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 271. 強直性脊椎炎 [臨床試験数:254,薬物数:252(DrugBank:59),標的遺伝子数:36,標的パスウェイ数:130] 

Searched query = "Ankylosing spondylitis", "Spondylarthritis ankylopoietica"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Inclusion_
agemin
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PhaseCountries
1NCT04156620December 3, 201911 November 2019Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpAA Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloArthritisAnkylosing Spondylitis or Non-radiographic Axial SpondyloarthritisDrug: Secukinumab;Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 YearsN/AAll500Phase 3
2NCT04077957October 7, 20197 October 2019Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDsTreat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled StudyAnkylosing Spondylitis;SpondyloarthritisDrug: Methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine;Drug: Etanercept (50mg per week, for 4 weeks);Drug: Etanercept (50mg per week, for 2 weeks);Drug: Etanercept (50mg per week)Nanfang Hospital of Southern Medical UniversityNot recruiting18 Years50 YearsAll100Phase 4China
3NCT04018599July 15, 201930 September 2019Comparison of PK and Tolerability of MSB11022 Administered by AI or PFSA Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy SubjectsRheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious UveitisDrug: 40 mg MSB11022Fresenius Kabi SwissBioSim GmbHPRA Health SciencesRecruiting18 Years55 YearsAll216Phase 1United States
4EUCTR2017-003065-95-HU16/04/201930 April 2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITISAnkylosing 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: bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: BIMEKIZUMAB
CAS Number: 1418205-77-2
Current Sponsor code: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Suspension for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
UCB Biopharma SPRLAuthorised Female: yes
Male: yes
300Phase 3United States;Spain;Turkey;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan
5EUCTR2018-003933-14-EE09/04/201930 April 2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Galapagos NVAuthorised Female: no
Male: yes
250Phase 2Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03639740January 15, 201914 January 2019Treat-to-target With Secukinumab in Axial SpondyloarthritisTReat-to-tArget (T2T) With seCukinumab in Axial Spondyloarthritis. IdEntification of MRI and Biochemical Biomarkers for Disease Activity, Treatment Response and Structural Damage Progression (the TRACE Study)Axial Spondyloarthritis;Ankylosing SpondylitisDrug: Secukinumab 150 milligram [Cosentyx]Professor Mikkel ØstergaardNovartis Healthcare A/SRecruiting18 Years70 YearsAll88Phase 4Denmark
7NCT03733925January 7, 201922 October 2019A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic ArthritisA Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of Golimumab (a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously) in the Treatment of Indian Patients With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic ArthritisSpondylitis, Ankylosing;Arthritis, PsoriaticDrug: GolimumabJohnson & Johnson Private LimitedRecruiting18 YearsN/AAll100Phase 4India
8NCT03839862January 1, 201925 February 2019Faecal Analyses in Spondyloarthritis TherapyFaecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition.Spondyloarthropathies;Ankylosing SpondylitisDrug: TNF-inhibitionRegion SkaneRecruiting18 YearsN/AAll50N/ASweden
9ChiCTR18000192272018-11-265 November 2018A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of Iguratimod in Chinese patients with active spondyloarthritis(SpA)/ankylosing spondylitis(AS)A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of Iguratimod in Chinese patients with active spondyloarthritis(SpA)/ankylosing spondylitisspondyloarthritis(SpA)/ankylosing spondylitis(AS)spondyloarthritis(SpA)/ankylosing spondylitis(AS):Iguratimod;Control group:Placebo;PLA General HospitalNot Recruiting1665Bothspondyloarthritis(SpA)/ankylosing spondylitis(AS):72;Control group:36;Post-marketChina
10NCT03729674November 26, 20183 December 2018Comparative Effectiveness and Safety of Biosimilar and Legacy DrugsComparative Effectiveness and Safety of Biosimilar and Legacy DrugsRheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's DiseaseDrug: Biosimilar;Drug: Originator (legacy) drugMcGill University Health CenterUniversité de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research GroupNot recruiting18 YearsN/AAll800Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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size
PhaseCountries
11JPRN-JapicCTI-18410607/11/20187 October 2019Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) (SURPASS)A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisIntervention name : Secukinumab
INN of the intervention : Secukinumab
Dosage And administration of the intervention : Secukinumab 150mg or 300mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Control intervention name : GP2017 (adalimumab biosimilar)
INN of the control intervention : Adalimumab
Dosage And administration of the control intervention : GP2017 (adalimumab biosimilar) 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 102
Novartis Pharma K.K.Not Recruiting18BOTH15Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
12EUCTR2017-004226-15-DK26/10/201826 November 2018Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied.CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-ArtRheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)
MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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] - Musculoskeletal Diseases [C05]
Product Name: Cannabidiol tablet 10 mg
Pharmaceutical Form: Tablet
CAS Number: 13956-29-1
Other descriptive name: CANNABIDIOL
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Dronabinol capsule 2.5. mg
Pharmaceutical Form: Capsule
INN or Proposed INN: DRONABINOL
CAS Number: 1972-08-3
King Christian 10th Hospital for RheumatologyAuthorisedFemale: yes
Male: yes
180Phase 2Denmark
13EUCTR2018-001060-35-ES19/09/20181 October 2018A long-term extension study to investigate the safety and effectiveness of Tildrakizumab in patients with Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis who have previously completed other studies with TildrakizumabA Multiple-Dose, Long-Term Extension Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects with Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis who have previously completed studies with TildrakizumabPsoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tildrakizumab 100 mg/ml
Product Code: MK-3222
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tildrakizumab
CAS Number: 1326244-10-3
Current Sponsor code: MK-3222
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Sun Pharma Global FZEAuthorisedFemale: yes
Male: yes
540Phase 3United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine;Russian Federation
14EUCTR2018-001060-35-HU29/08/20183 September 2018A long-term extension study to investigate the safety and effectiveness of Tildrakizumab in patients with Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis who have previously completed other studies with TildrakizumabA Multiple-Dose, Long-Term Extension Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects with Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis who have previously completed studies with TildrakizumabPsoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tildrakizumab 100 mg/ml
Product Code: MK-3222
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tildrakizumab
CAS Number: 1326244-10-3
Current Sponsor code: MK-3222
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Sun Pharma Global FZEAuthorisedFemale: yes
Male: yes
540Phase 3Russian Federation;United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine
15NCT03636984August 24, 201827 August 2018Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real WorldEfficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational StudyRheumatoid Arthritis;Ankylosing SpondylitisDrug: recombinant TNF-a receptor: IgG Fc fusion proteinZhejiang Hisun Pharmaceutical Co. Ltd.Not recruiting18 YearsN/AAll1000Phase 2/Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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sponsor
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agemin
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agemax
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size
PhaseCountries
16NCT03552276July 11, 201813 May 2019A Long Term Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis.A Multiple-Dose, Long-Term Extension Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Who Have Previously Completed Studies With Tildrakizumab.Psoriatic Arthritis;Ankylosing Spondylitis;Non-Radiographic Axial SpondyloarthritisDrug: tildrakizumab 200 mg (two 1-mL injections of 100 mg/mL);Drug: tildrakizumab 100 mg (one 1-mL injection of 100 mg/mL + 1 mL placebo)Sun Pharma Global FZENot recruiting18 YearsN/AAll540Phase 2/Phase 3United States;Argentina;Hungary;Mexico;Poland;Russian Federation;Spain;Ukraine
17EUCTR2018-000226-58-ES04/07/201828 February 2019A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)Ankylosing spondylitis (AS)
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tofacitinib
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Other descriptive name: TOFACITINIB CITRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Pfizer Inc., 235 East 42nd Street, New York, NY 10017Not Recruiting Female: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
18NCT03502616June 7, 20184 November 2019Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)Ankylosing SpondylitisDrug: TofacitinibPfizerNot recruiting18 YearsN/AAll270Phase 3United States;Australia;Bulgaria;Canada;China;Czechia;France;Hungary;Israel;Korea, Republic of;Poland;Russian Federation;Turkey;Ukraine;Slovakia;Spain;Taiwan
19ChiCTR-INR-170135742018-06-0111 December 2017Clinical Study on Treating Ankylosing Spondylitis with Chinese Herbal Decoction Zhitongzhu DecoctionClinical Study on Treating Ankylosing Spondylitis with Chinese Herbal Decoction Zhitongzhu DecoctionAnkylosing spondylitiscontrol group :Leflunomide; Intervention group :Chinese herbalshentongzhuyudecoction;The First Affiliated Hospital of Heilongjiang Chinese Medicine ColledgeNot Recruiting1625Malecontrol group :40; Intervention group :40;New Treatment Measure Clinical StudyChina
20EUCTR2017-004850-40-NL25/04/20185 June 2018Detection and monitoring of effects of biological therapy on bone formation in patients with Bechterew's disease or psoriatic arthritis with the use of a Positron Emission Tomography (PET) scan.[18F]Fluoride PET-CT imaging for detection and monitoring of bone formation in spondyloarthritis - [18F]Fluoride PET in SpASpondyloarthritis (ankylosing spondylitis and psoriatic arthritis);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: [18F]Fluoride
Pharmaceutical Form: Solution for injection
VU Medical Center, department of RheumatologyAuthorisedFemale: yes
Male: yes
48Phase 4Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03350815March 13, 201829 July 2019Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Parallel-group, Multicenter Study of Secukinumab to Compare 300 mg and 150 mg at Week 52 in Patients With Ankylosing Spondylitis Who Are Randomized to Dose Escalation After Not Achieving Inactive Disease During an Initial 16 Weeks of Open-label Treatment With Secukinumab 150 mg (ASLeap)Ankylosing SpondylitisDrug: 150 mg open-label secukinumab;Drug: 150 mg double-blinded secukinumab;Drug: 300 mg double-blinded secukinumabNovartis PharmaceuticalsRecruiting18 YearsN/AAll270Phase 4United States
22NCT03470688March 1, 201811 June 2018Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF AgentsAn Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian RheumatologyRheumatoid Arthritis;Psoriatic Arthritis;Ankylosing SpondylitisBiological: Originator;Biological: BiosimilarOpal Rheumatology Ltd.Merck Sharp & Dohme Corp.Recruiting18 YearsN/AAll5000Phase 4Australia
23NCT03473665March 1, 201811 June 2018Non-Steroidal Anti-inflammatory Drugs in Axial SpondyloarthritisNon-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot StudyAnkylosing Spondylitis;Axial SpondyloarthritisDrug: Indomethacin;Drug: Diclofenac;Drug: Meloxicam;Drug: CelecoxibColumbia UniversityRecruiting18 YearsN/AAll30Phase 4United States
24NCT03447704February 8, 20183 June 2019International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing SpondylitisAn International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisOther: placebo;Drug: BCD-085BiocadNot recruiting18 Years65 YearsAll228Phase 3Russian Federation
25EUCTR2017-000679-10-FR22/01/201828 February 2019Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASSAnkylosing 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] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: adalimumab
Product Code: GP2017
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: GP2017
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Novartis Pharma AGAuthorised Female: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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size
PhaseCountries
26EUCTR2017-001002-15-DE22/01/201818 June 2018A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitisAnkylosing 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: bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BIMEKIZUMAB
CAS Number: 1418205-77-2
Current Sponsor code: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
UCB BIOPHARMA SPRLAuthorisedFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Russian Federation;Bulgaria;Germany
27EUCTR2017-004037-93-DK17/01/201830 April 2019TReat-to-tArget (T2T) with seCukinumab in axial spondyloarthritis. IdEntification of MRI and biochemical biomarkers for disease activity, treatment response and structural damage progression (the TRACE study)TReat-to-tArget (T2T) with seCukinumab in axial spondyloarthritis. IdEntification of MRI and biochemical biomarkers for disease activity, treatment response and structural damage progression (the TRACE study)Axial spondyloarthritis and ankylosing spondylitis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Cosentyx
Product Name: Cosentyx
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 150-300
Videncenter for Reumatologi og Rygsygdomme, RigshospitaletAuthorised Female: yes
Male: yes
88Phase 4Denmark
28EUCTR2017-000679-10-CZ10/01/201820 August 2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASSAnkylosing 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] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: adalimumab
Product Code: GP2017
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: GP2017
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Novartis Pharma AGAuthorisedFemale: yes
Male: yes
837Phase 3Belgium;Poland;Romania;Germany;Argentina;Canada;Mexico;Czech Republic;United Kingdom;Turkey;Finland;Korea, Republic of;Netherlands;South Africa;Peru;Denmark;Australia;France;Colombia;Israel;Chile;Russian Federation;Spain;Slovakia;Taiwan;Philippines;United States;Portugal
29EUCTR2017-001970-41-DK21/12/201724 September 2018Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trialDose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation)Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis
MedDRA version: 20.0 Level: LLT Classification code 10040107 Term: Seropositive rheumatoid arthritis System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10062719 Term: Seronegative rheumatoid arthritis System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10041672 Term: Spondylitis ankylosing System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10045966 Term: Unspecified inflammatory spondylopathy System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Orencia
Product Name: Abatacept
Product Code: L04AA24
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125 -
Trade Name: Orencia
Product Name: Abatacept
Product Code: L04AA24
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 10 -
Trade Name: Humira
Product Name: Adalimumab
Product Code: L04AB04
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40 -
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: L04AB05
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200 -400
Trade Name: Enbrel
Product Name: Etanercept
Product Code: L04AB01
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 25 -50
Trade Name: Benepali
Product Name: Etanercept
Product Code: L04AB01
Pharmaceutical Form: Concentrate and solvent for suspension for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 25 -50
Trade Name: Simponi
Product Name: Golimumab
Product Code: L04AB06
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
MD, PhD Salome KristensenAuthorisedFemale: yes
Male: yes
180Phase 4Denmark
30EUCTR2017-000679-10-DE18/12/201718 June 2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASSAnkylosing 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] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: adalimumab
Product Code: GP2017
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: GP2017
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Novartis Pharma AGAuthorisedFemale: yes
Male: yes
837Phase 3Belgium;Poland;Romania;Germany;Argentina;Canada;Mexico;Czech Republic;United Kingdom;Turkey;Finland;Korea, Republic of;Netherlands;South Africa;Peru;Denmark;Australia;France;Colombia;Israel;Chile;Russian Federation;Spain;Slovakia;Taiwan;Philippines;United States;Portugal
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2017-000679-10-FI18/12/201729 January 2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASSAnkylosing 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] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: adalimumab
Product Code: GP2017
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: GP2017
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Novartis Pharma AGAuthorisedFemale: yes
Male: yes
837Phase 3Belgium;Poland;Romania;Germany;Argentina;Canada;Mexico;Czech Republic;United Kingdom;Turkey;Finland;Korea, Republic of;Netherlands;South Africa;Peru;Denmark;Australia;France;Colombia;Israel;Chile;Russian Federation;Spain;Slovakia;Taiwan;Philippines;United States;Portugal
32NCT03411798December 15, 20172 September 2019Sequential Application of Yisaipu® and DMARDs in Treating Mild-to-Moderate ASSequential Application of Yisaipu® and Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Treating Mild-to-Moderate Ankylosing Spondylitis: the Mid-term Follow-up ResultAnkylosing SpondylitisDrug: Yisaipu®Nanfang Hospital of Southern Medical UniversityNot recruitingN/AN/AAll76Phase 4China
33NCT03355573November 28, 201715 July 2019A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: BimekizumabUCB Biopharma S.P.R.L.Not recruiting18 YearsN/AAll256Phase 2United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine
34EUCTR2017-000679-10-DK23/11/201711 December 2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASSAnkylosing 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] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: adalimumab
Product Code: GP2017
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: GP2017
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Novartis Pharma AGAuthorisedFemale: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
35EUCTR2017-000679-10-ES23/11/201712 March 2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASSAnkylosing 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] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: adalimumab
Product Code: GP2017
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: GP2017
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Novartis Farmacéutica, S.A.AuthorisedFemale: yes
Male: yes
837Phase 3Belgium;Poland;Romania;Germany;Argentina;Canada;Mexico;Czech Republic;United Kingdom;Turkey;Finland;Korea, Republic of;Netherlands;South Africa;Peru;Denmark;Australia;France;Colombia;Israel;Chile;Russian Federation;Spain;Slovakia;Taiwan;Philippines;United States;Portugal
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT02980705November 6, 201717 June 2019Efficacy and Safety Study of SUNPG1622A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloarthritisActive Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisDrug: SUNPG1622 I dose;Drug: Placebo doseSun Pharma Global FZENot recruiting18 YearsN/AAll180Phase 2United States
37NCT03357471November 3, 201710 September 2018Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseModerate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's DiseaseDrug: e-DeviceUCB Biopharma S.P.R.L.Not recruiting18 YearsN/AAll70Phase 3United States
38NCT03329885November 2, 201720 August 2018A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Patients and Patients With Average to Very Serious PsoriasisA Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe PsoriasisRheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic SteatohepatitisOther: Placebo;Drug: BMS-986251Bristol-Myers SquibbNot recruiting18 Years70 YearsAll38Phase 1/Phase 2Netherlands
39EUCTR2017-001002-15-CZ01/11/201728 February 2019A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitisAnkylosing 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: bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BIMEKIZUMAB
CAS Number: 1418205-77-2
Current Sponsor code: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
UCB Biopharma SPRLAuthorised Female: yes
Male: yes
285Phase 2Hungary;Czech Republic;Spain;Bulgaria;Germany
40NCT03322618November 201716 December 2017Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood SamplesEvaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 (Monoclonal Antibody IPH4102 Targeting KIR3DL2) in Blood Samples Taken From Patients With Axial Spondyloarthritis and Healthy VolunteersAxial Spondyloarthritis (axSpA);Ankylosing Spondylitis (AS)Biological: blood samplesAssistance Publique Hopitaux De MarseilleNot recruiting18 YearsN/AAll36N/AFrance
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2017-001002-15-HU25/10/201730 October 2017A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitisAnkylosing 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: bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BIMEKIZUMAB
CAS Number: 1418205-77-2
Current Sponsor code: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
UCB BIOSCIENCES GmbHAuthorisedFemale: yes
Male: yes
285Phase 2Hungary
42NCT03178487October 24, 201711 November 2019A 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 SpondylitisAnkylosing Spondylitis (AS)Drug: Upadacitinib;Drug: Upadacitinib PlaceboAbbVieNot recruiting18 YearsN/AAll187Phase 2United 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
43NCT03215277October 4, 201728 October 2019A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing SpondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Bimekizumab;Drug: Certolizumab pegol;Other: PlaceboUCB Biopharma S.P.R.L.Not recruiting18 YearsN/AAll76Phase 2United States;Czechia;Germany;Greece;Moldova, Republic of;Netherlands;Poland;Russian Federation;Australia
44NCT03140657April 29, 201727 May 2019The Effects of Nanocurcumin on Treg Cells and Th17 Cells Responses in Ankylosing Spondylitis PatientsThe Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Ankylosing Spondylitis PatientsAnkylosing SpondylitisDrug: Nanocurcumin;Drug: PlaceboTabriz University of Medical SciencesNot recruiting23 Years46 YearsAll24Phase 2Iran, Islamic Republic of
45EUCTR2016-003936-19-HU20/03/201730 April 2019A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisA Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects with Active Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisAnkylosing spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tildrakizumab
Product Code: MK-3222
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tildrakizumab
CAS Number: 1326244-10-3
Current Sponsor code: MK-3222
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
SUN Pharmaceuticals Global FZENot Recruiting Female: yes
Male: yes
180Phase 2United States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03117270March 7, 201720 August 2018A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: filgotinib;Drug: Placebo Oral TabletGalapagos NVNot recruiting18 YearsN/AAll116Phase 2Belgium;Bulgaria;Czechia;Estonia;Poland;Spain;Ukraine
47EUCTR2016-003636-21-EE26/01/201713 February 2017A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitisankylosing spondylitis
MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: GLPG0634
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: GLPG0634
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Galapagos NVAuthorisedFemale: yes
Male: yes
100Phase 2Czech Republic;Estonia;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
48NCT04135508December 13, 20164 November 2019A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and HumiraA Multicenter, Randomized, Double-Blind, Phase III Clinical Trial Parallel Controlled With Humira to Evaluate the Efficacy and Safety of BAT1406 Injection in the Treatment of Ankylosing SpondylitisAnkylosing SpondylitisDrug: BAT1406;Drug: HumiraBio-Thera SolutionsNot recruiting16 Years65 YearsAll554Phase 3
49EUCTR2016-001102-42-HU21/11/201615 October 2018A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITISAnkylosing Spondylitis
MedDRA version: 19.0 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: bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection
INN or Proposed INN: bimekizumab
CAS Number: 1418205-77-2
Current Sponsor code: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
UCB Biopharma SPRLNot RecruitingFemale: yes
Male: yes
285Phase 2United States;Czech Republic;Hungary;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany
50NCT02896127October 18, 201622 October 2019Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes, to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing SpondylitisAnkylosing SpondyloarthritisDrug: Secukinumab;Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 YearsN/AAll458Phase 3China;Czechia;Korea, Republic of;United Kingdom;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2016-002061-54-IT13/10/20167 January 2019Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)Rheumatoid arthritis, seronegative spondylo arthritis, Crohn's Disease, Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: PT Classification code 10075634 Term: Acute haemorrhagic ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019
Pharmaceutical Form: Powder for solution for infusion
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLINot RecruitingFemale: yes
Male: yes
250Phase 4Italy
52NCT02963506October 20169 September 2019A Multicenter Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing SpondylitisA Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisOther: Placebo;Drug: BimekizumabUCB Biopharma S.P.R.L.Not recruiting18 YearsN/AAll303Phase 2United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic
53NCT02893254September 22, 201618 June 2018Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-a (IBI303) Compared to Adalimumab in Patients With Active Ankylosing SpondylitisASDrug: IBI303;Drug: AdalimumabInnovent Biologics (Suzhou) Co. Ltd.Not recruiting18 Years65 YearsAll438Phase 3
54NCT02685904September 6, 201625 March 2019A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing SpondylitisA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing SpondylitisAnkylosing SpondylitisBiological: ENIA11;Biological: PlaceboMycenax Biotech Inc.TSH Biopharm Corporation LimitedNot recruiting20 YearsN/AAll10Phase 3Taiwan
55NCT02758782September 201616 December 2017NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing SpondylitisCOmparison of the Effect of Treatment With NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of StrUctural Damage in the Spine Over Two Years in Patients With ankyLosing Spondylitis: a Randomized Controlled Multicentre TrialAnkylosing SpondylitisBiological: Golimumab;Drug: CelecoxibCharite University, Berlin, GermanyRecruiting18 YearsN/AAll170Phase 4Germany
No.TrialIDDate_
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Last_Refreshed_
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56NCT02763111September 20165 March 2018Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing SpondylitisInternational Multi-center Comparative Randomized Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: BCD-085;Other: PlaceboBiocadNot recruiting18 Years65 YearsAll88Phase 2
57EUCTR2015-005021-39-GB04/08/201612 February 2018Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis.A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis. - MEASURE 5Ankylosing Spondyloarthritis
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] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
454Phase 3Czech Republic;Korea, Democratic People's Republic of;China;United Kingdom
58NCT03932006June 30, 201613 May 2019A Multicenter,Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing SpondylitisA Multicenter,Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing SpondylitisAnkylosing SpondylitisDrug: Fengshigutong Capsule plus Imrecoxib;Drug: Fengshigutong Capsule;Drug: ImrecoxibSun Yat-sen UniversityRecruiting18 Years65 YearsAll180Phase 4China
59NCT02809781June 20164 July 2016A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing SpondylitisPhase III Study of Human Bone Marrow-Derived Mesenchymal Stem Cells to Treat ASSpondylitis;Spondylitis, Ankylosing;Ankylosis;Arthritis;Spondylarthritis;Spondylarthropathies;Spinal Diseases;Musculoskeletal Diseases;Bone DiseasesBiological: Intravenous infusion of MSCs;Drug: EtanerceptSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNanfang Hospital of Southern Medical University;Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting18 Years45 YearsBoth250Phase 2/Phase 3China
60NCT03557853June 20162 July 2018Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With GolimumabA Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab)Ankylosing Spondylitis;CoxitisDrug: Golimumab InjectionMSD Pharmaceuticals LLCNot recruiting18 YearsN/AAll39N/ARussian Federation
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
61NCT02763046May 31, 20164 November 2019A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the NSAID-sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis (ASTRUM)Ankylosing SpondylitisBiological: AIN457/Secukinumab;Drug: AIN457/Secukinumab Placebo; Biological: AIN457/SecukinumabNovartis PharmaceuticalsNot recruiting18 YearsN/AAll211Phase 4Germany
62NCT02538341May 201615 April 2019Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's DiseaseBiological: Herpes Zoster Vaccine;Drug: PlaceboUniversity of Alabama at BirminghamOregon Health and Science UniversityNot recruiting50 YearsN/AAll617Phase 2United States
63NCT02750592March 22, 201620 May 2019Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing SpondylitisAn Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: secukinumab 150mgNovartis PharmaceuticalsNot recruiting18 YearsN/AAll30Phase 3Japan
64EUCTR2015-004575-74-DE16/03/201630 April 2019Clinical study to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab in patients with ankylosing spondylitisA randomized, double-blind, placebo-controlled multicenter study of Secukinumab (AIN457) to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab over 16 weeks in patients with ankylosing spondylitis (ASTRUM) - ASTRUMAnkylosing 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] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Novartis Pharma GmbHAuthorised Female: yes
Male: yes
190Phase 4Germany
65JPRN-JapicCTI-16324101/3/20162 April 2019An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing SpondylitisAn Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisIntervention name : AIN457
Dosage And administration of the intervention : secukinumab 150mg : Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.
Control intervention name : null
Novartis Pharma K.K.18BOTH30Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
66NCT02638896January 20164 January 2016Dose Reduction of Etanercept in Patients With Ankylosing SpondylitisEfficacy and Safety of Etanercept Dose Reduction in Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanercept (Half-Dose);Drug: etanercept (Full-Dose);Drug: Sulfasalazine;Drug: CelecoxibZhixiang HuangNot recruiting18 Years45 YearsBoth100Phase 4
67NCT02762812January 20165 March 2018Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing SpondylitisInternational Multi-center Comparative Double-blind Randomized Clinical Trial to Evaluate Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Patients With Ankylosing SpondylitisAnkylosing SpondylitisBiological: BCD-055;Biological: Remicade®BiocadNot recruiting18 Years65 YearsAll199Phase 3Russian Federation
68EUCTR2015-001894-41-CZ20/11/201528 February 2019Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without x-ray evidence of ASPHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION.ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: CIMZIA certolizumab pegol 200 mg/ml solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
UCB BIOSCIENCES GmbHAuthorised Female: yes
Male: yes
300Phase 3United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Australia;Russian Federation;Bulgaria
69NCT02809300November 20154 July 2016Ankylosing Spondylitis and Antiphospholipid AntibodiesPrevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 PatientsAnkylosing SpondylarthritisBiological: blood collectionCHU de ReimsRecruiting18 YearsN/ABoth80N/AFrance
70NCT02469753October 23, 201518 December 2018Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic OutcomesInterest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic OutcomesAnkylosing SpondylitisDrug: NSAIDs;Drug: anti-TNFUniversity Hospital, BordeauxRecruiting18 YearsN/AAll225Phase 3France;Monaco
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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size
PhaseCountries
71EUCTR2015-001894-41-HU16/10/201528 February 2019Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without X-ray evidence of ASPHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION.ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: CIMZIA certolizumab pegol 200 mg/ml solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
UCB BIOSCIENCES GmbHAuthorised Female: yes
Male: yes
300Phase 3United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Australia;Russian Federation;Bulgaria
72EUCTR2015-002284-42-FI18/09/201528 September 2015The rationale for this study is to gain insight in the extent and impact of immunogenicity of TNF inhibitors in the European daily clinical practice. Furthermore, an European wide database will give insight in factors influencing immunogenicity and treatment outcome in terms of disease activitINTENT: immunogenicity in patients failing response on anti-TNF -Immunogenicity and pharmacokinetics in patients failing to respond to TNF inhibitors (phase 1); -Clinical effectiveness of subsequent TNF inhibitor treatment and predictive value of pharmacokinetics and immunogenicity (phase 2) - INTENTrheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specifyTrade Name: Enbrel
Product Name: etanercept
Pharmaceutical Form: Injection
Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Injection
Trade Name: Cimzia
Product Name: certolizumab pegol
Pharmaceutical Form: Injection
Trade Name: Simponi
Product Name: golimumab
Pharmaceutical Form: Injection
Trade Name: Remicade
Product Name: infliximab
Pharmaceutical Form: Infusion
READEAuthorisedFemale: yes
Male: yes
1650Phase 1Finland
73NCT02605642September 10, 201518 March 2019Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From RemicadePERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: CT-P13PfizerHospira, now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/AAll351Phase 3Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy
74NCT02505542July 201529 July 2019Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to PlaceboA Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to PlaceboAxial Spondyloarthrithis;Ankylosing SpondylitisBiological: Certolizumab Pegol;Other: PlaceboUCB BIOSCIENCES GmbHParexelNot recruiting18 Years45 YearsAll736Phase 3United States;Belgium;Bulgaria;Czechia;France;Germany;Hungary;Netherlands;Poland;Romania;Spain;Taiwan;Turkey;United Kingdom;Czech Republic
75NCT03800797May 25, 201521 January 2019Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing SpondylitisEfficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label StudyAnkylosing SpondylitisDrug: Loxoprofen sodium hydrogel patch;Drug: Loxoprofen sodium tabletSun Yat-sen UniversityNot recruiting18 Years65 YearsAll70Phase 4China
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
76NCT02159053May 18, 20151 October 201816-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: Secukinumab;Biological: PlaceboNovartis PharmaceuticalsNot recruiting18 YearsN/AAll350Phase 3United States;Australia;Austria;Bulgaria;Canada;Czechia;Denmark;Finland;Germany;Greece;Italy;Netherlands;Norway;Poland;Russian Federation;Slovakia;Spain;Switzerland;United Kingdom;Czech Republic;Mexico
77NCT02492217May 201516 December 2017Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) a Agent's Efficacy in Ankylosing Spondylitis PatientsBiomarkers Identification of Anti-TNF a Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass SpectrometryAnkylosing SpondylitisDrug: AdalimumabUniversidade Nova de LisboaRecruiting18 Years75 YearsAll70Phase 4Portugal
78NCT02293681April 10, 201516 December 2017An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip InvolvementA Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip InvolvementSpondylitis, AnkylosingDrug: Infliximab;Drug: NSAIDs;Drug: DMARDsJanssen Research & Development, LLCNot recruiting16 Years40 YearsAll76N/AChina
79NCT02359903February 201519 October 2017Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing SpondylitisInternational Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Infliximab (BCD-055);Drug: Infliximab (Remicade)BiocadNot recruiting18 Years65 YearsAll90Phase 1Belarus;Russian Federation
80ChiCTR18000148462014-12-0112 February 2018Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplastyEffect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty: A prospective randomized double-blind controlled trialosteonecrosis of the femoral head, femoral neck fracture, developmental dysplasia of hip, osteoarthritis, rheumatoid arthritis or ankylosing spondylitisExperiment group:preoperative intravenous parecoxib sodium and postoperative intravenous parecoxib sodium and patient-controlled analgesia;Control Group:preoperative intravenous pure 0.9% saline and postoperative intravenous parecoxib sodium and patient-controlled analgesia;Peking Union Medical College HospitalNot RecruitingBothExperiment group:50;Control Group:50;Post-marketChina
No.TrialIDDate_
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PhaseCountries
81NCT02313727December 201419 February 2015Combined Treatment With TNF Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic ProgressionCombined Treatment With TNF (Tumor Necrosis Factor) Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic ProgressionAnkylosing SpondylitisDrug: Pamidronate;Other: Placebo (NaCl 0.9%)Bnai Zion Medical CenterJanssen-Cilag Ltd.Not recruiting18 YearsN/AMale30Phase 4Israel
82NCT02328027December 201411 June 201899mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)A Phase I-IIa Study of Safety, Tolerance, Pharmacokinetics, Dosimetry and Benefice of Early Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 in Patients With Rheumatoid Arthritis or Ankylosing SpondylitisRheumatoid Arthritis;Ankylosing SpondylitisDrug: 99mTc-rhAnnexin V-128Advanced Accelerator ApplicationsNot recruiting18 YearsN/AAll16Phase 1/Phase 2Switzerland
83NCT01934933September 24, 201425 June 2018Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing SpondylitisA Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: celebrex;Drug: Enbrel;Drug: Enbrel plus CelebrexSun Yat-sen UniversityNot recruiting18 Years65 YearsAll150Phase 4China
84EUCTR2013-004406-25-PT19/09/20142 May 2016Biomarkers identification of efficacy in Ankylosing SpondylitisBiomarkers identification of anti-TNF a agent’s efficacy in Ankylosing Spondylitis patients using a transcriptome analysis and mass spectrometryAnkylosing Spondylitis
MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Faculdade de Ciências Médicas da Universidade Nova de LisboaAuthorisedFemale: yes
Male: yes
Portugal
85NCT02186873September 3, 201416 December 2017A Study of Golimumab in Participants With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Placebo;Drug: GolimumabJanssen Research & Development, LLCNot recruiting18 YearsN/AAll208Phase 3United States;Australia;Canada;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Ukraine;Brazil;Romania
No.TrialIDDate_
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PhaseCountries
86NCT02154425September 201411 June 2018A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating MothersA Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid ArthritisProcedure: Breast milk sampling;Biological: Certolizumab PegolUCB BIOSCIENCES, Inc.PPD;ParexelNot recruiting18 YearsN/AFemale17Phase 1United States;Netherlands;Switzerland;France
87NCT02202850August 12, 201416 December 2017Defining Remission With Etanercept in AS in Real Life Clinical PracticeDefining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Ankylosing Spondylitis Patients Treated With Etanercept (Enbrel (Registered))Ankylosing SpondylitisDrug: etanerceptPfizerNot recruiting18 YearsN/AAll76N/ABelgium
88NCT01870284July 201419 February 2015Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Ixekizumab;Drug: Placebo;Drug: AdalimumabEli Lilly and CompanyNot recruiting18 YearsN/ABoth0Phase 3United States;Argentina;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
89EUCTR2013-005013-13-LT08/04/201416 November 2015A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapySubjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: SB5
Other descriptive name: SB5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Humira®
Product Name: Humira®
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: not applicable
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Samsung Bioepis Co., Ltd.Not RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
90EUCTR2013-001090-24-GB26/03/201428 February 201916-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing SpondylitisAnkylosing spondylitis
MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma Services AGNot Recruiting Female: yes
Male: yes
222Phase 3Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
91NCT02047110January 28, 201411 June 2019BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)A 48 Weeks, Phase II, Randomized, Double-blind, Placebo-controlled, Proof of Concept and Dose Finding Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Ankylosing Spondylitis.Ankylosing Spondylitis (AS)Drug: placebo for risankizumab;Drug: risankizumabAbbVieBoehringer IngelheimNot recruiting18 Years70 YearsAll159Phase 2Belgium;Finland;France;Germany;Hong Kong;Italy;Korea, Republic of;Netherlands;Spain;Taiwan;United States
92NCT02008916January 14, 20149 October 201816-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis PatientsA Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Secukinumab;Drug: Placebo secukinumabNovartis PharmaceuticalsNot recruiting18 YearsN/AAll226Phase 3United States;Belgium;Czechia;Germany;Greece;Mexico;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;Norway;Sweden
93EUCTR2013-001090-24-DE08/01/20145 February 201816-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing SpondylitisAnkylosing spondylitis
MedDRA version: 18.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
222Phase 3Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom
94EUCTR2013-002860-19-NL07/01/201427 January 2014Cardiovascular risk in patients with Ankylosing SpondylitisThe risk of cardiovascular disease in Ankylosing Spondylitis; A Single Center Cross-Sectional Study Evaluating The Association Between Inflammation In Ankylosing Spondylitis And Vascular Inflammation - AS riskAnkylosing Spondylitis Atherosclerotic cardiovascular disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Atorvastatin
Product Name: Atorvastatin
Product Code: 5057732
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ATORVASTATIN
CAS Number: 134523-00-5
Other descriptive name: atorvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
AMCAuthorisedFemale: yes
Male: yes
Netherlands
95NCT01988506January 6, 201427 August 2018Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaRecruiting18 YearsN/AAll132Phase 2France
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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gender
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PhaseCountries
96NCT02019602January 201416 December 2017A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the PlacentaA Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid ArthritisProcedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab PegolUCB BIOSCIENCES, Inc.PPD;ParexelNot recruiting18 YearsN/AAll16Phase 1United States;France;Netherlands;Switzerland
97EUCTR2013-003666-13-ES26/12/20138 August 2016BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8Ankylosing Spondylitis
MedDRA version: 16.0 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: BI 655066
Other descriptive name: BI 655066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Boehringer Ingelheim España, S.A.Not RecruitingFemale: yes
Male: yes
212Phase 2United States;France;Taiwan;Hong Kong;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of
98NCT01863732November 6, 201318 December 2018Extension in AS: Sustainability of Benefits, Safety and TolerabilityAn Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: SecukinumabNovartis PharmaceuticalsNot recruiting18 YearsN/AAll274Phase 3United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom
99NCT02538757October 201321 August 2017Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE)Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE)Arthritis;Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease;Inflammatory ArthritisBiological: Herpes Zoster Vaccine;Drug: PlaceboUniversity of Alabama at BirminghamOregon Health and Science UniversityNot recruiting50 YearsN/AAll125Phase 2United States
100EUCTR2011-002325-22-GB26/09/201328 February 2019Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1Spondylitis, Ankylosing
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] - Musculoskeletal Diseases [C05]
Product Name: Ixekizumab
Product Code: LY2439821
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Ixekizumab
CAS Number: 1143503-69-8
Current Sponsor code: LY2439821
Other descriptive name: Monoclonal Antibody (MAb)
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Adalimumab
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Eli Lilly & CompanyNot Recruiting Female: yes
Male: yes
408Phase 3United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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gender
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PhaseCountries
101EUCTR2012-005026-30-HU15/08/20132 September 2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapySubjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 14.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Current Sponsor code: SB4
Other descriptive name: TNFR:Fc
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Enbrel®
Product Name: Enbrel®
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Other descriptive name: TNFR:Fc
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Samsung Bioepis Co., Ltd.AuthorisedFemale: yes
Male: yes
498Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
102NCT02132234June 201319 February 2015Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing SpondylitisEffects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing SpondylitisRheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;HypertensionDrug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: InfliximabJagiellonian UniversityDepartmet of Rheumatology, J Dietl Hospital, Krakow, PolandRecruiting18 YearsN/ABoth100Phase 4Poland
103ChiCTR-TRC-130034492013-04-2518 April 2017A multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing SpondylitisA multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing SpondylitisAnkylosing SpondylitisThalidomide 150mg:Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd, po., to the end;Thalidomide 100mg:Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end;Control group:Placebo po.;The General Hospital of People's Liberation ArmyNot Recruiting1865BothThalidomide 150mg:80;Thalidomide 100mg:80;Control group:40;Phase 2 studyChina
104NCT01786668April 201319 October 2017Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing SpondylitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)Ankylosing SpondylitisDrug: Tofacitinib 2 mg;Drug: Tofacitinib 5 mg;Drug: Tofacitinib 10 mg;Drug: PlaceboPfizerNot recruiting18 YearsN/AAll208Phase 2United States;Canada;Czech Republic;Germany;Hungary;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan
105NCT01895764March 201312 October 2015Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)Ankylosing SpondylitisDrug: Adalimumab;Drug: MethotrexateUniversity Hospital, ToursNot recruiting18 YearsN/ABoth110Phase 4France
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
106NCT01768858February 5, 201311 February 2019Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeAssessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeCrohn´s Disease;Ulcerative Colitis;Plaque Psoriasis;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: AdalimumabAbbVieRaffeiner GmbHNot recruiting18 Years99 YearsAll96Phase 2Austria
107NCT02201043February 20137 December 2015Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing SpondylitisAnkylosing SpondylitisDrug: Thalidomide 150mg;Drug: Thalidomide 100mg;Drug: PlaceboShanghai Pharmaceuticals Holding Co., LtdNot recruiting18 Years65 YearsBoth197Phase 2China
108NCT01965132January 1, 201318 June 2018Korean College of Rheumatology Biologics RegistryKorean College of Rheumatology Biologics RegistryRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: Biologic DMARDSeoul National University HospitalRecruiting18 YearsN/AAll3500Phase 3Korea, Republic of
109NCT01389388January 201325 May 2015Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint DiseaseCholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint DiseasesCarotid Artery Plaque;Ankylosing Spondylitis;Rheumatoid ArthritisDrug: RosuvastatinDiakonhjemmet HospitalNot recruiting35 Years80 YearsBoth114N/ANorway
110NCT01649375October 18, 20124 November 201916 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing SpondylitisAnklyosing SpondylitisDrug: Secukinumab (75 mg);Drug: Placebo;Drug: Secukinumab (150 mg)Novartis PharmaceuticalsNot recruiting18 YearsN/AAll219Phase 3Finland;Germany;Italy;Netherlands;Russian Federation;Singapore;Spain;Switzerland;United Kingdom;Austria;Canada;Czechia;United States;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
111NCT01789151October 20127 November 201699m-Technetium- Glucosamine in Arthritis99mTc-labelled D-Glucosamine in the Evaluation of Disease Activity in Patients With Degenerative and Inflammatory Rheumatic ConditionsRheumatoid Arthritis;Ankylosing SpondylitisDevice: Technetium labelled glucosamineUniversity of SydneyAbbVieNot recruiting18 Years90 YearsBothN/AAustralia
112JPRN-UMIN0000152972012/09/1923 April 2019The feasibility study of accelated infliximab infusion from initial administrationThe feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administrationpatient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.Chiba University HospitalRecruiting20years-old70years-oldMale and Female54Phase 2Japan
113EUCTR2012-000046-35-GB17/09/201220 February 2017Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2Ankylosing spondylitis
MedDRA version: 19.1 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
219Phase 3United States;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands
114EUCTR2011-001555-37-GB04/09/201228 February 2019Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitisAnkylosing spondylitis (AS)
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Celgene CorporationNot Recruiting Female: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
115NCT01694264September 1, 201216 December 2017Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFaA Randomized, Double-blinded, Phase 3, Multicenter, Investigator-initiated Trial for Entecavir for Prophylaxis of Hepatitis B Virus (HBV) Reactivation in HBV Surface Antigen or Anti-HBc Positive Patients Undergoing Anti-TNFa TreatmentChronic Hepatitis B;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Juvenile Idiopathic ArthritisDrug: Entecavir;Drug: PlaceboSeoul National University HospitalKonkuk University Medical Center;Kyungpook National University;Kyunghee University Medical Center;Kyung Hee University Hospital at Gangdong;Gachon University Gil Medical Center;Daegu Catholic University Medical Center;Eulji University Hospital;SMG-SNU Boramae Medical Center;The Catholic University of Korea;Severance Hospital;Ajou University School of Medicine;Ewha Womans University Mokdong Hospital;Inha University Hospital;Chonnam National University Hospital;Chonbuk National University Hospital;Chungnam National University Hospital;Hallym University Medical Center;Hanyang University;Dong-A University;Korea University Guro HospitalNot recruiting16 Years85 YearsAll43Phase 3Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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gender
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size
PhaseCountries
116EUCTR2011-001555-37-SE09/08/201228 February 2019Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitisAnkylosing spondylitis (AS)
MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Celgene CorporationNot Recruiting Female: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
117EUCTR2011-001555-37-SK31/07/201228 February 2019Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitisAnkylosing 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] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Celgene CorporationNot Recruiting Female: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
118EUCTR2011-001555-37-ES23/07/201228 February 2019Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitisAnkylosing 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] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Celgene CorporationNot Recruiting Female: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
119EUCTR2012-002458-21-NL23/07/201214 December 2015Open-label, Phase 4 Study, investigation of the frequency of Extra-Articular exposure in patients with Ankylosing Spondylitis treated with GolimumabOpen-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab - GO-EASYAnkylosing Spondylitis (Bechterew disease)
MedDRA version: 14.1 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Simponi
Pharmaceutical Form: Injection
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
MERCK SHARP & DOHME B.V.Not RecruitingFemale: yes
Male: yes
Phase 4Netherlands
120NCT01790022July 201219 February 2015Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) - a 12-week, Prospective, Open-label, Pilot StudyAnkylosing SpondylitisDrug: MethylprednisoloneSaratov State Medical UniversityCharite University, Berlin, GermanyNot recruiting18 YearsN/ABoth20Phase 2Russian Federation
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2011-001555-37-HU13/06/201228 February 2019Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitisAnkylosing 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] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Celgene CorporationNot RecruitingFemale: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
