12/02/2018	30/06/2017	A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitis	A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis - CAMARO	Autoimmune hepatitis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: mycophenolate mofeti Product Name: mycophenolate mofetil INN or Proposed INN: mycophenolate mofetil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: azathioprine Product Name: azathioprine INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: prednisolone Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE SODIUM SUCCINATE	Leiden university medical centre	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 4	Belgium;Netherlands
3	EUCTR2016-001038-91-NL (EUCTR)	18/11/2016	25/10/2016	A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitis	A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis - CAMARO	Autoimmune hepatitis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: mycophenolate mofeti Product Name: mycophenolate mofetil INN or Proposed INN: mycophenolate mofetil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: azathioprine Product Name: azathioprine INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: prednisolone Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE SODIUM SUCCINATE	Leiden university medical centre	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Netherlands
4	NCT01170351 (ClinicalTrials.gov)	December 2005	24/7/2010	Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis	Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis	Autoimmune Hepatitis	Drug: Cyclosporine-A	Tehran University of Medical Sciences	NULL	Completed	16 Years	65 Years	All	55	Phase 3	Iran, Islamic Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04371718
(ClinicalTrials.gov)

November 2020

29/4/2020

Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)

A Phase II, Randomized, Double-Blind, Placebo Controlled, Trial of JKB-122 as an Adjunct Therapy to Prednisolone and Azathioprine in the Induction of Remission in Autoimmune Hepatitis (AIH)

Autoimmune Hepatitis

Drug: JKB-122;Other: Placebo

TaiwanJ Pharmaceuticals Co., Ltd

NULL

Not yet recruiting

18 Years

65 Years

All

120

Phase 2

NULL

EUCTR2016-001038-91-BE
(EUCTR)

12/02/2018

30/06/2017

A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitis

A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis - CAMARO

Autoimmune hepatitis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: mycophenolate mofeti
Product Name: mycophenolate mofetil
INN or Proposed INN: mycophenolate mofetil
Other descriptive name: MYCOPHENOLATE MOFETIL
Trade Name: azathioprine
Product Name: azathioprine
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: prednisolone
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE SODIUM SUCCINATE

Leiden university medical centre

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Belgium;Netherlands

EUCTR2016-001038-91-NL
(EUCTR)

18/11/2016

25/10/2016

A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitis

A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis - CAMARO

Autoimmune hepatitis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Leiden university medical centre

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

NCT01170351
(ClinicalTrials.gov)

December 2005

24/7/2010

Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis

Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis

Autoimmune Hepatitis

Drug: Cyclosporine-A

Tehran University of Medical Sciences

NULL

Completed

16 Years

65 Years

All

Phase 3

Iran, Islamic Republic of

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02517684 (ClinicalTrials.gov)	April 2015	1/7/2015	Top-down Infliximab Study in Kids With Crohn's Disease	Top-down Infliximab Study in Kids With Crohn's Disease	Crohn's Disease	Drug: Infliximab;Drug: Prednisolone;Other: Exclusive enteral nutrition;Drug: Azathioprine	Erasmus Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development;Hospira, now a wholly owned subsidiary of Pfizer	Active, not recruiting	3 Years	17 Years	All	100	Phase 4	Belgium;Finland;Netherlands;Denmark;Italy;Poland
2	NCT00609752 (ClinicalTrials.gov)	February 2008	24/1/2008	Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease	Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease	Crohn Disease	Drug: prednisolone;Dietary Supplement: Alicalm (polymeric liquid formula)	University Hospital Birmingham	SHS International;Children's Memorial Research Foundation;St George's University Hospital Research Foundation	Recruiting	7 Years	17 Years	Both	80	Phase 4	United Kingdom
3	EUCTR2006-003870-88-DE (EUCTR)	27/11/2006	29/09/2006	A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I	A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I	In the present study, the corticosteroid-sparing effect of certolizumab pegol will be assessed in patients with moderate to severe Crohn’s disease who have received initial acute corticosteroid therapy (prednisone or prednisolone) for induction of remission. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	352	Phase 3b	Germany
4	EUCTR2005-003337-40-GB (EUCTR)	13/02/2006	13/01/2006	Autologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTIC	Autologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTIC	Patients with Crohn's disease who have not responded to immunosupressant medication	Product Name: Cyclophosphamide Product Code: N/A INN or Proposed INN: cyclophosphamide Other descriptive name: N/A INN or Proposed INN: cyclophosphamide Other descriptive name: N/A Product Name: Filgrastim Product Code: N/A INN or Proposed INN: Filgrastim Other descriptive name: N/A Product Name: rabbit antithymocyte globulin Product Code: rbATG INN or Proposed INN: rabbit antithymocyte globulin Other descriptive name: N/A Product Name: Mesna Product Code: N/A INN or Proposed INN: mensa Other descriptive name: N/A Product Name: methyl prednisolone Product Code: N/A INN or Proposed INN: methyl prednisolone Other descriptive name: N/A Product Name: ciprofloxacin Product Code: N/A INN or Proposed INN: ciprofloxacin Other descriptive name: N/A	European Group for Blood and Marrow Transplantation (EMBT)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	48		United Kingdom
5	NCT00796250 (ClinicalTrials.gov)	November 1, 2003	21/11/2008	Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)	Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine	Crohn's Disease	Biological: Infliximab;Drug: AZA;Drug: Placebo Prednisolone;Drug: Prednisolone;Biological: Placebo Infliximab	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	65 Years	All	9	Phase 3	NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02517684
(ClinicalTrials.gov)

April 2015

1/7/2015

Top-down Infliximab Study in Kids With Crohn's Disease

Crohn's Disease

Drug: Infliximab;Drug: Prednisolone;Other: Exclusive enteral nutrition;Drug: Azathioprine

Erasmus Medical Center

ZonMw: The Netherlands Organisation for Health Research and Development;Hospira, now a wholly owned subsidiary of Pfizer

Active, not recruiting

3 Years

17 Years

All

100

Phase 4

Belgium;Finland;Netherlands;Denmark;Italy;Poland

NCT00609752
(ClinicalTrials.gov)

February 2008

24/1/2008

Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease

Crohn Disease

Drug: prednisolone;Dietary Supplement: Alicalm (polymeric liquid formula)

University Hospital Birmingham

SHS International;Children's Memorial Research Foundation;St George's University Hospital Research Foundation

Recruiting

7 Years

17 Years

Both

Phase 4

United Kingdom

EUCTR2006-003870-88-DE
(EUCTR)

27/11/2006

29/09/2006

A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I

In the present study, the corticosteroid-sparing effect of certolizumab pegol will be assessed in patients with moderate to severe Crohn’s disease who have received initial acute corticosteroid therapy (prednisone or prednisolone) for induction of remission.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

352

Phase 3b

Germany

EUCTR2005-003337-40-GB
(EUCTR)

13/02/2006

13/01/2006

Autologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTIC

Patients with Crohn's disease who have not responded to immunosupressant medication

Product Name: Cyclophosphamide
Product Code: N/A
INN or Proposed INN: cyclophosphamide
Other descriptive name: N/A
INN or Proposed INN: cyclophosphamide
Other descriptive name: N/A
Product Name: Filgrastim
Product Code: N/A
INN or Proposed INN: Filgrastim
Other descriptive name: N/A
Product Name: rabbit antithymocyte globulin
Product Code: rbATG
INN or Proposed INN: rabbit antithymocyte globulin
Other descriptive name: N/A
Product Name: Mesna
Product Code: N/A
INN or Proposed INN: mensa
Other descriptive name: N/A
Product Name: methyl prednisolone
Product Code: N/A
INN or Proposed INN: methyl prednisolone
Other descriptive name: N/A
Product Name: ciprofloxacin
Product Code: N/A
INN or Proposed INN: ciprofloxacin
Other descriptive name: N/A

European Group for Blood and Marrow Transplantation (EMBT)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom

NCT00796250
(ClinicalTrials.gov)

November 1, 2003

21/11/2008

Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)

Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine

Crohn's Disease

Biological: Infliximab;Drug: AZA;Drug: Placebo Prednisolone;Drug: Prednisolone;Biological: Placebo Infliximab

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

65 Years

All

Phase 3

NULL

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000030000	2018/02/07	01/12/2017	The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.	The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. - The efficacy and safety of topical budezonide for pouchitis.	ulcerative colitispouchitis	Topical budesonido 2weeks of 2mg daily Topical prednisolone 2weeks 20mg daily Topical aminosalicylate 2weeks 1g daily	Department of Inflammatory Bowel DiseaseHyogo College of Medicine	NULL	Recruiting	Not applicable	Not applicable	Male and Female	30	Phase 1	Japan
2	NCT02425852 (ClinicalTrials.gov)	December 2016	21/4/2015	A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis	A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis	Ulcerative Colitis	Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	NULL	Recruiting	18 Years	N/A	All	146	Phase 4	France
3	EUCTR2010-020448-37-NL (EUCTR)	21/12/2011	16/09/2010	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE	Enceladus Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2A	Belgium;Netherlands
4	JPRN-UMIN000005358	2011/04/01	01/04/2011	Rapid LeukocyAPheresis InDuction for Ulcerative Colitis		ulcerative colitis	LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 3 days. LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 14 days.	Lower Gastroenterology, Hyogo College of Medicine	Department of Gastroenterology, Osaka City University and Department of Gastroenterology, Osaka Medical College	Complete: follow-up complete	12years-old	81years-old	Male and Female	40	Phase 2;Phase 3	Japan
5	EUCTR2010-020448-37-BE (EUCTR)	10/12/2010	22/12/2010	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE	Enceladus Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Belgium;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT00984568 (ClinicalTrials.gov)	November 2009	24/9/2009	Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)	Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study	Colitis, Ulcerative	Biological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: Azathioprine	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	N/A	All	28	Phase 3	Germany
7	EUCTR2009-010065-23-DE (EUCTR)	17/08/2009	14/04/2009	Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX	Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX	Active Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders	Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: 100 Trade Name: Pentasa 500 mg Retardtabletten Product Name: 5-Aminosalicylic acid (5-ASA) INN or Proposed INN: 5-Aminosalicylic acid Trade Name: Imurek 25mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Imurek 50mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Decortin H 1 mg INN or Proposed INN: prednisolone Trade Name: Decortin H 5mg INN or Proposed INN: prednisolone Trade Name: Decortin H 10mg INN or Proposed INN: prednisolone Trade Name: Decortin H 20mg INN or Proposed INN: prednisolone Trade Name: Decortin H 50 mg INN or Proposed INN: prednisolone	Essex Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Germany
8	EUCTR2004-005032-35-BE (EUCTR)	06/03/2007	23/11/2006	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890		Hungary;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Italy;Sweden
9	EUCTR2004-005032-35-IT (EUCTR)	10/05/2006	19/01/2007	A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis	A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Trade Name: PREDNISOLONE INN or Proposed INN: Prednisolone	ALIZYME	NULL	Not Recruiting			Female: yes Male: yes	890	Phase 3	Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
10	NCT00299013 (ClinicalTrials.gov)	March 2006	2/3/2006	Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis	A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis	Ulcerative Colitis	Drug: COLAL-PRED®;Drug: Prednisolone	Alizyme	NULL	Completed	18 Years	75 Years	Both	796	Phase 3	Australia;Belgium;Czech Republic;Denmark;France;Germany;Hungary;Israel;Italy;Poland;Russian Federation;South Africa;Spain;Sweden;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2004-005032-35-SE (EUCTR)	17/11/2005	14/09/2005	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890		Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
12	EUCTR2004-005032-35-CZ (EUCTR)	04/11/2005	16/09/2005	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890		Hungary;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Italy;Sweden
13	EUCTR2004-005032-35-DK (EUCTR)	24/10/2005	04/10/2005	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890		Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
14	EUCTR2004-005032-35-HU (EUCTR)	24/10/2005	22/09/2005	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890		Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-UMIN000030000

2018/02/07

01/12/2017

The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.

The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. - The efficacy and safety of topical budezonide for pouchitis.

ulcerative colitispouchitis

Topical budesonido
2weeks of 2mg daily
Topical prednisolone
2weeks 20mg daily
Topical aminosalicylate
2weeks 1g daily

Department of Inflammatory Bowel DiseaseHyogo College of Medicine

NULL

Recruiting

Not applicable

Male and Female

Phase 1

Japan

NCT02425852
(ClinicalTrials.gov)

December 2016

21/4/2015

A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis

A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis

Ulcerative Colitis

Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

NULL

Recruiting

18 Years

N/A

All

146

Phase 4

France

EUCTR2010-020448-37-NL
(EUCTR)

21/12/2011

16/09/2010

Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.

