Apremilast (DrugBank: Apremilast)
6 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 3 |
| 50 | 皮膚筋炎／多発性筋炎 | 3 |
| 56 | ベーチェット病 | 6 |
| 97 | 潰瘍性大腸炎 | 7 |
| 162 | 類天疱瘡（後天性表皮水疱症を含む。） | 1 |
| 271 | 強直性脊椎炎 | 16 |
| 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 | EUCTR2010-019926-15-CZ (EUCTR) | 27/01/2011 | 01/12/2010 | A Phase 2 placebo-controlled study to compare the effectiveness and safety of two doses of apremilast (CC-10004) in subjects with active rheumatoid arthritis, who have not responded to methotrexate treatment | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, TO COMPARE THE EFFICACY AND SAFETY OF TWO DOSES OF APREMILAST (CC-10004) IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis, a chronic systemic autoimmune inflammatory disease characterized by persisten synovial inflammations. MedDRA version: 14.0;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 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 | 210 | Phase 2 | United States;Czech Republic | ||
| 2 | NCT01285310 (ClinicalTrials.gov) | December 9, 2010 | 19/11/2010 | Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study, To Compare the Efficacy and Safety of Two Doses of Apremilast (CC-10004) in Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Apremilast 30 mg;Drug: Apremilast 20 mg;Drug: Placebo | Amgen | NULL | Terminated | 18 Years | N/A | All | 237 | Phase 2 | United States;Czechia;Poland;Spain;Czech Republic |
| 3 | NCT01250548 (ClinicalTrials.gov) | May 2010 | 26/8/2010 | The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment (CARAT) | The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment | Rheumatoid Arthritis | Biological: apremilast;Other: Placebo | Baylor Research Institute | NULL | Completed | 18 Years | N/A | Both | 34 | Phase 2 | United States |
| 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 | JPRN-jRCTs031200005 | 30/04/2020 | 10/04/2020 | Investigation on the safety and utility of apremilast for the treatment of refractory rash in patients with dermatomyositis | Investigation on the safety and utility of apremilast for the treatment of refractory rash in patients with dermatomyositis - ACDM | Dermatomyositis Collagen disease, inflammatory myopathy, cutaneous manifestation;D003882 | Oral administration of apremilast: Start with 10 mg of oral dose and gradually increase the dose until day 5, 30mg twice a day from day 6 (morning / evening) for a total of 12 weeks | Okiyama Naoko | NULL | Not Recruiting | >= 20age old | < 80age old | Both | 5 | Japan | |
| 2 | NCT03529955 (ClinicalTrials.gov) | June 12, 2018 | 24/4/2018 | Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis | A Phase 2, Open Label Single Arm Study for Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis | Dermatomyositis, Adult Type | Drug: Apremilast 30mg | Tulane University | NULL | Recruiting | 18 Years | 75 Years | All | 10 | Phase 2 | United States |
| 3 | NCT01140503 (ClinicalTrials.gov) | February 2010 | 6/4/2010 | A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With Dermatomyositis | An Open Label Study Evaluating the Safety and Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Dermatomyositis | Dermatomyositis | Drug: Apremilast | Stanford University | NULL | Terminated | 18 Years | N/A | All | 5 | N/A | United States |
| 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 | NCT04528082 (ClinicalTrials.gov) | July 15, 2021 | 24/8/2020 | Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN) | Behçet Disease | Drug: Apremilast;Drug: Placebo | Amgen | NULL | Not yet recruiting | 2 Years | 17 Years | All | 60 | Phase 3 | NULL |
| 2 | EUCTR2014-002108-25-GR (EUCTR) | 06/07/2016 | 08/06/2016 | Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE | SUBJECTS WITH ACTIVE BEHÇET’S DISEASE MedDRA version: 19.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of | ||
| 3 | EUCTR2014-002108-25-DE (EUCTR) | 17/06/2015 | 25/11/2014 | Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE | SUBJECTS WITH ACTIVE BEHÇET’S DISEASE MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | France;United States;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of | ||
| 4 | EUCTR2014-002108-25-IT (EUCTR) | 24/02/2015 | 13/05/2015 | Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE - NA | SUBJECTS WITH ACTIVE BEHÇET’S DISEASE MedDRA version: 18.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of | ||
| 5 | NCT02307513 (ClinicalTrials.gov) | December 30, 2014 | 2/12/2014 | A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease | A Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Subjects With Active Behcet's Disease | Behçet's Syndrome | Drug: Apremilast;Drug: Placebo | Amgen | NULL | Completed | 18 Years | N/A | All | 207 | Phase 3 | United States;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Lebanon;Turkey |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT00866359 (ClinicalTrials.gov) | August 1, 2009 | 18/3/2009 | A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Active-Treatment Extension to Evaluate the Efficacy and Safety of Apremilast(CC-10004) in the Treatment of Behçet Disease | Behcet Syndrome | Drug: Apremilast (CC-10004);Drug: Placebo | Amgen | NULL | Completed | 18 Years | N/A | All | 111 | Phase 2 | United States;Turkey |
