DDrare: Database of Drug Development for Rare Diseases

271. 強直性脊椎炎
［臨床試験数：531，薬物数：343（DrugBank：66），標的遺伝子数：41，標的パスウェイ数：141］

Searched query = "Ankylosing spondylitis", "Spondylarthritis ankylopoietica"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid; 0881; 150 mg double-blinded secukinumab; 150 mg open-label secukinumab; 300 mg double-blinded secukinumab; 331731-18-1; 40 mg MSB11022; 42942019; 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin; 5057732; 99mTc-rhAnnexin V-128; ABATACEPT; ABT-494; ADALIMUMAB; AIN457; AIN457, 150 mg; AIN457, 75 mg; AIN457A; AIN457F; ARCOXIA; ARCOXIA 90 mg comprimidos recubiertos con película; ARRY-371797; ARRY-371797, p38 inhibitor; AS; ATORVASTATIN; Abatacept; Acetaminophen; Aclasta; Adalimumab; Adalimumab (D2E7); Adalimumab (Humira); Adalimumab 40 mg sc every other week; Adalimumab, Etanercept, Golimumab or infliximab; Alendronate; Anti TNF alpha agent; Anti TNF alpha therapy; Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain); Anti-Human Interleukin-23 Monoclonal Antibody; Anti-TNF; Anti-TNF biologics; Anti-TNF therapy (etanercept or adalimumab); Anti-Tumor Necrosis Factor; Apremilast; Apremilast tablet 20 mg; Apremilast tablet 30 mg BID; Arcoxia; Atorvastatin; BAT1406; BCD-055; BCD-085; BDMARD treatment; BI 655066; BI 655066 90 mg/ml; BI 730357; BIMEKIZUMAB; BMS-188667; BMS-986251; Bawei Shenqi Pill; Behavioral: AbbVie Care 2.0; Behavioral: Cannabis questionnaire; Behavioral: General healthy eating; Behavioral: Low Starch Diet (LSD); Bimekizumab; Biologic DMARD; Biosimilar; Blood collection; Blood samples; CA2; CANNABIDIOL; CC; CC-10004; CDP870; CERTOLIZUMAB PEGOL; CIMZIA certolizumab pegol 200 mg/ml solution for injection; CNTO 148; COSENTYX; CP; CP-690,550; CP-690,550-10; CT-P13; CTLA4Ig; Cannabidiol; Cannabidiol tablet 10 mg; Cannabis; Celebrex; Celecoxib; Celecoxib 200 milligrams; Celecoxib 400 milligrams; Celecoxib, Celebrex®; Certolizumab; Certolizumab Pegol; Certolizumab pegol; Certolizumab pegol (CZP); Certolizumab pegol / CIMZIA; Chlor; Chloride; Cimzia; Cimzia 200 mg solution for injection; Cimzia®; Cosentyx; DMARDs; DRONABINOL; Device: Technetium labelled glucosamine; Diclofenac; Diclofenac 50 milligrams; Diclofenac SR; Diclophenac; Dronabinol; Dronabinol capsule 2.5. mg; Drug treatment; E-Device; ENBREL; ENIA11; ETANERCEPT; ETORICOXIB; Enbrel; Enbrel (Etanercept); Enbrel (etanercept); Enbrel plus Celebrex; Enbrel®; Entecavir; Etanercept; Etanercept (50mg per week); Etanercept (50mg per week, for 2 weeks); Etanercept (50mg per week, for 4 weeks); Etanercept (Enbrel); Etanercept (Full-Dose); Etanercept (Half-Dose); Etoricoxib; FILGOTINIB; Fengshigutong Capsule; Fengshigutong Capsule plus Imrecoxib; Filgotinib; Focetria (Monovalent MF59-Adjuvanted vaccine); GLPG0634; GOLIMUMAB; GP2017; GP2017 (adalimumab biosimilar); Glucosamine; Gold; Golimumab; Golimumab (CNTO 148); Golimumab Injection; Golimumab Liquid in Vial; Golimumab Pre-Filled Syringe; Herpes Zoster Vaccine; Human Anti-TNF IgG1 Monoclonal Antibody; Human Anti-TNFalfa; Human anti-TNFa monoclonal antibody; Human umbilical cord-derived MSCs; Humira; Humira 40 mg/0.8 ml solution for injection; Humira®; Hydroxychloroquine; Hyrimoz; IBI303; INFLIXIMAB; INTERLEUKIN 2; IXEKIZUMAB; Ibuprofen; Iguratimod; Ilumetri; Imrecoxib; Indomethacin; Infliximab; Infliximab (BCD-055); Infliximab (Remicade); Infliximab and MTX; Interleukin 2; Intravenous infusion of MSCs; Ixekizumab; Jaktinib Hydrochloride Tablets; KIN-1901; Kunxian capsule; L04AA24; L04AB01; L04AB04; L04AB05; LSD; LY2439821; Leflunomide; Loxoprofen; Loxoprofen sodium hydrogel patch; Loxoprofen sodium tablet; Lyophilized etanercept powder(Yisaipu); METHOTREXATE; MK-0663; MK-3222; MSC; MTX; MabThera; MabThera 500; Meloxicam; Meloxicam suppository; Meloxicam tablet; Methotrexate; Methylprednisolone; Misoprostol; Monoclonal Antibody (MAb); Méthotrexate; Méthotrexate Bellon Comprimé; N.A.; NAPROXEN; NSAIDs; NSAIDs and sulfasalazine; Nanocurcumin; Naprosyn; Naprosysn; Naproxen; Naproxen 500 mg tablets (PN 200 minus omeprazole); Non-anti-TNF biologics; None; NsNSAIDs; Null; Observational study; Olsalazine; Omeprazole; Oral; Orencia; Originator; Originator (legacy) drug; Other COX-2 inhibitor; Other Cox-2 inhibitors; Other Non-selective NSAIDs; Other: 0.9ml sodium chloride; Other: No anti-inflammatory treatment; Other: general population; PN 200 tablets (500 mg naproxen and 20 mg omeprazole); Pamidronate; Parecoxib; Part I - etoricoxib 60 mg; Part I - etoricoxib 90 mg; Part I- naproxen 1000 mg; Part II- etoricoxib 60 mg; Part II- etoricoxib 90 mg; Part II- naproxen 1000 mg; Placebo; Prednisolone; Prefilled liquid etanercept(Yisaipu); Procedure: Blood sampling from infant; Procedure: Blood sampling from mother; Procedure: Blood sampling from umbilical cord; Procedure: Breast milk sampling; Propanoic acid; REMICADE; REMICADE 100 mg polvo para concentrado para solución para perfusión; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; ROACTEMRA 20 mg/ml, concentrado para solución para perfusión; RTNV148B IgG; Rebamipide; Recombinant TNF-a receptor: IgG Fc fusion protein; Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class; Remicade; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remicade®; Remsima; Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; RhuTNFR:Fc; Risankizumab; Rituximab; Rituximab/ Mabthera; Ro 487-533/F01; Ro 487-5733/F01; Ro 487-7533/F01; Ro45-2294; RoActemra; RoActemra®; Rosuvastatin; SAR153191; SB4; SB4 (etanercept biosimilar); SB5; SECUKINUMAB; SHR0302; SSZ; SUNPG1622 I dose; Salazopyrin; Salazopyrin EN; Salazopyrin EN-Tabs; Salazopyrin En-Tabs; Salicylazosulfapyridine; Sarilumab; Secukinumab; Secukinumab (150 mg); Secukinumab (75 mg); Secukinumab (AIN457) 150 mg s.c.; Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.; Secukinumab 150 mg/1 ml Solution for injection; Secukinumab 150 milligram [Cosentyx]; Secukinumab 75 mg/0.5 ml Solution for injection; Simponi; Simponi®; Sodium chloride; Standard of Care; Stelara; Sulfasalazine; Sulfasalazine, SSZ; Sulphasalazine; Sulphasalazine (SSZ); Sulphasalazine 500 mg En-Tabs; Systemic non-biological treatments; TA-650 (Infliximab); THA; TNF alpha; TNF blockers (infliximab, adalimumab, etanercept); TNF-a antagonists, non-TNFs, DMARD non-biologics; TNF-alpha antagonists; TNF-inhibition; TNFR:Fc; TNR-001; TNR-001, TNFR:FC; TOCILIZUMAB; TOFACITINIB CITRATE; Taltz; Taltz (80 mg solution for injection in pre-filled syringe); Tapering or discontinuation of etanercept; Thalidomide; Thalidomide 100mg; Thalidomide 150mg; Tildrakizumab; Tildrakizumab 100 mg (one 1-mL injection of 100 mg/mL; Tildrakizumab 100 mg/ml; Tildrakizumab 200 mg (two 1-mL injections of 100 mg/mL); Tocilizumab; Tofacitinib; Tofacitinib 10 mg; Tofacitinib 2 mg; Tofacitinib 5 mg; Total Glucosides Paeony Capsules; Tramadol; Tramadol /acetaminophen; Tripterygium; Tripterygium Wilfordii; UCB4940; UPADACITINIB; Ultracet; Upadacitinib; Ustekinumab; Vessel; Voltaren resinat; Xeljanz; Yisaipu®; [18F]Fluoride