Active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PEG-liposomal prednisolone sodium phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE

Enceladus Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

Belgium;Netherlands

JPRN-UMIN000005358

2011/04/01

01/04/2011

Rapid LeukocyAPheresis InDuction for Ulcerative Colitis

ulcerative colitis

LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 3 days.
LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 14 days.

Lower Gastroenterology, Hyogo College of Medicine

Department of Gastroenterology, Osaka City University and Department of Gastroenterology, Osaka Medical College

Complete: follow-up complete

12years-old

81years-old

Male and Female

Phase 2;Phase 3

Japan

EUCTR2010-020448-37-BE
(EUCTR)

10/12/2010

22/12/2010

Product Name: PEG-liposomal prednisolone sodium phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE

Enceladus Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00984568
(ClinicalTrials.gov)

November 2009

24/9/2009

Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)

Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study

Colitis, Ulcerative

Biological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: Azathioprine

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

N/A

All

Phase 3

Germany

EUCTR2009-010065-23-DE
(EUCTR)

17/08/2009

14/04/2009

Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX

Active Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: 100
Trade Name: Pentasa 500 mg Retardtabletten
Product Name: 5-Aminosalicylic acid (5-ASA)
INN or Proposed INN: 5-Aminosalicylic acid
Trade Name: Imurek 25mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Imurek 50mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Decortin H 1 mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 5mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 10mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 20mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 50 mg
INN or Proposed INN: prednisolone

Essex Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany

EUCTR2004-005032-35-BE
(EUCTR)

06/03/2007

23/11/2006

A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.

Moderate acute ulcerative colitis.

Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate

Alizyme Therapeutics Limited

NULL

Not Recruiting

Female: yes
Male: yes

890

Hungary;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Italy;Sweden

EUCTR2004-005032-35-IT
(EUCTR)

10/05/2006

19/01/2007

A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Trade Name: PREDNISOLONE
INN or Proposed INN: Prednisolone

ALIZYME

NULL

Not Recruiting

Female: yes
Male: yes

890

Phase 3

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden

NCT00299013
(ClinicalTrials.gov)

March 2006

2/3/2006

Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

Ulcerative Colitis

Drug: COLAL-PRED®;Drug: Prednisolone

Alizyme

NULL

Completed

18 Years

75 Years

Both

796

Phase 3

Australia;Belgium;Czech Republic;Denmark;France;Germany;Hungary;Israel;Italy;Poland;Russian Federation;South Africa;Spain;Sweden;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2004-005032-35-SE
(EUCTR)

17/11/2005

14/09/2005

A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.

Moderate acute ulcerative colitis.

Alizyme Therapeutics Limited

NULL

Not Recruiting

Female: yes
Male: yes

890

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden

EUCTR2004-005032-35-CZ
(EUCTR)

04/11/2005

16/09/2005

A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.

Moderate acute ulcerative colitis.

Alizyme Therapeutics Limited

NULL

Not Recruiting

Female: yes
Male: yes

890

Hungary;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Italy;Sweden

EUCTR2004-005032-35-DK
(EUCTR)

24/10/2005

04/10/2005

A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.

Moderate acute ulcerative colitis.

Alizyme Therapeutics Limited

NULL

Not Recruiting

Female: yes
Male: yes

890

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden

EUCTR2004-005032-35-HU
(EUCTR)

24/10/2005

22/09/2005

A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.

Moderate acute ulcerative colitis.

Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate

Alizyme Therapeutics Limited

NULL

Not Recruiting

Female: yes
Male: yes

890

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03777319 (ClinicalTrials.gov)	December 5, 2018	10/12/2018	Spironolactone Versus Prednisolone in DMD	A Randomized Open Label Trial of Spironolactone Versus Prednisolone in Corticosteroid-naïve Boys With DMD	Muscular Dystrophy, Duchenne	Drug: Spironolactone;Drug: Prednisolone	Kevin Flanigan	Muscular Dystrophy Association	Recruiting	4 Years	7 Years	Male	24	Phase 1	United States
2	NCT02167217 (ClinicalTrials.gov)	April 17, 2014	3/2/2014	Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy	Phase 2 Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy	Duchenne Muscular Dystrophy	Drug: Prednisolone	Washington University School of Medicine	Nationwide Children's Hospital;Feinberg School of Medicine, Northwestern University;University of Texas Southwestern Medical Center;University of California, Davis;Nemours Hospital, Orlando, FL	Completed	1 Month	30 Months	Male	25	Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04302116 (ClinicalTrials.gov)	May 18, 2020	5/3/2020	Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm	Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial	Infantile Spasm;West Syndrome	Drug: Combination therapy with vigabatrin and prednisolone;Drug: Vigabatrin Tablets	Kullasate Sakpichaisakul	NULL	Recruiting	2 Months	14 Months	All	250	N/A	Thailand
2	NCT03876444 (ClinicalTrials.gov)	April 1, 2019	12/3/2019	Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms	Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial	Infantile Spasm	Drug: Intravenous Methylprednisolone;Drug: Oral Pednisolone	Suvasini Sharma	NULL	Recruiting	4 Months	30 Months	All	128	Phase 2;Phase 3	India
3	NCT02299115 (ClinicalTrials.gov)	September 5, 2017	18/11/2014	Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms	Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms	Infantile Spasms	Drug: Prednisolone;Drug: Vigabatrin	The Hospital for Sick Children	NULL	Withdrawn	2 Months	24 Months	All	0	Phase 3	Canada
4	NCT01828437 (ClinicalTrials.gov)	November 2012	7/4/2013	Addition of Pyridoxine to Prednisolone in Infantile Spasms	Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial	Infantile Spasms	Drug: Pyridoxine plus prednisolone;Drug: Prednisolone	Lady Hardinge Medical College	NULL	Completed	3 Months	36 Months	All	62	Phase 3	India
5	NCT01575639 (ClinicalTrials.gov)	February 2012	9/4/2012	Prednisolone in Infantile Spasms- High Dose Versus Usual Dose	Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.	Infantile Spasms;West Syndrome	Drug: Oral prednisolone	Lady Hardinge Medical College	NULL	Completed	3 Months	24 Months	Both	63	Phase 3	India
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2006-000788-27-DE (EUCTR)	23/09/2010	11/06/2010	International Collaborative Study of a type of epilepsy called Infantile Spasms	International Collaborative Infantile Spasms Study (ICISS) - ICISS	Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subsequent epilepsy and neuro-development. There is a high risk of underlying neurological disease that independently causes delayed development and other seizure disorders. There is a high risk of a poor outcome even when there is no other detectable underlying neurological disorder.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SABRIL INN or Proposed INN: Vigabatrin Trade Name: Synacthen Depot INN or Proposed INN: Tetracosactide Acetate Trade Name: Decortin H INN or Proposed INN: Prednisolone	Royal United Hospital Bath NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	410	Phase 4	Australia;Germany;United Kingdom;Switzerland;New Zealand
7	EUCTR2006-000788-27-GB (EUCTR)	20/04/2006	06/03/2006	International Collaborative Infantile Spasms Study (ICISS) - ICISS	International Collaborative Infantile Spasms Study (ICISS) - ICISS	Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subsequent epilepsy and neuro-development. There is a high risk of underlying neurological disease that independently causes delayed development and other seizure disorders. There is a high risk of a poor outcome even when there is no other detectable underlying neurological disorder.	Trade Name: SABRIL SACHETS INN or Proposed INN: Vigabatrin Trade Name: SYNACTHEN DEPOT INN or Proposed INN: Tetracosactide Acetate Trade Name: SOLUBLE PREDNISOLONE TABLETS INN or Proposed INN: Prednisolone	Royal United Hospital Bath NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	410	Phase 4	Germany;United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2007-006658-24-DE (EUCTR)	16/12/2009	08/09/2009	A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid - Bullous Pemphigoid Steroids & Tetracyclines Study	A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid - Bullous Pemphigoid Steroids & Tetracyclines Study	BP is a serious condition with a significant associated morbidity and mortality rate. Widespread tense and haemorrhagic blisters, skin erosions and severe itching cause patients a great deal of distress and pain. It occurs mainly in the elderly. The mortality rate in treated patients is estimated to range from 20% - 40% at one year. MedDRA version: 9.1;Level: LLT;Classification code 10006568;Term: Bullous pemphigoid NOS MedDRA version: 9.1;Classification code 10006567;Term: Bullous pemphigoid	Product Name: prednisolone INN or Proposed INN: prednisolone Product Name: doxycycline INN or Proposed INN: doxycycline	Universitätsklinikum Schleswig-Holstein	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	256		United Kingdom;Germany
