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	EUCTR2009-016068-35-NL (EUCTR)	15/12/2010	24/06/2010	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
2	EUCTR2010-019263-11-LT (EUCTR)	06/09/2010	03/06/2010	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN	Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Name: not applicable Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	270		Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
3	EUCTR2010-019263-11-FR (EUCTR)	02/08/2010	14/06/2010	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)	Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270		Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
4	EUCTR2010-019263-11-HU (EUCTR)	14/07/2010	20/05/2010	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)	Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Name: SAR153191 Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	270		Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
5	EUCTR2010-019263-11-BE (EUCTR)	08/07/2010	13/04/2010	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN	Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 3	France;Hungary;Czech Republic;Spain;Belgium;Lithuania;Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2010-019263-11-ES (EUCTR)	28/06/2010	21/04/2010	Estudio de extensión multicéntrico no controlado para evaluar la seguridad y la eficacia a largo plazo de SAR153191 en pacientes con espondilitis anquilosante (EA)______________________________________________A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)	Estudio de extensión multicéntrico no controlado para evaluar la seguridad y la eficacia a largo plazo de SAR153191 en pacientes con espondilitis anquilosante (EA)______________________________________________A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)	Espondilitis Anquilosante__________________________Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270		Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
7	EUCTR2010-019263-11-CZ (EUCTR)	03/06/2010	19/04/2010	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN	Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	270		Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
8	NCT01118728 (ClinicalTrials.gov)	June 2010	5/5/2010	Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis	A Multicenter Uncontrolled Extension Study Evaluating the Long Term Safety and Efficacy of SAR153191 in Patients With Ankylosing Spondylitis (AS)	Ankylosing Spondylitis	Drug: Sarilumab	Sanofi	Regeneron Pharmaceuticals	Terminated	18 Years	N/A	All	223	Phase 2	United States;Australia;Austria;Belgium;Canada;Czechia;France;Hungary;Lithuania;Netherlands;Poland;Spain;Czech Republic
9	EUCTR2010-019263-11-AT (EUCTR)	19/05/2010	13/04/2010	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN	A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN	Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	270		Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
10	EUCTR2009-016068-35-DE (EUCTR)	03/05/2010	11/12/2009	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	Ankylosing Spondylitis MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
No.	TrialID	Date_ enrollment	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	EUCTR2009-016068-35-FR (EUCTR)	26/04/2010	14/12/2009	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300		Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
12	EUCTR2009-016068-35-CZ (EUCTR)	25/03/2010	01/04/2010	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Austria;Lithuania
13	EUCTR2009-016068-35-LT (EUCTR)	23/03/2010	30/12/2009	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Name: not applicable Product Code: SAR153191 Product Name: not applicable Product Code: SAR153191 Product Name: not applicable Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
14	EUCTR2009-016068-35-ES (EUCTR)	22/02/2010	16/12/2009	Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	Espondilitis anquilosante___________________________Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
15	EUCTR2009-016068-35-BE (EUCTR)	19/02/2010	30/11/2009	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	300		France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;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
16	NCT01061723 (ClinicalTrials.gov)	February 2010	2/2/2010	Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis	A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)	Ankylosing Spondylitis	Drug: Sarilumab;Drug: Placebo	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	75 Years	All	301	Phase 2	United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Lithuania;Netherlands;Poland;Spain;Turkey;Czech Republic
17	EUCTR2009-016068-35-AT (EUCTR)	28/01/2010	11/01/2010	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
18	EUCTR2009-016068-35-HU (EUCTR)	25/01/2010	14/12/2009	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN	Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Product Name: SAR153191 Product Code: SAR153191 Product Name: SAR153191 Product Code: SAR153191 Product Name: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300		Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2009-016068-35-NL
(EUCTR)

15/12/2010

24/06/2010

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania

EUCTR2010-019263-11-LT
(EUCTR)

06/09/2010

03/06/2010

A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN

Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Name: not applicable
Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

270

Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania

EUCTR2010-019263-11-FR
(EUCTR)

02/08/2010

14/06/2010

A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)

Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania

EUCTR2010-019263-11-HU
(EUCTR)

14/07/2010

20/05/2010

A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)

Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Name: SAR153191
Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

270

Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania

EUCTR2010-019263-11-BE
(EUCTR)

08/07/2010

13/04/2010

A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN

Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 3

France;Hungary;Czech Republic;Spain;Belgium;Lithuania;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-019263-11-ES
(EUCTR)

28/06/2010

21/04/2010

Estudio de extensión multicéntrico no controlado para evaluar la seguridad y la eficacia a largo plazo de SAR153191 en pacientes con espondilitis anquilosante (EA)______________________________________________A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)

Espondilitis Anquilosante__________________________Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania

EUCTR2010-019263-11-CZ
(EUCTR)

03/06/2010

19/04/2010

A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN

Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

270

Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania

NCT01118728
(ClinicalTrials.gov)

June 2010

5/5/2010

Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

A Multicenter Uncontrolled Extension Study Evaluating the Long Term Safety and Efficacy of SAR153191 in Patients With Ankylosing Spondylitis (AS)

Ankylosing Spondylitis

Drug: Sarilumab

Sanofi

Regeneron Pharmaceuticals

Terminated

18 Years

N/A

All

223

Phase 2

United States;Australia;Austria;Belgium;Canada;Czechia;France;Hungary;Lithuania;Netherlands;Poland;Spain;Czech Republic

EUCTR2010-019263-11-AT
(EUCTR)

19/05/2010

13/04/2010

A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN

Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

270

Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania

EUCTR2009-016068-35-DE
(EUCTR)

03/05/2010

11/12/2009

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

Ankylosing Spondylitis
MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2009-016068-35-FR
(EUCTR)

26/04/2010

14/12/2009

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania

EUCTR2009-016068-35-CZ
(EUCTR)

25/03/2010

01/04/2010

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Austria;Lithuania

EUCTR2009-016068-35-LT
(EUCTR)

23/03/2010

30/12/2009

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Name: not applicable
Product Code: SAR153191
Product Name: not applicable
Product Code: SAR153191
Product Name: not applicable
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania

EUCTR2009-016068-35-ES
(EUCTR)

22/02/2010

16/12/2009

Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

Espondilitis anquilosante___________________________Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania

EUCTR2009-016068-35-BE
(EUCTR)

19/02/2010

30/11/2009

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

300

France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;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

NCT01061723
(ClinicalTrials.gov)

February 2010

2/2/2010

Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)

Ankylosing Spondylitis

Drug: Sarilumab;Drug: Placebo

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

75 Years

All

301

Phase 2

United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Lithuania;Netherlands;Poland;Spain;Turkey;Czech Republic

EUCTR2009-016068-35-AT
(EUCTR)

28/01/2010

11/01/2010

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania

EUCTR2009-016068-35-HU
(EUCTR)

25/01/2010

14/12/2009

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis

Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania