DDrare: Database of Drug Development for Rare Diseases

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	EUCTR2010-019872-65-LT (EUCTR)	11/04/2013	17/01/2013	Etoricoxib with naproxen in ankylosing spondylitis	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis	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]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosyn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
2	EUCTR2010-019872-65-CZ (EUCTR)	10/05/2011	03/03/2011	Etoricoxib with naproxen in ankylosing spondylitis	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis	Ankylosing Spondylitis (AS) MedDRA version: 16.1;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]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
3	EUCTR2010-019872-65-SK (EUCTR)	02/05/2011	28/02/2011	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis	Ankylosing Spondylitis (AS) MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis	Trade Name: ARCOXIA Product Name: etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: naproxen INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 3	Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
4	EUCTR2010-019872-65-AT (EUCTR)	14/01/2011	03/09/2010	Etoricoxib with naproxen in ankylosing spondylitis	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis	Ankylosing Spondylitis (AS) MedDRA version: 14.1;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]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 3	United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
5	EUCTR2010-019872-65-BE (EUCTR)	11/01/2011	31/08/2010	Etoricoxib with naproxen in ankylosing spondylitis	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis	Ankylosing Spondylitis (AS) MedDRA version: 16.1;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]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;South Africa;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2010-019872-65-EE (EUCTR)	29/11/2010	03/11/2010	Etoricoxib with naproxen in ankylosing spondylitis	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis	Ankylosing Spondylitis (AS) MedDRA version: 14.1;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]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;South Africa;Germany
7	EUCTR2010-019872-65-HU (EUCTR)	09/11/2010	10/08/2010	Etoricoxib with naproxen in ankylosing spondylitis	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis	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]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
8	EUCTR2010-019872-65-FI (EUCTR)	18/10/2010	30/08/2010	Etoricoxib with naproxen in ankylosing spondylitis	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis	Ankylosing Spondylitis (AS) MedDRA version: 14.1;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]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 3	United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
9	NCT01208207 (ClinicalTrials.gov)	September 27, 2010	22/9/2010	A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis	Spondylitis, Ankylosing	Drug: Part I - etoricoxib 60 mg;Drug: Part I - etoricoxib 90 mg;Drug: Part I- naproxen 1000 mg;Drug: Part I - Placebo to naproxen 500 mg;Drug: Part II- etoricoxib 60 mg;Drug: Part II- etoricoxib 90 mg;Drug: Part II- naproxen 1000 mg;Drug: Part I - Placebo to etoricoxib 60 mg;Drug: Part I - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to etoricoxib 60 mg;Drug: Part II - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to naproxen 500 mg	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	N/A	All	1015	Phase 3	Argentina;Austria;Belgium;Canada;Colombia;Czech Republic;Estonia;Finland;France;Germany;Hungary;India;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States
10	NCT00844805 (ClinicalTrials.gov)	September 2009	13/2/2009	Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)	Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial	Ankylosing Spondylitis;Axial Spondyloarthritis	Drug: Infliximab;Drug: Placebo;Drug: Naproxen	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	48 Years	All	158	Phase 3	Austria;Belgium;Denmark;France;Germany;Hungary;Korea, Republic of;Russian Federation;Ukraine;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
11	NCT00367211 (ClinicalTrials.gov)	September 2006	18/8/2006	Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.	A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.	Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis	Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole)	POZEN	NULL	Completed	18 Years	N/A	Both	400	Phase 3	United States
12	EUCTR2010-019872-65-DE (EUCTR)		04/08/2010	Etoricoxib with naproxen in ankylosing spondylitis	A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis	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]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

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EUCTR2010-019872-65-LT
(EUCTR)

11/04/2013

17/01/2013

Etoricoxib with naproxen in ankylosing spondylitis

A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis

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]

Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosyn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

EUCTR2010-019872-65-CZ
(EUCTR)

10/05/2011

03/03/2011

Etoricoxib with naproxen in ankylosing spondylitis

Ankylosing Spondylitis (AS)
MedDRA version: 16.1;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]

Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

EUCTR2010-019872-65-SK
(EUCTR)

02/05/2011

28/02/2011

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

Trade Name: ARCOXIA
Product Name: etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: naproxen
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 3

Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom

EUCTR2010-019872-65-AT
(EUCTR)

14/01/2011

03/09/2010

Etoricoxib with naproxen in ankylosing spondylitis

Ankylosing Spondylitis (AS)
MedDRA version: 14.1;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]

Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 3

United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

EUCTR2010-019872-65-BE
(EUCTR)

11/01/2011

31/08/2010

Etoricoxib with naproxen in ankylosing spondylitis

Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

900

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

EUCTR2010-019872-65-EE
(EUCTR)

29/11/2010

03/11/2010

Etoricoxib with naproxen in ankylosing spondylitis

Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

EUCTR2010-019872-65-HU
(EUCTR)

09/11/2010

10/08/2010

Etoricoxib with naproxen in ankylosing spondylitis

Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

EUCTR2010-019872-65-FI
(EUCTR)

18/10/2010

30/08/2010

Etoricoxib with naproxen in ankylosing spondylitis

Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 3

NCT01208207
(ClinicalTrials.gov)

September 27, 2010

22/9/2010

A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)

Spondylitis, Ankylosing

Drug: Part I - etoricoxib 60 mg;Drug: Part I - etoricoxib 90 mg;Drug: Part I- naproxen 1000 mg;Drug: Part I - Placebo to naproxen 500 mg;Drug: Part II- etoricoxib 60 mg;Drug: Part II- etoricoxib 90 mg;Drug: Part II- naproxen 1000 mg;Drug: Part I - Placebo to etoricoxib 60 mg;Drug: Part I - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to etoricoxib 60 mg;Drug: Part II - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to naproxen 500 mg

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

1015

Phase 3

Argentina;Austria;Belgium;Canada;Colombia;Czech Republic;Estonia;Finland;France;Germany;Hungary;India;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States

NCT00844805
(ClinicalTrials.gov)

September 2009

13/2/2009

Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial

Ankylosing Spondylitis;Axial Spondyloarthritis

Drug: Infliximab;Drug: Placebo;Drug: Naproxen

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

48 Years

All

158

Phase 3

Austria;Belgium;Denmark;France;Germany;Hungary;Korea, Republic of;Russian Federation;Ukraine;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

NCT00367211
(ClinicalTrials.gov)

September 2006

18/8/2006

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis

Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole)

POZEN

NULL

Completed

18 Years

N/A

Both

400

Phase 3

United States

EUCTR2010-019872-65-DE
(EUCTR)

04/08/2010

Etoricoxib with naproxen in ankylosing spondylitis

Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3