2	EUCTR2007-006658-24-GB (EUCTR)	05/03/2009	22/10/2008	A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid - Bullous Pemphigoid Steroids & Tetracyclines Study	A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid - Bullous Pemphigoid Steroids & Tetracyclines Study	BP is a serious condition with a significant associated morbidity and mortality rate. Widespread tense and haemorrhagic blisters, skin erosions and severe itching cause patients a great deal of distress and pain. It occurs mainly in the elderly. The mortality rate in treated patients is estimated to range from 20% - 40% at one year. MedDRA version: 14.0;Level: LLT;Classification code 10006568;Term: Bullous pemphigoid NOS;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.0;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders		University of Nottingham	NULL	Not Recruiting			Female: yes Male: yes	256	Phase 4	Germany;United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2013-000226-55-NL (EUCTR)	04/03/2015	24/06/2014	SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY	European Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARMEN	Primary membranous nephropathy MedDRA version: 17.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Trade Name: Tacrolimus Product Name: TACROLIMUS INN or Proposed INN: TACROLIMUS Other descriptive name: TACROLIMUS Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE ACETATE Trade Name: cyclophosphamide Product Name: cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE	Fundacion Renal Iñigo Alvarez Toledo	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	175		Spain;Netherlands
2	NCT01763580 (ClinicalTrials.gov)	July 16, 2012	6/12/2012	A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome	Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS)	MCNS;Minimal Change Nephrotic Syndrome (MCNS)	Drug: Tacrolimus;Drug: Prednisolone	Astellas Pharma Korea, Inc.	NULL	Completed	16 Years	78 Years	All	144	Phase 4	Korea, Republic of
3	ChiCTR-TRC-10000871	2010-09-01	2010-05-21	A randomized post-market trial of Huang Qi Huai for chilhood steroid-sensitive nephrotic syndrome	A randomized post-market trial of Huang Qi Huai for chilhood steroid-sensitive nephrotic syndrome	Steroid-sensitive primary nephrotic syndrome in children	Group A:Prednisolone (tablets) + Huai Qi Huang (particle);Group B:Prednisolone (tablets) + placebo (particle);	Children's Hospital Affiliated to Fudan UniversityNanjing Children's Hospital	NULL	Completed	1	12	Both	Group A:50;Group B:50;		China
4	NCT01185197 (ClinicalTrials.gov)	September 2010	13/8/2010	Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study	Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome	Nephrosis, Lipoid	Drug: Myfortic plus low-dose steroid;Drug: Prednisolone	The University of Hong Kong	NULL	Completed	18 Years	65 Years	All	20	Phase 4	China
5	EUCTR2009-016003-26-GB (EUCTR)	06/05/2010	17/03/2010	RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic	RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic	Primary Proteinuric Glomeruolnephritis Focal segmental glomeruloscerosis and IgA nephropathy MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders	Trade Name: Myfortic Product Name: Myfortic 360mg Tablets INN or Proposed INN: mycophenolic acid Other descriptive name: mycophenolate sodium Trade Name: Myfortic Product Name: Myfortic 180mg Tablets INN or Proposed INN: mycophenolic sodium Other descriptive name: mycophenolate sodium Product Name: Prednisolone INN or Proposed INN: prednisolone	UHB NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	ChiCTR-TRC-10001024	2008-01-01	2010-09-14	Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis	Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis	primary focal segmental glomerulosclerosis	group A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d ;	Shanghai Jiaotong University Affiliated Ruijin Hospital	NULL	Completed	18	75	Both	group A:30;group B:30;		China
7	JPRN-UMIN000000621	2007/03/01	28/02/2007	Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission		Minimal change nephrotic syndrome	Prednisolone (+), combination therapy (-) Prednisolone (+), combination therapy (+)	Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	50	Not selected	Japan
8	JPRN-C000000158	2006/03/01	01/04/2006	Mizoribin for primary nephrotic syndrome in children(JSRDC09)		Steroid-sensitive nephrotic syndrome	mizoribine+prednisolone	Japanese Study Group of Renal Disease in Children(JSRDC)	NULL	Complete: follow-up complete	1years-old	10years-old	Male and Female	50	Not selected	Japan
9	JPRN-C000000368	2004/04/01	27/03/2006	Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome		membranous nephropathy with primary steroid resistant nephrotic syndrome	mizoribine once a day per os administration (150mg) after breakfast for 2years. mizoribine 3 times a day per os administration (50mg each) after meals for 2years.	Project team for treatment of refractory nephrotic syndrome	The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan	Complete: follow-up complete	16years-old	75years-old	Male and Female	100	Not selected	Japan
10	JPRN-C000000369	2004/04/01	27/03/2006	Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome		membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndrome	CyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks	Project team for treatment of refractory nephrotic syndrome	The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan	Complete: follow-up complete	16years-old	75years-old	Male and Female	300	Not selected	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT00404833 (ClinicalTrials.gov)	January 2003	27/11/2006	Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental	A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS)	Glomerulonephritis, Membranous;Glomerulosclerosis, Focal	Drug: prednisolone and mycophenolate mofetil;Drug: prednisolone and chlorambucil	Hospital Authority, Hong Kong	The University of Hong Kong	Completed	18 Years	65 Years	Both	16	Phase 3	China
12	JPRN-C000000379	2001/04/01	01/04/2006	Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06)		Steroid-sensitive nephrotic syndrome	prednisolone mizoribine+prednisolone	Japanese Study Group of Renal Disease in Children(JSRDC)	NULL	Complete: follow-up complete	1years-old	10years-old	Male and Female	50	Not selected	Japan
13	EUCTR2015-001039-18-Outside-EU/EEA (EUCTR)		03/07/2015	Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndrome	Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study	Minimal change nephrotic syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Prograf INN or Proposed INN: TACROLIMUS Trade Name: Prograf INN or Proposed INN: TACROLIMUS Trade Name: Solondo INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Solondo INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE	Astellas Pharma Korea, Inc.	NULL	NA			Female: yes Male: yes	152		Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-000226-55-NL
(EUCTR)

04/03/2015

24/06/2014

SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY

European Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARMEN

Primary membranous nephropathy
MedDRA version: 17.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Trade Name: Tacrolimus
Product Name: TACROLIMUS
INN or Proposed INN: TACROLIMUS
Other descriptive name: TACROLIMUS
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: methylprednisolone
Other descriptive name: METHYLPREDNISOLONE
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE ACETATE
Trade Name: cyclophosphamide
Product Name: cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE

Fundacion Renal Iñigo Alvarez Toledo

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

175

Spain;Netherlands

NCT01763580
(ClinicalTrials.gov)

July 16, 2012

6/12/2012

A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome

Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS)

MCNS;Minimal Change Nephrotic Syndrome (MCNS)

Drug: Tacrolimus;Drug: Prednisolone

Astellas Pharma Korea, Inc.

NULL

Completed

16 Years

78 Years

All

144

Phase 4

Korea, Republic of

ChiCTR-TRC-10000871

2010-09-01

2010-05-21

A randomized post-market trial of Huang Qi Huai for chilhood steroid-sensitive nephrotic syndrome

Steroid-sensitive primary nephrotic syndrome in children

Group A:Prednisolone (tablets) + Huai Qi Huang (particle);Group B:Prednisolone (tablets) + placebo (particle);

Children's Hospital Affiliated to Fudan UniversityNanjing Children's Hospital

NULL

Completed

Both

Group A:50;Group B:50;

China

NCT01185197
(ClinicalTrials.gov)

September 2010

13/8/2010

Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study

Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome

Nephrosis, Lipoid

Drug: Myfortic plus low-dose steroid;Drug: Prednisolone

The University of Hong Kong

NULL

Completed

18 Years

65 Years

All

Phase 4

China

EUCTR2009-016003-26-GB
(EUCTR)

06/05/2010

17/03/2010

RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic

UHB NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

ChiCTR-TRC-10001024

2008-01-01

2010-09-14

Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis

primary focal segmental glomerulosclerosis

group A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d ;

Shanghai Jiaotong University Affiliated Ruijin Hospital

NULL

Completed

Both

group A:30;group B:30;

China

JPRN-UMIN000000621

2007/03/01

28/02/2007

Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission

Minimal change nephrotic syndrome

Prednisolone (+), combination therapy (-)
Prednisolone (+), combination therapy (+)

Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan

NULL

Complete: follow-up complete

16years-old

Not applicable

Male and Female

Not selected

Japan

JPRN-C000000158

2006/03/01

01/04/2006

Mizoribin for primary nephrotic syndrome in children(JSRDC09)

Steroid-sensitive nephrotic syndrome

mizoribine+prednisolone

Japanese Study Group of Renal Disease in Children(JSRDC)

NULL

Complete: follow-up complete

1years-old

10years-old

Male and Female

Not selected

Japan

JPRN-C000000368

2004/04/01

27/03/2006

Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome

membranous nephropathy with primary steroid resistant nephrotic syndrome

mizoribine once a day per os administration (150mg) after breakfast for 2years.

mizoribine 3 times a day per os administration (50mg each) after meals for 2years.

Project team for treatment of refractory nephrotic syndrome

The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan

Complete: follow-up complete

16years-old

75years-old

Male and Female

100

Not selected

Japan

JPRN-C000000369

2004/04/01

27/03/2006

Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome

membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndrome

CyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks
CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks

Project team for treatment of refractory nephrotic syndrome

The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan

Complete: follow-up complete

16years-old

75years-old

Male and Female

300

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00404833
(ClinicalTrials.gov)

January 2003

27/11/2006

Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental

A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS)

Glomerulonephritis, Membranous;Glomerulosclerosis, Focal

Drug: prednisolone and mycophenolate mofetil;Drug: prednisolone and chlorambucil

Hospital Authority, Hong Kong

The University of Hong Kong

Completed

18 Years

65 Years

Both

Phase 3

China

JPRN-C000000379

2001/04/01

01/04/2006

Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06)

Steroid-sensitive nephrotic syndrome

prednisolone
mizoribine+prednisolone

Japanese Study Group of Renal Disease in Children(JSRDC)

NULL

Complete: follow-up complete

1years-old

10years-old

Male and Female

Not selected

Japan

EUCTR2015-001039-18-Outside-EU/EEA
(EUCTR)

03/07/2015

Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndrome

Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study

Minimal change nephrotic syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Prograf
INN or Proposed INN: TACROLIMUS
Trade Name: Prograf
INN or Proposed INN: TACROLIMUS
Trade Name: Solondo
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Solondo
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE

Astellas Pharma Korea, Inc.

NULL

Female: yes
Male: yes

152

Korea, Republic of

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000022633	2016/06/06	06/06/2016	Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis.		autoimmune pancreatitis	Steroid treatment (total 56 weeks) Induction ~ 4 weeks : Prednisolone 10mg/day 4 weeks ~ 48 weeks : Prednisolone 5mg/day 48 weeks ~ 52 weeks : Prednisolone 2.5mg/day 52 weeks ~ 56 weeks : Prednisolone 1mg/day	Osaka University	NULL	Pending	20years-old	Not applicable	Male and Female	20	Not selected	Japan
2	JPRN-UMIN000003804	2010/05/01	25/06/2010	Randomized controlled trial which examines whether resuming steroid can prevent clinical relapse in the patients with asymptomatic high levels of serum IgG after ceasing steroid therapy for autoimmune pancreatitis		autoimmune pancreatitis	Prednisolone at a dose of 10mg/day is started. The dose is taperd by 2.5mg every 8-10 weeks until reaching 5mg/day. Maintenance therapy at a dose of 5 mg/day is continued. Resuming or increasing prednisolone is not planned. Patients during the course of tapering prednisolone continue to taper the dose until its complete cessation.	Department of Gastroenterology, University of Tokyo	NULL	Recruiting	20years-old	Not applicable	Male and Female	20	Not applicable	Japan