271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details
臨床試験数 : 563 / 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05155098 (ClinicalTrials.gov) | March 1, 2022 | 30/11/2021 | 2 Years Prospective Study to Collect Real-life Data on the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis | 2 Years Prospective Study to Collect Real-life Data On the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial spondyloarthriTis (PROMPT) | Moderate to Severe Plaque Psoriasis;Psoriatic Arthritis;Ankylosing Spondylitis;Non-radiographic Axial Spondyloarthritis | Other: secukinumab | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 80 Years | All | 360 | NULL | |
| 2 | NCT05257174 (ClinicalTrials.gov) | March 2022 | 28/1/2022 | The Effects of Jing Si Herbal Tea Liquid Packets on Fatigue in Patients With Inflammatory Arthritis | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Jing Si Herbal Tea Liquid Packets on Fatigue in Patients With Inflammatory Arthritis | Arthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Fatigue | Dietary Supplement: Jing Si Herbal Tea LIQUID PACKETS;Dietary Supplement: Placebo | Buddhist Tzu Chi General Hospital | NULL | Not yet recruiting | 20 Years | 99 Years | All | 150 | N/A | Taiwan |
| 3 | NCT05164198 (ClinicalTrials.gov) | January 15, 2022 | 8/11/2021 | Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity | Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity | Ankylosing Spondylitis;Axial Spondyloarthritis | Biological: Adalimumab and its biosimilars;Biological: Biological: Etanercept and its biosimilars;Biological: Golimumab;Biological: Infliximab biosimilar | Hanyang University Seoul Hospital | Linical Korea | Not yet recruiting | 18 Years | 65 Years | All | 448 | Phase 4 | NULL |
| 4 | NCT04924270 (ClinicalTrials.gov) | January 2022 | 7/6/2021 | Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases | Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial | Rheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative Colitis | Biological: Faecal microbiota transplantation;Other: Placebo | Torkell Ellingsen | Region of Southern Denmark;University of Southern Denmark | Not yet recruiting | 18 Years | 70 Years | All | 200 | Phase 2 | NULL |
| 5 | NCT05094128 (ClinicalTrials.gov) | November 22, 2021 | 20/10/2021 | A Study to Assess Disease Activity in Adult Participants With Ankylosing Spondylitis Who Receive Upadacitinib in a Real-world Setting | Effectiveness of Upadacitinib in Patients With Ankylosing Spondylitis Suffering From Typical Disease Activity and Pain in a Real-World Setting | Radiographic Axial Spondylarthritis (r-axSpA) | Drug: Upadacitinib | AbbVie | NULL | Recruiting | 18 Years | N/A | All | 352 | Germany | |
| 6 | NCT04876781 (ClinicalTrials.gov) | November 1, 2021 | 20/4/2021 | Korean Post-marketing Surveillance for Xeljanz XR | Korean Post-marketing Surveillance for Xeljanz XR (Registered) | Active Moderate to Severe Rheumatoid Arthritis;Active Ankylosing Spondylitis | Drug: Tofacitinib XR | Pfizer | NULL | Not yet recruiting | 18 Years | N/A | All | 200 | NULL | |
| 7 | NCT04947579 (ClinicalTrials.gov) | August 25, 2021 | 23/6/2021 | A Study of CC-99677 in Participants With Active Ankylosing Spondylitis | A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Drug: CC-99677;Other: Placebo | Celgene | NULL | Recruiting | 18 Years | 65 Years | All | 256 | Phase 2 | United States;Canada;Czechia;Germany;Poland;Romania;Russian Federation;Spain;Turkey |
| 8 | EUCTR2020-004284-98-GR (EUCTR) | 15/07/2021 | 05/04/2021 | Secukinumab open label roll-over extension protocol | An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment | Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis MedDRA version: 21.0;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;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 628 | Phase 4 | United States;Czechia;Greece;Spain;Guatemala;Russian Federation;Colombia;India;Egypt;Mexico;Poland;Belgium;Brazil;Malaysia;South Africa;Bulgaria;Korea, Republic of | ||
| 9 | EUCTR2019-004108-37-DE (EUCTR) | 09/07/2021 | 18/02/2021 | A study to determine how effective and safe the drug CC-99677 is for patients with active Ankylosing Spondylitis | A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 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] - Musculoskeletal Diseases [C05] | Product Code: CC-99677 60mg Capsule INN or Proposed INN: 146368 Other descriptive name: CC-99677 Product Code: CC-99677 30mg Capsule INN or Proposed INN: 146368 Other descriptive name: CC-99677 | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 256 | Phase 2 | United States;Czechia;Canada;Spain;Poland;Romania;Turkey;Russian Federation;Germany | ||
| 10 | NCT04934059 (ClinicalTrials.gov) | July 1, 2021 | 8/6/2021 | Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS). | A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis. | Ankylosing Spondylitis | Drug: Yuxuebi tablet;Drug: Placebo tablet | China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. | NULL | Not yet recruiting | 18 Years | 65 Years | All | 60 | Phase 4 | China |
| 11 | NCT04840485 (ClinicalTrials.gov) | June 9, 2021 | 7/4/2021 | Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis | A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase II/III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: SHR-1314;Drug: Placebo | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | NULL | Recruiting | 18 Years | N/A | All | 529 | Phase 2/Phase 3 | China |
| 12 | NCT04885751 (ClinicalTrials.gov) | June 1, 2021 | 26/4/2021 | Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy | Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid: A Single-center, Randomized, Open Labeled, Pilot Study | Rheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis;Other Musculoskeletal Disorder;Gastric Ulcer;Enteritis;NSAID-Associated Gastropathy;NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy | Drug: Eupatilin;Drug: Rebamipide | Seoul National University Boramae Hospital | Dong-A ST Co., Ltd. | Not yet recruiting | 19 Years | 70 Years | All | 50 | Phase 4 | NULL |
| 13 | NCT04527380 (ClinicalTrials.gov) | April 13, 2021 | 24/8/2020 | A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Psoriatic Arthritis;Enthesitis Related Arthritis | Drug: Ixekizumab;Drug: Adalimumab | Eli Lilly and Company | NULL | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | Argentina;Belgium;Czechia;Denmark;France;Germany;Italy;Mexico;Netherlands;Spain;Switzerland;United Kingdom |
| 14 | ChiCTR2100044377 | 2021-04-01 | 2021-03-17 | Study on the curative effect of spectrum therapy instrument in ankylosing spondylitis | Study on the curative effect of spectrum therapy instrument in ankylosing spondylitis | Ankylosing spondylitis | AS Spectrum Treatment Group:None; | The First Affiliated Hospital of Suzhou University | NULL | Recruiting | 19 | 74 | Both | AS Spectrum Treatment Group:40; | China | |
| 15 | ChiCTR2100044284 | 2021-03-09 | 2021-03-14 | Study on the effect of ginger with different thickness on the treatment of ankylosing spondylitis | Effect of Fuyang and Dumoxibustion on Ankylosing Spondylitis of Kidney-Yang Deficiency and on TNF-a and IL-6 | Ankylosing spondylitis | The control group:Celecoxib 20mg once daily;Ginger tube moxibustion group:Oral celecoxib 20mg once a day, combined with Du moxibustion (ginger thickness 3cm);Thick ginger du moxibustion group:Oral celecoxib 20mg once a day, combined with Du moxibustion (ginger 5cm thickness); | Affiliated Hospital of Nanjing University of Chinese Medicine | NULL | Recruiting | 18 | 60 | Male | The control group:20;Ginger tube moxibustion group:20;Thick ginger du moxibustion group:20; | China | |
| 16 | ChiCTR2100044045 | 2021-03-08 | 2021-03-09 | Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases including rheumatoid arthritis, ankylosing spondylitis and psoriasis | Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases including rheumatoid arthritis, ankylosing spondylitis and psoriasis | Immune-Mediated Inflammatory Diseases | Case series:Adalimumab; | Mianyang Hospital of Traditional Chinese Medicine | NULL | Recruiting | Both | Case series:50; | Phase 4 | China | ||
| 17 | EUCTR2018-000681-10-CZ (EUCTR) | 25/02/2021 | 22/12/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 18 | NCT04839315 (ClinicalTrials.gov) | February 15, 2021 | 5/4/2021 | COVID-19 Vaccination in Rheumatic Disease Patients | Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases | Systemic Lupus Erythematosus;Sjogren's Syndrome;Inflammatory Myositis;Psoriatic Arthritis;Gout;Ankylosing Spondylitis;Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis);Osteoarthritis | Biological: mRNA COVD19 vaccine | Mayo Clinic | NULL | Recruiting | 18 Years | N/A | All | 100 | Early Phase 1 | United States |
| 19 | ChiCTR2100043171 | 2021-02-08 | 2021-02-07 | Efficacy and safety of iguratimod combined with NSAIDs in the treatment of AXSPA /AS in the real world | Efficacy and safety of iguratimod combined with NSAIDs in the treatment of AXSPA /AS in the real world | Axial spinal arthritis/ankylosing spondylitis | test group:Iguratimod; | Qilu Hospital of Shandong University | NULL | Recruiting | Male | test group:278; | Phase 4 | China | ||
| 20 | EUCTR2020-004284-98-BG (EUCTR) | 05/02/2021 | 29/01/2021 | Secukinumab open label roll-over extension protocol | An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment | Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis MedDRA version: 21.0;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;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 628 | Phase 4 | United States;Czechia;Greece;Spain;Guatemala;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Mexico;Poland;Belgium;Brazil;Malaysia;Bulgaria;South Africa;Germany;Sweden;Korea, Republic of | ||
| 21 | ChiCTR2100042789 | 2021-02-01 | 2021-01-28 | Clinical Study on the Treatment of Ankylosing Spondylitis with Integrated Traditional Chinese and Western Medicine | Clinical Study on the Treatment of Ankylosing Spondylitis with Integrated Traditional Chinese and Western Medicine | Ankylosing Spondylitis | integrated traditional Chinese and western medicine:Bushen-Qiangdu-Zhilv decoction and Celecoxib Capsules; | Guangdong Provincial Hospital of Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | integrated traditional Chinese and western medicine:27; | China | |
| 22 | ChiCTR2100042477 | 2021-02-01 | 2021-01-22 | High-flow nasal cannula oxygen during endotracheal intubation in patients with ankylosing spondylitis: a prospective, single-arm study | High-flow nasal cannula oxygen during endotracheal intubation in patients with ankylosing spondylitis : a prospective, single-arm study | ankylosing spondylitis | Group HFNC:Nasal high-flow oxygen inhalation before tracheal intubation; | Shenzhen Second People's Hospital | NULL | Pending | 18 | 50 | Both | Group HFNC:30; | China | |
| 23 | EUCTR2018-000681-10-IT (EUCTR) | 23/12/2020 | 24/05/2021 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis - TALZ | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) Product Name: Ixekizumab Product Code: [TALTZ] INN or Proposed INN: ixekizumab Trade Name: Humira Product Name: Humira Product Code: [L04AB04] INN or Proposed INN: Adalimumab | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 24 | EUCTR2018-000681-10-DK (EUCTR) | 14/12/2020 | 31/08/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 25 | JPRN-JapicCTI-205414 | 12/12/2020 | 18/08/2020 | A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis | A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis | Nonradiographic axial spondyloarthritis / Ankylosing spondylitis | Intervention name : UCB4940 INN of the intervention : bimekizumab Dosage And administration of the intervention : 160mg administered by sc injection Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | recruiting | 18 | BOTH | 30 | Phase 3 | Japan, Asia except Japan, North America, Europe | |
| 26 | EUCTR2019-001684-77-HU (EUCTR) | 07/12/2020 | 08/12/2020 | A trial to test whether BI 730357 is effective in patients with active ankylosing spondylitis | A 12-weeks Phase II, randomized, double-blind, placebocontrolled, parallel-group, proof-of-concept trial of BI 730357 in patients with active ankylosing spondylitis | axial spondyloarthritis MedDRA version: 21.1;Level: LLT;Classification code 10041672;Term: Spondylitis ankylosing;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Physical Phenomena [G01] | Product Code: BI 730357 INN or Proposed INN: BI 730357 Other descriptive name: BI 730357 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Czechia;Hungary;Spain;Belgium;Ukraine;Romania;Georgia;Germany;Moldova, Republic of;Korea, Republic of | ||
| 27 | NCT04483700 (ClinicalTrials.gov) | December 2020 | 20/7/2020 | Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy | Ankylosing Spondylitis | Drug: Filgotinib;Drug: Placebo to Match Filgotinib | Gilead Sciences | Galapagos NV | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | NULL |
| 28 | NCT04483687 (ClinicalTrials.gov) | December 2020 | 20/7/2020 | Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy | Ankylosing Spondylitis | Drug: Filgotinib;Drug: Placebo to Match Filgotinib | Gilead Sciences | Galapagos NV | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | NULL |
| 29 | NCT04507659 (ClinicalTrials.gov) | December 2020 | 4/8/2020 | Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis | A Multi-center, Randomized, Double-blind, Placebo, Parallel-controlled Phase ? Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Jaktinib Hydrochloride Tablets;Drug: Placebo | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | NULL | Not yet recruiting | 18 Years | 65 Years | All | 105 | Phase 2 | NULL |
| 30 | EUCTR2018-000681-10-GB (EUCTR) | 24/11/2020 | 11/09/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;Switzerland;Italy;United Kingdom | ||
| 31 | EUCTR2018-000681-10-DE (EUCTR) | 23/11/2020 | 07/08/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 32 | NCT04481139 (ClinicalTrials.gov) | October 21, 2020 | 15/7/2020 | A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis Subjects | Ankylosing Spondylitis | Drug: SHR0302;Drug: SHR0302 placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 480 | Phase 2/Phase 3 | China |
| 33 | EUCTR2019-004163-47-GB (EUCTR) | 08/10/2020 | 05/08/2020 | A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis | A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 34 | ChiCTR2000038277 | 2020-10-01 | 2020-09-15 | The factor analysis of curative effect of AS and the indications analysis of Long-snake moxibustion based on content analysis method | The factor analysis of curative effect of AS and the indications analysis of Long-snake moxibustion based on content analysis method | Ankylosing spondylitis | Trial Group:Long-snake moxibustion;Control Group:Sulfasalazine Enteric-coated Tablets; | Nanchang Hongdu Hospital of TCM | NULL | Recruiting | 18 | 50 | Both | Trial Group:20;Control Group:20; | N/A | China |
| 35 | NCT04507763 (ClinicalTrials.gov) | August 1, 2020 | 27/7/2020 | Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis | Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Ankylosing Spondylitis (AS) With Etanercept | Ankylosing Spondylitis | Drug: Etanercept | Pfizer | NULL | Completed | 18 Years | N/A | All | 1 | Iraq | |
| 36 | EUCTR2019-004163-47-DE (EUCTR) | 23/07/2020 | 27/04/2020 | A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis | A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 37 | EUCTR2019-001177-90-SE (EUCTR) | 30/06/2020 | 17/12/2019 | Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpA | A randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of | ||
| 38 | EUCTR2019-003229-12-DE (EUCTR) | 30/06/2020 | 05/12/2019 | Evaluation of upadacitinib in adult subjects with axial spondyloarthritis | A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 690 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 39 | EUCTR2019-004163-47-HU (EUCTR) | 16/06/2020 | 01/04/2020 | A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis | A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 40 | NCT04436640 (ClinicalTrials.gov) | June 16, 2020 | 15/6/2020 | A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis | A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis | Axial Spondyloarthritis;Ankylosing Spondylitis;r-axSpa | Drug: Bimekizumab | UCB Biopharma SRL | NULL | Enrolling by invitation | 18 Years | N/A | All | 485 | Phase 3 | United States;Belgium;Bulgaria;China;Czechia;France;Germany;Hungary;Japan;Netherlands;Poland;Spain;Turkey;United Kingdom |
| 41 | EUCTR2019-003229-12-IT (EUCTR) | 09/06/2020 | 24/05/2021 | Evaluation of upadacitinib in adult subjects with axial spondyloarthritis | A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis - na | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: UPADACITINIB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 690 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 42 | EUCTR2019-004163-47-BG (EUCTR) | 04/06/2020 | 14/05/2020 | A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis | A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Japan;China;Netherlands;Germany;Bulgaria;Poland;Belgium;Hungary;Czech Republic;France;United Kingdom;Turkey;Spain;United States | ||
| 43 | EUCTR2019-004163-47-CZ (EUCTR) | 26/05/2020 | 07/04/2020 | A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis | A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 44 | NCT04402554 (ClinicalTrials.gov) | May 19, 2020 | 15/5/2020 | Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis | Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Behavioral: Cannabis questionnaire | University Hospital, Clermont-Ferrand | NULL | Completed | 18 Years | N/A | All | 501 | France | |
| 45 | EUCTR2019-001177-90-IT (EUCTR) | 06/05/2020 | 19/05/2021 | Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpA | A randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of | ||
| 46 | EUCTR2019-001177-90-BG (EUCTR) | 07/04/2020 | 12/02/2020 | Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpA | A randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Philippines;Czechia;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Malaysia;Belgium;Brazil;Bulgaria;Sweden;Korea, Republic of | ||
| 47 | EUCTR2019-003229-12-ES (EUCTR) | 10/03/2020 | 06/03/2020 | Evaluation of upadacitinib in adult subjects with axial spondyloarthritis | A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 690 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;China;Japan;New Zealand;Korea, Republic of | ||
| 48 | EUCTR2019-003229-12-GB (EUCTR) | 02/03/2020 | 16/12/2019 | Evaluation of upadacitinib in adult subjects with axial spondyloarthritis | A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 690 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 49 | EUCTR2019-001177-90-CZ (EUCTR) | 20/02/2020 | 19/12/2019 | Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpA | A randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | Korea, Republic of;Sweden;Bulgaria;Malaysia;Brazil;Belgium;Poland;Czech Republic;Egypt;India;Italy;Colombia;Russian Federation;Turkey;Guatemala;Thailand;Greece;Czechia;Philippines;United States | ||
| 50 | EUCTR2019-003229-12-HU (EUCTR) | 27/01/2020 | 02/12/2019 | Evaluation of upadacitinib in adult subjects with axial spondyloarthritis | A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 690 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 51 | EUCTR2019-001177-90-GR (EUCTR) | 23/01/2020 | 13/11/2019 | Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpA | A randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of | ||
| 52 | EUCTR2019-003229-12-SK (EUCTR) | 14/01/2020 | 15/11/2019 | Evaluation of upadacitinib in adult subjects with axial spondyloarthritis | A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Rinvoq Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 690 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 53 | NCT04156620 (ClinicalTrials.gov) | December 11, 2019 | 8/10/2019 | 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 | NULL | Active, not recruiting | 18 Years | N/A | All | 529 | Phase 3 | United States;Belgium;Brazil;Bulgaria;Colombia;Czechia;Greece;Guatemala;India;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Russian Federation;Sweden;Thailand;Turkey |
| 54 | NCT04205851 (ClinicalTrials.gov) | November 12, 2019 | 4/12/2019 | Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing Spondylitis | An Ascending Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Gimsilumab in Healthy Subjects and Subjects With Ankylosing Spondylitis | Inflammation;Rheumatic Diseases | Drug: KIN-1901;Drug: Placebo | Kinevant Sciences GmbH | NULL | Completed | 18 Years | 75 Years | All | 36 | Phase 1 | Canada |
| 55 | NCT04077957 (ClinicalTrials.gov) | October 7, 2019 | 1/9/2019 | 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 | NULL | Not yet recruiting | 18 Years | 50 Years | All | 100 | Phase 4 | China |
| 56 | JPRN-JapicCTI-194860 | 30/9/2019 | 16/07/2019 | 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 | Intervention name : UCB4940 INN of the intervention : bimekizumab Dosage And administration of the intervention : 160mg administered by sc injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd | NULL | complete | 18 | BOTH | 15 | Phase 3 | Japan, Asia except Japan, North America | |
| 57 | ChiCTR1900025749 | 2019-09-20 | 2019-09-07 | Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study | Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study | Ankylosing Spondylitis | Experimental:conventional synthetic Disease modifying anti-rheumatic drugs(csDMARDs);Experimental:Etanercept (Anbainuo 50mg per week, for 4 weeks);Experimental:Etanercept (Anbainuo 50mg per week, for 2 weeks);Positive Control:Etanercept (Anbainuo 50mg per week, for 12 weeks);Positive Control:Etanercept (Anbainuo 50mg per 10 days, for 12 weeks);Positive Control:Etanercept (Anbainuo 25mg per week, for 12 weeks);Positive Control:Etanercept (Anbainuo 25mg per 2 weeks, for 12 weeks); | Nanfang Hospital of Southern Medical University | NULL | Pending | 18 | 50 | Both | Experimental:50;Experimental:50;Experimental:50;Positive Control:50;Positive Control:50;Positive Control:50;Positive Control:50; | N/A | China |
| 58 | ChiCTR1900025635 | 2019-09-02 | 2019-09-03 | Three-dimensional kinematics and hip biomechanical study of hip joint replacement in ankylosing spondylitis | Three-dimensional kinematics and hip biomechanical study of hip joint replacement in ankylosing spondylitis | ankylosing spondylitis | Case series:unilateral THA was implanted on the same side with the same design and type of uncemented prosthesis, ankylosing spondylitis; | 99 Huaihai Road West, Xuzhou, Jiangsu, China | NULL | Pending | 18 | 75 | Both | Case series:20; | N/A | China |
| 59 | EUCTR2018-003933-14-BE (EUCTR) | 19/07/2019 | 24/04/2019 | 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;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;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 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: no Male: yes | 250 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 60 | EUCTR2017-003065-95-NL (EUCTR) | 03/07/2019 | 25/07/2019 | A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitis | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Netherlands;Germany;China;Japan | ||
| 61 | NCT04943237 (ClinicalTrials.gov) | July 1, 2019 | 19/6/2021 | Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing Spondylitis | Anti-TNF Therapy and Nerve Conduction Studies in Patients With Ankylosing Spondylitis | Anti - TNF Therapy;Ankylosing Spondylitis;Neuropathy | Drug: Anti-TNF agents;Drug: Conventional therapy users for the last 5 years | Istanbul Physical Medicine Rehabilitation Training and Research Hospital | NULL | Completed | 20 Years | 65 Years | All | 60 | Turkey | |
| 62 | EUCTR2017-003065-95-GB (EUCTR) | 01/07/2019 | 29/03/2019 | 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 63 | EUCTR2018-003933-14-BG (EUCTR) | 21/06/2019 | 27/03/2019 | 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: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;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 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | Czechia;Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 64 | EUCTR2017-003065-95-BG (EUCTR) | 19/06/2019 | 10/05/2019 | A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitis | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 65 | EUCTR2017-003065-95-CZ (EUCTR) | 17/06/2019 | 04/06/2019 | A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitis | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 66 | EUCTR2017-003065-95-FR (EUCTR) | 11/06/2019 | 21/05/2019 | 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 THEEFFICACY 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan | ||
| 67 | EUCTR2017-003065-95-DE (EUCTR) | 11/06/2019 | 04/02/2019 | A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitis | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 68 | EUCTR2018-003933-14-CZ (EUCTR) | 28/05/2019 | 29/04/2019 | 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: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;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 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of | ||
| 69 | EUCTR2018-003933-14-LV (EUCTR) | 27/05/2019 | 07/03/2019 | 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;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;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 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of | ||
| 70 | EUCTR2018-003933-14-ES (EUCTR) | 30/04/2019 | 21/05/2019 | 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;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;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 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 71 | EUCTR2017-003065-95-ES (EUCTR) | 29/04/2019 | 21/05/2019 | 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 THEEFFICACY 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 72 | NCT03928743 (ClinicalTrials.gov) | April 25, 2019 | 23/4/2019 | 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 | Drug: Bimekizumab;Other: Placebo | UCB Biopharma SRL | NULL | Active, not recruiting | 18 Years | N/A | All | 332 | Phase 3 | United States;Belgium;Bulgaria;China;Czechia;France;Germany;Hungary;Japan;Netherlands;Poland;Spain;Turkey;United Kingdom |
| 73 | EUCTR2017-003065-95-BE (EUCTR) | 19/04/2019 | 26/02/2019 | A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitis | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 74 | EUCTR2017-003065-95-HU (EUCTR) | 16/04/2019 | 25/03/2019 | 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 THEEFFICACY 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 75 | EUCTR2018-003933-14-EE (EUCTR) | 09/04/2019 | 14/03/2019 | 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: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;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 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia | ||
| 76 | ChiCTR2000034142 | 2019-04-01 | 2020-06-26 | Study on TCM Syndrome Classification and Diagnosis and Treatment of Ankylosing Spondylitis by Metabolomics | Study on TCM Syndrome Classification and Diagnosis and Treatment of Ankylosing Spondylitis by Metabolomics | Ankylosing spondylitis | Experimental group:Take Chinese medicine preparation Wen-Shen Juan-Bi-Tang orally;Experimental group 2:Take Chinese medicine preparation modified Wen-Shen Juan-Bi-Tang orally;NSAID:Take celecoxib orally; | Jiangsu Province Hospital of TCM | NULL | Pending | 25 | 70 | Both | Experimental group:40;Experimental group 2:40;NSAID:40; | N/A | China |
| 77 | EUCTR2017-000679-10-GR (EUCTR) | 05/03/2019 | 19/12/2018 | 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 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 78 | NCT03733925 (ClinicalTrials.gov) | January 7, 2019 | 5/11/2018 | 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 | NULL | Completed | 18 Years | N/A | All | 100 | Phase 4 | India |
| 79 | NCT03839862 (ClinicalTrials.gov) | January 1, 2019 | 11/2/2019 | 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 | NULL | Recruiting | 18 Years | N/A | All | 50 | Sweden | |
| 80 | ChiCTR1800019227 | 2018-11-26 | 2018-10-31 | 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 | NULL | Pending | 16 | 65 | Both | spondyloarthritis(SpA)/ankylosing spondylitis(AS):72;Control group:36; | China | |
| 81 | JPRN-JapicCTI-184106 | 07/11/2018 | 11/09/2018 | 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. | NULL | complete | 18 | BOTH | 15 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa | |
| 82 | EUCTR2017-004226-15-DK (EUCTR) | 26/10/2018 | 05/01/2018 | 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;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 Other descriptive name: CANNABIDIOL Product Name: Dronabinol capsule 2.5. mg INN or Proposed INN: DRONABINOL | King Christian 10th Hospital for Rheumatology | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Denmark | ||
| 83 | EUCTR2017-000679-10-SK (EUCTR) | 24/10/2018 | 02/10/2017 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 84 | EUCTR2018-000226-58-DE (EUCTR) | 18/10/2018 | 16/05/2018 | 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] | Product Name: Tofacitinib 5 mg Product Code: CP-690,550 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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 | ||
| 85 | EUCTR2018-001060-35-ES (EUCTR) | 19/09/2018 | 17/07/2018 | 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;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 INN or Proposed INN: Tildrakizumab Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody | Sun Pharma Global FZE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine;Russian Federation | ||
| 86 | EUCTR2018-001060-35-HU (EUCTR) | 29/08/2018 | 21/06/2018 | A long-term extension study to investigate the safety of Tildrakizumab in patients with Psoricatic Arthritis who have previously completed other studies with Tildrakizumab | A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab | Psoriatic Arthritis (PsA) MedDRA version: 21.0;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;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] | Trade Name: Ilumetri Product Name: Tildrakizumab 100 mg/ml Product Code: MK-3222 INN or Proposed INN: Tildrakizumab Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody | Sun Pharma Global FZE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 286 | Phase 3 | United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine;Russian Federation | ||
| 87 | NCT03636984 (ClinicalTrials.gov) | August 24, 2018 | 13/8/2018 | 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. | NULL | Not yet recruiting | 18 Years | N/A | All | 1000 | NULL | |
| 88 | EUCTR2018-000226-58-GB (EUCTR) | 13/08/2018 | 15/05/2018 | 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] | Product Name: Tofacitinib 5 mg Product Code: CP-690,550 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of | ||
| 89 | EUCTR2018-000226-58-BG (EUCTR) | 07/08/2018 | 31/05/2018 | 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] | Product Name: Tofacitinib 5 mg Product Code: CP-690,550 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of | ||
| 90 | EUCTR2017-000957-37-NL (EUCTR) | 18/07/2018 | 31/10/2017 | 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 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 INN or Proposed INN: Bimekizumab Trade Name: Cimzia 200 mg solution for injection Product Name: Certolizumab Pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Netherlands;Moldova, Republic of | ||
| 91 | EUCTR2017-000679-10-PT (EUCTR) | 16/07/2018 | 15/01/2018 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 837 | Phase 3 | Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 92 | EUCTR2018-000226-58-FR (EUCTR) | 12/07/2018 | 23/04/2018 | 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 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of | ||
| 93 | EUCTR2018-000226-58-CZ (EUCTR) | 09/07/2018 | 04/05/2018 | 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 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of | ||
| 94 | EUCTR2018-000226-58-AT (EUCTR) | 06/07/2018 | 14/05/2018 | 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] | Product Name: Tofacitinib 5 mg Product Code: CP-690,550 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | 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 | ||
| 95 | EUCTR2018-000226-58-ES (EUCTR) | 04/07/2018 | 09/05/2018 | 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 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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 | ||
| 96 | EUCTR2018-000226-58-HU (EUCTR) | 26/06/2018 | 26/04/2018 | 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 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | 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;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of | ||
| 97 | EUCTR2017-000679-10-PL (EUCTR) | 19/06/2018 | 28/03/2018 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan | ||
| 98 | EUCTR2017-000679-10-NL (EUCTR) | 07/06/2018 | 18/12/2017 | 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 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 99 | NCT03502616 (ClinicalTrials.gov) | June 7, 2018 | 11/4/2018 | 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 | NULL | Completed | 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 |
| 100 | ChiCTR-INR-17013574 | 2018-06-01 | 2017-11-28 | 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 | NULL | Pending | 16 | 25 | Male | control group :40;Intervention group :40; | China | |
| 101 | EUCTR2017-004850-40-NL (EUCTR) | 25/04/2018 | 28/02/2018 | 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 | VU Medical Center, department of Rheumatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 4 | Netherlands | ||
| 102 | EUCTR2017-000431-14-HR (EUCTR) | 06/04/2018 | 19/04/2018 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 103 | NCT03350815 (ClinicalTrials.gov) | March 13, 2018 | 31/10/2017 | 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 | NULL | Completed | 18 Years | N/A | All | 323 | Phase 4 | United States |
| 104 | NCT03473665 (ClinicalTrials.gov) | March 1, 2018 | 13/3/2018 | 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 | NULL | Terminated | 18 Years | N/A | All | 9 | Phase 4 | United States |
| 105 | EUCTR2017-000431-14-DE (EUCTR) | 21/02/2018 | 31/07/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 106 | NCT03447704 (ClinicalTrials.gov) | February 9, 2018 | 21/2/2018 | 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 | Drug: BCD-085;Other: placebo | Biocad | NULL | Active, not recruiting | 18 Years | 65 Years | All | 228 | Phase 3 | Russian Federation |
| 107 | EUCTR2017-000431-14-SE (EUCTR) | 24/01/2018 | 20/12/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 108 | EUCTR2017-000679-10-FR (EUCTR) | 22/01/2018 | 22/09/2017 | 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 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany | ||
| 109 | EUCTR2017-001002-15-DE (EUCTR) | 22/01/2018 | 20/09/2017 | A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab 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 - BE AGILE 2 | 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 INN or Proposed INN: BIMEKIZUMAB | UCB BIOPHARMA SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 285 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Poland;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 110 | EUCTR2017-004037-93-DK (EUCTR) | 17/01/2018 | 07/11/2017 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Afdeling for Rygkirurgi, Led- og Bindevævssygdomme ; Rigshospitalet - Glostrup | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | Phase 4 | Denmark | ||
| 111 | EUCTR2017-000679-10-CZ (EUCTR) | 10/01/2018 | 25/09/2017 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 112 | EUCTR2017-000431-14-NL (EUCTR) | 05/01/2018 | 22/08/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 113 | ChiCTR-DDD-17014196 | 2018-01-01 | 2017-12-28 | HLA-B27 tested by different methods and comparison | HLA-B27 tested by different methods and comparison | Ankylosing spondylitis | Gold Standard:Detect HLA-B27 by cytometry;Index test:SSP and SSO; | Dalian Blood Center | NULL | Recruiting | 5 | 90 | Both | Target condition:200;Difficult condition:0 | China | |
| 114 | EUCTR2017-000431-14-GB (EUCTR) | 28/12/2017 | 08/08/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 115 | EUCTR2017-001970-41-DK (EUCTR) | 21/12/2017 | 15/09/2017 | 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: 21.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10062719;Term: Seronegative rheumatoid arthritis;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859 MedDRA version: 21.1;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;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 INN or Proposed INN: ABATACEPT Trade Name: Orencia Product Name: Abatacept Product Code: L04AA24 INN or Proposed INN: ABATACEPT Trade Name: Humira Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: L04AB05 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Enbrel Product Name: Etanercept Product Code: L04AB01 INN or Proposed INN: ETANERCEPT | MD, PhD Salome Kristensen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Denmark | ||
| 116 | EUCTR2017-000679-10-FI (EUCTR) | 18/12/2017 | 05/10/2017 | 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 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 117 | EUCTR2017-001002-15-BG (EUCTR) | 18/12/2017 | 26/09/2017 | 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 - BE AGILE 2 | 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 285 | Phase 2 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 118 | EUCTR2017-000679-10-DE (EUCTR) | 18/12/2017 | 24/08/2017 | 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 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 119 | NCT03411798 (ClinicalTrials.gov) | December 15, 2017 | 14/12/2017 | 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 | NULL | Completed | N/A | N/A | All | 76 | Phase 4 | China |
| 120 | EUCTR2017-000431-14-CZ (EUCTR) | 13/12/2017 | 08/08/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2;Phase 3 | Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Portugal;United States;Finland;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 121 | NCT03259074 (ClinicalTrials.gov) | November 30, 2017 | 21/8/2017 | Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) | 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 | Biological: Secukinumab;Biological: GP2017 (adalimumab biosimilar) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 860 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Chile;Colombia;Czechia;Denmark;Finland;France;Germany;Greece;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;United Kingdom;Monaco |
| 122 | NCT03355573 (ClinicalTrials.gov) | November 28, 2017 | 22/11/2017 | 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 | Ankylosing Spondylitis | Drug: Bimekizumab | UCB Biopharma SRL | NULL | Active, not recruiting | 18 Years | N/A | All | 256 | Phase 2 | United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine |
| 123 | EUCTR2017-000679-10-ES (EUCTR) | 23/11/2017 | 18/09/2017 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | 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 | ||
| 124 | EUCTR2017-000679-10-DK (EUCTR) | 23/11/2017 | 25/10/2017 | 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 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 125 | EUCTR2017-000679-10-GB (EUCTR) | 16/11/2017 | 08/08/2017 | 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 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 837 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan | ||
| 126 | EUCTR2017-000431-14-BE (EUCTR) | 15/11/2017 | 30/08/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 127 | EUCTR2017-000957-37-DE (EUCTR) | 15/11/2017 | 14/07/2017 | Study to test the efficacy and safety of bimekizumab andcertolizumab 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 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 INN or Proposed INN: Bimekizumab Trade Name: Cimzia 200 mg solution for injection Product Name: Certolizumab Pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Netherlands;United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Moldova, Republic of | ||
| 128 | EUCTR2017-000431-14-PL (EUCTR) | 15/11/2017 | 20/10/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 129 | EUCTR2017-001002-15-ES (EUCTR) | 13/11/2017 | 02/10/2017 | 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 285 | Phase 2 | Hungary;Spain;Germany | ||
| 130 | EUCTR2017-000431-14-FR (EUCTR) | 13/11/2017 | 19/07/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2;Phase 3 | Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of;Portugal;United States;Finland;Spain;Switzerland;United Kingdom;France;Hungary | ||
| 131 | NCT02980705 (ClinicalTrials.gov) | November 6, 2017 | 30/11/2016 | 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 Pharmaceutical Industries Limited | NULL | Terminated | 18 Years | N/A | All | 180 | Phase 2 | United States;Hungary;Poland;Spain |
| 132 | NCT03357471 (ClinicalTrials.gov) | November 3, 2017 | 23/11/2017 | 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. | NULL | Completed | 18 Years | N/A | All | 70 | Phase 3 | United States |
| 133 | NCT03329885 (ClinicalTrials.gov) | November 2, 2017 | 31/10/2017 | A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants 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 | Drug: BMS-986251;Other: Placebo | Bristol-Myers Squibb | NULL | Terminated | 18 Years | 70 Years | All | 38 | Phase 1/Phase 2 | Netherlands |
| 134 | EUCTR2017-001002-15-CZ (EUCTR) | 01/11/2017 | 29/08/2017 | A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab 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 INN or Proposed INN: BIMEKIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 285 | Phase 2 | Hungary;Czech Republic;Spain;Bulgaria;Germany | ||
| 135 | NCT03322618 (ClinicalTrials.gov) | November 2017 | 17/10/2017 | 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 | NULL | Not yet recruiting | 18 Years | N/A | All | 36 | N/A | France |
| 136 | EUCTR2017-001002-15-HU (EUCTR) | 25/10/2017 | 29/08/2017 | A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab 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 INN or Proposed INN: BIMEKIZUMAB | UCB BIOSCIENCES GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 285 | Phase 2 | Hungary | ||
| 137 | NCT03178487 (ClinicalTrials.gov) | October 24, 2017 | 5/6/2017 | A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis | Ankylosing Spondylitis (AS) | Drug: Upadacitinib;Drug: Placebo | AbbVie | NULL | Completed | 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 |
| 138 | EUCTR2017-000431-14-PT (EUCTR) | 09/10/2017 | 09/08/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 139 | EUCTR2017-000957-37-GR (EUCTR) | 05/10/2017 | 13/09/2017 | Study to test the efficacy and safety of Bimekizumab andCertolizumab 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 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 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 Trade Name: Cimzia 200 mg solution for injection Product Name: Certolizumab Pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Moldova, Republic of;Germany;Netherlands;Russian Federation;Australia;Poland;Greece;Czech Republic;United States | ||
| 140 | NCT03215277 (ClinicalTrials.gov) | October 4, 2017 | 5/7/2017 | 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. | NULL | Completed | 18 Years | N/A | All | 76 | Phase 2 | United States;Czechia;Germany;Greece;Moldova, Republic of;Netherlands;Poland;Russian Federation;Australia |
| 141 | EUCTR2017-000431-14-ES (EUCTR) | 02/10/2017 | 08/08/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2;Phase 3 | Portugal;United States;Hungary;Canada;Spain;Australia;New Zealand;Japan;Switzerland;Korea, Republic of | ||
| 142 | NCT04480359 (ClinicalTrials.gov) | October 1, 2017 | 16/7/2020 | Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis | The Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Bawei Shenqi Pill;Drug: Bawei Shenqi Pill placebo;Drug: Meloxicam | Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 18 Years | 70 Years | All | 80 | Phase 2/Phase 3 | China |
| 143 | EUCTR2017-000431-14-HU (EUCTR) | 26/09/2017 | 04/09/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 144 | EUCTR2017-000957-37-CZ (EUCTR) | 25/09/2017 | 12/07/2017 | 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 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 INN or Proposed INN: Bimekizumab Trade Name: Cimzia 200 mg solution for injection Product Name: Certolizumab Pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of | ||
| 145 | EUCTR2017-000431-14-DK (EUCTR) | 25/09/2017 | 25/07/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 146 | EUCTR2017-000431-14-FI (EUCTR) | 06/09/2017 | 01/08/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis | Active Ankylosing Spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2;Phase 3 | Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 147 | EUCTR2016-001102-42-GB (EUCTR) | 24/05/2017 | 22/03/2017 | 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: 19.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: bimekizumab Product Code: UCB4940 INN or Proposed INN: bimekizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 285 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom | ||
| 148 | NCT03140657 (ClinicalTrials.gov) | April 29, 2017 | 28/4/2017 | 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 | NULL | Completed | 23 Years | 46 Years | All | 24 | Phase 2 | Iran, Islamic Republic of |
| 149 | EUCTR2016-003636-21-BE (EUCTR) | 12/04/2017 | 13/02/2017 | 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: 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: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Estonia;Czech Republic;Poland;Spain;Belgium;Ukraine;Bulgaria;Germany | ||
| 150 | EUCTR2016-003636-21-BG (EUCTR) | 11/04/2017 | 03/02/2017 | 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: 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: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany | ||
| 151 | EUCTR2016-003936-19-ES (EUCTR) | 04/04/2017 | 10/02/2017 | 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 INN or Proposed INN: Tildrakizumab Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody | SUN Pharmaceuticals Global FZE | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom | ||
| 152 | EUCTR2016-003936-19-HU (EUCTR) | 20/03/2017 | 06/01/2017 | 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 INN or Proposed INN: Tildrakizumab Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody | SUN Pharmaceuticals Global FZE | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom | ||
| 153 | NCT03117270 (ClinicalTrials.gov) | March 7, 2017 | 30/3/2017 | 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 | NULL | Completed | 18 Years | N/A | All | 116 | Phase 2 | Belgium;Bulgaria;Czechia;Estonia;Poland;Spain;Ukraine |
| 154 | EUCTR2016-003636-21-CZ (EUCTR) | 14/02/2017 | 19/12/2016 | 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: 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: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany | ||
| 155 | EUCTR2016-001102-42-BG (EUCTR) | 10/02/2017 | 05/01/2017 | 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: 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 INN or Proposed INN: bimekizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 285 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom | ||
| 156 | EUCTR2016-001102-42-DE (EUCTR) | 09/02/2017 | 16/11/2016 | 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: 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 INN or Proposed INN: bimekizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 285 | Phase 2 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany | ||
| 157 | EUCTR2016-003636-21-ES (EUCTR) | 01/02/2017 | 22/12/2016 | 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 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany | ||
| 158 | EUCTR2016-003636-21-EE (EUCTR) | 26/01/2017 | 08/12/2016 | 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 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Czech Republic;Estonia;Spain;Poland;Belgium;Ukraine;Bulgaria;Germany | ||
| 159 | EUCTR2016-001102-42-ES (EUCTR) | 28/12/2016 | 27/10/2016 | 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 INN or Proposed INN: bimekizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 285 | Phase 2 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany | ||
| 160 | EUCTR2016-001102-42-CZ (EUCTR) | 16/12/2016 | 03/11/2016 | 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: 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 INN or Proposed INN: bimekizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 285 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom | ||
| 161 | NCT04135508 (ClinicalTrials.gov) | December 13, 2016 | 17/10/2019 | 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 | NULL | Completed | 16 Years | 65 Years | All | 554 | Phase 3 | NULL |
| 162 | EUCTR2016-001102-42-HU (EUCTR) | 21/11/2016 | 28/09/2016 | 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 INN or Proposed INN: bimekizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 285 | Phase 2 | United States;Czech Republic;Hungary;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany | ||
| 163 | NCT02896127 (ClinicalTrials.gov) | October 18, 2016 | 4/5/2016 | 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 | NULL | Completed | 18 Years | N/A | All | 458 | Phase 3 | China;Czechia;Korea, Republic of;United Kingdom;Czech Republic |
| 164 | EUCTR2016-002061-54-IT (EUCTR) | 13/10/2016 | 15/11/2018 | 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;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;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 | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | ||
| 165 | NCT02963506 (ClinicalTrials.gov) | October 2016 | 10/11/2016 | A 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. | NULL | Completed | 18 Years | N/A | All | 303 | Phase 2 | United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic |
| 166 | NCT02893254 (ClinicalTrials.gov) | September 22, 2016 | 29/8/2016 | 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. | NULL | Completed | 18 Years | 65 Years | All | 438 | Phase 3 | NULL |
| 167 | EUCTR2015-005021-39-CZ (EUCTR) | 15/09/2016 | 14/07/2016 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 454 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Korea, Democratic People's Republic of;China;United Kingdom | ||
| 168 | NCT02763111 (ClinicalTrials.gov) | September 2016 | 3/4/2016 | 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 | NULL | Completed | 18 Years | 65 Years | All | 88 | Phase 2 | NULL |
| 169 | NCT02758782 (ClinicalTrials.gov) | September 2016 | 20/4/2016 | 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 | NULL | Completed | 18 Years | N/A | All | 156 | Phase 4 | Germany |
| 170 | EUCTR2015-005021-39-GB (EUCTR) | 04/08/2016 | 12/07/2016 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 454 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Korea, Democratic People's Republic of;China;United Kingdom | ||
| 171 | EUCTR2016-000615-33-DE (EUCTR) | 29/07/2016 | 06/07/2016 | 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 (CONSUL) | 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 (CONSUL) - CONSUL | ankylosing spondylitis (AS) MedDRA version: 21.1;Level: LLT;Classification code 10041672;Term: Spondylitis ankylosing;System Organ Class: 100000004859 MedDRA version: 21.1;Classification code 10048398;Term: Spondylitis ankylosing aggravated;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Simponi Trade Name: Celebrex | Charite Universitaetsmedizin | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 4 | Germany | ||
| 172 | NCT03932006 (ClinicalTrials.gov) | June 30, 2016 | 26/4/2019 | 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 | NULL | Recruiting | 18 Years | 65 Years | All | 180 | Phase 4 | China |
| 173 | NCT03557853 (ClinicalTrials.gov) | June 2016 | 5/6/2018 | 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 | NULL | Unknown status | 18 Years | N/A | All | 39 | Russian Federation | |
| 174 | NCT02763046 (ClinicalTrials.gov) | May 31, 2016 | 3/5/2016 | Study 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 | Drug: Secukinumab (AIN457) 150 mg s.c.;Drug: Placebo - Secukinumab (AIN457) 150 mg s.c. | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 211 | Phase 4 | Germany |
| 175 | NCT02750800 (ClinicalTrials.gov) | April 7, 2016 | 13/4/2016 | Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) | Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis | Biological: Adalimumab;Behavioral: AbbVie Care 2.0 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 427 | Hungary | |
| 176 | NCT02750592 (ClinicalTrials.gov) | March 22, 2016 | 4/4/2016 | 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 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection. | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 30 | Phase 3 | Japan |
| 177 | EUCTR2015-004575-74-DE (EUCTR) | 16/03/2016 | 18/02/2016 | 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 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 190 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Germany | ||
| 178 | JPRN-JapicCTI-163241 | 01/3/2016 | 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. | NULL | 18 | BOTH | 30 | Phase 3 | NULL | |||
| 179 | EUCTR2015-001894-41-BG (EUCTR) | 12/02/2016 | 28/10/2015 | Multicenter study evaluating certolizumab pegol compared to placebo insubjects 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 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Hungary;Czech Republic;Canada;Poland;Australia;Russian Federation;Bulgaria | ||
| 180 | NCT02638896 (ClinicalTrials.gov) | January 2016 | 20/12/2015 | 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 | NULL | Not yet recruiting | 18 Years | 45 Years | Both | 100 | Phase 4 | NULL |
| 181 | NCT02762812 (ClinicalTrials.gov) | January 2016 | 4/4/2016 | 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 | NULL | Completed | 18 Years | 65 Years | All | 199 | Phase 3 | Russian Federation |
| 182 | EUCTR2015-001894-41-CZ (EUCTR) | 20/11/2015 | 21/08/2015 | 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 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Hungary;Czech Republic;Canada;Poland;Australia;Russian Federation;Bulgaria | ||
| 183 | NCT02809300 (ClinicalTrials.gov) | November 2015 | 20/6/2016 | 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 | NULL | Recruiting | 18 Years | N/A | Both | 80 | N/A | France |
| 184 | NCT02469753 (ClinicalTrials.gov) | October 23, 2015 | 9/6/2015 | 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 | NULL | Recruiting | 18 Years | N/A | All | 225 | Phase 3 | France;Monaco |
| 185 | EUCTR2015-001894-41-HU (EUCTR) | 16/10/2015 | 19/08/2015 | 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 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Czech Republic;Hungary;Canada;Poland;Australia;Russian Federation;Bulgaria | ||
| 186 | EUCTR2015-002284-42-FI (EUCTR) | 18/09/2015 | 28/08/2015 | The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit | INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT | rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify | Trade Name: Enbrel Product Name: etanercept Trade Name: Humira Product Name: adalimumab Trade Name: Cimzia Product Name: certolizumab pegol Trade Name: Simponi Product Name: golimumab Trade Name: Remicade Product Name: infliximab | READE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1650 | Phase 1 | Finland | ||
| 187 | NCT02552212 (ClinicalTrials.gov) | September 2015 | 15/9/2015 | 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 | Axial Spondyloarthritis;Nonradiographic Axial Spondyloarthritis;Nr-axSpA | Biological: Certolizumab Pegol;Other: Placebo | UCB BIOSCIENCES GmbH | NULL | Completed | 18 Years | N/A | All | 317 | Phase 3 | United States;Australia;Bulgaria;Canada;Czechia;Hungary;Poland;Russian Federation;Taiwan;Czech Republic |
| 188 | EUCTR2014-004887-39-PL (EUCTR) | 08/08/2015 | 07/07/2015 | A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd | NULL | Not Recruiting | Female: yes Male: yes | Poland | ||||
| 189 | ChiCTR-IPR-15006753 | 2015-08-01 | 2015-07-15 | A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of methotrexate in Chinese patients with active non-radiographic axial spondyloarthritis(SpA)/ankylosing spondylitis. | A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of methotrexate in Chinese patients with active non-radiographic axial spondyloarthritis(SpA)/ankylosing spondylitis. | spondyloarthritis(SpA)/ankylosing spondylitis(AS) | AS+peripheral arthritis:MTX;AS+peripheral arthritis:placebo;AS:MTX;AS:placebo;nr-axial SpA+peripheral arthritis:MTX;nr-axial SpA+peripheral arthritis:placebo;nr-xial SpA:MTX;nr-xial SpA:placebo; | Department of rheumatology of the Chinese PLA General Hospital | NULL | Pending | Both | AS+peripheral arthritis:77;AS+peripheral arthritis:77;AS:77;AS:77;nr-axial SpA+peripheral arthritis:77;nr-axial SpA+peripheral arthritis:77;nr-xial SpA:77;nr-xial SpA:77; | China | |||
| 190 | EUCTR2013-005575-41-GB (EUCTR) | 28/07/2015 | 27/02/2015 | 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 - MEASURE 4 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;United Kingdom;Switzerland;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 191 | EUCTR2013-005575-41-BG (EUCTR) | 28/05/2015 | 18/03/2015 | 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 - MEASURE 4 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 192 | NCT03800797 (ClinicalTrials.gov) | May 25, 2015 | 7/1/2019 | 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 | NULL | Completed | 18 Years | 65 Years | All | 70 | Phase 4 | China |
| 193 | NCT02159053 (ClinicalTrials.gov) | May 18, 2015 | 28/2/2014 | 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 | NULL | Completed | 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 |
| 194 | EUCTR2013-005575-41-ES (EUCTR) | 11/05/2015 | 03/03/2015 | 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 - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 17.1;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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;United States;Slovakia;Greece;Finland | ||
| 195 | EUCTR2013-005575-41-PL (EUCTR) | 04/05/2015 | 19/03/2015 | 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 - MEASURE 4 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 196 | NCT02492217 (ClinicalTrials.gov) | May 2015 | 3/7/2015 | 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 | NULL | Completed | 18 Years | 75 Years | All | 69 | Phase 4 | Portugal |
| 197 | EUCTR2013-005575-41-NO (EUCTR) | 29/04/2015 | 23/02/2015 | 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 - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 17.1;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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Netherlands;Germany;Norway | ||
| 198 | EUCTR2013-005575-41-DE (EUCTR) | 27/04/2015 | 03/02/2015 | 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 - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 18.0;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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 199 | EUCTR2013-005575-41-SK (EUCTR) | 16/04/2015 | 13/03/2015 | 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 - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 18.0;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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 200 | EUCTR2013-005575-41-DK (EUCTR) | 13/04/2015 | 25/02/2015 | 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 - MEASURE 4 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany | ||
| 201 | EUCTR2013-005575-41-NL (EUCTR) | 13/04/2015 | 10/02/2015 | 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 - MEASURE 4 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands | ||
| 202 | NCT02293681 (ClinicalTrials.gov) | April 10, 2015 | 14/11/2014 | 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 | NULL | Terminated | 16 Years | 40 Years | All | 76 | N/A | China |
| 203 | EUCTR2013-005575-41-FI (EUCTR) | 08/04/2015 | 20/02/2015 | 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 - MEASURE 4 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 204 | EUCTR2013-005575-41-GR (EUCTR) | 02/04/2015 | 29/04/2015 | 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 - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 18.0;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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 205 | EUCTR2013-005575-41-CZ (EUCTR) | 31/03/2015 | 30/01/2015 | 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 - MEASURE 4 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 206 | EUCTR2013-005575-41-AT (EUCTR) | 23/03/2015 | 05/02/2015 | 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 - MEASURE 4 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 207 | EUCTR2013-005575-41-IT (EUCTR) | 05/03/2015 | 11/03/2016 | 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 - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 18.1;Level: LLT;Classification code 10002555;Term: Ankles swollen;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | NOVARTIS FARMA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | Slovakia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway | ||
| 208 | NCT02359903 (ClinicalTrials.gov) | February 2015 | 30/1/2015 | 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 | NULL | Completed | 18 Years | 65 Years | All | 90 | Phase 1 | Belarus;Russian Federation |
| 209 | NCT02333383 (ClinicalTrials.gov) | December 31, 2014 | 6/1/2015 | Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients | A Prospective, Mono-Country, Multi-Center Study to Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis Patients on Adalimumab Therapy | Ankylosing Spondylitis | Drug: Adalimumab | AbbVie | NULL | Completed | 19 Years | 100 Years | All | 201 | Korea, Republic of | |
| 210 | EUCTR2014-000241-74-DE (EUCTR) | 30/12/2014 | 01/10/2014 | 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 - GO - ALIVE | 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] - Immune System Diseases [C20] | Product Name: golimumab INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti-TNFa monoclonal antibody | Janssen Biologics, BV | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Mexico;Canada;Poland;Brazil;Ukraine;Romania;Australia;Russian Federation;Germany;Korea, Republic of | ||
| 211 | NCT02328027 (ClinicalTrials.gov) | December 11, 2014 | 18/12/2014 | 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 | NULL | Terminated | 18 Years | N/A | All | 16 | Phase 1/Phase 2 | Switzerland |
| 212 | ChiCTR1800014846 | 2014-12-01 | 2018-02-09 | 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 | NULL | Completed | Both | Experiment group:50;Control Group:50; | China | |||
| 213 | NCT01934933 (ClinicalTrials.gov) | September 24, 2014 | 17/8/2013 | 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 | NULL | Completed | 18 Years | 65 Years | All | 150 | Phase 4 | China |
| 214 | EUCTR2011-005689-39-SK (EUCTR) | 24/09/2014 | 07/07/2014 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | 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 (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] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 2 | United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of | ||
| 215 | EUCTR2013-004406-25-PT (EUCTR) | 19/09/2014 | 21/02/2014 | 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: 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: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Faculdade de Ciências Médicas da Universidade Nova de Lisboa | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal | ||
| 216 | NCT02186873 (ClinicalTrials.gov) | September 3, 2014 | 8/7/2014 | 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 | NULL | Completed | 18 Years | N/A | All | 208 | Phase 3 | United States;Australia;Canada;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Ukraine;Brazil;Romania |
| 217 | EUCTR2011-005689-39-NL (EUCTR) | 01/09/2014 | 23/06/2014 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | 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 (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] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Netherlands;Korea, Republic of | ||
| 218 | EUCTR2014-002056-40-NO (EUCTR) | 12/08/2014 | 13/06/2014 | A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis | A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH | Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning | Diakonhjemmet Hospital AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Norway | ||||
| 219 | NCT02202850 (ClinicalTrials.gov) | August 12, 2014 | 23/7/2014 | 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 | NULL | Completed | 18 Years | N/A | All | 84 | Belgium | |
| 220 | EUCTR2013-003812-30-NL (EUCTR) | 21/07/2014 | 26/05/2014 | A multicentre study to measure the transfer of Cimzia from women to infants via the placenta | A MULTICENTER POSTMARKETING STUDY TO EVALUATETHE PLACENTAL TRANSFER OF CERTOLIZUMAB PEGOL INPREGNANT WOMEN RECEIVING TREATMENT WITH CIMZIA®(CERTOLIZUMAB PEGOL) | Rheumatoid ArthritisAxial spondyloarthritisPsoriatic arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 17.0;Classification code 10037160;Term: Psoriatic arthritis;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cimzia Product Name: Certolizumab pegol / CIMZIA INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Biosciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 1 | France;United States;Germany;Netherlands;Switzerland | ||
| 221 | NCT01870284 (ClinicalTrials.gov) | July 2014 | 3/6/2013 | 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 | NULL | Withdrawn | 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 |
| 222 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | 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 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 223 | EUCTR2013-001090-24-NO (EUCTR) | 29/04/2014 | 07/03/2014 | 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: 16.1;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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Czech Republic;Mexico;Greece;Spain;Belgium;Russian Federation;Germany;Norway;United Kingdom;Sweden | ||
| 224 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | 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: 17.1;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 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 225 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | 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 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 226 | NCT04582084 (ClinicalTrials.gov) | April 4, 2014 | 3/10/2020 | Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis | Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance Study | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Etanercept | AryoGen Pharmed Co. | NULL | Completed | 18 Years | N/A | All | 583 | Iran, Islamic Republic of | |
| 227 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | 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: 18.1;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 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 228 | EUCTR2013-001090-24-GB (EUCTR) | 26/03/2014 | 31/12/2013 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden | ||
| 229 | EUCTR2013-003666-13-DE (EUCTR) | 25/03/2014 | 01/11/2013 | 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: 18.1;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 Other descriptive name: BI 655066 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2 | France;United States;Hong Kong;Taiwan;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of | ||
| 230 | EUCTR2013-003666-13-NL (EUCTR) | 07/03/2014 | 03/01/2014 | 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: 17.0;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 Other descriptive name: BI 655066 | Boehringer-Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | France;United States;Hong Kong;Taiwan;Finland;Belgium;Spain;Germany;Netherlands;Italy;Korea, Republic of | ||
| 231 | NCT04345458 (ClinicalTrials.gov) | March 6, 2014 | 3/4/2020 | Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis | Safety and Efficacy of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis on the Basis of NSAID Therapy: A Multicenter Randomized, Double-blind, Parallel Group Phase III Trial | Ankylosing Spondylitis | Drug: prefilled liquid etanercept(Yisaipu);Drug: lyophilized etanercept powder(Yisaipu) | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | NULL | Completed | 18 Years | 65 Years | All | 640 | Phase 3 | China |
| 232 | EUCTR2013-003666-13-BE (EUCTR) | 28/02/2014 | 13/12/2013 | 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: 18.0;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 Other descriptive name: BI 655066 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2 | France;United States;Hong Kong;Taiwan;Finland;Spain;Belgium;Netherlands;Germany;Italy;Korea, Republic of | ||
| 233 | EUCTR2013-001090-24-GR (EUCTR) | 25/02/2014 | 09/12/2013 | 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: 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: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom | ||
| 234 | EUCTR2013-001090-24-BE (EUCTR) | 13/02/2014 | 14/01/2014 | 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: 16.1;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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United Kingdom;Sweden;United States;Portugal;Czech Republic;Mexico;Greece;Spain;Belgium;Russian Federation;Norway;Germany | ||
| 235 | EUCTR2013-001090-24-PT (EUCTR) | 23/01/2014 | 14/11/2013 | 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: 17.0;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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden | ||
| 236 | EUCTR2013-001089-40-BE (EUCTR) | 23/01/2014 | 02/12/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients 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] | Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab 150 mg/1 ml Solution for injection Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab 75 mg/0.5 ml Solution for injection | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | ||
| 237 | EUCTR2011-005689-39-DE (EUCTR) | 20/01/2014 | 24/05/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | 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 (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] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 2 | United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of | ||
| 238 | NCT02008916 (ClinicalTrials.gov) | January 14, 2014 | 8/12/2013 | 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 | NULL | Completed | 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 |
| 239 | EUCTR2013-003666-13-IT (EUCTR) | 09/01/2014 | 11/11/2013 | 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. | Ankylosing Spondylitis MedDRA version: 16.1;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 INN or Proposed INN: N.A. Other descriptive name: BI 655066 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2 | United States;France;Taiwan;Hong Kong;Finland;Spain;Belgium;Netherlands;Germany;Italy;Korea, Republic of | ||
| 240 | EUCTR2013-001090-24-DE (EUCTR) | 08/01/2014 | 24/10/2013 | 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom | ||
| 241 | EUCTR2013-002860-19-NL (EUCTR) | 07/01/2014 | 15/08/2013 | 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 SpondylitisAtherosclerotic cardiovascular disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Atorvastatin Product Name: Atorvastatin Product Code: 5057732 INN or Proposed INN: ATORVASTATIN Other descriptive name: atorvastatin | AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 242 | EUCTR2013-001089-40-BG (EUCTR) | 07/01/2014 | 21/11/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients 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] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 274 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | ||
| 243 | EUCTR2013-001090-24-CZ (EUCTR) | 30/12/2013 | 08/11/2013 | 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: 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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom | ||
| 244 | EUCTR2013-001090-24-ES (EUCTR) | 26/12/2013 | 12/11/2013 | 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: 16.1;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 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden | ||
| 245 | EUCTR2013-003666-13-ES (EUCTR) | 26/12/2013 | 24/10/2013 | 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 INN or Proposed INN: - Other descriptive name: BI 655066 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2 | United States;France;Taiwan;Hong Kong;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of | ||
| 246 | EUCTR2013-003666-13-FI (EUCTR) | 13/12/2013 | 31/10/2013 | 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: 16.1;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 Other descriptive name: BI 655066 | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2 | United States;France;Hong Kong;Taiwan;Finland;Spain;Belgium;Germany;Netherlands;Italy;Korea, Republic of | ||
| 247 | EUCTR2013-001089-40-DE (EUCTR) | 20/11/2013 | 07/08/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients 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] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457, 150 mg INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457, 75 mg INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 274 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | ||
| 248 | NCT01863732 (ClinicalTrials.gov) | November 6, 2013 | 23/5/2013 | 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;Other: Placebo (Pbo) | Novartis Pharmaceuticals | NULL | Completed | 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 |
| 249 | EUCTR2011-002325-22-ES (EUCTR) | 28/10/2013 | 08/08/2013 | 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: 16.0;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 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| 250 | EUCTR2011-002325-22-BE (EUCTR) | 28/10/2013 | 09/08/2013 | 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: 16.0;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 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;South Africa;Netherlands;Germany | |||
| 251 | EUCTR2011-002325-22-DE (EUCTR) | 25/10/2013 | 09/08/2013 | 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: 16.0;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 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| 252 | EUCTR2013-001089-40-NL (EUCTR) | 24/10/2013 | 26/09/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients 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] | Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany | ||
| 253 | EUCTR2013-001089-40-GB (EUCTR) | 03/10/2013 | 16/07/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients 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] | Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | ||
| 254 | EUCTR2011-002325-22-GB (EUCTR) | 26/09/2013 | 18/06/2013 | 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 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | ||
| 255 | EUCTR2011-002325-22-HU (EUCTR) | 26/09/2013 | 17/07/2013 | 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: 16.0;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 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| 256 | EUCTR2013-001089-40-IT (EUCTR) | 27/08/2013 | 02/07/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 16.0;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 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Farma SpA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany | ||
| 257 | EUCTR2012-005026-30-HU (EUCTR) | 15/08/2013 | 20/02/2013 | 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 | 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 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | ||
| 258 | EUCTR2011-005689-39-CZ (EUCTR) | 07/08/2013 | 23/05/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | 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 (AS) MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 259 | EUCTR2012-004939-23-FR (EUCTR) | 16/07/2013 | 28/10/2021 | Effet de la COmbinaison de Méthotrexate et d’Adalimumab sur la Réduction de l’Immunisation au cours de la Spondylarthrite ankylosante | Effet de la COmbinaison de Méthotrexate et d’Adalimumab sur la Réduction de l’Immunisation au cours de la Spondylarthrite ankylosante | Cette étude portera sur une population avec une spondylarthrite ankylosante (SA) active nécessitant un traitement par adalimumab MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: METOJECT INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM | CHRU de TOURS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 4 | France | ||
| 260 | EUCTR2011-005689-39-HU (EUCTR) | 27/06/2013 | 22/05/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | 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 (AS) MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc, 235 East 42nd Street, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 261 | EUCTR2011-005689-39-ES (EUCTR) | 26/06/2013 | 24/06/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | 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 (AS) MedDRA version: 16.0;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: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 262 | EUCTR2012-005026-30-PL (EUCTR) | 17/05/2013 | 08/03/2013 | 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: 17.1;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 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 263 | EUCTR2012-005026-30-CZ (EUCTR) | 15/05/2013 | 22/02/2013 | 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: 17.0;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 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 264 | ChiCTR-TRC-13003449 | 2013-04-25 | 2013-06-07 | 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 | NULL | Completed | 18 | 65 | Both | Thalidomide 150mg:80;Thalidomide 100mg:80;Control group:40; | 2 (Phase 2 study) | China |
| 265 | EUCTR2011-001555-37-EE (EUCTR) | 19/04/2013 | 19/03/2013 | 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: 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: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 456 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 266 | EUCTR2010-019872-65-LT (EUCTR) | 11/04/2013 | 17/01/2013 | Etoricoxib with naproxen in ankylosing spondylitis | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosyn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany | ||
| 267 | EUCTR2012-005026-30-BG (EUCTR) | 10/04/2013 | 05/03/2013 | 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: 17.1;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 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India | |||
| 268 | NCT01786668 (ClinicalTrials.gov) | April 2013 | 6/2/2013 | 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 | NULL | Completed | 18 Years | N/A | All | 208 | Phase 2 | United States;Canada;Czech Republic;Germany;Hungary;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan |
| 269 | NCT01895764 (ClinicalTrials.gov) | March 2013 | 24/4/2013 | 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 | NULL | Completed | 18 Years | N/A | Both | 110 | Phase 4 | France |
| 270 | NCT02201043 (ClinicalTrials.gov) | February 2013 | 23/7/2014 | 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 | NULL | Completed | 18 Years | 65 Years | Both | 197 | Phase 2 | China |
| 271 | NCT01965132 (ClinicalTrials.gov) | January 1, 2013 | 11/10/2013 | 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 | NULL | Recruiting | 18 Years | N/A | All | 7000 | Korea, Republic of | |
| 272 | NCT01389388 (ClinicalTrials.gov) | January 2013 | 16/4/2010 | 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 | NULL | Completed | 35 Years | 80 Years | Both | 114 | N/A | Norway |
| 273 | EUCTR2012-000046-35-DE (EUCTR) | 20/12/2012 | 19/09/2012 | 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 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands | ||
| 274 | EUCTR2011-001555-37-NL (EUCTR) | 05/12/2012 | 15/05/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 456 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Germany;Netherlands;Sweden | ||
| 275 | EUCTR2011-001555-37-BG (EUCTR) | 14/11/2012 | 14/08/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 456 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;South Africa;Netherlands;Germany;Sweden | ||
| 276 | EUCTR2012-000046-35-ES (EUCTR) | 13/11/2012 | 26/09/2012 | 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 | Ankylosing spondylitis MedDRA version: 15.0;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] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands | ||
| 277 | EUCTR2012-000046-35-NL (EUCTR) | 30/10/2012 | 16/08/2012 | 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: 19.0;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 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 3 | Italy;Czech Republic;Canada;Singapore;Netherlands;Germany;United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom | ||
| 278 | NCT01649375 (ClinicalTrials.gov) | October 18, 2012 | 20/7/2012 | 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 | NULL | Completed | 18 Years | N/A | All | 219 | Phase 3 | United States;Austria;Canada;Czechia;Finland;Germany;Italy;Netherlands;Russian Federation;Singapore;Spain;Switzerland;United Kingdom;Czech Republic |
| 279 | EUCTR2012-000046-35-FI (EUCTR) | 10/10/2012 | 28/08/2012 | 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 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands | ||
| 280 | EUCTR2011-001555-37-DE (EUCTR) | 20/09/2012 | 08/05/2012 | 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: 18.0;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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 456 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 281 | JPRN-UMIN000015297 | 2012/09/19 | 01/10/2014 | 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 | NULL | Recruiting | 20years-old | 70years-old | Male and Female | 54 | Phase 2 | Japan |
| 282 | EUCTR2012-000046-35-GB (EUCTR) | 17/09/2012 | 20/07/2012 | 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 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 3 | Spain;United States;Finland;Austria;Russian Federation;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Singapore;Germany;Netherlands | ||
| 283 | EUCTR2011-001555-37-GB (EUCTR) | 04/09/2012 | 16/04/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 456 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 284 | NCT01668004 (ClinicalTrials.gov) | September 3, 2012 | 1/8/2012 | The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) | Open-Label, Phase 4 Study, Investigating the Incidence of Extra-Articular Manifestations in Subjects With Ankylosing Spondylitis Treated With Golimumab; Protocol No. MK-8259-012 | Ankylosing Spondylitis | Biological: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 101 | Phase 4 | Netherlands |
| 285 | EUCTR2011-001555-37-CZ (EUCTR) | 14/08/2012 | 30/05/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | 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 | ||
| 286 | EUCTR2011-001555-37-SE (EUCTR) | 09/08/2012 | 29/05/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 456 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 287 | EUCTR2011-001555-37-SK (EUCTR) | 31/07/2012 | 15/05/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 456 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 288 | EUCTR2012-000046-35-IT (EUCTR) | 31/07/2012 | 02/08/2012 | 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 | 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 | Ankylosing spondylitis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: SECUKINUMAB | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Singapore;Netherlands;Germany | ||
| 289 | EUCTR2012-002458-21-NL (EUCTR) | 23/07/2012 | 03/07/2012 | 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 INN or Proposed INN: GOLIMUMAB | MERCK SHARP & DOHME B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Netherlands | ||
| 290 | EUCTR2011-001555-37-ES (EUCTR) | 23/07/2012 | 28/05/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 456 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 291 | EUCTR2011-001555-37-AT (EUCTR) | 03/07/2012 | 30/05/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | 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 | ||
| 292 | EUCTR2011-001555-37-PL (EUCTR) | 30/06/2012 | 29/05/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 456 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 293 | EUCTR2011-001555-37-HU (EUCTR) | 13/06/2012 | 02/05/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | 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 | ||
| 294 | EUCTR2011-001555-37-FR (EUCTR) | 06/06/2012 | 23/08/2012 | 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 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 456 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 295 | JPRN-UMIN000007806 | 2012/06/01 | 01/05/2012 | 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 | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 54 | Phase 2 | Japan | |
| 296 | NCT01610947 (ClinicalTrials.gov) | May 14, 2012 | 24/5/2012 | 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 | NULL | Completed | 18 Years | N/A | All | 398 | N/A | France |
| 297 | NCT01583374 (ClinicalTrials.gov) | May 2, 2012 | 20/4/2012 | 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 | Amgen | NULL | Completed | 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 |
| 298 | NCT03880968 (ClinicalTrials.gov) | March 1, 2012 | 12/3/2019 | 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 | Completed | 18 Years | 65 Years | All | 311 | NULL | |
| 299 | NCT01709656 (ClinicalTrials.gov) | March 2012 | 10/10/2012 | 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 | NULL | Completed | 16 Years | 65 Years | Both | 120 | N/A | China |
| 300 | NCT01571206 (ClinicalTrials.gov) | March 2012 | 23/3/2012 | 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 | NULL | Completed | 18 Years | 75 Years | Both | 174 | Phase 1 | Korea, Republic of |
| 301 | NCT02922192 (ClinicalTrials.gov) | January 1, 2012 | 28/9/2016 | 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;Kaiser Permanente;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta Pharmaceuticals, Inc.;Pfizer;University of Pittsburgh | Completed | 18 Years | N/A | All | 90360 | NULL | |
| 302 | EUCTR2010-024529-18-BE (EUCTR) | 16/12/2011 | 20/10/2011 | 2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis | A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 | Ankylosing spondylitis MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Germany;Netherlands;Bulgaria;Peru;Belgium | |||
| 303 | EUCTR2010-024529-18-DE (EUCTR) | 28/11/2011 | 01/08/2011 | 2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis | A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 | Ankylosing spondylitis MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | |||
| 304 | EUCTR2010-024529-18-BG (EUCTR) | 14/11/2011 | 09/11/2011 | 2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis | A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 | Ankylosing spondylitis 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] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | |||
| 305 | NCT01517620 (ClinicalTrials.gov) | November 2011 | 15/1/2012 | 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 | NULL | Completed | 16 Years | 65 Years | Both | 38 | Phase 4 | China | |
| 306 | NCT01330901 (ClinicalTrials.gov) | October 2011 | 5/4/2011 | 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 | NULL | Completed | 18 Years | N/A | Both | 22 | Phase 2 | Germany |
| 307 | NCT01358175 (ClinicalTrials.gov) | October 2011 | 19/5/2011 | 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 | NULL | Completed | 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 |
| 308 | EUCTR2010-024529-18-GB (EUCTR) | 02/08/2011 | 18/07/2011 | 2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis | A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE 1 | Ankylosing spondylitis MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany | |||
| 309 | EUCTR2010-024529-18-IT (EUCTR) | 25/07/2011 | 29/12/2011 | 2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis | A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis | Ankylosing spondylitis 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: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 350 | Taiwan;Mexico;Canada;Belgium;Turkey;Peru;Bulgaria;Russian Federation;Germany;United Kingdom;Italy | |||
| 310 | EUCTR2011-000844-56-DE (EUCTR) | 12/07/2011 | 09/06/2011 | 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 - TOPAS | Ankylosing spondylitis MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Stelara Product Name: Ustekinumab | Charité Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Germany | ||
| 311 | ChiCTR-TRC-11001417 | 2011-06-01 | 2011-07-10 | 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 | NULL | Recruiting | Both | 1:80;2:80; | I+2 (Phase 1+Phase 2) | China | ||
| 312 | EUCTR2009-017443-34-BE (EUCTR) | 16/05/2011 | 08/10/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Phase 2;Phase 3 | Czech Republic;Slovakia;Spain;Belgium;Lithuania;Bulgaria;Germany;Italy;United Kingdom | ||
| 313 | EUCTR2010-019872-65-CZ (EUCTR) | 10/05/2011 | 03/03/2011 | Etoricoxib with naproxen in ankylosing spondylitis | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | Ankylosing Spondylitis (AS) MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany | ||
| 314 | EUCTR2010-019872-65-SK (EUCTR) | 02/05/2011 | 28/02/2011 | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | Ankylosing Spondylitis (AS) MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: ARCOXIA Product Name: etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: naproxen INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom | ||
| 315 | EUCTR2009-017488-40-BE (EUCTR) | 22/03/2011 | 01/09/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | ||
| 316 | NCT01327638 (ClinicalTrials.gov) | February 15, 2011 | 11/3/2011 | 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 | Organon and Co | NULL | Completed | 16 Years | N/A | All | 21108 | NULL | |
| 317 | NCT01361542 (ClinicalTrials.gov) | February 2011 | 24/5/2011 | 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 | NULL | Completed | 18 Years | 55 Years | Both | 24 | N/A | India |
| 318 | EUCTR2009-017443-34-DE (EUCTR) | 17/01/2011 | 02/09/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;United Kingdom;Germany;Belgium;Bulgaria;Spain;Italy;Lithuania | |||
| 319 | EUCTR2010-019872-65-AT (EUCTR) | 14/01/2011 | 03/09/2010 | Etoricoxib with naproxen in ankylosing spondylitis | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | Ankylosing Spondylitis (AS) MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany | ||
| 320 | EUCTR2010-019872-65-BE (EUCTR) | 11/01/2011 | 31/08/2010 | Etoricoxib with naproxen in ankylosing spondylitis | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | Ankylosing Spondylitis (AS) MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;South Africa;Germany | ||
| 321 | EUCTR2009-017443-34-BG (EUCTR) | 07/01/2011 | 24/11/2010 | 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: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra® Product Code: Ro 487-5733/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | |||
| 322 | ChiCTR-TRC-11001193 | 2011-01-01 | 2011-02-22 | 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 | NULL | Completed | 18 | 60 | Both | Treatment group:66;Control group:22; | China | |
| 323 | NCT01411215 (ClinicalTrials.gov) | January 2011 | 13/5/2011 | 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 | NULL | Terminated | 18 Years | N/A | All | 160 | N/A | China |
| 324 | NCT01420432 (ClinicalTrials.gov) | January 2011 | 11/8/2011 | 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 | NULL | Recruiting | 18 Years | 60 Years | Both | 10 | Phase 1 | China |
| 325 | EUCTR2009-016068-35-NL (EUCTR) | 15/12/2010 | 24/06/2010 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 326 | EUCTR2009-017443-34-ES (EUCTR) | 14/12/2010 | 06/10/2010 | 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.Estudio en fase II/III ininterrumpido, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la reducción de los signos y síntomas y la inhibición de los daños estructurales durante el tratamiento con tocilizumab en comparación con placebo en pacientes con espondilitis anquilosante que no han respondido a los antiinflamatorios no esteroideos y no han recibido tratamiento previo con antagonistas del TNF. | 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.Estudio en fase II/III ininterrumpido, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la reducción de los signos y síntomas y la inhibición de los daños estructurales durante el tratamiento con tocilizumab en comparación con placebo en pacientes con espondilitis anquilosante que no han respondido a los antiinflamatorios no esteroideos y no han recibido tratamiento previo con antagonistas del TNF. | Ankylosing Spondylitis (AS)Espondilitis anquilosante (EA) MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania | |||
| 327 | EUCTR2009-017488-40-ES (EUCTR) | 14/12/2010 | 06/10/2010 | 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. Estudio aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la seguridad y la reducción de los signos ysíntomas durante el tratamiento con tocilizumab (TCZ) en comparación con placebo en pacientes con espondilitis anquilosante que han tenido una respuesta insuficiente al tratamiento previo con un antagonista del TNF. | 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. Estudio aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la seguridad y la reducción de los signos ysíntomas durante el tratamiento con tocilizumab (TCZ) en comparación con placebo en pacientes con espondilitis anquilosante que han tenido una respuesta insuficiente al tratamiento previo con un antagonista del TNF. | Ankylosing SpondylitisEspondilitis Anquilosante MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Belgium;Spain;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 328 | EUCTR2009-017488-40-BG (EUCTR) | 08/12/2010 | 22/11/2010 | 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: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra® Product Code: Ro 487-533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 329 | NCT01793285 (ClinicalTrials.gov) | December 2010 | 30/1/2013 | 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 | NULL | Completed | 18 Years | N/A | All | 85 | N/A | Spain |
| 330 | EUCTR2010-019872-65-EE (EUCTR) | 29/11/2010 | 03/11/2010 | Etoricoxib with naproxen in ankylosing spondylitis | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | Ankylosing Spondylitis (AS) MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;South Africa;Germany | ||
| 331 | EUCTR2009-017488-40-DK (EUCTR) | 16/11/2010 | 16/09/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 332 | EUCTR2010-019872-65-HU (EUCTR) | 09/11/2010 | 10/08/2010 | Etoricoxib with naproxen in ankylosing spondylitis | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany | ||
| 333 | EUCTR2009-017443-34-LT (EUCTR) | 02/11/2010 | 18/08/2010 | 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: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania | |||
| 334 | EUCTR2009-017488-40-LT (EUCTR) | 02/11/2010 | 19/08/2010 | 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: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 335 | EUCTR2009-017488-40-GB (EUCTR) | 01/11/2010 | 09/08/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | ||
| 336 | EUCTR2009-017443-34-GB (EUCTR) | 01/11/2010 | 09/08/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Slovakia;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | ||
| 337 | EUCTR2009-017443-34-CZ (EUCTR) | 27/10/2010 | 29/09/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | |||
| 338 | EUCTR2009-017488-40-DE (EUCTR) | 18/10/2010 | 02/09/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 339 | EUCTR2010-019872-65-FI (EUCTR) | 18/10/2010 | 30/08/2010 | Etoricoxib with naproxen in ankylosing spondylitis | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | Ankylosing Spondylitis (AS) MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany | ||
| 340 | EUCTR2009-017488-40-CZ (EUCTR) | 12/10/2010 | 20/09/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 341 | NCT01220518 (ClinicalTrials.gov) | October 2010 | 4/10/2010 | 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 | NULL | Completed | 18 Years | 75 Years | Both | 257 | Phase 1 | Korea, Republic of |
| 342 | NCT01212653 (ClinicalTrials.gov) | October 2010 | 30/9/2010 | 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 | NULL | Completed | 18 Years | 75 Years | Both | 50 | Phase 4 | China |
| 343 | NCT01209689 (ClinicalTrials.gov) | October 2010 | 24/9/2010 | A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (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 | Spondylitis, Ankylosing | Drug: Tocilizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 113 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;India;Italy;Lithuania;Netherlands;Poland;Slovakia;South Africa;Spain;United Kingdom |
| 344 | NCT01248793 (ClinicalTrials.gov) | October 2010 | 24/11/2010 | 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. | NULL | Completed | 18 Years | N/A | All | 213 | Phase 3 | China |
| 345 | NCT01208207 (ClinicalTrials.gov) | September 27, 2010 | 22/9/2010 | A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108) | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis | Spondylitis, Ankylosing | Drug: Part I - etoricoxib 60 mg;Drug: Part I - etoricoxib 90 mg;Drug: Part I- naproxen 1000 mg;Drug: Part I - Placebo to naproxen 500 mg;Drug: Part II- etoricoxib 60 mg;Drug: Part II- etoricoxib 90 mg;Drug: Part II- naproxen 1000 mg;Drug: Part I - Placebo to etoricoxib 60 mg;Drug: Part I - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to etoricoxib 60 mg;Drug: Part II - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to naproxen 500 mg | Organon and Co | NULL | Completed | 18 Years | N/A | All | 1015 | Phase 3 | Argentina;Austria;Belgium;Canada;Colombia;Czech Republic;Estonia;Finland;France;Germany;Hungary;India;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States |
| 346 | EUCTR2009-017488-40-IT (EUCTR) | 22/09/2010 | 28/09/2010 | 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 - ND | 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 - ND | Ankylosing Spondylitis MedDRA version: 9.1;Level: LLT;Classification code 10002556 | Trade Name: RoActemra INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;United Kingdom;Italy | |||
| 347 | EUCTR2009-017443-34-IT (EUCTR) | 22/09/2010 | 28/09/2010 | 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 naìve 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 naìve to TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy | |||
| 348 | EUCTR2009-011591-30-GB (EUCTR) | 21/09/2010 | 20/10/2009 | 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 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany;Netherlands;United Kingdom | ||
| 349 | EUCTR2009-017488-40-SK (EUCTR) | 13/09/2010 | 16/08/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 350 | EUCTR2009-017443-34-SK (EUCTR) | 13/09/2010 | 17/08/2010 | 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 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Slovakia;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | |||
| 351 | EUCTR2010-019263-11-LT (EUCTR) | 06/09/2010 | 03/06/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: not applicable Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania | |||
| 352 | NCT01209702 (ClinicalTrials.gov) | September 2010 | 24/9/2010 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs | 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 NSAIDs | Spondylitis, Ankylosing | Biological: tocilizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 306 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;France;Germany;India;Italy;Lithuania;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom;Mexico;Netherlands |
| 353 | NCT01091675 (ClinicalTrials.gov) | September 2010 | 22/3/2010 | Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to =2 NSAIDs | Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis (AS) and Inadequate Response to =2 Nonsteroidal Antiinflammatory Drug (NSAID) | Ankylosing Spondylitis | Drug: Etoricoxib | Spanish Foundation of Rheumatology | NULL | Completed | 18 Years | N/A | All | 58 | Phase 3 | Spain |
| 354 | EUCTR2010-020913-10-GB (EUCTR) | 11/08/2010 | 23/07/2010 | 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 INN or Proposed INN: Etanercept Trade Name: Enbrel Product Name: Enbrel | Norfolk & Norwich University Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 355 | EUCTR2010-019263-11-FR (EUCTR) | 02/08/2010 | 14/06/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | France;Hungary;Czech Republic;Spain;Belgium;Lithuania;Austria | ||
| 356 | EUCTR2009-011719-19-CZ (EUCTR) | 20/07/2010 | 20/07/2010 | 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: 14.1;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders 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 | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Hungary;Czech Republic;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 357 | EUCTR2009-011719-19-DE (EUCTR) | 19/07/2010 | 17/02/2010 | N/A | 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: 18.1;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.1;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] - Immune System Diseases [C20] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Italy;France;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Netherlands;United States;United Kingdom | ||
| 358 | EUCTR2010-019263-11-HU (EUCTR) | 14/07/2010 | 20/05/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: SAR153191 Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania | |||
| 359 | EUCTR2010-019263-11-BE (EUCTR) | 08/07/2010 | 13/04/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | France;Hungary;Czech Republic;Spain;Belgium;Lithuania;Austria | ||
| 360 | EUCTR2009-011719-19-BE (EUCTR) | 02/07/2010 | 23/04/2010 | NA | 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: 16.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 16.0;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] - Immune System Diseases [C20] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;United Kingdom;Italy;France;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Germany;Netherlands | ||
| 361 | EUCTR2009-011719-19-NL (EUCTR) | 29/06/2010 | 06/05/2010 | 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: 14.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Italy;United Kingdom | ||
| 362 | EUCTR2010-019263-11-ES (EUCTR) | 28/06/2010 | 21/04/2010 | Estudio de extensión multicéntrico no controlado para evaluar la seguridad y la eficacia a largo plazo de SAR153191 en pacientes con espondilitis anquilosante (EA)______________________________________________A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | Estudio de extensión multicéntrico no controlado para evaluar la seguridad y la eficacia a largo plazo de SAR153191 en pacientes con espondilitis anquilosante (EA)______________________________________________A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | Espondilitis Anquilosante__________________________Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria | ||
| 363 | EUCTR2010-019263-11-CZ (EUCTR) | 03/06/2010 | 19/04/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania | |||
| 364 | EUCTR2009-018085-35-DK (EUCTR) | 21/05/2010 | 05/05/2010 | 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;Classification code 10048398;Term: Spondylitis ankylosing aggravated;Classification code 10041671;Term: Spondylitis ankylopoietica;Classification code 10002556;Term: Ankylosing spondylitis;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 INN or Proposed INN: ADALIMUMAB | Regionalhospital Silkeborg | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | |||
| 365 | EUCTR2010-019263-11-AT (EUCTR) | 19/05/2010 | 13/04/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania | |||
| 366 | EUCTR2009-011591-30-NL (EUCTR) | 17/05/2010 | 18/11/2009 | Safety and tolerability of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitis | 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 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: AIN457 Product Code: AIN457 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | United States;Germany;Netherlands;United Kingdom | |||
| 367 | EUCTR2009-011719-19-GB (EUCTR) | 13/05/2010 | 15/03/2010 | 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: 14.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of Companies | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 368 | EUCTR2009-011719-19-HU (EUCTR) | 13/05/2010 | 12/04/2010 | N/A | 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: 16.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 16.0;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] - Immune System Diseases [C20] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany;Netherlands | ||
| 369 | ChiCTR-ONRC-10000858 | 2010-05-10 | 2010-04-28 | 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 | NULL | Completed | 18 | 45 | Both | Group A:15;GroupB:12; | I (Phase 1 study) | China |
| 370 | EUCTR2009-016068-35-DE (EUCTR) | 03/05/2010 | 11/12/2009 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 371 | EUCTR2009-016068-35-FR (EUCTR) | 26/04/2010 | 14/12/2009 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany | ||
| 372 | ChiCTR-TRC-11001274 | 2010-04-01 | 2011-01-28 | 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 | NULL | Completed | 18 | 60 | Both | B group:120;C group:180; | China | |
| 373 | NCT01313858 (ClinicalTrials.gov) | April 2010 | 10/3/2011 | 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. | NULL | Completed | 18 Years | N/A | All | 1613 | N/A | Germany |
| 374 | NCT01060098 (ClinicalTrials.gov) | April 2010 | 29/1/2010 | T Cells and TNF (Tumor Necrosis Factor): 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 | NULL | Completed | 18 Years | 80 Years | All | 48 | United Kingdom | |
