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	EUCTR2019-003229-12-DE (EUCTR)	30/06/2020	05/12/2019	Evaluation of upadacitinib in adult subjects with axial spondyloarthritis	A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis	Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	690	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
2	EUCTR2019-003229-12-ES (EUCTR)	10/03/2020	06/03/2020	Evaluation of upadacitinib in adult subjects with axial spondyloarthritis	A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis	Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	690	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;China;Japan;New Zealand;Korea, Republic of
3	EUCTR2019-003229-12-GB (EUCTR)	02/03/2020	16/12/2019	Evaluation of upadacitinib in adult subjects with axial spondyloarthritis	A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis	Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	690	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
4	EUCTR2019-003229-12-HU (EUCTR)	27/01/2020	02/12/2019	Evaluation of upadacitinib in adult subjects with axial spondyloarthritis	A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis	Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	690	Phase 3	United States;Taiwan;Ukraine;Turkey;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Australia;New Zealand;China;Japan;Korea, Republic of
5	EUCTR2019-003229-12-SK (EUCTR)	14/01/2020	15/11/2019	Evaluation of upadacitinib in adult subjects with axial spondyloarthritis	A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis	Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	690	Phase 3	United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;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	EUCTR2017-000431-14-HR (EUCTR)	06/04/2018	19/04/2018	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2;Phase 3	United States;Portugal;Finland;Spain;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
7	EUCTR2017-000431-14-DE (EUCTR)	21/02/2018	31/07/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2;Phase 3	Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
8	EUCTR2017-000431-14-SE (EUCTR)	24/01/2018	20/12/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2;Phase 3	Portugal;United States;Finland;Spain;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
9	EUCTR2017-000431-14-NL (EUCTR)	05/01/2018	22/08/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	228	Phase 2;Phase 3	United States;Portugal;Finland;Spain;Switzerland;Hungary;Canada;Poland;Australia;Denmark;Netherlands;Japan;New Zealand;Korea, Republic of
10	EUCTR2017-000431-14-GB (EUCTR)	28/12/2017	08/08/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2;Phase 3	Portugal;United States;Finland;Spain;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;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	EUCTR2017-000431-14-CZ (EUCTR)	13/12/2017	08/08/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2;Phase 3	Germany;Netherlands;Japan;New Zealand;Sweden;Korea, Republic of;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;United States;Portugal;Finland;Spain;Hungary
12	EUCTR2017-000431-14-PL (EUCTR)	15/11/2017	20/10/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2;Phase 3	Portugal;United States;Finland;Spain;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
13	EUCTR2017-000431-14-BE (EUCTR)	15/11/2017	30/08/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2;Phase 3	Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
14	EUCTR2017-000431-14-FR (EUCTR)	13/11/2017	19/07/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	228	Phase 2;Phase 3	Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of;Portugal;United States;Finland;Spain;Switzerland;United Kingdom;France;Hungary
15	NCT03178487 (ClinicalTrials.gov)	October 24, 2017	5/6/2017	A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis ( SELECT Axis 1 )	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis	Ankylosing Spondylitis (AS)	Drug: Upadacitinib;Drug: Upadacitinib Placebo	AbbVie	NULL	Active, not recruiting	18 Years	N/A	All	187	Phase 2	United States;Australia;Belgium;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Spain;Sweden;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2017-000431-14-PT (EUCTR)	09/10/2017	09/08/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2;Phase 3	Portugal;United States;Finland;Spain;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
17	EUCTR2017-000431-14-ES (EUCTR)	02/10/2017	08/08/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	228	Phase 2;Phase 3	Portugal;United States;Hungary;Canada;Spain;Australia;New Zealand;Japan;Switzerland;Korea, Republic of
18	EUCTR2017-000431-14-HU (EUCTR)	26/09/2017	04/09/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	228	Phase 2;Phase 3	United States;Hungary;Canada;Australia;New Zealand;Japan;Switzerland;Korea, Republic of
19	EUCTR2017-000431-14-DK (EUCTR)	25/09/2017	25/07/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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]		AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2;Phase 3	Portugal;United States;Finland;Spain;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
20	EUCTR2017-000431-14-FI (EUCTR)	06/09/2017	01/08/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis	Active Ankylosing Spondylitis 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: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2;Phase 3	Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of;United States;Portugal;Finland;Spain;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia

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

EUCTR2019-003229-12-DE
(EUCTR)

30/06/2020

05/12/2019

Evaluation of upadacitinib in adult subjects with axial spondyloarthritis

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis

Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

690

Phase 3

United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of

EUCTR2019-003229-12-ES
(EUCTR)

10/03/2020

06/03/2020

Evaluation of upadacitinib in adult subjects with axial spondyloarthritis

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

690

Phase 3

United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;China;Japan;New Zealand;Korea, Republic of

EUCTR2019-003229-12-GB
(EUCTR)

02/03/2020

16/12/2019

Evaluation of upadacitinib in adult subjects with axial spondyloarthritis

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

690

Phase 3

United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of

EUCTR2019-003229-12-HU
(EUCTR)

27/01/2020

02/12/2019

Evaluation of upadacitinib in adult subjects with axial spondyloarthritis

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

690

Phase 3

United States;Taiwan;Ukraine;Turkey;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Australia;New Zealand;China;Japan;Korea, Republic of

EUCTR2019-003229-12-SK
(EUCTR)

14/01/2020

15/11/2019

Evaluation of upadacitinib in adult subjects with axial spondyloarthritis

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

690

Phase 3

United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;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

EUCTR2017-000431-14-HR
(EUCTR)

06/04/2018

19/04/2018

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Active Ankylosing Spondylitis
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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 2;Phase 3

United States;Portugal;Finland;Spain;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of

EUCTR2017-000431-14-DE
(EUCTR)

21/02/2018

31/07/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 2;Phase 3

Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of

EUCTR2017-000431-14-SE
(EUCTR)

24/01/2018

20/12/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Active Ankylosing Spondylitis
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]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 2;Phase 3

Portugal;United States;Finland;Spain;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of

EUCTR2017-000431-14-NL
(EUCTR)

05/01/2018

22/08/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

228

Phase 2;Phase 3

United States;Portugal;Finland;Spain;Switzerland;Hungary;Canada;Poland;Australia;Denmark;Netherlands;Japan;New Zealand;Korea, Republic of

EUCTR2017-000431-14-GB
(EUCTR)

28/12/2017

08/08/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 2;Phase 3

Portugal;United States;Finland;Spain;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;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

EUCTR2017-000431-14-CZ
(EUCTR)

13/12/2017

08/08/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 2;Phase 3

Germany;Netherlands;Japan;New Zealand;Sweden;Korea, Republic of;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;United States;Portugal;Finland;Spain;Hungary

EUCTR2017-000431-14-PL
(EUCTR)

15/11/2017

20/10/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Active Ankylosing Spondylitis
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]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 2;Phase 3

Portugal;United States;Finland;Spain;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of

EUCTR2017-000431-14-BE
(EUCTR)

15/11/2017

30/08/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 2;Phase 3

Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of

EUCTR2017-000431-14-FR
(EUCTR)

13/11/2017

19/07/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

228

Phase 2;Phase 3

Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of;Portugal;United States;Finland;Spain;Switzerland;United Kingdom;France;Hungary

NCT03178487
(ClinicalTrials.gov)

October 24, 2017

5/6/2017

A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis ( SELECT Axis 1 )

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis

Ankylosing Spondylitis (AS)

Drug: Upadacitinib;Drug: Upadacitinib Placebo

AbbVie

NULL

Active, not recruiting

18 Years

N/A

All

187

Phase 2

United States;Australia;Belgium;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Spain;Sweden;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000431-14-PT
(EUCTR)

09/10/2017

09/08/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 2;Phase 3

Portugal;United States;Finland;Spain;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of

EUCTR2017-000431-14-ES
(EUCTR)

02/10/2017

08/08/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

228

Phase 2;Phase 3

Portugal;United States;Hungary;Canada;Spain;Australia;New Zealand;Japan;Switzerland;Korea, Republic of

EUCTR2017-000431-14-HU
(EUCTR)

26/09/2017

04/09/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

228

Phase 2;Phase 3

United States;Hungary;Canada;Australia;New Zealand;Japan;Switzerland;Korea, Republic of

EUCTR2017-000431-14-DK
(EUCTR)

25/09/2017

25/07/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Active Ankylosing Spondylitis
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]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2;Phase 3

Portugal;United States;Finland;Spain;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of

EUCTR2017-000431-14-FI
(EUCTR)

06/09/2017

01/08/2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 2;Phase 3

Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of;United States;Portugal;Finland;Spain;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia