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.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04156620 | December 3, 2019 | 11 November 2019 | Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA | A 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 SpondyloArthritis | Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis | Drug: Secukinumab;Drug: Placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 500 | Phase 3 | ||
| 2 | NCT04077957 | October 7, 2019 | 7 October 2019 | Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs | Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study | Ankylosing Spondylitis;Spondyloarthritis | Drug: 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 University | Not recruiting | 18 Years | 50 Years | All | 100 | Phase 4 | China | |
| 3 | NCT04018599 | July 15, 2019 | 30 September 2019 | Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS | A 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 Subjects | Rheumatoid 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 Uveitis | Drug: 40 mg MSB11022 | Fresenius Kabi SwissBioSim GmbH | PRA Health Sciences | Recruiting | 18 Years | 55 Years | All | 216 | Phase 1 | United States |
| 4 | EUCTR2017-003065-95-HU | 16/04/2019 | 30 April 2019 | A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS | Ankylosing spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 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 SPRL | Authorised | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan | |||
| 5 | EUCTR2018-003933-14-EE | 09/04/2019 | 30 April 2019 | A 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 NV | Authorised | Female: no Male: yes | 250 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03639740 | January 15, 2019 | 14 January 2019 | Treat-to-target With Secukinumab in Axial Spondyloarthritis | 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;Ankylosing Spondylitis | Drug: Secukinumab 150 milligram [Cosentyx] | Professor Mikkel Østergaard | Novartis Healthcare A/S | Recruiting | 18 Years | 70 Years | All | 88 | Phase 4 | Denmark |
| 7 | NCT03733925 | January 7, 2019 | 22 October 2019 | A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis | A 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 Arthritis | Spondylitis, Ankylosing;Arthritis, Psoriatic | Drug: Golimumab | Johnson & Johnson Private Limited | Recruiting | 18 Years | N/A | All | 100 | Phase 4 | India | |
| 8 | NCT03839862 | January 1, 2019 | 25 February 2019 | Faecal Analyses in Spondyloarthritis Therapy | Faecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition. | Spondyloarthropathies;Ankylosing Spondylitis | Drug: TNF-inhibition | Region Skane | Recruiting | 18 Years | N/A | All | 50 | N/A | Sweden | |
| 9 | ChiCTR1800019227 | 2018-11-26 | 5 November 2018 | A 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 spondylitis | spondyloarthritis(SpA)/ankylosing spondylitis(AS) | spondyloarthritis(SpA)/ankylosing spondylitis(AS):Iguratimod;Control group:Placebo; | PLA General Hospital | Not Recruiting | 16 | 65 | Both | spondyloarthritis(SpA)/ankylosing spondylitis(AS):72;Control group:36; | Post-market | China | |
| 10 | NCT03729674 | November 26, 2018 | 3 December 2018 | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs | Rheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's Disease | Drug: Biosimilar;Drug: Originator (legacy) drug | McGill University Health Center | Université 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 Group | Not recruiting | 18 Years | N/A | All | 800 | Phase 3 | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | JPRN-JapicCTI-184106 | 07/11/2018 | 7 October 2019 | Effect 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 Spondylitis | Ankylosing Spondylitis | Intervention 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 Recruiting | 18 | BOTH | 15 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa | ||
| 12 | EUCTR2017-004226-15-DK | 26/10/2018 | 26 November 2018 | Can-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-Art | Rheumatoid 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 Rheumatology | Authorised | Female: yes Male: yes | 180 | Phase 2 | Denmark | |||
| 13 | EUCTR2018-001060-35-ES | 19/09/2018 | 1 October 2018 | A 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 Tildrakizumab | 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 (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 FZE | Authorised | Female: yes Male: yes | 540 | Phase 3 | United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine;Russian Federation | |||
| 14 | EUCTR2018-001060-35-HU | 29/08/2018 | 3 September 2018 | A 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 Tildrakizumab | 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 (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 FZE | Authorised | Female: yes Male: yes | 540 | Phase 3 | Russian Federation;United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine | |||
| 15 | NCT03636984 | August 24, 2018 | 27 August 2018 | Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World | Efficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational Study | Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: recombinant TNF-a receptor: IgG Fc fusion protein | Zhejiang Hisun Pharmaceutical Co. Ltd. | Not recruiting | 18 Years | N/A | All | 1000 | Phase 2/Phase 3 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03552276 | July 11, 2018 | 13 May 2019 | A 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 Spondyloarthritis | Drug: 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 FZE | Not recruiting | 18 Years | N/A | All | 540 | Phase 2/Phase 3 | United States;Argentina;Hungary;Mexico;Poland;Russian Federation;Spain;Ukraine | |
| 17 | EUCTR2018-000226-58-ES | 04/07/2018 | 28 February 2019 | A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS) | A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) | Ankylosing spondylitis (AS) MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz Product Name: Tofacitinib 5 mg Product Code: CP-690,550 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 10017 | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of | |||
| 18 | NCT03502616 | June 7, 2018 | 4 November 2019 | Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS) | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis | Drug: Tofacitinib | Pfizer | Not recruiting | 18 Years | N/A | All | 270 | Phase 3 | United States;Australia;Bulgaria;Canada;China;Czechia;France;Hungary;Israel;Korea, Republic of;Poland;Russian Federation;Turkey;Ukraine;Slovakia;Spain;Taiwan | |
| 19 | ChiCTR-INR-17013574 | 2018-06-01 | 11 December 2017 | Clinical Study on Treating Ankylosing Spondylitis with Chinese Herbal Decoction Zhitongzhu Decoction | Clinical Study on Treating Ankylosing Spondylitis with Chinese Herbal Decoction Zhitongzhu Decoction | Ankylosing spondylitis | control group :Leflunomide; Intervention group :Chinese herbalshentongzhuyudecoction; | The First Affiliated Hospital of Heilongjiang Chinese Medicine Colledge | Not Recruiting | 16 | 25 | Male | control group :40; Intervention group :40; | New Treatment Measure Clinical Study | China | |
| 20 | EUCTR2017-004850-40-NL | 25/04/2018 | 5 June 2018 | Detection 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 SpA | Spondyloarthritis (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 Rheumatology | Authorised | Female: yes Male: yes | 48 | Phase 4 | Netherlands | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03350815 | March 13, 2018 | 29 July 2019 | Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis | A 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 Spondylitis | Drug: 150 mg open-label secukinumab;Drug: 150 mg double-blinded secukinumab;Drug: 300 mg double-blinded secukinumab | Novartis Pharmaceuticals | Recruiting | 18 Years | N/A | All | 270 | Phase 4 | United States | |
| 22 | NCT03470688 | March 1, 2018 | 11 June 2018 | Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents | An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology | Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis | Biological: Originator;Biological: Biosimilar | Opal Rheumatology Ltd. | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 5000 | Phase 4 | Australia |
| 23 | NCT03473665 | March 1, 2018 | 11 June 2018 | Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis | Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study | Ankylosing Spondylitis;Axial Spondyloarthritis | Drug: Indomethacin;Drug: Diclofenac;Drug: Meloxicam;Drug: Celecoxib | Columbia University | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | United States | |
| 24 | NCT03447704 | February 8, 2018 | 3 June 2019 | International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis | An 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 Spondylitis | Ankylosing Spondylitis | Other: placebo;Drug: BCD-085 | Biocad | Not recruiting | 18 Years | 65 Years | All | 228 | Phase 3 | Russian Federation | |
| 25 | EUCTR2017-000679-10-FR | 22/01/2018 | 28 February 2019 | Effect 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 - SURPASS | Ankylosing spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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 AG | Authorised | Female: yes Male: yes | 837 | Phase 3 | Portugal;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. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2017-001002-15-DE | 22/01/2018 | 18 June 2018 | A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis | A 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 spondylitis | Ankylosing Spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 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 SPRL | Authorised | Female: yes Male: yes | 285 | Phase 2 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Russian Federation;Bulgaria;Germany | |||
| 27 | EUCTR2017-004037-93-DK | 17/01/2018 | 30 April 2019 | 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) | 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, Rigshospitalet | Authorised | Female: yes Male: yes | 88 | Phase 4 | Denmark | |||
| 28 | EUCTR2017-000679-10-CZ | 10/01/2018 | 20 August 2018 | Effect 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 - SURPASS | Ankylosing spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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 AG | Authorised | Female: yes Male: yes | 837 | Phase 3 | Belgium;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 | |||
| 29 | EUCTR2017-001970-41-DK | 21/12/2017 | 24 September 2018 | Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial | Dose 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 Kristensen | Authorised | Female: yes Male: yes | 180 | Phase 4 | Denmark | |||
| 30 | EUCTR2017-000679-10-DE | 18/12/2017 | 18 June 2018 | Effect 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 - SURPASS | Ankylosing spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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 AG | Authorised | Female: yes Male: yes | 837 | Phase 3 | Belgium;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. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2017-000679-10-FI | 18/12/2017 | 29 January 2018 | Effect 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 - SURPASS | Ankylosing spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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 AG | Authorised | Female: yes Male: yes | 837 | Phase 3 | Belgium;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 | |||
| 32 | NCT03411798 | December 15, 2017 | 2 September 2019 | Sequential Application of Yisaipu® and DMARDs in Treating Mild-to-Moderate AS | Sequential Application of Yisaipu® and Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Treating Mild-to-Moderate Ankylosing Spondylitis: the Mid-term Follow-up Result | Ankylosing Spondylitis | Drug: Yisaipu® | Nanfang Hospital of Southern Medical University | Not recruiting | N/A | N/A | All | 76 | Phase 4 | China | |
| 33 | NCT03355573 | November 28, 2017 | 15 July 2019 | A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis | A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Bimekizumab | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | 256 | Phase 2 | United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine | |
| 34 | EUCTR2017-000679-10-DK | 23/11/2017 | 11 December 2017 | Effect 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 - SURPASS | Ankylosing spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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 AG | Authorised | Female: yes Male: yes | 837 | Phase 3 | Portugal;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 | |||
| 35 | EUCTR2017-000679-10-ES | 23/11/2017 | 12 March 2018 | Effect 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 - SURPASS | Ankylosing spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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. | Authorised | Female: yes Male: yes | 837 | Phase 3 | Belgium;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. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT02980705 | November 6, 2017 | 17 June 2019 | Efficacy and Safety Study of SUNPG1622 | A 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 Spondyloarthritis | Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis | Drug: SUNPG1622 I dose;Drug: Placebo dose | Sun Pharma Global FZE | Not recruiting | 18 Years | N/A | All | 180 | Phase 2 | United States | |
| 37 | NCT03357471 | November 3, 2017 | 10 September 2018 | Study 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 Disease | A 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 Disease | Moderate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's Disease | Drug: e-Device | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | 70 | Phase 3 | United States | |
| 38 | NCT03329885 | November 2, 2017 | 20 August 2018 | A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Patients and Patients With Average to Very Serious Psoriasis | A 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 Psoriasis | Rheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic Steatohepatitis | Other: Placebo;Drug: BMS-986251 | Bristol-Myers Squibb | Not recruiting | 18 Years | 70 Years | All | 38 | Phase 1/Phase 2 | Netherlands | |
| 39 | EUCTR2017-001002-15-CZ | 01/11/2017 | 28 February 2019 | A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis | A 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 spondylitis | Ankylosing Spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 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 SPRL | Authorised | Female: yes Male: yes | 285 | Phase 2 | Hungary;Czech Republic;Spain;Bulgaria;Germany | |||
| 40 | NCT03322618 | November 2017 | 16 December 2017 | Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples | Evaluation 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 Volunteers | Axial Spondyloarthritis (axSpA);Ankylosing Spondylitis (AS) | Biological: blood samples | Assistance Publique Hopitaux De Marseille | Not recruiting | 18 Years | N/A | All | 36 | N/A | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2017-001002-15-HU | 25/10/2017 | 30 October 2017 | A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis | A 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 spondylitis | Ankylosing Spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 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 GmbH | Authorised | Female: yes Male: yes | 285 | Phase 2 | Hungary | |||
| 42 | NCT03178487 | October 24, 2017 | 11 November 2019 | A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis ( SELECT Axis 1 ) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis | Ankylosing Spondylitis (AS) | Drug: Upadacitinib;Drug: Upadacitinib Placebo | AbbVie | Not recruiting | 18 Years | N/A | All | 187 | Phase 2 | United States;Australia;Belgium;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Spain;Sweden;United Kingdom | |
| 43 | NCT03215277 | October 4, 2017 | 28 October 2019 | A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis | A 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 Spondylitis | Ankylosing Spondylitis | Drug: Bimekizumab;Drug: Certolizumab pegol;Other: Placebo | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | 76 | Phase 2 | United States;Czechia;Germany;Greece;Moldova, Republic of;Netherlands;Poland;Russian Federation;Australia | |
| 44 | NCT03140657 | April 29, 2017 | 27 May 2019 | The Effects of Nanocurcumin on Treg Cells and Th17 Cells Responses in Ankylosing Spondylitis Patients | The Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Ankylosing Spondylitis Patients | Ankylosing Spondylitis | Drug: Nanocurcumin;Drug: Placebo | Tabriz University of Medical Sciences | Not recruiting | 23 Years | 46 Years | All | 24 | Phase 2 | Iran, Islamic Republic of | |
| 45 | EUCTR2016-003936-19-HU | 20/03/2017 | 30 April 2019 | A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis | A 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 Spondyloarthritis | Ankylosing 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 FZE | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT03117270 | March 7, 2017 | 20 August 2018 | A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis | A 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 Spondylitis | Ankylosing Spondylitis | Drug: filgotinib;Drug: Placebo Oral Tablet | Galapagos NV | Not recruiting | 18 Years | N/A | All | 116 | Phase 2 | Belgium;Bulgaria;Czechia;Estonia;Poland;Spain;Ukraine | |
| 47 | EUCTR2016-003636-21-EE | 26/01/2017 | 13 February 2017 | A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis | A 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 spondylitis | ankylosing 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 NV | Authorised | Female: yes Male: yes | 100 | Phase 2 | Czech Republic;Estonia;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany | |||
| 48 | NCT04135508 | December 13, 2016 | 4 November 2019 | A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira | A 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 Spondylitis | Ankylosing Spondylitis | Drug: BAT1406;Drug: Humira | Bio-Thera Solutions | Not recruiting | 16 Years | 65 Years | All | 554 | Phase 3 | ||
| 49 | EUCTR2016-001102-42-HU | 21/11/2016 | 15 October 2018 | A 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 SPONDYLITIS | Ankylosing 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 SPRL | Not Recruiting | Female: yes Male: yes | 285 | Phase 2 | United States;Czech Republic;Hungary;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany | |||
| 50 | NCT02896127 | October 18, 2016 | 22 October 2019 | Study 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 | Ankylosing Spondyloarthritis | Drug: Secukinumab;Drug: Placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 458 | Phase 3 | China;Czechia;Korea, Republic of;United Kingdom;Czech Republic | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2016-002061-54-IT | 13/10/2016 | 7 January 2019 | Switch 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. GEMELLI | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | |||
| 52 | NCT02963506 | October 2016 | 9 September 2019 | A Multicenter Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis | 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 Spondylitis | Ankylosing Spondylitis | Other: Placebo;Drug: Bimekizumab | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | 303 | Phase 2 | United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic | |
| 53 | NCT02893254 | September 22, 2016 | 18 June 2018 | Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing Spondylitis | A 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 Spondylitis | AS | Drug: IBI303;Drug: Adalimumab | Innovent Biologics (Suzhou) Co. Ltd. | Not recruiting | 18 Years | 65 Years | All | 438 | Phase 3 | ||
| 54 | NCT02685904 | September 6, 2016 | 25 March 2019 | A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis | Ankylosing Spondylitis | Biological: ENIA11;Biological: Placebo | Mycenax Biotech Inc. | TSH Biopharm Corporation Limited | Not recruiting | 20 Years | N/A | All | 10 | Phase 3 | Taiwan |
| 55 | NCT02758782 | September 2016 | 16 December 2017 | NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis | COmparison 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 Trial | Ankylosing Spondylitis | Biological: Golimumab;Drug: Celecoxib | Charite University, Berlin, Germany | Recruiting | 18 Years | N/A | All | 170 | Phase 4 | Germany | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT02763111 | September 2016 | 5 March 2018 | Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis | International 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 Spondylitis | Ankylosing Spondylitis | Drug: BCD-085;Other: Placebo | Biocad | Not recruiting | 18 Years | 65 Years | All | 88 | Phase 2 | ||
| 57 | EUCTR2015-005021-39-GB | 04/08/2016 | 12 February 2018 | Study 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 5 | Ankylosing 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 AG | Authorised | Female: yes Male: yes | 454 | Phase 3 | Czech Republic;Korea, Democratic People's Republic of;China;United Kingdom | |||
| 58 | NCT03932006 | June 30, 2016 | 13 May 2019 | A Multicenter,Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis | A Multicenter,Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Fengshigutong Capsule plus Imrecoxib;Drug: Fengshigutong Capsule;Drug: Imrecoxib | Sun Yat-sen University | Recruiting | 18 Years | 65 Years | All | 180 | Phase 4 | China | |
| 59 | NCT02809781 | June 2016 | 4 July 2016 | A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing Spondylitis | Phase III Study of Human Bone Marrow-Derived Mesenchymal Stem Cells to Treat AS | Spondylitis;Spondylitis, Ankylosing;Ankylosis;Arthritis;Spondylarthritis;Spondylarthropathies;Spinal Diseases;Musculoskeletal Diseases;Bone Diseases | Biological: Intravenous infusion of MSCs;Drug: Etanercept | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Nanfang Hospital of Southern Medical University;Second Affiliated Hospital of Guangzhou Medical University | Recruiting | 18 Years | 45 Years | Both | 250 | Phase 2/Phase 3 | China |
| 60 | NCT03557853 | June 2016 | 2 July 2018 | Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab | A Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab) | Ankylosing Spondylitis;Coxitis | Drug: Golimumab Injection | MSD Pharmaceuticals LLC | Not recruiting | 18 Years | N/A | All | 39 | N/A | Russian Federation | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT02763046 | May 31, 2016 | 4 November 2019 | A 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 Spondylitis | A 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 Spondylitis | Biological: AIN457/Secukinumab;Drug: AIN457/Secukinumab Placebo; Biological: AIN457/Secukinumab | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 211 | Phase 4 | Germany | |
| 62 | NCT02538341 | May 2016 | 15 April 2019 | Safety 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 Disease | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Not recruiting | 50 Years | N/A | All | 617 | Phase 2 | United States |
| 63 | NCT02750592 | March 22, 2016 | 20 May 2019 | Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis | An 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 Spondylitis | Ankylosing Spondylitis | Drug: secukinumab 150mg | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 30 | Phase 3 | Japan | |
| 64 | EUCTR2015-004575-74-DE | 16/03/2016 | 30 April 2019 | Clinical study to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab in patients with ankylosing spondylitis | A 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) - ASTRUM | Ankylosing Spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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 GmbH | Authorised | Female: yes Male: yes | 190 | Phase 4 | Germany | |||
| 65 | JPRN-JapicCTI-163241 | 01/3/2016 | 2 April 2019 | An 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 Spondylitis | An 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 Spondylitis | Ankylosing Spondylitis | Intervention 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. | 18 | BOTH | 30 | Phase 3 | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | NCT02638896 | January 2016 | 4 January 2016 | Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis | Efficacy and Safety of Etanercept Dose Reduction in Patients With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: etanercept (Half-Dose);Drug: etanercept (Full-Dose);Drug: Sulfasalazine;Drug: Celecoxib | Zhixiang Huang | Not recruiting | 18 Years | 45 Years | Both | 100 | Phase 4 | ||
| 67 | NCT02762812 | January 2016 | 5 March 2018 | Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis | International 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 Spondylitis | Ankylosing Spondylitis | Biological: BCD-055;Biological: Remicade® | Biocad | Not recruiting | 18 Years | 65 Years | All | 199 | Phase 3 | Russian Federation | |
| 68 | EUCTR2015-001894-41-CZ | 20/11/2015 | 28 February 2019 | Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without x-ray evidence of AS | PHASE 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 GmbH | Authorised | Female: yes Male: yes | 300 | Phase 3 | United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Australia;Russian Federation;Bulgaria | |||
| 69 | NCT02809300 | November 2015 | 4 July 2016 | Ankylosing Spondylitis and Antiphospholipid Antibodies | Prevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 Patients | Ankylosing Spondylarthritis | Biological: blood collection | CHU de Reims | Recruiting | 18 Years | N/A | Both | 80 | N/A | France | |
| 70 | NCT02469753 | October 23, 2015 | 18 December 2018 | Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes | Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes | Ankylosing Spondylitis | Drug: NSAIDs;Drug: anti-TNF | University Hospital, Bordeaux | Recruiting | 18 Years | N/A | All | 225 | Phase 3 | France;Monaco | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2015-001894-41-HU | 16/10/2015 | 28 February 2019 | Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without X-ray evidence of AS | PHASE 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 GmbH | Authorised | Female: yes Male: yes | 300 | Phase 3 | United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Australia;Russian Federation;Bulgaria | |||
| 72 | EUCTR2015-002284-42-FI | 18/09/2015 | 28 September 2015 | The 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 activit | INTENT: 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) - INTENT | rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify | Trade 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 | READE | Authorised | Female: yes Male: yes | 1650 | Phase 1 | Finland | |||
| 73 | NCT02605642 | September 10, 2015 | 18 March 2019 | Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade | PERSIST: 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 Arthritis | Drug: CT-P13 | Pfizer | Hospira, now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | All | 351 | Phase 3 | Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy |
| 74 | NCT02505542 | July 2015 | 29 July 2019 | Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo | A 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 Placebo | Axial Spondyloarthrithis;Ankylosing Spondylitis | Biological: Certolizumab Pegol;Other: Placebo | UCB BIOSCIENCES GmbH | Parexel | Not recruiting | 18 Years | 45 Years | All | 736 | Phase 3 | United States;Belgium;Bulgaria;Czechia;France;Germany;Hungary;Netherlands;Poland;Romania;Spain;Taiwan;Turkey;United Kingdom;Czech Republic |
| 75 | NCT03800797 | May 25, 2015 | 21 January 2019 | Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis | Efficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label Study | Ankylosing Spondylitis | Drug: Loxoprofen sodium hydrogel patch;Drug: Loxoprofen sodium tablet | Sun Yat-sen University | Not recruiting | 18 Years | 65 Years | All | 70 | Phase 4 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT02159053 | May 18, 2015 | 1 October 2018 | 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis | A 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 Spondylitis | Spondylitis, Ankylosing | Biological: Secukinumab;Biological: Placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 350 | Phase 3 | United States;Australia;Austria;Bulgaria;Canada;Czechia;Denmark;Finland;Germany;Greece;Italy;Netherlands;Norway;Poland;Russian Federation;Slovakia;Spain;Switzerland;United Kingdom;Czech Republic;Mexico | |
| 77 | NCT02492217 | May 2015 | 16 December 2017 | Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) a Agent's Efficacy in Ankylosing Spondylitis Patients | Biomarkers Identification of Anti-TNF a Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass Spectrometry | Ankylosing Spondylitis | Drug: Adalimumab | Universidade Nova de Lisboa | Recruiting | 18 Years | 75 Years | All | 70 | Phase 4 | Portugal | |
| 78 | NCT02293681 | April 10, 2015 | 16 December 2017 | An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement | A Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip Involvement | Spondylitis, Ankylosing | Drug: Infliximab;Drug: NSAIDs;Drug: DMARDs | Janssen Research & Development, LLC | Not recruiting | 16 Years | 40 Years | All | 76 | N/A | China | |
| 79 | NCT02359903 | February 2015 | 19 October 2017 | Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis | International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Infliximab (BCD-055);Drug: Infliximab (Remicade) | Biocad | Not recruiting | 18 Years | 65 Years | All | 90 | Phase 1 | Belarus;Russian Federation | |
| 80 | ChiCTR1800014846 | 2014-12-01 | 12 February 2018 | Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty | Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty: A prospective randomized double-blind controlled trial | osteonecrosis of the femoral head, femoral neck fracture, developmental dysplasia of hip, osteoarthritis, rheumatoid arthritis or ankylosing spondylitis | Experiment 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 Hospital | Not Recruiting | Both | Experiment group:50;Control Group:50; | Post-market | China | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | NCT02313727 | December 2014 | 19 February 2015 | Combined Treatment With TNF Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression | Combined Treatment With TNF (Tumor Necrosis Factor) Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression | Ankylosing Spondylitis | Drug: Pamidronate;Other: Placebo (NaCl 0.9%) | Bnai Zion Medical Center | Janssen-Cilag Ltd. | Not recruiting | 18 Years | N/A | Male | 30 | Phase 4 | Israel |
| 82 | NCT02328027 | December 2014 | 11 June 2018 | 99mTc-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 Spondylitis | Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: 99mTc-rhAnnexin V-128 | Advanced Accelerator Applications | Not recruiting | 18 Years | N/A | All | 16 | Phase 1/Phase 2 | Switzerland | |
| 83 | NCT01934933 | September 24, 2014 | 25 June 2018 | Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis | A Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: celebrex;Drug: Enbrel;Drug: Enbrel plus Celebrex | Sun Yat-sen University | Not recruiting | 18 Years | 65 Years | All | 150 | Phase 4 | China | |
| 84 | EUCTR2013-004406-25-PT | 19/09/2014 | 2 May 2016 | Biomarkers identification of efficacy in Ankylosing Spondylitis | Biomarkers identification of anti-TNF a agent’s efficacy in Ankylosing Spondylitis patients using a transcriptome analysis and mass spectrometry | Ankylosing 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 Lisboa | Authorised | Female: yes Male: yes | Portugal | |||||
| 85 | NCT02186873 | September 3, 2014 | 16 December 2017 | A Study of Golimumab in Participants With Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Placebo;Drug: Golimumab | Janssen Research & Development, LLC | Not recruiting | 18 Years | N/A | All | 208 | Phase 3 | United States;Australia;Canada;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Ukraine;Brazil;Romania | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | NCT02154425 | September 2014 | 11 June 2018 | A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers | A 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 Arthritis | Procedure: Breast milk sampling;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Not recruiting | 18 Years | N/A | Female | 17 | Phase 1 | United States;Netherlands;Switzerland;France |
| 87 | NCT02202850 | August 12, 2014 | 16 December 2017 | Defining Remission With Etanercept in AS in Real Life Clinical Practice | Defining 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 Spondylitis | Drug: etanercept | Pfizer | Not recruiting | 18 Years | N/A | All | 76 | N/A | Belgium | |
| 88 | NCT01870284 | July 2014 | 19 February 2015 | Study 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 | Spondylitis, Ankylosing | Drug: Ixekizumab;Drug: Placebo;Drug: Adalimumab | Eli Lilly and Company | Not recruiting | 18 Years | N/A | Both | 0 | Phase 3 | United States;Argentina;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom | |
| 89 | EUCTR2013-005013-13-LT | 08/04/2014 | 16 November 2015 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A 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 Therapy | Subjects 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 Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||||
| 90 | EUCTR2013-001090-24-GB | 26/03/2014 | 28 February 2019 | 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients | A 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 Spondylitis | Ankylosing 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 AG | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | NCT02047110 | January 28, 2014 | 11 June 2019 | BI 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: risankizumab | AbbVie | Boehringer Ingelheim | Not recruiting | 18 Years | 70 Years | All | 159 | Phase 2 | Belgium;Finland;France;Germany;Hong Kong;Italy;Korea, Republic of;Netherlands;Spain;Taiwan;United States |
| 92 | NCT02008916 | January 14, 2014 | 9 October 2018 | 16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients | A 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 Spondylitis | Spondylitis, Ankylosing | Drug: Secukinumab;Drug: Placebo secukinumab | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 226 | Phase 3 | United States;Belgium;Czechia;Germany;Greece;Mexico;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;Norway;Sweden | |
| 93 | EUCTR2013-001090-24-DE | 08/01/2014 | 5 February 2018 | 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients | A 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 Spondylitis | Ankylosing 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 AG | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom | |||
| 94 | EUCTR2013-002860-19-NL | 07/01/2014 | 27 January 2014 | Cardiovascular risk in patients with Ankylosing Spondylitis | The 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 risk | Ankylosing 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- | AMC | Authorised | Female: yes Male: yes | Netherlands | |||||
| 95 | NCT01988506 | January 6, 2014 | 27 August 2018 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid 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 Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Recruiting | 18 Years | N/A | All | 132 | Phase 2 | France |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | NCT02019602 | January 2014 | 16 December 2017 | A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta | A 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 Arthritis | Procedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Not recruiting | 18 Years | N/A | All | 16 | Phase 1 | United States;France;Netherlands;Switzerland |
| 97 | EUCTR2013-003666-13-ES | 26/12/2013 | 8 August 2016 | BI 655066 proof of concept dose finding study in 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. - BI 1311.8 | Ankylosing 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 Recruiting | Female: yes Male: yes | 212 | Phase 2 | United States;France;Taiwan;Hong Kong;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of | |||
| 98 | NCT01863732 | November 6, 2013 | 18 December 2018 | Extension in AS: Sustainability of Benefits, Safety and Tolerability | An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Biological: Secukinumab | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 274 | Phase 3 | United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom | |
| 99 | NCT02538757 | October 2013 | 21 August 2017 | Safety 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 Arthritis | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Not recruiting | 50 Years | N/A | All | 125 | Phase 2 | United States |
| 100 | EUCTR2011-002325-22-GB | 26/09/2013 | 28 February 2019 | Study 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-A1 | Spondylitis, 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 & Company | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | EUCTR2012-005026-30-HU | 15/08/2013 | 2 September 2013 | A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A 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 Therapy | Subjects 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. | Authorised | Female: yes Male: yes | 498 | Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | ||||
| 102 | NCT02132234 | June 2013 | 19 February 2015 | Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis | Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis | Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Hypertension | Drug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: Infliximab | Jagiellonian University | Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland | Recruiting | 18 Years | N/A | Both | 100 | Phase 4 | Poland |
| 103 | ChiCTR-TRC-13003449 | 2013-04-25 | 18 April 2017 | A multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing Spondylitis | A multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing Spondylitis | Ankylosing Spondylitis | Thalidomide 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 Army | Not Recruiting | 18 | 65 | Both | Thalidomide 150mg:80;Thalidomide 100mg:80;Control group:40; | Phase 2 study | China | |
| 104 | NCT01786668 | April 2013 | 19 October 2017 | Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis | A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as) | Ankylosing Spondylitis | Drug: Tofacitinib 2 mg;Drug: Tofacitinib 5 mg;Drug: Tofacitinib 10 mg;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 208 | Phase 2 | United States;Canada;Czech Republic;Germany;Hungary;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan | |
| 105 | NCT01895764 | March 2013 | 12 October 2015 | Effect 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 Spondylitis | Drug: Adalimumab;Drug: Methotrexate | University Hospital, Tours | Not recruiting | 18 Years | N/A | Both | 110 | Phase 4 | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | NCT01768858 | February 5, 2013 | 11 February 2019 | Assessment 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 Practice | Assessment 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 Practice | Crohn´s Disease;Ulcerative Colitis;Plaque Psoriasis;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Adalimumab | AbbVie | Raffeiner GmbH | Not recruiting | 18 Years | 99 Years | All | 96 | Phase 2 | Austria |
| 107 | NCT02201043 | February 2013 | 7 December 2015 | Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Thalidomide 150mg;Drug: Thalidomide 100mg;Drug: Placebo | Shanghai Pharmaceuticals Holding Co., Ltd | Not recruiting | 18 Years | 65 Years | Both | 197 | Phase 2 | China | |
| 108 | NCT01965132 | January 1, 2013 | 18 June 2018 | Korean College of Rheumatology Biologics Registry | Korean College of Rheumatology Biologics Registry | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Biologic DMARD | Seoul National University Hospital | Recruiting | 18 Years | N/A | All | 3500 | Phase 3 | Korea, Republic of | |
| 109 | NCT01389388 | January 2013 | 25 May 2015 | Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint Disease | Cholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint Diseases | Carotid Artery Plaque;Ankylosing Spondylitis;Rheumatoid Arthritis | Drug: Rosuvastatin | Diakonhjemmet Hospital | Not recruiting | 35 Years | 80 Years | Both | 114 | N/A | Norway | |
| 110 | NCT01649375 | October 18, 2012 | 4 November 2019 | 16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis | A 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 Spondylitis | Anklyosing Spondylitis | Drug: Secukinumab (75 mg);Drug: Placebo;Drug: Secukinumab (150 mg) | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 219 | Phase 3 | Finland;Germany;Italy;Netherlands;Russian Federation;Singapore;Spain;Switzerland;United Kingdom;Austria;Canada;Czechia;United States;Czech Republic | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | NCT01789151 | October 2012 | 7 November 2016 | 99m-Technetium- Glucosamine in Arthritis | 99mTc-labelled D-Glucosamine in the Evaluation of Disease Activity in Patients With Degenerative and Inflammatory Rheumatic Conditions | Rheumatoid Arthritis;Ankylosing Spondylitis | Device: Technetium labelled glucosamine | University of Sydney | AbbVie | Not recruiting | 18 Years | 90 Years | Both | N/A | Australia | |
| 112 | JPRN-UMIN000015297 | 2012/09/19 | 23 April 2019 | The feasibility study of accelated infliximab infusion from initial administration | The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration | patient 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 Hospital | Recruiting | 20years-old | 70years-old | Male and Female | 54 | Phase 2 | Japan | |
| 113 | EUCTR2012-000046-35-GB | 17/09/2012 | 20 February 2017 | Efficacy 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 2 | Ankylosing 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 AG | Authorised | Female: yes Male: yes | 219 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands | |||
| 114 | EUCTR2011-001555-37-GB | 04/09/2012 | 28 February 2019 | Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitis | A 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 spondylitis | 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] - 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 Corporation | Not Recruiting | Female: yes Male: yes | 456 | Phase 3 | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | |||
| 115 | NCT01694264 | September 1, 2012 | 16 December 2017 | Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFa | A 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 Treatment | Chronic Hepatitis B;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Juvenile Idiopathic Arthritis | Drug: Entecavir;Drug: Placebo | Seoul National University Hospital | Konkuk 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 Hospital | Not recruiting | 16 Years | 85 Years | All | 43 | Phase 3 | Korea, Republic of |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 116 | EUCTR2011-001555-37-SE | 09/08/2012 | 28 February 2019 | Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitis | A 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 spondylitis | Ankylosing 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 Corporation | Not Recruiting | Female: yes Male: yes | 456 | Phase 3 | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | |||
| 117 | EUCTR2011-001555-37-SK | 31/07/2012 | 28 February 2019 | Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitis | A 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 spondylitis | Ankylosing spondylitis (AS) MedDRA version: 14.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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 Corporation | Not Recruiting | Female: yes Male: yes | 456 | Phase 3 | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | |||
| 118 | EUCTR2011-001555-37-ES | 23/07/2012 | 28 February 2019 | Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitis | A 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 spondylitis | Ankylosing spondylitis (AS) MedDRA version: 14.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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 Corporation | Not Recruiting | Female: yes Male: yes | 456 | Phase 3 | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | |||
| 119 | EUCTR2012-002458-21-NL | 23/07/2012 | 14 December 2015 | Open-label, Phase 4 Study, investigation of the frequency of Extra-Articular exposure in patients with Ankylosing Spondylitis treated with Golimumab | Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab - GO-EASY | Ankylosing 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 Recruiting | Female: yes Male: yes | Phase 4 | Netherlands | ||||
| 120 | NCT01790022 | July 2012 | 19 February 2015 | Efficacy 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 Study | Ankylosing Spondylitis | Drug: Methylprednisolone | Saratov State Medical University | Charite University, Berlin, Germany | Not recruiting | 18 Years | N/A | Both | 20 | Phase 2 | Russian Federation |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 121 | EUCTR2011-001555-37-HU | 13/06/2012 | 28 February 2019 | Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitis | A 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 spondylitis | Ankylosing spondylitis (AS) MedDRA version: 14.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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 Corporation | Not Recruiting | Female: yes Male: yes | 456 | Phase 3 | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | |||
| 122 | EUCTR2011-001555-37-FR | 06/06/2012 | 28 February 2019 | Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitis | A 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 spondylitis | Ankylosing spondylitis (AS) MedDRA version: 14.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - 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 Corporation | Not Recruiting | Female: yes Male: yes | 456 | Phase 3 | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | |||
| 123 | JPRN-UMIN000007806 | 2012/06/01 | 2 April 2019 | The feasibility study of accelated infliximab infusion during maintenance phase | patient 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 Hospital | Not Recruiting | Not applicable | Not applicable | Male and Female | 54 | Phase 2 | Japan | ||
| 124 | NCT01610947 | May 14, 2012 | 25 February 2019 | Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity | Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial | Spondyloarthritis | Drug: Adalimumab, Etanercept, Golimumab or infliximab | University Hospital, Montpellier | Not recruiting | 18 Years | N/A | All | 398 | N/A | France | |
| 125 | NCT01583374 | May 2, 2012 | 24 September 2018 | Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis | A 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 SPONDYLITIS | Ankylosing Spondyloarthritis | Drug: Apremilast tablet 20 mg;Drug: Apremilast tablet 30 mg BID;Drug: Placebo | Celgene | Not recruiting | 18 Years | N/A | All | 490 | Phase 3 | United States;Australia;Austria;Bulgaria;Canada;Czechia;Estonia;France;Germany;Hungary;Netherlands;Poland;Romania;Russian Federation;Slovakia;Spain;Sweden;United Kingdom;Czech Republic | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 126 | NCT03880968 | March 1, 2012 | 1 April 2019 | Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis | Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis: a Prospective, Randomized Multicentric Study on Disease Activity Guided Etanercept Tapering or Discontinuation | Spondylitis, Ankylosing | Drug: tapering or discontinuation of etanercept | Second Affiliated Hospital, School of Medicine, Zhejiang University | Shanghai 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 Hospital | Not recruiting | 18 Years | 65 Years | All | 311 | Phase 4 | |
| 127 | NCT01571206 | March 2012 | 19 February 2015 | An 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 1.1 | An 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 1.1 | Ankylosing Spondylitis | Biological: Infliximab | Celltrion | Not recruiting | 18 Years | 75 Years | Both | 174 | Phase 1 | Korea, Republic of | |
| 128 | NCT01709656 | March 2012 | 19 February 2015 | A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis | A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis | Ankylosing Spondylitis | Biological: MSC;Drug: celecoxib, Celebrex® | Sun Yat-sen University | Not recruiting | 16 Years | 65 Years | Both | 120 | N/A | China | |
| 129 | NCT01517620 | November 2011 | 19 February 2015 | Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy | Ankylosing Spondylitis | Drug: Total Glucosides Paeony Capsules | Sun Yat-sen University | Not recruiting | 16 Years | 65 Years | Both | 38 | Phase 4 | China | ||
| 130 | NCT01330901 | October 2011 | 19 February 2015 | Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis | UsTekinumab for the Treatment Of Patients With Active Ankylosing Spondylitis (TOPAS) - a 28-week, Prospective, Open-label, Proof-of-concept Study | Ankylosing Spondylitis | Drug: Ustekinumab | Charite University, Berlin, Germany | Not recruiting | 18 Years | N/A | Both | 22 | Phase 2 | Germany | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 131 | NCT01358175 | October 2011 | 16 December 2017 | 16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis | A 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 Spondylitis | Ankylosing Spondylitis | Drug: Secukinumab (75 mg);Drug: Secukinumab (150 mg);Drug: Placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 371 | Phase 3 | United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom | |
| 132 | ChiCTR-TRC-11001417 | 2011-06-01 | 18 April 2017 | clinical study of Mecenchymal Stem Cells transplantation in Ankylosing Spondylitis | clinical study of Mecenchymal Stem Cells transplantation in Ankylosing Spondylitis | Ankylosing Spondylitis (AS) | 1:oral salicylazosulfapyridine and indomethacin;2:Mecenchymal Stem Cells(MSC) transplantation ; | Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Recruiting | Both | 1:80;2:80; | Phase 1+Phase 2 | China | |||
| 133 | NCT01327638 | February 15, 2011 | 19 November 2018 | Safety 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 Patients | Spondylarthropathies; Spondylitis, Ankylosing | Drug: etoricoxib;Drug: Other COX-2 inhibitor;Drug: nsNSAIDs | Merck Sharp & Dohme Corp. | Not recruiting | 16 Years | N/A | All | 21108 | Phase 2 | ||
| 134 | NCT01361542 | February 2011 | 19 February 2015 | Effect Of Anti TNF Alpha Therapy And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population | Effect Of Anti TNF Alpha Therapy On Disease Activity And Bone Health, And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population | Ankylosing Spondylitis | Drug: anti TNF alpha agent;Drug: Anti TNF alpha therapy | All India Institute of Medical Sciences, New Delhi | Not recruiting | 18 Years | 55 Years | Both | 24 | N/A | India | |
| 135 | ChiCTR-TRC-11001193 | 2011-01-01 | 18 April 2017 | Tripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trial | Tripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trial | ankylosing spondylitis | Treatment group: tripterygium wilfordii tablets ;Control group:Placebo; | Jiangsu Provincial Hospital of Traditional Chinese Medicine | Not Recruiting | 18 | 60 | Both | Treatment group:66;Control group:22; | Post-market | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 136 | NCT01411215 | January 2011 | 19 October 2017 | A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department | A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department | Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: Enbrel | Pfizer | Not recruiting | 18 Years | N/A | All | 160 | N/A | China | |
| 137 | NCT01420432 | January 2011 | 19 February 2015 | Safety 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 AS | Ankylosing Spondylitis | Biological: Human umbilical cord-derived MSCs | Shandong University | Recruiting | 18 Years | 60 Years | Both | 10 | Phase 1 | China | |
| 138 | NCT01793285 | December 2010 | 19 October 2017 | An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial | Retrospective, Multicentric, National, Observational Study, to Follow-up the Patients Who Participated in the Loadet Study (RELOADET Study) | Ankylosing Spondylitis | Drug: ETANERCEPT | Pfizer | Not recruiting | 18 Years | N/A | All | 85 | N/A | Spain | |
| 139 | EUCTR2009-017443-34-GB | 01/11/2010 | 19 March 2012 | A 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 therapy | A 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 therapy | Ankylosing 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. | Authorised | Female: yes Male: yes | 502 | Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania | ||||
| 140 | EUCTR2009-017488-40-GB | 01/11/2010 | 16 October 2012 | A 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 therapy | A 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 therapy | Ankylosing 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. | Authorised | Female: yes Male: yes | 250 | United Kingdom;Italy;Germany;Bulgaria;Denmark;Lithuania;Belgium;Spain;Czech Republic | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 141 | NCT01212653 | October 2010 | 19 February 2015 | Effect 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 AS | Ankylosing Spondylitis(AS) | Drug: Simponi;Other: 0.9ml sodium chloride | Chinese University of Hong Kong | Not recruiting | 18 Years | 75 Years | Both | 50 | Phase 4 | China | |
| 142 | NCT01220518 | October 2010 | 19 February 2015 | Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS) | Randomized, Double-blind, Parallel-group, Phase 1 Study | Ankylosing Spondylitis | Drug: Infliximab | Celltrion | Not recruiting | 18 Years | 75 Years | Both | 257 | Phase 1 | Korea, Republic of | |
| 143 | NCT01248793 | October 2010 | 19 October 2017 | Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Placebo;Drug: Golimumab;Drug: Golimumab (placebo group) | Centocor, Inc. | Not recruiting | 18 Years | N/A | All | 213 | Phase 3 | China | |
| 144 | EUCTR2009-011591-30-GB | 21/09/2010 | 29 May 2012 | An 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 - A2209E1 | An 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 - A2209E1 | Ankylosing 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 AG | Authorised | Female: yes Male: yes | 60 | Germany;United Kingdom;Netherlands | ||||
| 145 | NCT01208207 | September 2010 | 16 December 2017 | A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108) | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis | Spondylitis, Ankylosing | Drug: Part I - etoricoxib 60 mg;Drug: Part I - etoricoxib 90 mg;Drug: Part I- naproxen 1000 mg;Drug: Part I - Placebo to naproxen 500 mg;Drug: Part II- etoricoxib 60 mg;Drug: Part II- etoricoxib 90 mg;Drug: Part II- naproxen 1000 mg;Drug: Part I - Placebo to etoricoxib 60 mg;Drug: Part I - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to etoricoxib 60 mg;Drug: Part II - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to naproxen 500 mg | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 1015 | Phase 3 | Argentina;Austria;Belgium;Canada;Colombia;Czech Republic;Estonia;Finland;France;Germany;Hungary;India;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 146 | EUCTR2010-020913-10-GB | 11/08/2010 | 19 March 2012 | An 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 - ANSWERS | An 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 - ANSWERS | Ankylosing spondylitis | Trade 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 Trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 147 | EUCTR2009-018085-35-DK | 21/05/2010 | 3 October 2016 | Intestinal inflammation in ankylosing spondylitis assessed by stoll samples and endoscopy and the effects of adalimumab on inflammation | Intestinal Inflammation in Ankylosing Spondylitis assessed by Fecal Calprotectin, Capsular Endoscopy and Colonoscopy and the effects of Adalimumab on mucosal healing - INTASAH | Ankylosing 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 Silkeborg | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | ||||
| 148 | EUCTR2010-019263-11-AT | 19/05/2010 | 26 June 2012 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | Ankylosing Spondylitis MedDRA version: 12.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis | Product Code: SAR153191 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 & Développement | Not Recruiting | Female: yes Male: yes | 270 | Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania | ||||
| 149 | ChiCTR-ONRC-10000858 | 2010-05-10 | 18 April 2017 | Research on safety tolerance and pharmacokinetics of oral muti-dose Thalidomide | Research on safety tolerance and pharmacokinetics of oral muti-dose Thalidomide | Ankylosing Spondylitis | Group A:Muti-dose Thalidomide;GroupB:Muti-dose Thalidomide and Diclofenac sodium enteric-coated tablets ; | Chinese PLA General Hospital | Not Recruiting | 18 | 45 | Both | Group A:15;GroupB:12; | Phase 1 study | China | |
| 150 | ChiCTR-TRC-11001274 | 2010-04-01 | 18 April 2017 | Integrated Traditional Chinese and Western medicine for ankylosing spondylitis | integrated Traditional Chinese and Western medicine for ankylosing spondylitis with Gan-shen deficiency and Moist Heat Arthralgia Spasm Syndrome type | ankylosing spondylitis;M45.911 | B group:Qiangji Granule placebo, Sulfasalazine, Ibuprofen;C group:Qiangji Granule placebo, Sulfasalazine, Ibuprofen; | School of Chinese Medicine Southern Medical University | Not Recruiting | 18 | 60 | Both | B group:120;C group:180; | Post-market | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 151 | NCT01060098 | April 2010 | 30 March 2015 | T Cells and TNF: The Impact of TNF Blockade | T Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha Agents | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: anti-TNF therapy (etanercept or adalimumab) | Imperial College London | Not recruiting | 18 Years | 80 Years | Both | 52 | N/A | United Kingdom | |
| 152 | NCT01313858 | April 2010 | 19 October 2017 | A 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 Spondylitis | Arthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, Ankylosing | Drug: Simponi®;Drug: Methotrexate | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 1613 | N/A | Germany | |
| 153 | EUCTR2009-011719-19-FR | 29/03/2010 | 7 December 2015 | 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) | 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 Companies | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom | |||
| 154 | EUCTR2009-016587-36-ES | 15/03/2010 | 19 March 2012 | Artritis 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.A | Not Recruiting | Female: yes Male: yes | 70 | Spain | ||||
| 155 | EUCTR2009-016068-35-BE | 19/02/2010 | 18 August 2014 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis | Product Code: SAR153191 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 & Développement | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 156 | EUCTR2009-017309-12-ES | 18/02/2010 | 3 November 2014 | Evaluación de la respuesta a etoricoxib en pacientes con Espondilitis Anquilosante (EA) e inadecuada respuesta > o = a 2 AINES | Evaluación de la respuesta a etoricoxib en pacientes con Espondilitis Anquilosante (EA) e inadecuada respuesta > o = a 2 AINES | Espondilitis 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 Recruiting | Female: yes Male: yes | Spain | |||||
| 157 | NCT01114880 | January 2010 | 19 October 2017 | Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis | A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Biological: adalimumab;Other: placebo | Abbott | Not recruiting | 18 Years | 65 Years | All | 344 | Phase 3 | China | |
| 158 | EUCTR2010-019872-65-DE | 8 December 2014 | Etoricoxib with naproxen in ankylosing spondylitis | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | Ankylosing Spondylitis (AS) MedDRA version: 17.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 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 Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany | ||||
| 159 | ChiCTR-ONRC-11001846 | 2009-12-03 | 18 April 2017 | The research of immue state and current treatment in Ankylosing spondylitis | The research of immue state and current treatment in Ankylosing spondylitis | Ankylosing spondylitis | Traditional therapy group:DMARDs;biological agent group:biological agent;thalidomide group:thalidomide; | Department of Clinical Immunology, Xijing Hospital, Fourth Military Medical University | Not Recruiting | 18 | 65 | Both | Traditional therapy group:500;biological agent group:500;thalidomide group:500; | Pilot study | ||
| 160 | EUCTR2009-012424-87-GB | 26/11/2009 | 19 March 2012 | T 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 TNF | T 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 TNF | Rheumatoid 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 London | Authorised | Female: yes Male: yes | United Kingdom | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 161 | EUCTR2009-015515-40-NL | 20/11/2009 | 19 March 2012 | PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMS INTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVAS | PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMS INTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVAS | The 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. | Authorised | Female: yes Male: yes | 80 | Netherlands | ||||
| 162 | NCT01006681 | November 2009 | 19 February 2015 | Vaccination Against Influenza H1N1 in Rheumatic Diseases | Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory Drugs | Influenza;Rheumatic Diseases | Biological: Focetria (Monovalent MF59-Adjuvanted vaccine) | Tel-Aviv Sourasky Medical Center | Not recruiting | 18 Years | 65 Years | Both | 400 | Phase 2 | ||
| 163 | NCT02456363 | November 2009 | 8 June 2015 | Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis | Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis—A Registry Project | Ankylosing Spondylitis | Biological: TNF alpha;Drug: NSAIDs and sulfasalazine | Chung Shan Medical University | Recruiting | 18 Years | N/A | Both | 300 | Phase 2 | Taiwan | |
| 164 | NCT01104987 | October 2009 | 22 August 2016 | Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS) | Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective Trial | Ankylosing Spondylitis;Osteoporosis | Drug: alendronate | Göteborg University | Not recruiting | 18 Years | 80 Years | Both | 16 | Phase 4 | Sweden | |
| 165 | NCT01421303 | October 2009 | 19 October 2017 | Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel. | Work Productivity In A Cohort Of Employed Ankylosing Spondylitis Patients Treated With Etanercept | Ankylosing Spondylitis | Drug: Enbrel | Pfizer | Not recruiting | 18 Years | N/A | All | 80 | Phase 4 | Belgium | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 166 | NCT00844805 | September 2009 | 16 December 2017 | Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) | Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial | Ankylosing Spondylitis;Axial Spondyloarthritis | Drug: Infliximab;Drug: Placebo;Drug: Naproxen | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 48 Years | All | 158 | Phase 3 | Austria;Belgium;Denmark;France;Germany;Hungary;Korea, Republic of;Russian Federation;Ukraine;United States | |
| 167 | NCT01077843 | August 17, 2009 | 16 December 2017 | Post-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 Germany | Ankylosing Spondylitis | Drug: Etoricoxib;Drug: Other Cox-2 inhibitors;Drug: Other Non-selective NSAIDs;Other: No anti-inflammatory treatment | Merck Sharp & Dohme Corp. | Not recruiting | N/A | N/A | All | 27381 | N/A | ||
| 168 | NCT00944658 | August 2009 | 15 July 2019 | Spondylitis Trial of Apremilast for Better Rheumatic Therapy | Randomized, 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 Spondylitis | Drug: Apremilast;Drug: Placebo (sugar pill) | Imperial College London | Celgene Corporation | Not recruiting | 18 Years | N/A | All | 38 | Phase 2 | United Kingdom |
| 169 | EUCTR2007-003096-39-IT | 29/07/2009 | 19 March 2012 | Effects 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 - CREST | Effects 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 - CREST | Ankylosing 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 LEDERLE | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 170 | NCT00762463 | July 2009 | 19 October 2017 | Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis | A 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 Therapy | Ankylosing Spondylitis | Drug: Celecoxib;Drug: Diclofenac SR | Pfizer | Not recruiting | 18 Years | 65 Years | All | 240 | Phase 3 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 171 | NCT00910273 | July 2009 | 19 October 2017 | Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients | Effects of Etanercept on Endothelial Function and Carotid Intima-media Thickness (IMT) in Patients With Active AS | Ankylosing Spondylitis | Drug: etanercept | Pfizer | Lincoln Medical and Mental Health Center | Not recruiting | 18 Years | N/A | All | 34 | Phase 4 | Italy |
| 172 | EUCTR2008-006885-27-NL | 21/04/2009 | 26 June 2012 | EFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS | EFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS | PERIPHERAL 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 Rheumatology | Not Recruiting | Female: yes Male: yes | Netherlands | |||||
| 173 | NCT01081717 | April 14, 2009 | 15 July 2019 | Golimumab Safety and Surveillance Program Using the Ingenix NHI Database | A 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 Treatments | Rheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing Spondylitis | Drug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general population | Janssen Biotech, Inc. | Not recruiting | N/A | 99 Years | All | 1064 | N/A | United States | |
| 174 | EUCTR2008-007510-30-HU | 09/02/2009 | 19 March 2012 | A 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 THERAPY | A 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 THERAPY | ANKYLOSING 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 Recruiting | Female: yes Male: yes | 126 | Phase 2 | Hungary;Poland | |||
| 175 | EUCTR2008-002631-33-GB | 14/01/2009 | 19 March 2012 | Randomized, 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 - CAIN457A2209 | Randomized, 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 - CAIN457A2209 | Ankylosing 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 AG | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Germany;United Kingdom;Netherlands | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 176 | EUCTR2007-007637-39-DE | 17/12/2008 | 19 March 2012 | Effects of NSAIDs on RAdiographic Damage in AS (ENRADAS) – a prospective randomised controlled trial - Amendment 2 - ENRADAS | Effects of NSAIDs on RAdiographic Damage in AS (ENRADAS) – a prospective randomised controlled trial - Amendment 2 - ENRADAS | Ankylosing 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 Mitte | Authorised | Female: yes Male: yes | 174 | Germany | ||||
| 177 | NCT00811499 | December 2008 | 19 February 2015 | A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: ARRY-371797, p38 inhibitor; oral;Drug: Placebo | Array BioPharma | Not recruiting | 18 Years | N/A | Both | 25 | Phase 2 | United States;Canada | ||
| 178 | NCT00766402 | October 2008 | 19 February 2015 | An 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;Pain | Drug: Tramadol /acetaminophen;Drug: Diclofenac | Johnson & Johnson Taiwan Ltd | Not recruiting | 18 Years | 70 Years | Both | 8 | Phase 4 | ||
| 179 | NCT00889694 | October 2008 | 19 February 2015 | Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis | Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical Trial | Early Ankylosing Spondylitis | Drug: Tripterygium;Drug: Sulfasalazine;Drug: placebo | Sun Yat-sen University | Recruiting | 18 Years | 65 Years | Both | 80 | Phase 2/Phase 3 | ||
| 180 | NCT02489760 | July 2008 | 1 February 2016 | Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study | Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study | Ankylosing Spondylitis | Biological: Adalimumab;Biological: Etanercept | Chung Shan Medical University | Not recruiting | 18 Years | 70 Years | Both | 30 | Phase 4 | Taiwan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 181 | EUCTR2007-003358-27-DE | 02/05/2008 | 19 March 2012 | Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira Study | Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira Study | Juvenile 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 Augustin | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | ||||
| 182 | NCT01188655 | May 2008 | 19 October 2017 | Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis | Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis | Spondylitis, Ankylosing | Drug: Enbrel | Pfizer | Not recruiting | 18 Years | N/A | All | 89 | N/A | ||
| 183 | JPRN-JapicCTI-080580 | 01/4/2008 | 2 April 2019 | A Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing Spondylitis | A Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing Spondylitis | Ankylosing Spondylitis | Intervention 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. | 15 | BOTH | 30 | Phase 3 | |||
| 184 | NCT00647517 | March 2008 | 19 February 2015 | Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis | Chung Shan Medical University Hospital, Taiwan | Ankylosing Spondylitis | Drug: Ultracet | Chung Shan Medical University | Not recruiting | 18 Years | 65 Years | Both | 60 | Phase 4 | Taiwan | |
| 185 | NCT00667355 | February 2008 | 19 October 2017 | A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis | A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Biological: adalimumab | Abbott | Eisai Co., Ltd. | Not recruiting | 15 Years | N/A | All | 41 | Phase 3 | Japan |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 186 | NCT01072058 | February 2008 | 19 February 2015 | Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker | Prospective 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 Blocker | Arthritis, Rheumatoid;Spondylitis, Ankylosing | Drug: TNF blockers (infliximab, adalimumab, etanercept) | University of Sao Paulo | Not recruiting | 18 Years | 70 Years | Both | 100 | Phase 4 | Brazil | |
| 187 | NCT00558506 | January 2008 | 19 February 2015 | Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis | Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: abatacept | Charite University, Berlin, Germany | Bristol-Myers Squibb | Recruiting | 18 Years | 65 Years | Both | 30 | Phase 2 | Germany |
| 188 | NCT00936143 | January 2008 | 1 February 2016 | Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis | An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis | Spondylitis | Drug: infliximab | Gu Jieruo | Not recruiting | 16 Years | 65 Years | Both | 70 | Phase 4 | China | |
| 189 | NCT00953979 | January 2008 | 19 February 2015 | Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis | A 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 Trial | Ankylosing Spondylitis;Treatment | Drug: kunxian capsule | Gu Jieruo | China-Japan Friendship Hospital;Dongguan People's Hospital;Zhanjiang People's Hospital;Huashan Hospital | Not recruiting | 18 Years | 65 Years | Both | 126 | Phase 4 | China |
| 190 | NCT00576706 | December 2007 | 19 February 2015 | PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity | A 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 Complications | Rheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis | Drug: Rebamipide;Drug: Misoprostol | Korea Otsuka Pharmaceutical Co.,Ltd. | Not recruiting | 19 Years | N/A | Both | 396 | Phase 3 | Korea, Republic of | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 191 | EUCTR2007-000087-25-GB | 22/10/2007 | 19 March 2012 | An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07 | An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07 | Ankylosing 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 Trust | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
| 192 | EUCTR2007-002967-28-DE | 19/10/2007 | 19 March 2012 | Pilot open label clinical trial with Abatacept in Ankylosing Spondylitis - ABATACEPT-AS-01 | Pilot open label clinical trial with Abatacept in Ankylosing Spondylitis - ABATACEPT-AS-01 | T 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 Medicine | Not Recruiting | Female: yes Male: yes | 30 | Germany | ||||
| 193 | NCT00507403 | October 2007 | 16 December 2017 | Infliximab and Methotrexate in Ankylosing Spondylitis | Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: infliximab | University Hospital, Tours | Institut National de la Santé Et de la Recherche Médicale, France | Not recruiting | 18 Years | 65 Years | All | 30 | Phase 4 | France |
| 194 | NCT00544557 | October 2007 | 19 October 2017 | Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis | Observational Study Of The Use Of Enbrel (Registered) (Etanercept) In Routine Clinical Practice To Treat Ankylosing Spondylitis (as) Patients: An Effectiveness, Safety, And Health Economic Evaluation | Ankylosing Spondylitis | Drug: Etanercept | Pfizer | Not recruiting | 18 Years | N/A | All | 1715 | Phase 4 | Germany | |
| 195 | ChiCTR-TRC-13004564 | 2007-07-01 | 18 April 2017 | 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. | 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 Spondylitis | CM: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 Medicine | Not Recruiting | 18 | 60 | Both | CM:15;WM treatment group:15; | Phase 1 study | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 196 | NCT02915354 | July 2007 | 28 November 2016 | Relapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Following-up Study | Relapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Three Years' Following-up Study | Spondylitis, Ankylosing;Recurrence | Drug: Etanercept | Sun Yat-sen University | Not recruiting | 18 Years | N/A | Both | 35 | Phase 4 | China | |
| 197 | NCT00724529 | June 2007 | 19 February 2015 | Post Marketing Surveillance of Remicade | Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD) | Crohn's Disease;Ankylosing Spondylitis | Biological: Infliximab | Janssen Korea, Ltd., Korea | Not recruiting | N/A | N/A | Both | 938 | Phase 4 | Korea, Republic of | |
| 198 | NCT00760669 | May 2007 | 19 October 2017 | An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants | Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients | Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, Psoriatic | Drug: Infliximab; observational study;Drug: Methotrexate | Janssen Korea, Ltd., Korea | Not recruiting | N/A | N/A | All | 1061 | Phase 4 | Korea, Republic of | |
| 199 | EUCTR2006-005157-29-FR | 27/04/2007 | 19 March 2012 | EFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE - SPAXIM | EFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE - SPAXIM | Les 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-TOURS | Authorised | Female: yes Male: yes | France | |||||
| 200 | EUCTR2006-002748-27-NL | 13/04/2007 | 19 March 2012 | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | Active, 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 France | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Netherlands;France | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 201 | EUCTR2006-001579-40-FR | 02/04/2007 | 12 June 2012 | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Spondyloarthropathies 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 France | Authorised | Female: yes Male: yes | 100 | Hungary;Denmark;France;Spain | ||||
| 202 | NCT00432653 | March 2007 | 19 February 2015 | Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis | Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: rituximab | Charite University, Berlin, Germany | Hoffmann-La Roche | Not recruiting | 18 Years | 65 Years | Both | 20 | Phase 2/Phase 3 | Germany |
| 203 | NCT00434044 | February 2007 | 19 February 2015 | Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis | Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Enbrel (etanercept) | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 150 | Phase 3 | ||
| 204 | NCT00420238 | January 2007 | 19 October 2017 | Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Etanercept (Enbrel);Other: Placebo | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 70 Years | All | 82 | Phase 4 | France;Germany;Hungary;Netherlands | |
| 205 | EUCTR2006-002306-64-DE | 28/12/2006 | 27 January 2014 | Open 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-01 | Open 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-01 | Moderate to severe ankylosing spondylitis who have had an inadequate response to or do not tolerate conventional therapy including NSAIDs, DMARDs and TNF alpha inhibitors | Trade 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 Universitaetsmedizin | Not Recruiting | Female: yes Male: yes | Germany | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 206 | NCT00410046 | December 2006 | 19 October 2017 | Extension Study Evaluating Etanercept in Ankylosing Spondylitis | An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Enbrel (etanercept) | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | All | 84 | Phase 4 | Denmark;Finland;Sweden;United Kingdom | |
| 207 | NCT00873730 | December 2006 | 19 October 2017 | Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain | 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 | Ankylosing Spondylitis | Drug: etanercept;Drug: etanercept/placebo | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 70 Years | All | 108 | Phase 4 | ||
| 208 | EUCTR2006-002349-35-ES | 30/09/2006 | 19 March 2012 | Estudio 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. - LOADET | Estudio 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. - LOADET | Espondilitis anquilosante Ankylosing spondylitis | Trade 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. | Authorised | Female: yes Male: yes | Spain | |||||
| 209 | NCT00367211 | September 2006 | 19 February 2015 | Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. | A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. | Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole) | POZEN | Not recruiting | 18 Years | N/A | Both | 400 | Phase 3 | United States | |
| 210 | NCT00458185 | August 2006 | 19 February 2015 | Study Evaluating Etanercept in Patients With Ankylosing Spondylitis | Multicentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 70 Years | Both | 40 | Phase 4 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 211 | EUCTR2006-001061-42-GB | 31/07/2006 | 19 March 2012 | An 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 Division | Authorised | Female: yes Male: yes | 108 | Finland;United Kingdom;Denmark;Sweden | ||||
| 212 | EUCTR2005-005358-27-GB | 12/07/2006 | 19 March 2012 | Efficacy of Rituximab (Mabthera) in active ankylosing spondylitis: a clinical and magnetic resonance imaging study - Rituximab in AS | Efficacy of Rituximab (Mabthera) in active ankylosing spondylitis: a clinical and magnetic resonance imaging study - Rituximab in AS | Ankylosing 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 Staffordshire | Authorised | Female: yes Male: yes | 10 | United Kingdom | ||||
| 213 | NCT01685424 | June 30, 2006 | 16 December 2017 | Etoricoxib 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 Analysis | Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Gout;Arthritis | Drug: Etoricoxib | Merck Sharp & Dohme Corp. | Not recruiting | N/A | N/A | All | 79189 | N/A | United States | |
| 214 | EUCTR2004-003299-12-FI | 26/04/2006 | 1 May 2012 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA | Ankylosing 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 Recruiting | Female: yes Male: yes | 345 | Finland;United Kingdom;Germany;Belgium | ||||
| 215 | NCT00478660 | February 2006 | 19 February 2015 | An 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 Spondylitis | Drug: adalimumab (Humira) | Abbott | Not recruiting | 18 Years | N/A | Both | 1250 | Phase 3 | Austria;Belgium;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 216 | EUCTR2005-004826-21-FI | 20/01/2006 | 22 July 2013 | 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 | 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 | Active Ankylosing Spondylitis | Product Name: Humira Pharmaceutical Form: Injection* INN or Proposed INN: Adalimumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | Abbott GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 1200 | Greece;Finland;Belgium;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden | ||||
| 217 | NCT02922192 | January 2006 | 17 October 2016 | Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis | Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis | Rheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing Spondylitis | Drug: TNF-a antagonists, non-TNFs, DMARD non-biologics | Biologics & Biosimilars Collective Intelligence Consortium | 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;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;UPMC | Not recruiting | 18 Years | N/A | Both | 100000 | N/A | |
| 218 | NCT00237419 | December 2005 | 19 February 2015 | Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis | An 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 Spondylitis | Drug: infliximab | Rheumazentrum Ruhrgebiet | Centocor BV;Trial Coordination Center, 9713 GZ Groningen;PPD | Recruiting | 18 Years | N/A | Both | 149 | N/A | Belgium;Finland;France;Germany;Netherlands;United Kingdom |
| 219 | NCT00247962 | December 2005 | 19 October 2017 | Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis | A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: etanercept;Drug: sulphasalazine (SSZ) | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | All | 566 | Phase 4 | Australia;Austria;China;Czech Republic;Denmark;Finland;France;Germany;Hungary;Ireland;Italy;Netherlands;Poland;Qatar;Saudi Arabia;Spain;Sweden;United Kingdom;Greece;Portugal;Switzerland | |
| 220 | NCT00265083 | December 2005 | 19 October 2017 | A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Biological: golimumab;Biological: Golimumab (CNTO 148); placebo | Centocor, Inc. | Schering-Plough | Not recruiting | 18 Years | N/A | All | 356 | Phase 3 | United States;Belgium;Canada;Finland;France;Germany;Korea, Republic of;Netherlands;Taiwan;United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 221 | EUCTR2005-001549-41-HU | 25/11/2005 | 18 April 2012 | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects 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 Inc | Authorised | Female: yes Male: yes | 525 | Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | ||||
| 222 | EUCTR2005-002460-29-DE | 12/09/2005 | 18 April 2012 | An 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) - EASIC | An 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) - EASIC | Ankylosing 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 Recruiting | Female: yes Male: yes | 130 | Finland;United Kingdom;Germany;Belgium | ||||
| 223 | NCT00778869 | August 2005 | 19 October 2017 | Analysis 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 Controls | Spondylitis, Ankylosing | Biological: Remicade | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 70 Years | All | 10 | Phase 4 | ||
| 224 | NCT00195416 | June 2005 | 19 February 2015 | Study Investigating Enbrel Treatment for Ankylosing Spondylitis | A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 526 | Phase 4 | Korea, Republic of | |
| 225 | NCT00202865 | May 1, 2005 | 16 December 2017 | Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352) | CANaDian Evaluation of Low DosE Infliximab in Ankylosing Spondylitis | Spondylitis, Ankylosing | Biological: infliximab;Biological: Placebo | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 76 | Phase 3 | Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 226 | NCT00235105 | March 2005 | 19 February 2015 | D2E7-Early AS | Adalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension Phase | Ankylosing Spondylitis | Drug: Adalimumab 40 mg sc every other week | Charite University, Berlin, Germany | Abbott | Not recruiting | 18 Years | N/A | Both | 46 | Phase 2/Phase 3 | Germany |
| 227 | NCT00432432 | February 2005 | 19 February 2015 | Combination Methotrexate and Infliximab | The Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging Correlation | Ankylosing Spondylitis | Drug: Infliximab and MTX | Chinese University of Hong Kong | Not recruiting | 18 Years | 70 Years | Both | 38 | Phase 4 | ||
| 228 | NCT02840695 | January 2005 | 16 December 2017 | Effect 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 Fractures | Drug: bDMARD treatment | Uppsala University | Not recruiting | 30 Years | 60 Years | All | 9858 | N/A | ||
| 229 | NCT00779012 | October 1, 2004 | 16 December 2017 | A 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 Spondylitis | Spondylitis, Ankylosing | Biological: Infliximab | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 70 Years | All | 42 | Phase 4 | ||
| 230 | NCT00779935 | October 1, 2004 | 16 December 2017 | Growth 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 Study | Spondylitis, Ankylosing | Biological: Remicade | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 70 Years | All | 44 | Phase 4 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 231 | NCT00133315 | September 2004 | 19 February 2015 | TNFalfa Blocking Treatment of Spondylarthropathies | TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies | Spondylarthropathies;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Infliximab;Drug: Etanercept;Drug: Adalimumab | Hvidovre University Hospital | Not recruiting | 18 Years | N/A | Both | 50 | Phase 4 | Denmark | |
| 232 | NCT00418548 | June 2004 | 19 February 2015 | Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis | A 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 Spondylitis | Ankylosing Spondylitis | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 70 Years | Both | 350 | Phase 3 | ||
| 233 | NCT00725543 | June 2004 | 19 October 2017 | Investigation 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 Infusions | Spondylitis, Ankylosing | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Not recruiting | N/A | N/A | All | 358 | N/A | |
| 234 | NCT01038011 | June 2004 | 16 December 2017 | Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot Study | Ankylosing Spondylitis | Drug: drug treatment | University of Zurich | Sanofi | Not recruiting | 18 Years | N/A | All | Phase 2 | Switzerland | ||
| 235 | NCT00444340 | April 2004 | 19 February 2015 | An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis | An Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Enbrel (Etanercept) | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 70 | Phase 4 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 236 | NCT00224562 | February 2004 | 19 February 2015 | The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists | The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists | Rheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;Psoriasis | Drug: TNF-alpha antagonists | Assistance Publique - Hôpitaux de Paris | Recruiting | N/A | N/A | Both | N/A | France | ||
| 237 | NCT00085644 | January 2004 | 19 October 2017 | Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis | A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Biological: adalimumab (D2E7);Biological: placebo | Abbott | Not recruiting | 18 Years | N/A | All | 315 | Phase 3 | United States | |
| 238 | NCT00195819 | December 2003 | 19 October 2017 | Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis | A Phase 3, Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Biological: adalimumab (D2E7);Biological: placebo | Abbott | Not recruiting | 18 Years | N/A | All | 82 | Phase 3 | Canada;United States | |
| 239 | NCT00243750 | September 2003 | 19 February 2015 | Methotrexate in Ankylosing Spondylitis (MTX in AS) | Open Study for the Evaluation of the Efficacy of Methotrexate 20mg Given Subcutaneously in Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Methotrexate | Charite University, Berlin, Germany | Not recruiting | 18 Years | 70 Years | Both | 20 | Phase 2 | Germany | |
| 240 | NCT00818168 | July 2003 | 19 October 2017 | Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED) | Remicade Safety Line (Ankylosing Spondylitis) | Spondylitis, Ankylosing | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Not recruiting | 18 Years | N/A | All | 320 | N/A | Germany |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 241 | NCT00439283 | April 2003 | 19 February 2015 | Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis | Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand | Ankylosing Spondylitis | Drug: infliximab;Drug: methotrexate | Association de Recherche Clinique en Rhumatologie | Not recruiting | 18 Years | N/A | Both | 240 | Phase 3 | France | |
| 242 | NCT00648141 | January 2003 | 19 February 2015 | Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis | A 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 Spondylitis | Spondylitis, Ankylosing | Drug: Celecoxib;Drug: Diclofenac | Pfizer | Not recruiting | 18 Years | 75 Years | Both | 458 | Phase 3 | Germany | |
| 243 | NCT01850121 | January 2003 | 22 August 2016 | Remicade in the Treatment of Patients With Active Ankylosing Spondylitis | Remicade in the Treatment of Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Infliximab | Göteborg University | Not recruiting | 18 Years | 60 Years | Both | 19 | Phase 2/Phase 3 | Sweden | |
| 244 | NCT00207701 | September 2002 | 19 February 2015 | A 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 Therapy | Ankylosing Spondylitis | Drug: infliximab | Centocor, Inc. | Centocor BV, Netherlands | Not recruiting | 18 Years | N/A | Both | 279 | Phase 3 | |
| 245 | NCT02528201 | September 2002 | 31 August 2015 | A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis | A Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Celecoxib 200 milligrams;Drug: Celecoxib 400 milligrams;Drug: diclofenac 50 milligrams | Pfizer | Not recruiting | 18 Years | 75 Years | Both | 330 | Phase 4 | Norway | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 246 | NCT00421980 | June 2002 | 19 February 2015 | An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis | An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 66 Years | Both | 84 | Phase 3 | Belgium | |
| 247 | NCT00244166 | May 2002 | 19 February 2015 | Prednisolone in Active Ankylosing Spondylitis (AS) | Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone | Ankylosing Spondylitis | Drug: prednisolone | Charite University, Berlin, Germany | Recruiting | 18 Years | 70 Years | Both | 75 | Phase 2/Phase 3 | Germany | |
| 248 | NCT00356356 | April 2002 | 19 February 2015 | 16.0040 Ankylosing Spondylitis Study | Open-label, Long-term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037 | Ankylosing Spondylitis | Drug: Etanercept | Amgen | Immunex Corporation | Not recruiting | 18 Years | N/A | Both | 257 | Phase 3 | United States |
| 249 | NCT00421915 | March 2002 | 19 February 2015 | Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis | Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data | Ankylosing Spondylitis | Drug: Enbrel (etanercept) | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 70 Years | Both | 84 | Phase 3 | ||
| 250 | NCT01289743 | February 2002 | 19 February 2015 | Etanercept (Enbrel) in Ankylosing Spondylitis | An Open-label Study of Etanercept (Enbrel) Efficacy in Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Etanercept | Charite University, Berlin, Germany | Rheumazentrum Ruhrgebiet | Not recruiting | 18 Years | 65 Years | Both | 24 | Phase 2 | Germany |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 251 | NCT02183168 | July 2001 | 19 February 2015 | 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 Spondylitis | A 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 Spondylitis | Spondylitis, Ankylosing | Drug: Meloxicam suppository;Drug: Meloxicam tablet;Drug: Indomethacin | Boehringer Ingelheim | Not recruiting | N/A | N/A | Both | 192 | Phase 3 | ||
| 252 | NCT00000433 | October 1999 | 19 February 2015 | Blocking Tumor Necrosis Factor in Ankylosing Spondylitis | Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis | Spondylitis, Ankylosing | Drug: Anti-Tumor Necrosis Factor | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | 80 Years | Both | 42 | Phase 2 | United States | |
| 253 | NCT00004288 | May 1996 | 19 February 2015 | Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: olsalazine | National Center for Research Resources (NCRR) | University of Rochester | Not recruiting | 18 Years | 65 Years | Male | 4 | Phase 2 | ||
| 254 | JPRN-JapicCTI-070346 | 23 April 2019 | Clinical study of TA-650 in patients with ankylosing spondylitis | Clinical study of TA-650 in patients with ankylosing spondylitis | Ankylosing spondylitis | Intervention name : TA-650 (Infliximab) Dosage And administration of the intervention : Intravenous drip infusion | Mitsubishi Tanabe Pharma Corporation | 16 | BOTH | Phase 3 |