122EUCTR2011-001555-37-FR06/06/201228 February 2019Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitisAnkylosing 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] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Celgene CorporationNot Recruiting Female: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
123JPRN-UMIN0000078062012/06/012 April 2019The feasibility study of accelated infliximab infusion during maintenance phasepatient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.Chiba University HospitalNot RecruitingNot applicableNot applicableMale and Female54Phase 2Japan
124NCT01610947May 14, 201225 February 2019Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease ActivityEffect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled TrialSpondyloarthritisDrug: Adalimumab, Etanercept, Golimumab or infliximabUniversity Hospital, MontpellierNot recruiting18 YearsN/AAll398N/AFrance
125NCT01583374May 2, 201224 September 2018Study of Apremilast to Treat Subjects With Active Ankylosing SpondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITISAnkylosing SpondyloarthritisDrug: Apremilast tablet 20 mg;Drug: Apremilast tablet 30 mg BID;Drug: PlaceboCelgeneNot recruiting18 YearsN/AAll490Phase 3United States;Australia;Austria;Bulgaria;Canada;Czechia;Estonia;France;Germany;Hungary;Netherlands;Poland;Romania;Russian Federation;Slovakia;Spain;Sweden;United Kingdom;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT03880968March 1, 20121 April 2019Treat-to-Target Strategy With Etanercept for Ankylosing SpondylitisTreat-to-Target Strategy With Etanercept for Ankylosing Spondylitis: a Prospective, Randomized Multicentric Study on Disease Activity Guided Etanercept Tapering or DiscontinuationSpondylitis, AnkylosingDrug: tapering or discontinuation of etanerceptSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityShanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine;First Affiliated Hospital of Wenzhou Medical University;The First Hospital of Jiaxing;Shaoxing Second Hospital;Shanghai Jiao Tong University Affiliated Sixth People’s Hospital;Ningbo Medical Center Lihuili Hospital;Wenzhou Central Hospital;Zhejiang Provincial People’s Hospital;Shaoxing People's HospitalNot recruiting18 Years65 YearsAll311Phase 4
127NCT01571206March 201219 February 2015An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1Ankylosing SpondylitisBiological: InfliximabCelltrionNot recruiting18 Years75 YearsBoth174Phase 1Korea, Republic of
128NCT01709656March 201219 February 2015A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing SpondylitisA Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing SpondylitisAnkylosing SpondylitisBiological: MSC;Drug: celecoxib, Celebrex®Sun Yat-sen UniversityNot recruiting16 Years65 YearsBoth120N/AChina
129NCT01517620November 201119 February 2015Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF TherapyAnkylosing SpondylitisDrug: Total Glucosides Paeony CapsulesSun Yat-sen UniversityNot recruiting16 Years65 YearsBoth38Phase 4China
130NCT01330901October 201119 February 2015Ustekinumab for the Treatment of Patients With Active Ankylosing SpondylitisUsTekinumab for the Treatment Of Patients With Active Ankylosing Spondylitis (TOPAS) - a 28-week, Prospective, Open-label, Proof-of-concept StudyAnkylosing SpondylitisDrug: UstekinumabCharite University, Berlin, GermanyNot recruiting18 YearsN/ABoth22Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT01358175October 201116 December 201716 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Secukinumab (75 mg);Drug: Secukinumab (150 mg);Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 YearsN/AAll371Phase 3United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom
132ChiCTR-TRC-110014172011-06-0118 April 2017clinical study of Mecenchymal Stem Cells transplantation in Ankylosing Spondylitisclinical study of Mecenchymal Stem Cells transplantation in Ankylosing SpondylitisAnkylosing Spondylitis (AS)1:oral salicylazosulfapyridine and indomethacin;2:Mecenchymal Stem Cells(MSC) transplantation ;Sun Yat-sen Memorial Hospital of Sun Yat-sen UniversityRecruitingBoth1:80;2:80;Phase 1+Phase 2China
133NCT01327638February 15, 201119 November 2018Safety of Etoricoxib (MK-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082)Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis PatientsSpondylarthropathies; Spondylitis, AnkylosingDrug: etoricoxib;Drug: Other COX-2 inhibitor;Drug: nsNSAIDsMerck Sharp & Dohme Corp.Not recruiting16 YearsN/AAll21108Phase 2
134NCT01361542February 201119 February 2015Effect Of Anti TNF Alpha Therapy And Their Adverse Effects In Ankylosing Spondylitis In A North Indian PopulationEffect Of Anti TNF Alpha Therapy On Disease Activity And Bone Health, And Their Adverse Effects In Ankylosing Spondylitis In A North Indian PopulationAnkylosing SpondylitisDrug: anti TNF alpha agent;Drug: Anti TNF alpha therapyAll India Institute of Medical Sciences, New DelhiNot recruiting18 Years55 YearsBoth24N/AIndia
135ChiCTR-TRC-110011932011-01-0118 April 2017Tripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trialTripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trialankylosing spondylitisTreatment group: tripterygium wilfordii tablets ;Control group:Placebo;Jiangsu Provincial Hospital of Traditional Chinese MedicineNot Recruiting1860BothTreatment group:66;Control group:22;Post-marketChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT01411215January 201119 October 2017A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient DepartmentA Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology DepartmentRheumatoid Arthritis;Ankylosing SpondylitisDrug: EnbrelPfizerNot recruiting18 YearsN/AAll160N/AChina
137NCT01420432January 201119 February 2015Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Ankylosing Spondylitis (AS)Phase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat ASAnkylosing SpondylitisBiological: Human umbilical cord-derived MSCsShandong UniversityRecruiting18 Years60 YearsBoth10Phase 1China
138NCT01793285December 201019 October 2017An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical TrialRetrospective, Multicentric, National, Observational Study, to Follow-up the Patients Who Participated in the Loadet Study (RELOADET Study)Ankylosing SpondylitisDrug: ETANERCEPTPfizerNot recruiting18 YearsN/AAll85N/ASpain
139EUCTR2009-017443-34-GB01/11/201019 March 2012A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyAnkylosing Spondylitis
MedDRA version: 12.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
F. Hoffmann-La Roche Ltd.AuthorisedFemale: yes
Male: yes
502Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania
140EUCTR2009-017488-40-GB01/11/201016 October 2012A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyAnkylosing Spondylitis
MedDRA version: 12.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
F. Hoffmann-La Roche Ltd.AuthorisedFemale: yes
Male: yes
250United Kingdom;Italy;Germany;Bulgaria;Denmark;Lithuania;Belgium;Spain;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT01212653October 201019 February 2015Effect of Anti-TNF (Alpha) Treatment on Vascular Stiffness in Ankylosing Spondylitis (AS)Effect of Anti-TNF(Alpha)Treatment on Circulating Endothelial Progenitor Cells (EPCs) and Vascular Stiffness in ASAnkylosing Spondylitis(AS)Drug: Simponi;Other: 0.9ml sodium chlorideChinese University of Hong KongNot recruiting18 Years75 YearsBoth50Phase 4China
142NCT01220518October 201019 February 2015Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)Randomized, Double-blind, Parallel-group, Phase 1 StudyAnkylosing SpondylitisDrug: InfliximabCelltrionNot recruiting18 Years75 YearsBoth257Phase 1Korea, Republic of
143NCT01248793October 201019 October 2017Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing SpondylitisA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Placebo;Drug: Golimumab;Drug: Golimumab (placebo group)Centocor, Inc.Not recruiting18 YearsN/AAll213Phase 3China
144EUCTR2009-011591-30-GB21/09/201029 May 2012An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1Ankylosing spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 12.0 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Product Name: AIN457
Product Code: AIN457
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
60Germany;United Kingdom;Netherlands
145NCT01208207September 201016 December 2017A 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 SpondylitisSpondylitis, AnkylosingDrug: 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 mgMerck Sharp & Dohme Corp.Not recruiting18 YearsN/AAll1015Phase 3Argentina;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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2010-020913-10-GB11/08/201019 March 2012An open label, pilot, multi-centre, step-down, randomised controlled trial to examine whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with Ankylosing Spondylitis who have responded to 50mg once weekly - ANSWERSAn open label, pilot, multi-centre, step-down, randomised controlled trial to examine whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with Ankylosing Spondylitis who have responded to 50mg once weekly - ANSWERSAnkylosing spondylitisTrade Name: Enbrel®
Product Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Enbrel
Product Name: Enbrel
Pharmaceutical Form: Solution for injection
Norfolk & Norwich University Hospitals NHS Foundation TrustAuthorisedFemale: yes
Male: yes
United Kingdom
147EUCTR2009-018085-35-DK21/05/20103 October 2016Intestinal inflammation in ankylosing spondylitis assessed by stoll samples and endoscopy and the effects of adalimumab on inflammationIntestinal Inflammation in Ankylosing Spondylitis assessed by Fecal Calprotectin, Capsular Endoscopy and Colonoscopy and the effects of Adalimumab on mucosal healing - INTASAHAnkylosing spondylitis Inflammatory bowel disease
MedDRA version: 14.0 Level: PT Classification code 10061371 Term: Spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0 Level: LLT Classification code 10041672 Term: Spondylitis ankylosing System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0 Level: LLT Classification code 10048398 Term: Spondylitis ankylosing aggravated System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0 Level: LLT Classification code 10041671 Term: Spondylitis ankylopoietica System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0 Level: LLT Classification code 10041673 Term: Spondylitis NOS System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Regionalhospital SilkeborgNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
148EUCTR2010-019263-11-AT19/05/201026 June 2012A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAINA multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAINAnkylosing Spondylitis
MedDRA version: 12.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
sanofi-aventis Recherche & DéveloppementNot RecruitingFemale: yes
Male: yes
270Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
149ChiCTR-ONRC-100008582010-05-1018 April 2017Research on safety tolerance and pharmacokinetics of oral muti-dose ThalidomideResearch on safety tolerance and pharmacokinetics of oral muti-dose ThalidomideAnkylosing SpondylitisGroup A:Muti-dose Thalidomide;GroupB:Muti-dose Thalidomide and Diclofenac sodium enteric-coated tablets ;Chinese PLA General HospitalNot Recruiting1845BothGroup A:15;GroupB:12;Phase 1 studyChina
150ChiCTR-TRC-110012742010-04-0118 April 2017Integrated Traditional Chinese and Western medicine for ankylosing spondylitisintegrated Traditional Chinese and Western medicine for ankylosing spondylitis with Gan-shen deficiency and Moist Heat Arthralgia Spasm Syndrome typeankylosing spondylitis;M45.911B group:Qiangji Granule placebo, Sulfasalazine, Ibuprofen;C group:Qiangji Granule placebo, Sulfasalazine, Ibuprofen;School of Chinese Medicine Southern Medical UniversityNot Recruiting1860BothB group:120;C group:180;Post-marketChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
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size
PhaseCountries
151NCT01060098April 201030 March 2015T Cells and TNF: The Impact of TNF BlockadeT Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha AgentsRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: anti-TNF therapy (etanercept or adalimumab)Imperial College LondonNot recruiting18 Years80 YearsBoth52N/AUnited Kingdom