| 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 | EUCTR2014-002981-64-BG (EUCTR) | 20/01/2016 | 25/09/2015 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Subjects with active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| 2 | EUCTR2014-002981-64-NL (EUCTR) | 12/10/2015 | 19/05/2015 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Subjects with active ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | United States;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand | ||
| 3 | EUCTR2014-002981-64-DE (EUCTR) | 29/09/2015 | 08/06/2015 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Subjects with active ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| 4 | EUCTR2014-002981-64-HU (EUCTR) | 14/09/2015 | 27/05/2015 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Subjects with active ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | United States;Slovakia;Ukraine;Turkey;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand | ||
| 5 | EUCTR2014-002981-64-IT (EUCTR) | 20/08/2015 | 05/11/2020 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A Phase 2, randomized, placebo-controlled, multicenter study to investigate the efficacy and safety of apremilast (CC-10004) for treatment of subjects with active ulcerative colitis - na | Subjects with active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: [CC-10004] INN or Proposed INN: Apremilast Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | CELGENE CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | United States;Czechia;Slovakia;Spain;Ukraine;Turkey;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2014-002981-64-CZ (EUCTR) | 13/08/2015 | 05/05/2015 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Subjects with active ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | |||
| 7 | NCT02289417 (ClinicalTrials.gov) | January 8, 2015 | 10/11/2014 | Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis | A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Apremilast;Drug: Placebo | Amgen | NULL | Completed | 18 Years | N/A | All | 170 | Phase 2 | United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Russian Federation;Ukraine;Czech Republic |
| 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 | EUCTR2018-002564-10-NL (EUCTR) | 23/04/2019 | 23/04/2019 | PDE4 inhibitor (apremilast) in pemphigoid. | Short-term safety, efficacy and mode of action of apremilast in mild to moderate cutaneous pemphigoid: a phase IIa open label single arm study. - SAMP trial | Pemphigoid;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Universitair Medisch Centrum Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | Netherlands |
| 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 | 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] | 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 | |||
| 2 | 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] | 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;Germany;Netherlands;Sweden | |||
| 3 | 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] | 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;Bulgaria;South Africa;Netherlands;Germany;Sweden | |||
| 4 | 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] | 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 | |||
| 5 | 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] | 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 | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | 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 | ||
| 7 | 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] | 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 | |||
| 8 | 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] | 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 | |||
| 9 | 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] | 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 | |||
| 10 | 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 | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | 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] | 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-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 | ||
| 13 | 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] | 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 | |||
| 14 | 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 |
| 15 | NCT00944658 (ClinicalTrials.gov) | August 2009 | 20/7/2009 | Spondylitis Trial of Apremilast for Better Rheumatic Therapy | Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004)in the Treatment of Ankylosing Spondylitis (AS) | Ankylosing Spondylitis | Drug: Apremilast;Drug: Placebo (sugar pill) | Imperial College London | Celgene Corporation | Completed | 18 Years | N/A | All | 38 | Phase 2 | United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | 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 |