| 375 | NCT01109940 (ClinicalTrials.gov) | April 2010 | 22/4/2010 | Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis | 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 | Ankylosing Spondylitis | Biological: AIN457A | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | Both | 39 | Phase 2 | United States;Germany;Netherlands;United Kingdom |
| 376 | EUCTR2009-011719-19-FR (EUCTR) | 29/03/2010 | 04/02/2010 | 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;Classification code 10051265;Term: Spondyloarthropathy | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of Companies | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 377 | EUCTR2009-016068-35-CZ (EUCTR) | 25/03/2010 | 01/04/2010 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 378 | EUCTR2009-016068-35-LT (EUCTR) | 23/03/2010 | 30/12/2009 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: not applicable Product Code: SAR153191 Product Name: not applicable Product Code: SAR153191 Product Name: not applicable Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 379 | EUCTR2009-016587-36-ES (EUCTR) | 15/03/2010 | 27/01/2010 | 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 INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB | Schering Plough, S.A | NULL | Not Recruiting | Female: yes Male: yes | 70 | Spain | |||
| 380 | EUCTR2009-011591-30-DE (EUCTR) | 03/03/2010 | 08/12/2009 | 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: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: AIN457 Product Code: AIN457 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Netherlands;Germany;United Kingdom | |||
| 381 | EUCTR2009-016068-35-ES (EUCTR) | 22/02/2010 | 16/12/2009 | Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Espondilitis anquilosante___________________________Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 382 | EUCTR2009-016068-35-BE (EUCTR) | 19/02/2010 | 30/11/2009 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany | |||
| 383 | EUCTR2009-017309-12-ES (EUCTR) | 18/02/2010 | 18/12/2009 | 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 INN or Proposed INN: ETORICOXIB Other descriptive name: ETORICOXIB | FUNDACIÓN ESPAÑOLA DE REUMATOLOGÍA (FER) | NULL | Not Recruiting | Female: yes Male: yes | Spain | ||||
| 384 | EUCTR2009-016068-35-AT (EUCTR) | 28/01/2010 | 11/01/2010 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 385 | EUCTR2009-016068-35-HU (EUCTR) | 25/01/2010 | 14/12/2009 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: SAR153191 Product Code: SAR153191 Product Name: SAR153191 Product Code: SAR153191 Product Name: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany | ||
| 386 | NCT01114880 (ClinicalTrials.gov) | January 2010 | 5/2/2010 | 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 | NULL | Completed | 18 Years | 65 Years | All | 344 | Phase 3 | China |
| 387 | ChiCTR-ONRC-11001846 | 2009-12-03 | 2011-12-28 | 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 | NULL | Completed | 18 | 65 | Both | Traditional therapy group:500;biological agent group:500;thalidomide group:500; | NULL | |
| 388 | EUCTR2009-012424-87-GB (EUCTR) | 26/11/2009 | 14/10/2009 | 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;Classification code 10037160;Term: Psoriatic arthritis MedDRA version: 12.0;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Enbrel INN or Proposed INN: etanercept Trade Name: Humira INN or Proposed INN: adalimumab Trade Name: Enbrel INN or Proposed INN: etanercept Trade Name: Enbrel INN or Proposed INN: Etanercept | Imperial College London South Kensington London | NULL | Not Recruiting | Female: yes Male: yes | 55 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 389 | EUCTR2009-015515-40-NL (EUCTR) | 20/11/2009 | 28/09/2009 | PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMSINTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVAS | PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMSINTO 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 | Wyeth Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Netherlands | |||
| 390 | NCT02456363 (ClinicalTrials.gov) | November 2009 | 14/12/2014 | 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 | NULL | Recruiting | 18 Years | N/A | Both | 300 | Phase 2 | Taiwan |
| 391 | NCT01006681 (ClinicalTrials.gov) | November 2009 | 31/10/2009 | 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 | NULL | Not yet recruiting | 18 Years | 65 Years | Both | 400 | Phase 2 | NULL |
| 392 | NCT01421303 (ClinicalTrials.gov) | October 2009 | 19/8/2011 | 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 | NULL | Completed | 18 Years | N/A | All | 80 | Belgium | |
| 393 | NCT01104987 (ClinicalTrials.gov) | October 2009 | 13/4/2010 | 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 | NULL | Completed | 18 Years | 80 Years | Both | 16 | Sweden | |
| 394 | NCT00844805 (ClinicalTrials.gov) | September 2009 | 13/2/2009 | Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) | Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial | Ankylosing Spondylitis;Axial Spondyloarthritis | Drug: Infliximab;Drug: Placebo;Drug: Naproxen | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 48 Years | All | 158 | Phase 3 | Austria;Belgium;Denmark;France;Germany;Hungary;Korea, Republic of;Russian Federation;Ukraine;United States |
| 395 | NCT01077843 (ClinicalTrials.gov) | August 17, 2009 | 26/2/2010 | 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 | Organon and Co | NULL | Completed | N/A | N/A | All | 27381 | NULL | |
| 396 | EUCTR2007-003096-39-IT (EUCTR) | 29/07/2009 | 27/03/2009 | 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 INN or Proposed INN: Etanercept | WYETH LEDERLE | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 397 | NCT00762463 (ClinicalTrials.gov) | July 2009 | 29/9/2008 | 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's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | 65 Years | All | 240 | Phase 3 | China |
| 398 | ChiCTR-ONRC-11001565 | 2009-06-01 | 2011-09-16 | research of genetic gene and immune state in Ankylosing Spondylitis | research of genetic gene and immune state in ankylosing spondylitis | Ankylosing Spondylitis | AS patients:None;Healthy control:None; | Department of Clinical Immunology, Xijing Hospital, Fourth Military Medical University | NULL | Completed | 18 | 65 | Both | AS patients:500;Healthy control:500; | NULL | |
| 399 | EUCTR2008-006885-27-NL (EUCTR) | 21/04/2009 | 05/11/2008 | 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 INN or Proposed INN: adalimumab Other descriptive name: ADALIMUMAB | Clinical Immunology and Rheumatology | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 400 | NCT01081717 (ClinicalTrials.gov) | April 14, 2009 | 4/3/2010 | 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. | NULL | Completed | N/A | 99 Years | All | 1064 | United States | |
| 401 | EUCTR2008-004229-40-GB (EUCTR) | 09/03/2009 | 22/11/2010 | 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) - START - 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) - START - Spondylitis Trial of Apremilast for better Rheumatic Therapy | Ankylosing Spondylitis MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 402 | EUCTR2008-007510-30-PL (EUCTR) | 06/03/2009 | 03/02/2009 | 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 | Array BioPharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Hungary;Poland | ||
| 403 | NCT00809159 (ClinicalTrials.gov) | March 2009 | 16/12/2008 | Double Blind, Placebo Controlled Study to Assess Efficacy of AIN457 in Moderate to Severe Ankylosing Spondylitis | 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 | Ankylosing Spondylitis | Biological: AIN457;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 60 | Phase 2 | United States;Germany;Netherlands;United Kingdom |
| 404 | EUCTR2008-002631-33-NL (EUCTR) | 23/02/2009 | 17/09/2008 | Efficacy of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitis | Randomized, double-blind, placebo-controlled, multi-center, phase II, proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209 | ankylosing spondylitis MedDRA version: 13.1;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: AIN457 Product Code: AIN457 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Germany;United Kingdom;Netherlands | ||
| 405 | EUCTR2008-007510-30-HU (EUCTR) | 09/02/2009 | 29/12/2008 | 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 | Array BioPharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | Hungary;Poland | ||
| 406 | EUCTR2008-002631-33-GB (EUCTR) | 14/01/2009 | 25/07/2008 | 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 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Germany;United Kingdom;Netherlands | ||
| 407 | EUCTR2007-007637-39-DE (EUCTR) | 17/12/2008 | 15/04/2008 | 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 | Charité - Campus Mitte | NULL | Not Recruiting | Female: yes Male: yes | 174 | Phase 4 | Germany | ||
| 408 | NCT00811499 (ClinicalTrials.gov) | December 16, 2008 | 17/12/2008 | A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: ARRY-371797, p38 inhibitor; oral;Drug: Placebo | Pfizer | NULL | Terminated | 18 Years | N/A | All | 25 | Phase 2 | United States;Canada | |
| 409 | EUCTR2008-002631-33-DE (EUCTR) | 15/12/2008 | 20/08/2008 | 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 - A2209 | 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 - A2209 | 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 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United Kingdom;Germany;Netherlands | ||
| 410 | NCT00766402 (ClinicalTrials.gov) | October 2008 | 3/10/2008 | 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 | NULL | Terminated | 18 Years | 70 Years | Both | 8 | Phase 4 | NULL |
| 411 | NCT00889694 (ClinicalTrials.gov) | October 2008 | 27/4/2009 | 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 | NULL | Enrolling by invitation | 18 Years | 65 Years | Both | 80 | Phase 2/Phase 3 | NULL |
| 412 | NCT00715091 (ClinicalTrials.gov) | September 2008 | 14/7/2008 | Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis | Effects of NSAIDs on RAdiographic Damage in Ankylosing Spondylitis (ENRADAS) - a Prospective Randomised Controlled Trial | Ankylosing Spondylitis | Drug: diclophenac | Charite University, Berlin, Germany | NULL | Completed | 18 Years | 65 Years | Both | 180 | Phase 4 | Germany |
| 413 | NCT02489760 (ClinicalTrials.gov) | July 2008 | 27/6/2015 | 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 | NULL | Active, not recruiting | 18 Years | 70 Years | Both | 30 | Phase 4 | Taiwan |
| 414 | EUCTR2007-003358-27-DE (EUCTR) | 02/05/2008 | 21/11/2007 | 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® INN or Proposed INN: adalimumab | Center of Pediatrics and Neonatology, Asklepios Clinic Sankt Augustin | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | |||
| 415 | NCT01188655 (ClinicalTrials.gov) | May 2008 | 24/8/2010 | 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 | NULL | Completed | 18 Years | N/A | All | 89 | N/A | NULL |
| 416 | EUCTR2006-001579-40-DK (EUCTR) | 16/04/2008 | 04/09/2007 | 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 INN or Proposed INN: infliximab | Schering-Plough France | NULL | Not Recruiting | Female: yes Male: yes | 120 | France;Hungary;Spain;Denmark | |||
| 417 | JPRN-JapicCTI-080580 | 01/4/2008 | 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 | NULL | |||
| 418 | EUCTR2006-002748-27-HU (EUCTR) | 01/04/2008 | 30/01/2008 | 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: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Netherlands;France | |||
| 419 | NCT00647517 (ClinicalTrials.gov) | March 2008 | 26/3/2008 | 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 | NULL | Completed | 18 Years | 65 Years | Both | 60 | Phase 4 | Taiwan |
| 420 | NCT01072058 (ClinicalTrials.gov) | February 2008 | 18/2/2010 | 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 | NULL | Active, not recruiting | 18 Years | 70 Years | Both | 100 | Phase 4 | Brazil |
| 421 | NCT00936143 (ClinicalTrials.gov) | January 2008 | 7/7/2009 | 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 | NULL | Completed | 16 Years | 65 Years | Both | 70 | Phase 4 | China |
| 422 | EUCTR2006-001579-40-HU (EUCTR) | 18/12/2007 | 19/10/2007 | 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 INN or Proposed INN: infliximab | Schering-Plough France | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;Hungary;Spain;Denmark | ||
| 423 | NCT00576706 (ClinicalTrials.gov) | December 2007 | 17/12/2007 | 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. | NULL | Completed | 19 Years | N/A | Both | 396 | Phase 3 | Korea, Republic of |
| 424 | EUCTR2007-000087-25-GB (EUCTR) | 22/10/2007 | 27/07/2007 | 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 | Cambridge University Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 425 | EUCTR2007-002967-28-DE (EUCTR) | 19/10/2007 | 24/08/2007 | 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 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Charité University Medicine | NULL | Not Recruiting | Female: yes Male: yes | 30 | Germany | |||
| 426 | NCT00544557 (ClinicalTrials.gov) | October 2007 | 15/10/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 1715 | Germany | |
| 427 | EUCTR2006-001579-40-ES (EUCTR) | 31/07/2007 | 04/05/2007 | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximabESTUDIO DE LA ENTESITIS PERIFÉRICA CON ECOGRAFÍA DOPPLER EN LAS ESPONDILOARTROPATÍAS TRATADAS CON INFLIXIMAB - EUSpA | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximabESTUDIO DE LA ENTESITIS PERIFÉRICA CON ECOGRAFÍA DOPPLER EN LAS ESPONDILOARTROPATÍAS TRATADAS CON INFLIXIMAB - EUSpA | SpondyloarthropathiesEspondiloartropatias MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Remicade INN or Proposed INN: infliximab | Schering-Plough France | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Denmark;France;Spain | |||
| 428 | ChiCTR-TRC-13004564 | 2007-07-01 | 2013-07-05 | 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 | NULL | Completed | 18 | 60 | Both | CM:15;WM treatment group:15; | I (Phase 1 study) | China |
| 429 | NCT02915354 (ClinicalTrials.gov) | July 2007 | 23/9/2016 | 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 | NULL | Completed | 18 Years | N/A | Both | 35 | Phase 4 | China |
| 430 | EUCTR2005-004826-21-BE (EUCTR) | 01/06/2007 | 20/01/2006 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Greece;Finland;Spain;Belgium;Ireland;Austria;Denmark;Germany;Norway;Italy;Sweden;United Kingdom | |||
| 431 | NCT00724529 (ClinicalTrials.gov) | June 2007 | 25/7/2008 | 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 | NULL | Completed | N/A | N/A | Both | 938 | Korea, Republic of | |
| 432 | NCT00760669 (ClinicalTrials.gov) | May 2007 | 24/9/2008 | 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 | NULL | Completed | N/A | N/A | All | 1061 | Korea, Republic of | |
| 433 | EUCTR2006-005157-29-FR (EUCTR) | 27/04/2007 | 13/04/2007 | 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 INN or Proposed INN: METHOTREXATE Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | CHRU-TOURS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 434 | EUCTR2006-002748-27-NL (EUCTR) | 13/04/2007 | 20/11/2006 | 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 INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Netherlands;France | |||
| 435 | EUCTR2006-001579-40-FR (EUCTR) | 02/04/2007 | 26/03/2007 | 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 INN or Proposed INN: infliximab | Schering-Plough France | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Hungary;Spain;Denmark | ||
| 436 | NCT00434044 (ClinicalTrials.gov) | February 2007 | 9/2/2007 | 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 | NULL | Completed | 18 Years | N/A | Both | 150 | Phase 3 | NULL |
| 437 | EUCTR2006-002748-27-DE (EUCTR) | 15/01/2007 | 15/12/2006 | 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 | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Netherlands;France | |||
| 438 | EUCTR2006-001061-42-FI (EUCTR) | 09/01/2007 | 10/07/2006 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc | Wyeth Pharmaceuticals France, Wyeth Research Division | NULL | Not Recruiting | Female: yes Male: yes | 108 | Finland;United Kingdom;Denmark;Sweden | |||
| 439 | NCT00420238 (ClinicalTrials.gov) | January 2007 | 8/1/2007 | 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 | NULL | Completed | 18 Years | 70 Years | All | 82 | Phase 4 | France;Germany;Hungary;Netherlands |
| 440 | EUCTR2006-002306-64-DE (EUCTR) | 28/12/2006 | 04/10/2006 | 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 INN or Proposed INN: rituximab | Charité Universitaetsmedizin | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 441 | EUCTR2005-001549-41-GR (EUCTR) | 08/12/2006 | 10/08/2006 | 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) | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 3;Phase 4 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden | ||
| 442 | EUCTR2006-002748-27-FR (EUCTR) | 01/12/2006 | 19/12/2006 | A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis | Active, severe and advanced axial ankylosing spondylitis. | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;Hungary;Germany;Netherlands | ||
| 443 | NCT00410046 (ClinicalTrials.gov) | December 2006 | 8/12/2006 | 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 | NULL | Completed | 18 Years | N/A | All | 84 | Phase 4 | Denmark;Finland;Sweden;United Kingdom |
| 444 | NCT00873730 (ClinicalTrials.gov) | December 2006 | 1/4/2009 | 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 | NULL | Completed | 18 Years | 70 Years | All | 108 | Phase 4 | NULL |
| 445 | EUCTR2005-001549-41-CZ (EUCTR) | 28/11/2006 | 17/10/2006 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 525 | Portugal;Finland;Hungary;United Kingdom;Germany;Czech Republic;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 446 | EUCTR2006-001061-42-DK (EUCTR) | 03/11/2006 | 15/09/2006 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc | Wyeth Pharmaceuticals France, Wyeth Research Division | NULL | Not Recruiting | Female: yes Male: yes | 108 | Finland;United Kingdom;Denmark;Sweden | |||
| 447 | EUCTR2004-003299-12-GB (EUCTR) | 11/10/2006 | 24/01/2006 | 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 Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | Finland;Belgium;Germany;United Kingdom | ||
| 448 | EUCTR2006-002349-35-ES (EUCTR) | 30/09/2006 | 02/08/2006 | 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 anquilosanteAnkylosing spondylitis | Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001, TNFR:FC | Wyeth Farma S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 449 | NCT00367211 (ClinicalTrials.gov) | September 2006 | 18/8/2006 | Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. | A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. | Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis | Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole) | POZEN | NULL | Completed | 18 Years | N/A | Both | 400 | Phase 3 | United States |
| 450 | EUCTR2006-001061-42-SE (EUCTR) | 23/08/2006 | 13/06/2006 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc | Wyeth Pharmaceuticals France, Wyeth Research Division | NULL | Not Recruiting | Female: yes Male: yes | 108 | Finland;United Kingdom;Denmark;Sweden | |||
| 451 | NCT00458185 (ClinicalTrials.gov) | August 2006 | 5/4/2007 | 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 | NULL | Completed | 18 Years | 70 Years | Both | 40 | Phase 4 | NULL |
| 452 | EUCTR2006-001061-42-GB (EUCTR) | 31/07/2006 | 11/06/2006 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc | Wyeth Pharmaceuticals France, Wyeth Research Division | NULL | Not Recruiting | Female: yes Male: yes | 108 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Denmark;United Kingdom;Sweden | ||
| 453 | EUCTR2005-005358-27-GB (EUCTR) | 12/07/2006 | 10/04/2006 | 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 | University Hospital of North Staffordshire | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 454 | NCT01685424 (ClinicalTrials.gov) | June 30, 2006 | 23/8/2012 | 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 | Organon and Co | NULL | Completed | N/A | N/A | All | 79189 | United States | |
| 455 | EUCTR2005-001549-41-PT (EUCTR) | 29/06/2006 | 16/03/2006 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 525 | Finland;Hungary;Portugal;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 456 | EUCTR2005-004826-21-GR (EUCTR) | 28/06/2006 | 13/07/2006 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 457 | EUCTR2004-003299-12-FI (EUCTR) | 26/04/2006 | 28/12/2005 | 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 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Finland;United Kingdom;Germany;Belgium | |||
| 458 | EUCTR2004-003299-12-DE (EUCTR) | 04/04/2006 | 02/01/2006 | 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 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Finland;United Kingdom;Germany;Belgium | |||
| 459 | EUCTR2005-004826-21-AT (EUCTR) | 28/03/2006 | 03/03/2006 | 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 | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 460 | EUCTR2005-001549-41-DK (EUCTR) | 24/03/2006 | 21/12/2005 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 461 | EUCTR2004-003299-12-BE (EUCTR) | 20/03/2006 | 01/02/2006 | 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 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | Finland;Belgium;Germany;United Kingdom | ||
| 462 | EUCTR2005-001549-41-SE (EUCTR) | 15/03/2006 | 16/02/2006 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 463 | EUCTR2005-001549-41-FI (EUCTR) | 08/03/2006 | 14/11/2005 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Portugal;Hungary;Finland;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 464 | EUCTR2005-004826-21-GB (EUCTR) | 06/03/2006 | 12/12/2005 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Greece;Finland;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden | |||
| 465 | EUCTR2005-004826-21-IE (EUCTR) | 03/03/2006 | 11/01/2006 | 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 | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 466 | EUCTR2005-004826-21-IT (EUCTR) | 28/02/2006 | 23/06/2006 | 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 - 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 - RHAPSODY | Active Ankylosing Spondylitis MedDRA version: 6.1;Level: PT;Classification code 10002556 | INN or Proposed INN: Adalimumab | ABBOTT | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 467 | EUCTR2005-004826-21-DK (EUCTR) | 20/02/2006 | 05/01/2006 | 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 | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Greece;Finland;Belgium;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden | ||
| 468 | EUCTR2005-002460-29-BE (EUCTR) | 17/02/2006 | 08/02/2006 | 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 INN or Proposed INN: Infliximab Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain) | Rheumazentrum Ruhrgebiet. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 4 | Finland;Belgium;Germany;United Kingdom | ||
| 469 | EUCTR2005-004826-21-ES (EUCTR) | 17/02/2006 | 19/01/2006 | 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. Revisión de la seguridad y eficacia con adalimumab en pacientes con espondilitis anquilosante activa. Estudio abierto para evaluar la respuesta a adalimumab en pacientes que no han respondido al tratamiento convencional o a los inhibidores del TNF alfa. - 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. Revisión de la seguridad y eficacia con adalimumab en pacientes con espondilitis anquilosante activa. Estudio abierto para evaluar la respuesta a adalimumab en pacientes que no han respondido al tratamiento convencional o a los inhibidores del TNF alfa. - RHAPSODY | Active Ankylosing Spondylitis Espondilitis anquilosante activa | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Greece;Finland;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden | |||
| 470 | EUCTR2005-001549-41-DE (EUCTR) | 15/02/2006 | 28/11/2005 | A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 471 | EUCTR2005-001549-41-IT (EUCTR) | 14/02/2006 | 09/10/2008 | A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondilitis (AS) MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Enbrel INN or Proposed INN: Etanercept Trade Name: Salazopyrin En-Tabs INN or Proposed INN: Sulfasalazine | WYETH LEDERLE | NULL | Not Recruiting | Female: yes Male: yes | 525 | Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden | |||
| 472 | EUCTR2005-001549-41-GB (EUCTR) | 02/02/2006 | 29/11/2005 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden | ||
| 473 | EUCTR2005-004826-21-SE (EUCTR) | 01/02/2006 | 23/12/2005 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 474 | NCT00478660 (ClinicalTrials.gov) | February 2006 | 23/5/2007 | 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 | NULL | Completed | 18 Years | N/A | Both | 1250 | Phase 3 | Austria;Belgium;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom |
| 475 | EUCTR2005-004826-21-DE (EUCTR) | 30/01/2006 | 07/12/2005 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 476 | EUCTR2005-004826-21-NO (EUCTR) | 26/01/2006 | 05/12/2005 | 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 INN or Proposed INN: Adalimumab | Abbott Laboratories | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 477 | EUCTR2005-002460-29-FI (EUCTR) | 20/01/2006 | 12/12/2005 | 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) - EASIC | 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) - EASIC | Ankylosing spondylitis (AS) | Product Name: Remicade Product Code: cA2 INN or Proposed INN: Infliximab Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain) | Rheumazentrum Ruhrgebiet. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Finland;United Kingdom;Germany;Belgium | |||
| 478 | EUCTR2005-004826-21-FI (EUCTR) | 20/01/2006 | 28/11/2005 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Greece;Finland;Belgium;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden | |||
| 479 | EUCTR2005-001549-41-IE (EUCTR) | 09/01/2006 | 31/03/2006 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 3 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden | ||
| 480 | EUCTR2005-001549-41-ES (EUCTR) | 27/12/2005 | 27/10/2005 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3;Phase 4 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden | ||
| 481 | EUCTR2005-001549-41-AT (EUCTR) | 27/12/2005 | 22/11/2005 | A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND | Subjects with Ankylosing Spondylitis (AS) | Trade Name: Enbrel (etanercept) Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 525 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden | |||
| 482 | EUCTR2005-002460-29-GB (EUCTR) | 22/12/2005 | 03/10/2005 | 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) - EASIC | 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) - EASIC | Ankylosing spondylitis (AS) | Product Name: Remicade Product Code: cA2 INN or Proposed INN: Infliximab Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain) | Rheumazentrum Ruhrgebiet. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Belgium;Germany;United Kingdom | ||
| 483 | NCT00247962 (ClinicalTrials.gov) | December 2005 | 31/10/2005 | 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 | NULL | Completed | 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 |
| 484 | EUCTR2005-001549-41-HU (EUCTR) | 25/11/2005 | 13/10/2005 | 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 INN or Proposed INN: Etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Salazopyrin En-Tabs Product Name: sulphasalazine 500 mg En-Tabs Product Code: SSZ INN or Proposed INN: sulphasalazine Other descriptive name: sulfasalazine, SSZ | Wyeth Research Division of Wyeth Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3;Phase 4 | Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden;Portugal;Greece;Finland;Spain | ||
| 485 | EUCTR2005-002460-29-DE (EUCTR) | 12/09/2005 | 05/07/2005 | 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 INN or Proposed INN: Infliximab Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain) | Rheumazentrum Ruhrgebiet. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Finland;United Kingdom;Germany;Belgium | |||
| 486 | NCT00778869 (ClinicalTrials.gov) | August 2005 | 23/10/2008 | 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. | NULL | Completed | 18 Years | 70 Years | All | 10 | Phase 4 | NULL |
| 487 | NCT00195416 (ClinicalTrials.gov) | June 2005 | 12/9/2005 | 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 | NULL | Completed | 18 Years | N/A | Both | 526 | Korea, Republic of | |
| 488 | NCT00202865 (ClinicalTrials.gov) | May 1, 2005 | 16/9/2005 | 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. | NULL | Completed | 18 Years | N/A | All | 76 | Phase 3 | Canada |
| 489 | NCT00432432 (ClinicalTrials.gov) | February 2005 | 6/2/2007 | 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 | NULL | Completed | 18 Years | 70 Years | Both | 38 | Phase 4 | NULL |
| 490 | NCT02840695 (ClinicalTrials.gov) | January 2005 | 18/7/2016 | 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 | NULL | Completed | 30 Years | 60 Years | All | 9858 | N/A | NULL |
| 491 | NCT00779012 (ClinicalTrials.gov) | October 1, 2004 | 23/10/2008 | 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. | NULL | Completed | 18 Years | 70 Years | All | 42 | Phase 4 | NULL |
| 492 | NCT00779935 (ClinicalTrials.gov) | October 1, 2004 | 23/10/2008 | 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. | NULL | Completed | 18 Years | 70 Years | All | 44 | Phase 4 | NULL |
| 493 | NCT00133315 (ClinicalTrials.gov) | September 2004 | 22/8/2005 | 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 | NULL | Completed | 18 Years | N/A | Both | 50 | Phase 4 | Denmark |
| 494 | NCT00418548 (ClinicalTrials.gov) | June 2004 | 4/1/2007 | 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 | NULL | Completed | 18 Years | 70 Years | Both | 350 | Phase 3 | NULL |
| 495 | NCT00725543 (ClinicalTrials.gov) | June 2004 | 25/7/2008 | 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. | Completed | N/A | N/A | All | 358 | N/A | NULL |
| 496 | NCT00444340 (ClinicalTrials.gov) | April 2004 | 5/3/2007 | 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 | NULL | Completed | 18 Years | N/A | Both | 70 | Phase 4 | NULL |
| 497 | NCT00224562 (ClinicalTrials.gov) | February 2004 | 14/9/2005 | 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 | NULL | Recruiting | N/A | N/A | Both | N/A | France | |
| 498 | NCT00085644 (ClinicalTrials.gov) | January 2004 | 10/6/2004 | 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 | NULL | Completed | 18 Years | N/A | All | 315 | Phase 3 | United States |
| 499 | NCT00195819 (ClinicalTrials.gov) | December 2003 | 16/9/2005 | 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 | NULL | Completed | 18 Years | N/A | All | 82 | Phase 3 | Canada;United States |
| 500 | NCT00243750 (ClinicalTrials.gov) | September 2003 | 24/10/2005 | 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 | NULL | Active, not recruiting | 18 Years | 70 Years | Both | 20 | Phase 2 | Germany |
| 501 | NCT00439283 (ClinicalTrials.gov) | April 2003 | 22/2/2007 | 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 | NULL | Completed | 18 Years | N/A | Both | 240 | Phase 3 | France |
| 502 | NCT01850121 (ClinicalTrials.gov) | January 2003 | 6/5/2013 | 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 | NULL | Completed | 18 Years | 60 Years | Both | 19 | Sweden | |
| 503 | NCT00648141 (ClinicalTrials.gov) | January 2003 | 28/3/2008 | 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 | NULL | Completed | 18 Years | 75 Years | Both | 458 | Phase 3 | Germany |
| 504 | NCT00207701 (ClinicalTrials.gov) | September 2002 | 13/9/2005 | 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 | Completed | 18 Years | N/A | Both | 279 | Phase 3 | NULL |
| 505 | NCT02528201 (ClinicalTrials.gov) | September 2002 | 18/6/2015 | 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 | NULL | Completed | 18 Years | 75 Years | Both | 330 | Phase 4 | Norway |
| 506 | NCT00421980 (ClinicalTrials.gov) | June 2002 | 8/1/2007 | 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 | NULL | Completed | 18 Years | 66 Years | Both | 84 | Phase 3 | Belgium |
| 507 | NCT00244166 (ClinicalTrials.gov) | May 2002 | 25/10/2005 | 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 | NULL | Recruiting | 18 Years | 70 Years | Both | 75 | Phase 2/Phase 3 | Germany |
| 508 | NCT00421915 (ClinicalTrials.gov) | March 2002 | 8/1/2007 | 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 | NULL | Completed | 18 Years | 70 Years | Both | 84 | Phase 3 | NULL |
| 509 | NCT02183168 (ClinicalTrials.gov) | July 2001 | 4/7/2014 | 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 | NULL | Completed | N/A | N/A | Both | 192 | Phase 3 | NULL |
| 510 | NCT00000433 (ClinicalTrials.gov) | October 1999 | 18/1/2000 | 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) | NULL | Completed | 18 Years | 80 Years | Both | 42 | Phase 2 | United States |
| 511 | NCT00004288 (ClinicalTrials.gov) | May 1996 | 18/10/1999 | Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: olsalazine | National Center for Research Resources (NCRR) | University of Rochester | Completed | 18 Years | 65 Years | Male | 4 | Phase 2 | NULL | |
| 512 | EUCTR2010-019872-65-DE (EUCTR) | 04/08/2010 | Etoricoxib with naproxen in ankylosing spondylitis | A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis | Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: Naprosyn Product Name: Naprosysn INN or Proposed INN: NAPROXEN Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany | |||
| 513 | EUCTR2018-000681-10-NL (EUCTR) | 07/01/2021 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland;Italy | |||
| 514 | EUCTR2018-000681-10-BE (EUCTR) | 22/10/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | |||
| 515 | JPRN-JapicCTI-070346 | 22/01/2007 | 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 | NULL | 16 | BOTH | Phase 3 | NULL | ||||
| 516 | EUCTR2020-004284-98-CZ (EUCTR) | 05/11/2020 | Secukinumab open label roll-over extension protocol | An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment | Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis MedDRA version: 21.0;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;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 628 | Phase 4 | United States;Czechia;Greece;Spain;Guatemala;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Mexico;Poland;Belgium;Brazil;Malaysia;South Africa;Bulgaria;Germany;Sweden;Korea, Republic of | |||
| 517 | EUCTR2018-000681-10-FR (EUCTR) | 06/08/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | |||
| 518 | EUCTR2014-004532-18-Outside-EU/EEA (EUCTR) | 12/11/2014 | A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic 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 MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbott | NULL | NA | Female: yes Male: yes | 41 | Japan | ||||
| 519 | EUCTR2020-004284-98-PL (EUCTR) | 15/12/2020 | Secukinumab open label roll-over extension protocol | An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment | Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis MedDRA version: 21.0;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;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 628 | Phase 4 | United States;Czechia;Greece;Spain;Guatemala;Turkey;Russian Federation;Colombia;India;Egypt;Mexico;Belgium;Poland;Brazil;Malaysia;Bulgaria;South Africa;Germany;Sweden;Korea, Republic of |