152NCT01313858April 201019 October 2017A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing SpondylitisArthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, AnkylosingDrug: Simponi®;Drug: MethotrexateMerck Sharp & Dohme Corp.Not recruiting18 YearsN/AAll1613N/AGermany
153EUCTR2009-011719-19-FR29/03/20107 December 2015PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)axial spondyloarthritis (axial SpA)
MedDRA version: 12.1 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies
MedDRA version: 12.1 Level: LLT Classification code 10051265 Term: Spondyloarthropathy
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
Pharmaceutical Form: Solution for injection
INN or Proposed INN: certolizumab pegol
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of CompaniesNot RecruitingFemale: yes
Male: yes
500Phase 3France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom
154EUCTR2009-016587-36-ES15/03/201019 March 2012Artritis de cadera asociada a la EA. Eficacia y Seguridad del tratamiento precoz con Infliximab (Remicade®)Artritis de cadera asociada a la EA. Eficacia y Seguridad del tratamiento precoz con Infliximab (Remicade®)Espondilitis anquilosante
MedDRA version: 12.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Trade Name: REMICADE 100 mg polvo para concentrado para solución para perfusión
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: INFLIXIMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Schering Plough, S.ANot RecruitingFemale: yes
Male: yes
70Spain
155EUCTR2009-016068-35-BE19/02/201018 August 2014A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNA randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNAnkylosing Spondylitis
MedDRA version: 12.0 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Sanofi-aventis Recherche & DéveloppementNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
156EUCTR2009-017309-12-ES18/02/20103 November 2014Evaluación de la respuesta a etoricoxib en pacientes con Espondilitis Anquilosante (EA) e inadecuada respuesta > o = a 2 AINESEvaluación de la respuesta a etoricoxib en pacientes con Espondilitis Anquilosante (EA) e inadecuada respuesta > o = a 2 AINESEspondilitis Anquilosante
MedDRA version: 9 Level: PT Classification code 10002556 Term: Ankylosing spondylitis
Trade Name: ARCOXIA 90 mg comprimidos recubiertos con película
Pharmaceutical Form: Tablet
INN or Proposed INN: ETORICOXIB
Other descriptive name: ETORICOXIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
FUNDACIÓN ESPAÑOLA DE REUMATOLOGÍA (FER)Not RecruitingFemale: yes
Male: yes
Spain
157NCT01114880January 201019 October 2017Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing SpondylitisA Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab;Other: placeboAbbottNot recruiting18 Years65 YearsAll344Phase 3China
158EUCTR2010-019872-65-DE8 December 2014Etoricoxib with naproxen in ankylosing spondylitisA 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 SpondylitisAnkylosing 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ETORICOXIB
CAS Number: 202409-33-4
Current Sponsor code: MK-0663
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ETORICOXIB
CAS Number: 202409-33-4
Current Sponsor code: MK-0663
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Naprosyn
Product Name: Naprosysn
Pharmaceutical Form: Tablet
INN or Proposed INN: NAPROXEN
CAS Number: 22204-53-1
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.Not RecruitingFemale: yes
Male: yes
900Phase 3United 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
159ChiCTR-ONRC-110018462009-12-0318 April 2017The research of immue state and current treatment in Ankylosing spondylitisThe research of immue state and current treatment in Ankylosing spondylitisAnkylosing spondylitisTraditional therapy group:DMARDs;biological agent group:biological agent;thalidomide group:thalidomide;Department of Clinical Immunology, Xijing Hospital, Fourth Military Medical UniversityNot Recruiting1865BothTraditional therapy group:500;biological agent group:500;thalidomide group:500;Pilot study
160EUCTR2009-012424-87-GB26/11/200919 March 2012T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNFT cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNFRheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 12.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis
MedDRA version: 12.0 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Imperial College London South Kensington LondonAuthorisedFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
161EUCTR2009-015515-40-NL20/11/200919 March 2012PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMS INTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVASPREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMS INTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVASThe diagnosis of Ankylosing Spondylitis (AS) requires radiographically proven sacroiliitis.Inflammation on MRI is a prognostic factor for the development of AS. The aim is the decrease of inflammation on MRI of the SI joint and/or spine by giving them, a short period, anti-TNF therapy. The study is designed as a randomized, double-blind, placebo-controlled trial. After inclusion patients are randomly assigned to the etanercept- or placebo-arm of the study in a 1:1 ratio during 16 weeks.Trade Name: Enbrel
Pharmaceutical Form: Powder for injection*
Pharmaceutical form of the placebo: Powder for injection*
Route of administration of the placebo: Subcutaneous use
Wyeth Pharmaceuticals B.V.AuthorisedFemale: yes
Male: yes
80Netherlands
162NCT01006681November 200919 February 2015Vaccination Against Influenza H1N1 in Rheumatic DiseasesEfficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory DrugsInfluenza;Rheumatic DiseasesBiological: Focetria (Monovalent MF59-Adjuvanted vaccine)Tel-Aviv Sourasky Medical CenterNot recruiting18 Years65 YearsBoth400Phase 2
163NCT02456363November 20098 June 2015Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing SpondylitisAnti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis—A Registry ProjectAnkylosing SpondylitisBiological: TNF alpha;Drug: NSAIDs and sulfasalazineChung Shan Medical UniversityRecruiting18 YearsN/ABoth300Phase 2Taiwan
164NCT01104987October 200922 August 2016Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective TrialAnkylosing Spondylitis;OsteoporosisDrug: alendronateGöteborg UniversityNot recruiting18 Years80 YearsBoth16Phase 4Sweden
165NCT01421303October 200919 October 2017Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.Work Productivity In A Cohort Of Employed Ankylosing Spondylitis Patients Treated With EtanerceptAnkylosing SpondylitisDrug: EnbrelPfizerNot recruiting18 YearsN/AAll80Phase 4Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
166NCT00844805September 200916 December 2017Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis TrialAnkylosing Spondylitis;Axial SpondyloarthritisDrug: Infliximab;Drug: Placebo;Drug: NaproxenMerck Sharp & Dohme Corp.Not recruiting18 Years48 YearsAll158Phase 3Austria;Belgium;Denmark;France;Germany;Hungary;Korea, Republic of;Russian Federation;Ukraine;United States
167NCT01077843August 17, 200916 December 2017Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in a Cohort of Patients With Ankylosing Spondylitis (AS) in the UK, France and GermanyAnkylosing SpondylitisDrug: Etoricoxib;Drug: Other Cox-2 inhibitors;Drug: Other Non-selective NSAIDs;Other: No anti-inflammatory treatmentMerck Sharp & Dohme Corp.Not recruitingN/AN/AAll27381N/A
168NCT00944658August 200915 July 2019Spondylitis Trial of Apremilast for Better Rheumatic TherapyRandomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004)in the Treatment of Ankylosing Spondylitis (AS)Ankylosing SpondylitisDrug: Apremilast;Drug: Placebo (sugar pill)Imperial College LondonCelgene CorporationNot recruiting18 YearsN/AAll38Phase 2United Kingdom
169EUCTR2007-003096-39-IT29/07/200919 March 2012Effects of Etanercept on Endothelial Function and Carotid Intima-Media Thickness In Patients With Active Ankylosing Spondylitis: a 52-Weeks, Randomized, Double Blind, Placebo-Controlled Study - CRESTEffects of Etanercept on Endothelial Function and Carotid Intima-Media Thickness In Patients With Active Ankylosing Spondylitis: a 52-Weeks, Randomized, Double Blind, Placebo-Controlled Study - CRESTAnkylosing Spondylitis
MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
WYETH LEDERLENot RecruitingFemale: yes
Male: yes
Italy
170NCT00762463July 200919 October 2017Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing SpondylitisA 6-Week, Randomized, Double-Blind, Parallel-Group Study To Evaluate The Symptomatic Effects And Safety Of Celecoxib 200mg QD Compared To Diclofenac 75mg SR QD In Chinese Patients With Ankylosing Spondylitis, With 6-Week Extension Phase Treatment On Celecoxib 400 Mg QD Or Maintaining Double-Blind Phase TherapyAnkylosing SpondylitisDrug: Celecoxib;Drug: Diclofenac SRPfizerNot recruiting18 Years65 YearsAll240Phase 3China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
171NCT00910273July 200919 October 2017Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis PatientsEffects of Etanercept on Endothelial Function and Carotid Intima-media Thickness (IMT) in Patients With Active ASAnkylosing SpondylitisDrug: etanerceptPfizerLincoln Medical and Mental Health CenterNot recruiting18 YearsN/AAll34Phase 4Italy
172EUCTR2008-006885-27-NL21/04/200926 June 2012EFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITISEFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITISPERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS
MedDRA version: 9.1 Level: LLT Classification code 10051265 Term: Spondyloarthropathy
Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
CAS Number: na
Current Sponsor code: na
Other descriptive name: ADALIMUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Clinical Immunology and RheumatologyNot RecruitingFemale: yes
Male: yes
Netherlands
173NCT01081717April 14, 200915 July 2019Golimumab Safety and Surveillance Program Using the Ingenix NHI DatabaseA Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological TreatmentsRheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing SpondylitisDrug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general populationJanssen Biotech, Inc.Not recruitingN/A99 YearsAll1064N/AUnited States
174EUCTR2008-007510-30-HU09/02/200919 March 2012A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPYA PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPYANKYLOSING SPONDYLITIS
MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Product Name: ARRY-371797
Pharmaceutical Form: Capsule, hard
CAS Number: 765914-60-1
Current Sponsor code: ARRY-371797
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 100-200
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Array BioPharma Inc.Not RecruitingFemale: yes
Male: yes
126Phase 2Hungary;Poland
175EUCTR2008-002631-33-GB14/01/200919 March 2012Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - CAIN457A2209Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - CAIN457A2209Ankylosing Spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Product Name: AIN457
Product Code: AIN457
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Concentration unit: mg/l milligram(s)/litre
Concentration type: up to
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
30Phase 2Germany;United Kingdom;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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176EUCTR2007-007637-39-DE17/12/200819 March 2012Effects of NSAIDs on RAdiographic Damage in AS (ENRADAS) – a prospective randomised controlled trial - Amendment 2 - ENRADASEffects of NSAIDs on RAdiographic Damage in AS (ENRADAS) – a prospective randomised controlled trial - Amendment 2 - ENRADASAnkylosing spondylitis patients (according to mod. New York criteria) who have have active disease at inclusion defined as BASDAI question 2 (related to back pain) >= 4 (VAS, range 0-10) without NSAID treatment and with a clinical indication for NSAID therapy based on signs and symptoms.
MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Trade Name: Voltaren resinat
Product Name: Voltaren resinat
Product Code: not applicable
Pharmaceutical Form: Capsule, hard
Charité - Campus MitteAuthorisedFemale: yes
Male: yes
174Germany
177NCT00811499December 200819 February 2015A Study of ARRY-371797 in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: ARRY-371797, p38 inhibitor; oral;Drug: PlaceboArray BioPharmaNot recruiting18 YearsN/ABoth25Phase 2United States;Canada
178NCT00766402October 200819 February 2015An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet®) vs. Diclofenac (Voltaren®) in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)Spondylitis, Ankylosing;PainDrug: Tramadol /acetaminophen;Drug: DiclofenacJohnson & Johnson Taiwan LtdNot recruiting18 Years70 YearsBoth8Phase 4
179NCT00889694October 200819 February 2015Clinical Study of Tripterygium Capsule to Treat Early Ankylosing SpondylitisClinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical TrialEarly Ankylosing SpondylitisDrug: Tripterygium;Drug: Sulfasalazine;Drug: placeboSun Yat-sen UniversityRecruiting18 Years65 YearsBoth80Phase 2/Phase 3
180NCT02489760July 20081 February 2016Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch StudyEtanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch StudyAnkylosing SpondylitisBiological: Adalimumab;Biological: EtanerceptChung Shan Medical UniversityNot recruiting18 Years70 YearsBoth30Phase 4Taiwan
No.TrialIDDate_
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Last_Refreshed_
on
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size
PhaseCountries
181EUCTR2007-003358-27-DE02/05/200819 March 2012Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira StudyPhase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira StudyJuvenile ankylosing spondylitis
MedDRA version: 10 Level: LLT Classification code 10002556 Term:
Trade Name: Humira®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Center of Pediatrics and Neonatology, Asklepios Clinic Sankt AugustinNot RecruitingFemale: yes
Male: yes
Phase 3Germany
182NCT01188655May 200819 October 2017Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing SpondylitisObservational Non-Interventional Study With Enbrel in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: EnbrelPfizerNot recruiting18 YearsN/AAll89N/A
183JPRN-JapicCTI-08058001/4/20082 April 2019A Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing SpondylitisA Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing SpondylitisAnkylosing SpondylitisIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : Every other week,Subcutaneous, 40mg
Control intervention name : null
Abbott Japan Co., Ltd.Eisai Co., Ltd.15BOTH30Phase 3
184NCT00647517March 200819 February 2015Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing SpondylitisChung Shan Medical University Hospital, TaiwanAnkylosing SpondylitisDrug: UltracetChung Shan Medical UniversityNot recruiting18 Years65 YearsBoth60Phase 4Taiwan
185NCT00667355February 200819 October 2017A Study of Adalimumab in Japanese Subjects With Active Ankylosing SpondylitisA Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumabAbbottEisai Co., Ltd.Not recruiting15 YearsN/AAll41Phase 3Japan
No.TrialIDDate_
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186NCT01072058February 200819 February 2015Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF BlockerProspective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF BlockerArthritis, Rheumatoid;Spondylitis, AnkylosingDrug: TNF blockers (infliximab, adalimumab, etanercept)University of Sao PauloNot recruiting18 Years70 YearsBoth100Phase 4Brazil
187NCT00558506January 200819 February 2015Pilot Open Label Clinical Trial With Abatacept in Ankylosing SpondylitisPilot Open Label Clinical Trial With Abatacept in Ankylosing SpondylitisAnkylosing SpondylitisDrug: abataceptCharite University, Berlin, GermanyBristol-Myers SquibbRecruiting18 Years65 YearsBoth30Phase 2Germany
188NCT00936143January 20081 February 2016Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing SpondylitisAn Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing SpondylitisSpondylitisDrug: infliximabGu JieruoNot recruiting16 Years65 YearsBoth70Phase 4China
189NCT00953979January 200819 February 2015Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing SpondylitisA Clinical Trial About the Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis: a 12-week, Multi-center, Randomized, Double-blind, Active Drug and Placebo Compared Clinical TrialAnkylosing Spondylitis;TreatmentDrug: kunxian capsuleGu JieruoChina-Japan Friendship Hospital;Dongguan People's Hospital;Zhanjiang People's Hospital;Huashan HospitalNot recruiting18 Years65 YearsBoth126Phase 4China
190NCT00576706December 200719 February 2015PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal ToxicityA Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal ComplicationsRheumatoid Arthritis;Osteoarthritis;Ankylosing SpondylitisDrug: Rebamipide;Drug: MisoprostolKorea Otsuka Pharmaceutical Co.,Ltd.Not recruiting19 YearsN/ABoth396Phase 3Korea, Republic of
No.TrialIDDate_
enrollement
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191EUCTR2007-000087-25-GB22/10/200719 March 2012An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07Ankylosing Spondylitis
MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Trade Name: Aclasta
Pharmaceutical Form: Intravenous infusion
Cambridge University Hospitals NHS Foundation TrustNot RecruitingFemale: yes
Male: yes
United Kingdom
192EUCTR2007-002967-28-DE19/10/200719 March 2012Pilot open label clinical trial with Abatacept in Ankylosing Spondylitis - ABATACEPT-AS-01Pilot open label clinical trial with Abatacept in Ankylosing Spondylitis - ABATACEPT-AS-01T cell responses have been demonstrated against proteoglycan (an important cartilage protein) in human arthritides including ankylosing spondylitis. We suggest that a chronic, probably T cell mediated, immune response against cartilage is relevant in the pathogenesis of AS. Based on the above described findings about the role of T-cells in ankylosing spondylitis we assume that Abatacept has the potential to be an effective drug for treating ankylosing spondylitis.Trade Name: not applicable
Product Name: Orencia
Product Code: BMS-188667
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Abatacept
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Other descriptive name: CTLA4Ig
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Charité University MedicineNot RecruitingFemale: yes
Male: yes
30Germany
193NCT00507403October 200716 December 2017Infliximab and Methotrexate in Ankylosing SpondylitisEffect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing SpondylitisAnkylosing SpondylitisDrug: infliximabUniversity Hospital, ToursInstitut National de la Santé Et de la Recherche Médicale, FranceNot recruiting18 Years65 YearsAll30Phase 4France
194NCT00544557October 200719 October 2017Study Evaluating The Use Of Etanercept In Patients With Ankylosing SpondylitisObservational Study Of The Use Of Enbrel (Registered) (Etanercept) In Routine Clinical Practice To Treat Ankylosing Spondylitis (as) Patients: An Effectiveness, Safety, And Health Economic EvaluationAnkylosing SpondylitisDrug: EtanerceptPfizerNot recruiting18 YearsN/AAll1715Phase 4Germany
195ChiCTR-TRC-130045642007-07-0118 April 2017A 48 Week Randomized Controlled Trial to Evaluate the Clinical Outcomes of Ankylosing Spondylitis Managed by Chinese Medicine Compared with Western Medicine, a pilot study.A 48 Week Randomized Controlled Trial to Evaluate the Clinical Outcomes of Ankylosing Spondylitis Managed by Chinese Medicine Compared with Western Medicine, a pilot study.Ankylosing SpondylitisCM:Decoction of Chinese herbs + Moxibustion on 'Governor Vessel (GV)' + standard AS exercise regimen;WM treatment group:Celecoxib 200mg twice daily + standard AS exercise regimen;Guangdong Provincial Hospital of Chinese MedicineNot Recruiting1860BothCM:15;WM treatment group:15;Phase 1 studyChina
No.TrialIDDate_
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196NCT02915354July 200728 November 2016Relapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Following-up StudyRelapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Three Years' Following-up StudySpondylitis, Ankylosing;RecurrenceDrug: EtanerceptSun Yat-sen UniversityNot recruiting18 YearsN/ABoth35Phase 4China
197NCT00724529June 200719 February 2015Post Marketing Surveillance of RemicadePost Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD)Crohn's Disease;Ankylosing SpondylitisBiological: InfliximabJanssen Korea, Ltd., KoreaNot recruitingN/AN/ABoth938Phase 4Korea, Republic of
198NCT00760669May 200719 October 2017An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis ParticipantsPost Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis PatientsSpondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, PsoriaticDrug: Infliximab; observational study;Drug: MethotrexateJanssen Korea, Ltd., KoreaNot recruitingN/AN/AAll1061Phase 4Korea, Republic of
199EUCTR2006-005157-29-FR27/04/200719 March 2012EFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE - SPAXIMEFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE - SPAXIMLes patients seront traités par infliximab, avec ou sans méthotrexate associé, selon la pratique habituelle en accord avec le libellé de l’A.M.M. Seuls le nombre de prélèvements sanguins et de visites diffèreront des modalités thérapeutiques habituelles.
MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
MedDRA version: 9.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders
Trade Name: Méthotrexate Bellon Comprimé
Pharmaceutical Form: Cachet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: REMICADE
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277313
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 5-
CHRU-TOURSAuthorisedFemale: yes
Male: yes
France
200EUCTR2006-002748-27-NL13/04/200719 March 2012A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisActive, severe and advanced axial ankylosing spondylitis
MedDRA version: 8.1 Level: LLT Classification code 10048811 Term: Bechterew's disease
Trade Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Current Sponsor code: 0881
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Wyeth Pharmaceuticals FranceNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
No.TrialIDDate_
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201EUCTR2006-001579-40-FR02/04/200712 June 2012Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpAStudy of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpASpondyloarthropathies
MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Trade Name: Remicade
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: infliximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Schering-Plough FranceAuthorisedFemale: yes
Male: yes
100Hungary;Denmark;France;Spain
202NCT00432653March 200719 February 2015Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing SpondylitisOpen Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing SpondylitisAnkylosing SpondylitisDrug: rituximabCharite University, Berlin, GermanyHoffmann-La RocheNot recruiting18 Years65 YearsBoth20Phase 2/Phase 3Germany
203NCT00434044February 200719 February 2015Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing SpondylitisMulticenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/ABoth150Phase 3
204NCT00420238January 200719 October 2017Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing SpondylitisAnkylosing SpondylitisDrug: Etanercept (Enbrel);Other: PlaceboWyeth is now a wholly owned subsidiary of PfizerNot recruiting18 Years70 YearsAll82Phase 4France;Germany;Hungary;Netherlands
205EUCTR2006-002306-64-DE28/12/200627 January 2014Open label clinical trial with Rituximab (MabThera ®) in Ankylosing Spondylitis - Extension of open label trial: Re-Treatment of patients who have shown response to first course of Rituximab - Ritux-AS-01Open label clinical trial with Rituximab (MabThera ®) in Ankylosing Spondylitis - Extension of open label trial: Re-Treatment of patients who have shown response to first course of Rituximab - Ritux-AS-01Moderate to severe ankylosing spondylitis who have had an inadequate response to or do not tolerate conventional therapy including NSAIDs, DMARDs and TNF alpha inhibitorsTrade Name: Rituximab/ Mabthera
Product Name: MabThera
Product Code: Ro45-2294
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: rituximab
CAS Number: 174722-31
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Charité UniversitaetsmedizinNot RecruitingFemale: yes
Male: yes
Germany
No.TrialIDDate_
enrollement
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206NCT00410046December 200619 October 2017Extension Study Evaluating Etanercept in Ankylosing SpondylitisAn Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/AAll84Phase 4Denmark;Finland;Sweden;United Kingdom
207NCT00873730December 200619 October 2017Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in SpainA 12-week Randomized, Double-blind, Multicenter Pilot Study to Evaluate the Effect of Etanercept 100 mg and 50 mg Weekly in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanercept;Drug: etanercept/placeboWyeth is now a wholly owned subsidiary of PfizerNot recruiting18 Years70 YearsAll108Phase 4
208EUCTR2006-002349-35-ES30/09/200619 March 2012Estudio piloto randomizado, doble ciego, multicéntrico a 12 semanas para evaluar el efecto de etanercept 100mg y 50mg semanales en sujetos con espondilitis anquilosante. A 12-week randomized, double-blind, multicenter pilot study to evaluate the effect of etanercept 100 mg and 50 mg weekly in subjects with ankylosing spondylitis. - LOADETEstudio piloto randomizado, doble ciego, multicéntrico a 12 semanas para evaluar el efecto de etanercept 100mg y 50mg semanales en sujetos con espondilitis anquilosante. A 12-week randomized, double-blind, multicenter pilot study to evaluate the effect of etanercept 100 mg and 50 mg weekly in subjects with ankylosing spondylitis. - LOADETEspondilitis anquilosante Ankylosing spondylitisTrade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: etanercept
Current Sponsor code: 0881
Other descriptive name: TNR-001, TNFR:FC
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Wyeth Farma S.A.AuthorisedFemale: yes
Male: yes
Spain
209NCT00367211September 200619 February 2015Study 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 SpondylitisDrug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole)POZENNot recruiting18 YearsN/ABoth400Phase 3United States
210NCT00458185August 200619 February 2015Study Evaluating Etanercept in Patients With Ankylosing SpondylitisMulticentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanerceptWyeth is now a wholly owned subsidiary of PfizerNot recruiting18 Years70 YearsBoth40Phase 4
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211EUCTR2006-001061-42-GB31/07/200619 March 2012An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS)An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS)Ankylosing spondylitis (AS).Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Etanercept
Current Sponsor code: 0881
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 50-
Wyeth Pharmaceuticals France, Wyeth Research DivisionAuthorisedFemale: yes
Male: yes
108Finland;United Kingdom;Denmark;Sweden
212EUCTR2005-005358-27-GB12/07/200619 March 2012Efficacy of Rituximab (Mabthera) in active ankylosing spondylitis: a clinical and magnetic resonance imaging study - Rituximab in ASEfficacy of Rituximab (Mabthera) in active ankylosing spondylitis: a clinical and magnetic resonance imaging study - Rituximab in ASAnkylosing spondylitis (AS) is an inflammatory condition primarily affecting the spine. The disease may remain symptomatic and progressive life-long. It is part of the family of spondyloarthropathies which also comprises psoriatic arthritis, reactive arthritis and enteropathic arthritis.Trade Name: MabThera 500
Pharmaceutical Form: Concentrate for solution for infusion
University Hospital of North StaffordshireAuthorisedFemale: yes
Male: yes
10United Kingdom
213NCT01685424June 30, 200616 December 2017Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated AnalysisOsteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Gout;ArthritisDrug: EtoricoxibMerck Sharp & Dohme Corp.Not recruitingN/AN/AAll79189N/AUnited States
214EUCTR2004-003299-12-FI26/04/20061 May 2012A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAAnkylosing Spondylitis (AS)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 and-100
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 and-100
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Janssen Biologics B.V.Not RecruitingFemale: yes
Male: yes
345Finland;United Kingdom;Germany;Belgium
215NCT00478660February 200619 February 2015An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)Ankylosing SpondylitisDrug: adalimumab (Humira)AbbottNot recruiting18 YearsN/ABoth1250Phase 3Austria;Belgium;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
No.TrialIDDate_
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216EUCTR2005-004826-21-FI20/01/200622 July 2013Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYActive Ankylosing SpondylitisProduct Name: Humira
Pharmaceutical Form: Injection*
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Abbott GmbH & Co. KGNot RecruitingFemale: yes
Male: yes
1200Greece;Finland;Belgium;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
217NCT02922192January 200617 October 2016Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive AnalysisIncidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive AnalysisRheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing SpondylitisDrug: TNF-a antagonists, non-TNFs, DMARD non-biologicsBiologics & Biosimilars Collective Intelligence ConsortiumHealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMC;HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMCNot recruiting18 YearsN/ABoth100000N/A
218NCT00237419December 200519 February 2015Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing SpondylitisAn Open Label Extension, Investigator Initiated Trial to Examine Radiographic Progression , Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis. EASIC (European Ankylosing Spondylitis Infliximab Cohort)Ankylosing SpondylitisDrug: infliximabRheumazentrum RuhrgebietCentocor BV;Trial Coordination Center, 9713 GZ Groningen;PPDRecruiting18 YearsN/ABoth149N/ABelgium;Finland;France;Germany;Netherlands;United Kingdom
219NCT00247962December 200519 October 2017Study Evaluating Etanercept and Sulphasalazine in Ankylosing SpondylitisA Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanercept;Drug: sulphasalazine (SSZ)Wyeth is now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/AAll566Phase 4Australia;Austria;China;Czech Republic;Denmark;Finland;France;Germany;Hungary;Ireland;Italy;Netherlands;Poland;Qatar;Saudi Arabia;Spain;Sweden;United Kingdom;Greece;Portugal;Switzerland
220NCT00265083December 200519 October 2017A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: golimumab;Biological: Golimumab (CNTO 148); placeboCentocor, Inc.Schering-PloughNot recruiting18 YearsN/AAll356Phase 3United States;Belgium;Canada;Finland;France;Germany;Korea, Republic of;Netherlands;Taiwan;United Kingdom
No.TrialIDDate_
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221EUCTR2005-001549-41-HU25/11/200518 April 2012A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDSubjects with Ankylosing Spondylitis (AS)Trade Name: Enbrel (etanercept)
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Etanercept
Current Sponsor code: 0881
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 50-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Salazopyrin En-Tabs
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
Pharmaceutical Form: Coated tablet
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Wyeth Research Division of Wyeth Pharmaceuticals IncAuthorisedFemale: yes
Male: yes
525Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
222EUCTR2005-002460-29-DE12/09/200518 April 2012An Open Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC (European Ankylosing Spondylitis Infliximab Cohort) - EASICAn Open Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC (European Ankylosing Spondylitis Infliximab Cohort) - EASICAnkylosing spondylitis (AS)Product Name: Remicade
Product Code: cA2
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Infliximab
Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain)
Concentration unit: mg milligram(s)
Concentration number: 100-
Rheumazentrum Ruhrgebiet.Not RecruitingFemale: yes
Male: yes
130Finland;United Kingdom;Germany;Belgium
223NCT00778869August 200519 October 2017Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED)Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment Compared to Healthy ControlsSpondylitis, AnkylosingBiological: RemicadeMerck Sharp & Dohme Corp.Not recruiting18 Years70 YearsAll10Phase 4
224NCT00195416June 200519 February 2015Study Investigating Enbrel Treatment for Ankylosing SpondylitisA Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/ABoth526Phase 4Korea, Republic of
225NCT00202865May 1, 200516 December 2017Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)CANaDian Evaluation of Low DosE Infliximab in Ankylosing SpondylitisSpondylitis, AnkylosingBiological: infliximab;Biological: PlaceboMerck Sharp & Dohme Corp.Not recruiting18 YearsN/AAll76Phase 3Canada
No.TrialIDDate_
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226NCT00235105March 200519 February 2015D2E7-Early ASAdalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension PhaseAnkylosing SpondylitisDrug: Adalimumab 40 mg sc every other weekCharite University, Berlin, GermanyAbbottNot recruiting18 YearsN/ABoth46Phase 2/Phase 3Germany
227NCT00432432February 200519 February 2015Combination Methotrexate and InfliximabThe Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging CorrelationAnkylosing SpondylitisDrug: Infliximab and MTXChinese University of Hong KongNot recruiting18 Years70 YearsBoth38Phase 4
228NCT02840695January 200516 December 2017Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)Ankylosing Spondylitis;Spinal FracturesDrug: bDMARD treatmentUppsala UniversityNot recruiting30 Years60 YearsAll9858N/A
229NCT00779012October 1, 200416 December 2017A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)Post-Registration Open-Label, Non-Comparative, Multicenter Study of Rate of Efficacy and Tolerance of the Use of Anti-TNF Chimeric Monoclonal Antibodies (Remicade) in Treatment of Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: InfliximabMerck Sharp & Dohme Corp.Not recruiting18 Years70 YearsAll42Phase 4
230NCT00779935October 1, 200416 December 2017Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED)Baseline Serum Vascular Endothelial Growth Factor (VEGF) Concentration as Predictive Factor of Response to Infliximab (Remicade) Therapy in Patients With Active Ankylosing Spondylitis Despite Conventional Treatment: a Multicenter Pilot StudySpondylitis, AnkylosingBiological: RemicadeMerck Sharp & Dohme Corp.Not recruiting18 Years70 YearsAll44Phase 4
No.TrialIDDate_
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231NCT00133315September 200419 February 2015TNFalfa Blocking Treatment of SpondylarthropathiesTNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With SpondylarthropathiesSpondylarthropathies;Ankylosing Spondylitis;Psoriatic ArthritisDrug: Infliximab;Drug: Etanercept;Drug: AdalimumabHvidovre University HospitalNot recruiting18 YearsN/ABoth50Phase 4Denmark
232NCT00418548June 200419 February 2015Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing SpondylitisA Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNot recruiting18 Years70 YearsBoth350Phase 3
233NCT00725543June 200419 October 2017Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive InfusionsSpondylitis, AnkylosingBiological: InfliximabMerck Sharp & Dohme Corp.Centocor, Inc.Not recruitingN/AN/AAll358N/A
234NCT01038011June 200416 December 2017Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot StudyAnkylosing SpondylitisDrug: drug treatmentUniversity of ZurichSanofiNot recruiting18 YearsN/AAllPhase 2Switzerland
235NCT00444340April 200419 February 2015An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing SpondylitisAn Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing SpondylitisAnkylosing SpondylitisDrug: Enbrel (Etanercept)Wyeth is now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/ABoth70Phase 4
No.TrialIDDate_
enrollement
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236NCT00224562February 200419 February 2015The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a AntagonistsThe RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a AntagonistsRheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;PsoriasisDrug: TNF-alpha antagonistsAssistance Publique - Hôpitaux de ParisRecruitingN/AN/ABothN/AFrance
237NCT00085644January 200419 October 2017Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisA Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab (D2E7);Biological: placeboAbbottNot recruiting18 YearsN/AAll315Phase 3United States
238NCT00195819December 200319 October 2017Safety and Efficacy of Adalimumab in Patients With Active Ankylosing SpondylitisA Phase 3, Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab (D2E7);Biological: placeboAbbottNot recruiting18 YearsN/AAll82Phase 3Canada;United States
239NCT00243750September 200319 February 2015Methotrexate in Ankylosing Spondylitis (MTX in AS)Open Study for the Evaluation of the Efficacy of Methotrexate 20mg Given Subcutaneously in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: MethotrexateCharite University, Berlin, GermanyNot recruiting18 Years70 YearsBoth20Phase 2Germany
240NCT00818168July 200319 October 2017Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)Remicade Safety Line (Ankylosing Spondylitis)Spondylitis, AnkylosingBiological: InfliximabMerck Sharp & Dohme Corp.Centocor, Inc.Not recruiting18 YearsN/AAll320N/AGermany
No.TrialIDDate_
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241NCT00439283April 200319 February 2015Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing SpondylitisStudy of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on DemandAnkylosing SpondylitisDrug: infliximab;Drug: methotrexateAssociation de Recherche Clinique en RhumatologieNot recruiting18 YearsN/ABoth240Phase 3France
242NCT00648141January 200319 February 2015Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing SpondylitisA 12-Week Symptomatic Effect Evaluation to Compare Celecoxib 200 mg QD, Celecoxib 200 mg BID and Diclofenac 75 mg SR BID in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Celecoxib;Drug: DiclofenacPfizerNot recruiting18 Years75 YearsBoth458Phase 3Germany
243NCT01850121January 200322 August 2016Remicade in the Treatment of Patients With Active Ankylosing SpondylitisRemicade in the Treatment of Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: InfliximabGöteborg UniversityNot recruiting18 Years60 YearsBoth19Phase 2/Phase 3Sweden
244NCT00207701September 200219 February 2015A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug TherapyAnkylosing SpondylitisDrug: infliximabCentocor, Inc.Centocor BV, NetherlandsNot recruiting18 YearsN/ABoth279Phase 3
245NCT02528201September 200231 August 2015A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing SpondylitisA Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Celecoxib 200 milligrams;Drug: Celecoxib 400 milligrams;Drug: diclofenac 50 milligramsPfizerNot recruiting18 Years75 YearsBoth330Phase 4Norway
No.TrialIDDate_
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246NCT00421980June 200219 February 2015An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing SpondylitisAn Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNot recruiting18 Years66 YearsBoth84Phase 3Belgium
247NCT00244166May 200219 February 2015Prednisolone in Active Ankylosing Spondylitis (AS)Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With PrednisoloneAnkylosing SpondylitisDrug: prednisoloneCharite University, Berlin, GermanyRecruiting18 Years70 YearsBoth75Phase 2/Phase 3Germany
248NCT00356356April 200219 February 201516.0040 Ankylosing Spondylitis StudyOpen-label, Long-term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037Ankylosing SpondylitisDrug: EtanerceptAmgenImmunex CorporationNot recruiting18 YearsN/ABoth257Phase 3United States
249NCT00421915March 200219 February 2015Study Evaluating Etanercept Treatment of Patients With Ankylosing SpondylitisMulticenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final DataAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNot recruiting18 Years70 YearsBoth84Phase 3
250NCT01289743February 200219 February 2015Etanercept (Enbrel) in Ankylosing SpondylitisAn Open-label Study of Etanercept (Enbrel) Efficacy in Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptCharite University, Berlin, GermanyRheumazentrum RuhrgebietNot recruiting18 Years65 YearsBoth24Phase 2Germany
No.TrialIDDate_
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251NCT02183168July 200119 February 2015Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing SpondylitisA Randomized, Open Label, 3-arm Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Meloxicam suppository;Drug: Meloxicam tablet;Drug: IndomethacinBoehringer IngelheimNot recruitingN/AN/ABoth192Phase 3
252NCT00000433October 199919 February 2015Blocking Tumor Necrosis Factor in Ankylosing SpondylitisAnti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Anti-Tumor Necrosis FactorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 Years80 YearsBoth42Phase 2United States
253NCT00004288May 199619 February 2015Phase II Pilot Study of Olsalazine for Ankylosing SpondylitisAnkylosing SpondylitisDrug: olsalazineNational Center for Research Resources (NCRR)University of RochesterNot recruiting18 Years65 YearsMale4Phase 2
254JPRN-JapicCTI-07034623 April 2019Clinical study of TA-650 in patients with ankylosing spondylitisClinical study of TA-650 in patients with ankylosing spondylitisAnkylosing spondylitisIntervention name : TA-650 (Infliximab)
Dosage And administration of the intervention : Intravenous drip infusion
Mitsubishi Tanabe Pharma Corporation16BOTHPhase 3

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