271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
| 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 | ITMCTR2000003433 | 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 |
| 2 | 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 |
| 3 | 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 |
| 4 | 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 |
| 5 | 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 |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 |
| 20 | 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 |