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2018-000226-58-DE (EUCTR)	18/10/2018	16/05/2018	A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)	A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)	Ankylosing spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
2	EUCTR2018-000226-58-GB (EUCTR)	13/08/2018	15/05/2018	A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)	A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)	Ankylosing spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib 5 mg Product Code: CP -690,550 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
3	EUCTR2018-000226-58-BG (EUCTR)	07/08/2018	31/05/2018	A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)	A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)	Ankylosing spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib 5 mg Product Code: CP -690,550 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
4	EUCTR2018-000226-58-FR (EUCTR)	12/07/2018	23/04/2018	A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)	A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)	Ankylosing spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Xeljanz Product Name: Tofacitinib 5 mg Product Code: CP -690,550 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
5	EUCTR2018-000226-58-CZ (EUCTR)	09/07/2018	04/05/2018	A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)	A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)	Ankylosing spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Xeljanz Product Name: Tofacitinib 5 mg Product Code: CP -690,550 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2018-000226-58-AT (EUCTR)	06/07/2018	14/05/2018	A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)	A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)	Ankylosing spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib 5 mg Product Code: CP -690,550 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
7	EUCTR2018-000226-58-ES (EUCTR)	04/07/2018	09/05/2018	A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)	A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)	Ankylosing spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
8	EUCTR2018-000226-58-HU (EUCTR)	26/06/2018	26/04/2018	A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)	A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)	Ankylosing spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Xeljanz Product Name: Tofacitinib 5 mg Product Code: CP -690,550 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
9	NCT03502616 (ClinicalTrials.gov)	June 7, 2018	11/4/2018	Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)	A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis	Drug: Tofacitinib	Pfizer	NULL	Completed	18 Years	N/A	All	270	Phase 3	United States;Australia;Bulgaria;Canada;China;Czechia;France;Hungary;Israel;Korea, Republic of;Poland;Russian Federation;Turkey;Ukraine;Slovakia;Spain;Taiwan
10	EUCTR2011-005689-39-SK (EUCTR)	24/09/2014	07/07/2014	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 2	United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2011-005689-39-NL (EUCTR)	01/09/2014	23/06/2014	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Netherlands;Korea, Republic of
12	EUCTR2011-005689-39-DE (EUCTR)	20/01/2014	24/05/2013	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 2	United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
13	EUCTR2011-005689-39-CZ (EUCTR)	07/08/2013	23/05/2013	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
14	EUCTR2011-005689-39-HU (EUCTR)	27/06/2013	22/05/2013	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc, 235 East 42nd Street, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
15	EUCTR2011-005689-39-ES (EUCTR)	26/06/2013	24/06/2013	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT01786668 (ClinicalTrials.gov)	April 2013	6/2/2013	Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis	A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)	Ankylosing Spondylitis	Drug: Tofacitinib 2 mg;Drug: Tofacitinib 5 mg;Drug: Tofacitinib 10 mg;Drug: Placebo	Pfizer	NULL	Completed	18 Years	N/A	All	208	Phase 2	United States;Canada;Czech Republic;Germany;Hungary;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-000226-58-DE
(EUCTR)

18/10/2018

16/05/2018

A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)

A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)

Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of

EUCTR2018-000226-58-GB
(EUCTR)

13/08/2018

15/05/2018

A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)

A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)

Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Tofacitinib 5 mg
Product Code: CP -690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of

EUCTR2018-000226-58-BG
(EUCTR)

07/08/2018

31/05/2018

A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)

A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)

Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Tofacitinib 5 mg
Product Code: CP -690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of

EUCTR2018-000226-58-FR
(EUCTR)

12/07/2018

23/04/2018

A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)

A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)

Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP -690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

EUCTR2018-000226-58-CZ
(EUCTR)

09/07/2018

04/05/2018

A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)

A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)

Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP -690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-000226-58-AT
(EUCTR)

06/07/2018

14/05/2018

A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)

A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)

Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Tofacitinib 5 mg
Product Code: CP -690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

EUCTR2018-000226-58-ES
(EUCTR)

04/07/2018

09/05/2018

A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)

A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

EUCTR2018-000226-58-HU
(EUCTR)

26/06/2018

26/04/2018

A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)

A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)

Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP -690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of

NCT03502616
(ClinicalTrials.gov)

June 7, 2018

11/4/2018

Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis

Drug: Tofacitinib

Pfizer

NULL

Completed

18 Years

N/A

All

270

Phase 3

United States;Australia;Bulgaria;Canada;China;Czechia;France;Hungary;Israel;Korea, Republic of;Poland;Russian Federation;Turkey;Ukraine;Slovakia;Spain;Taiwan

EUCTR2011-005689-39-SK
(EUCTR)

24/09/2014

07/07/2014

A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

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

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 2

United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-005689-39-NL
(EUCTR)

01/09/2014

23/06/2014

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Netherlands;Korea, Republic of

EUCTR2011-005689-39-DE
(EUCTR)

20/01/2014

24/05/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

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

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 2

United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of

EUCTR2011-005689-39-CZ
(EUCTR)

07/08/2013

23/05/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of

EUCTR2011-005689-39-HU
(EUCTR)

27/06/2013

22/05/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

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

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of

EUCTR2011-005689-39-ES
(EUCTR)

26/06/2013

24/06/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis (AS)
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;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

NCT01786668
(ClinicalTrials.gov)

April 2013

6/2/2013

Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)

Ankylosing Spondylitis

Drug: Tofacitinib 2 mg;Drug: Tofacitinib 5 mg;Drug: Tofacitinib 10 mg;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

208

Phase 2

United States;Canada;Czech Republic;Germany;Hungary;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan