Active comparator (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 1 |
| 46 | 悪性関節リウマチ | 64 |
| 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 | NCT03822364 (ClinicalTrials.gov) | November 26, 2018 | 18/12/2018 | Staccato Apomorphine Single and Multi Dose PK | A Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's Disease | Parkinson Disease | Drug: 009-1;Drug: active comparator;Drug: 009-0;Drug: 009-2;Drug: 009-3;Drug: 009-4;Drug: 009-5 | Alexza Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 60 Years | All | 56 | Phase 1 | 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 | EUCTR2019-002676-14-BG (EUCTR) | 20/08/2020 | 27/05/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;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] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina | ||
| 2 | NCT04413617 (ClinicalTrials.gov) | July 29, 2020 | 19/5/2020 | TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis | Drug: PF-06650833;Drug: PF-06651600;Drug: Tofacitinib | Pfizer | NULL | Recruiting | 18 Years | 70 Years | All | 450 | Phase 2 | Bulgaria;Canada;Chile;Czechia;Georgia;Hungary;Poland;Slovakia;Spain;Ukraine |
| 3 | EUCTR2019-002676-14-CZ (EUCTR) | 07/07/2020 | 11/05/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;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] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina | ||
| 4 | EUCTR2019-002676-14-HU (EUCTR) | 18/06/2020 | 14/04/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;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] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina | ||
| 5 | EUCTR2019-002676-14-SE (EUCTR) | 01/06/2020 | 14/04/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;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] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina | ||
| 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 | JPRN-jRCT2071200057 | 08/07/2017 | 25/11/2020 | Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects; Multicenter study | A Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study | Rheumatoid arthritis;D001172 | Experimental: FKB327 (Adalimumab biosimilar) Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1. Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug Active Comparator: US licenced Adalimumab Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1. Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug | Yazawa Rie | NULL | Complete | >= 20age old | < 45age old | Male | 130 | Phase 1 | Japan |
| 7 | JPRN-jRCT2071200058 | 21/12/2015 | 25/11/2020 | Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects | A Phase I, Randomized, Single-Blind, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-004 Study | Rheumatoid arthritis;D001172 | Experimental: FKB327 (Adalimumab biosimilar) Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1. Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug Active Comparator: US licenced Adalimumab Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1. Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug | Yonemura Takuma | NULL | Complete | >= 20age old | < 45age old | Male | 130 | Phase 1 | Japan |
| 8 | NCT02137226 (ClinicalTrials.gov) | January 26, 2015 | 12/5/2014 | BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis | Efficacy, Safety and Immunogenicity of BI 695501 Versus Adalimumab in Patients With Active Rheumatoid Arthritis: a Randomized, Double-blind,Parallel Arm, Multiple Dose, Active Comparator Trial | Arthritis, Rheumatoid | Drug: BI 695501;Drug: US-licensed Humira® | Boehringer Ingelheim | NULL | Completed | 18 Years | 80 Years | All | 645 | Phase 3 | United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;New Zealand;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine;Argentina;Colombia;Mexico;Philippines;South Africa |
| 9 | EUCTR2012-002945-40-DE (EUCTR) | 22/09/2014 | 01/04/2014 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis MedDRA version: 19.0;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 Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | United States;Serbia;Estonia;Thailand;Spain;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of | ||
| 10 | NCT02097264 (ClinicalTrials.gov) | September 2014 | 24/3/2014 | A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomised, Active Comparator, Double-blind, Multi Centre, Parallel, Phase 2a Trial, Investigating the Mechanism of Action, of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Inflammation;Rheumatoid Arthritis | Drug: NNC0109-0012;Drug: Adalimumab;Drug: placebo | Novo Nordisk A/S | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 2 | Ireland;Portugal;Spain;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 |
| 11 | EUCTR2012-002945-40-BG (EUCTR) | 21/08/2014 | 05/08/2014 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis MedDRA version: 19.0;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 Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Russian Federation;Chile;Hungary;Poland;Malaysia;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of | ||
| 12 | EUCTR2012-002945-40-ES (EUCTR) | 07/07/2014 | 29/04/2014 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis 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 Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Colombia;France;Hungary;Mexico;Argentina;Poland;Malaysia;Belgium;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of | ||
| 13 | EUCTR2012-002945-40-HU (EUCTR) | 27/05/2014 | 04/04/2014 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis 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 Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of | ||
| 14 | EUCTR2012-002945-40-EE (EUCTR) | 09/05/2014 | 10/04/2014 | BI695501 compared to adalimumab in patients with active rheumatoid arthritis | Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Rheumatoid arthritis 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 Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | United States;Serbia;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;New Zealand;Korea, Republic of | ||
| 15 | EUCTR2013-001492-20-PT (EUCTR) | 05/03/2014 | 24/01/2014 | A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | Rheumatoid arthritis 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] - Skin and Connective Tissue Diseases [C17] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Other descriptive name: NNC0109-0012 Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Portugal;Spain;Ireland;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 | EUCTR2013-001492-20-ES (EUCTR) | 31/01/2014 | 16/01/2014 | A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | Rheumatoid arthritis 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] - Skin and Connective Tissue Diseases [C17] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Other descriptive name: NNC0109-0012 Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Portugal;Spain;Ireland;United Kingdom | ||
| 17 | EUCTR2013-001492-20-GB (EUCTR) | 24/12/2013 | 18/10/2013 | A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate | Rheumatoid arthritis 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] - Skin and Connective Tissue Diseases [C17] | Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Other descriptive name: NNC0109-0012 Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Portugal;Hungary;Czech Republic;Spain;Belgium;Poland;Ireland;Germany;Netherlands;Italy;United Kingdom | ||
| 18 | EUCTR2011-002894-48-NO (EUCTR) | 11/04/2013 | 06/09/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;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 Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 19 | EUCTR2011-002894-48-BG (EUCTR) | 06/02/2013 | 20/11/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 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 Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 20 | EUCTR2011-002894-48-DE (EUCTR) | 25/01/2013 | 24/07/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 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 Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;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 |
| 21 | EUCTR2011-002894-48-ES (EUCTR) | 18/01/2013 | 29/10/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;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 Code: BI 695500 INN or Proposed INN: Not applicable Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 22 | EUCTR2011-002894-48-GR (EUCTR) | 16/11/2012 | 19/10/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;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 Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 23 | EUCTR2011-002894-48-PT (EUCTR) | 09/11/2012 | 09/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 15.1;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 Code: BI 695500 INN or Proposed INN: No Active Name Specified Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 24 | EUCTR2011-002894-48-HU (EUCTR) | 16/10/2012 | 16/08/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 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 Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 25 | EUCTR2007-002066-35-SK (EUCTR) | 10/10/2012 | 15/04/2008 | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira® | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Czech Republic;Hungary;Slovakia;Greece;Bulgaria;Germany;Italy | ||
| 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 |
| 26 | EUCTR2011-002894-48-EE (EUCTR) | 08/10/2012 | 08/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;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 Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 27 | EUCTR2011-002894-48-GB (EUCTR) | 14/09/2012 | 06/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;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] | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 1;Phase 3 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 28 | EUCTR2011-002894-48-NL (EUCTR) | 10/09/2012 | 14/12/2011 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 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 Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 29 | NCT01682512 (ClinicalTrials.gov) | September 5, 2012 | 10/8/2012 | Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis | Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial. | Arthritis, Rheumatoid | Drug: BI 695500;Drug: Rituxan®;Drug: MabThera® | Boehringer Ingelheim | NULL | Terminated | 18 Years | 80 Years | All | 294 | Phase 3 | United States;Argentina;Belgium;Bulgaria;Canada;Chile;Germany;Greece;Hungary;Ireland;Mexico;Netherlands;Poland;Portugal;Spain;Ukraine;United Kingdom;Brazil;Estonia;France;Guatemala;Italy;New Zealand;Norway;Peru;Russian Federation;Serbia;South Africa;Sweden |
| 30 | EUCTR2011-002894-48-BE (EUCTR) | 02/08/2012 | 18/07/2012 | Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial | Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. | Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 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 Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 459 | Phase 1;Phase 3 | Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;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 |
| 31 | EUCTR2010-020839-39-BE (EUCTR) | 10/05/2011 | 25/11/2010 | Efficacy and safety of CDP6038 in patients with rheumatoid arthritis withan unsuccessful response to anti-TNF therapy | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 | Rheumatoid Arthritis 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: CDP6038 Product Code: CDP6038 Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB | UCB Biosciences, Inc. A Member of the UCB Group of Companies | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Belgium;United Kingdom | ||
| 32 | EUCTR2010-020839-39-GB (EUCTR) | 25/02/2011 | 12/10/2010 | Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapy | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 | Rheumatoid Arthritis MedDRA version: 14.1;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: Olikizumab Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB | UCB Biosciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;United States | |||
| 33 | NCT01285752 (ClinicalTrials.gov) | February 2011 | 27/1/2011 | A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: AK106-001616;Drug: Active comparator | Asahi Kasei Pharma Corporation | NULL | Completed | 18 Years | 65 Years | Both | 240 | Phase 2 | Czech Republic;Germany;Hungary;Poland;Slovakia;Ukraine;United Kingdom | |
| 34 | NCT01242488 (ClinicalTrials.gov) | November 2010 | 15/11/2010 | Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy | Rheumatoid Arthritis | Biological: CDP6038;Biological: Tocilizumab (Actemra or RoActemra);Other: Placebo sc;Other: Placebo iv | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 221 | Phase 2 | United States;Belgium;United Kingdom |
| 35 | EUCTR2008-008338-35-FI (EUCTR) | 13/08/2009 | 14/05/2009 | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CP-690,550 Trade Name: Humira Product Name: Humira | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain | ||
| 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 |
| 36 | EUCTR2008-008338-35-DE (EUCTR) | 14/07/2009 | 04/05/2009 | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CP-690,550 Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Finland;United Kingdom;Czech Republic;Germany;Denmark;Bulgaria;Spain | ||
| 37 | EUCTR2008-008338-35-ES (EUCTR) | 19/06/2009 | 27/03/2009 | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato | CP 690,550 está estudiándose como fármaco antirreumático modificador de la enfermedad (FARME) en el tratamiento de la artritis reumatoide activa moderada o grave en adultosCP-690,550 ins being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CP-690,550 Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB | Pfizer, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain | ||
| 38 | EUCTR2008-008338-35-BG (EUCTR) | 16/06/2009 | 22/05/2009 | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Code: CP-690,550 Trade Name: Humira Product Name: Humira | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain | ||
| 39 | EUCTR2008-008338-35-GB (EUCTR) | 11/06/2009 | 09/04/2009 | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CP-690,550 Trade Name: Humira Product Name: Humira | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Bulgaria;Spain | ||
| 40 | EUCTR2008-008338-35-DK (EUCTR) | 03/06/2009 | 29/04/2009 | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CP-690,550 Trade Name: Humira Product Name: Humira | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;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 |
| 41 | EUCTR2008-008338-35-SK (EUCTR) | 25/05/2009 | 09/09/2009 | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CP-690,550 Trade Name: Humira Product Name: Humira | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom | ||
| 42 | EUCTR2008-008338-35-CZ (EUCTR) | 20/05/2009 | 18/03/2009 | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE | CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: CP-690,550 Trade Name: Humira Product Name: Humira | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom | ||
| 43 | NCT00902369 (ClinicalTrials.gov) | May 2009 | 14/5/2009 | A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: AK106-001616;Drug: Placebo;Drug: Active comparator | Asahi Kasei Pharma Corporation | NULL | Completed | 18 Years | 65 Years | Both | 130 | Phase 2 | Czech Republic;Germany;Hungary;Lithuania;Romania;United Kingdom | |
| 44 | NCT00853385 (ClinicalTrials.gov) | May 2009 | 27/2/2009 | A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis | Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate | Rheumatoid Arthritis | Drug: CP 690,550;Drug: CP-690,550;Other: Placebo;Biological: Biologic TNFi | Pfizer | NULL | Completed | 18 Years | N/A | All | 717 | Phase 3 | United States;Australia;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Costa Rica;Croatia;Czech Republic;Denmark;Dominican Republic;Finland;Germany;Korea, Republic of;Mexico;Philippines;Poland;Slovakia;Spain;Thailand;United Kingdom |
| 45 | EUCTR2007-002066-35-HU (EUCTR) | 28/03/2008 | 23/07/2007 | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira® | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2B | Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece | ||
| 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 |
| 46 | EUCTR2007-002066-35-GR (EUCTR) | 11/02/2008 | 20/09/2007 | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira® | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2B | Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece | ||
| 47 | EUCTR2007-002066-35-DE (EUCTR) | 01/02/2008 | 17/02/2009 | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg Injektionslösung in Fertigspritze INN or Proposed INN: Adalimumab | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2B | Hungary;Czech Republic;Germany;Bulgaria;Italy;Greece | ||
| 48 | EUCTR2007-002066-35-BG (EUCTR) | 31/01/2008 | 15/02/2008 | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira® | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Czech Republic;Hungary;Greece;Bulgaria;Germany;Italy | ||
| 49 | EUCTR2007-002066-35-CZ (EUCTR) | 09/01/2008 | 23/10/2007 | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira® | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2B | Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece | ||
| 50 | NCT00550446 (ClinicalTrials.gov) | September 2007 | 25/10/2007 | A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis | A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Adalimumab;Drug: CP-690-550;Drug: CP-690,550;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 386 | Phase 2 | United States;Brazil;Bulgaria;Chile;Croatia;Czech Republic;Germany;Greece;Hungary;Italy;Korea, Republic of;Mexico;Romania;Slovakia;Ukraine |
| 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 |
| 51 | EUCTR2005-000158-61-LT (EUCTR) | 03/05/2006 | 06/01/2006 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celebrex INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 52 | EUCTR2005-000158-61-DE (EUCTR) | 18/04/2006 | 16/05/2006 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 53 | EUCTR2005-000158-61-CZ (EUCTR) | 18/01/2006 | 05/12/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Czech Republic;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania;Hungary;Germany;United Kingdom | |||
| 54 | EUCTR2005-000158-61-EE (EUCTR) | 16/01/2006 | 11/11/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 55 | EUCTR2005-000158-61-LV (EUCTR) | 28/10/2005 | 22/11/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 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 |
| 56 | EUCTR2005-000158-61-IE (EUCTR) | 21/10/2005 | 13/09/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: Celebrex Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Spain;Ireland;Italy;Latvia;Lithuania | |||
| 57 | EUCTR2005-000158-61-AT (EUCTR) | 10/08/2005 | 07/06/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Czech Republic;Estonia;Hungary;Spain;Ireland;Lithuania;Denmark;Austria;Germany;Latvia;Italy;United Kingdom | ||
| 58 | EUCTR2005-000158-61-ES (EUCTR) | 09/08/2005 | 09/06/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: Artilog Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline s.a. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 59 | EUCTR2005-000158-61-HU (EUCTR) | 08/08/2005 | 08/06/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 60 | EUCTR2005-000158-61-GB (EUCTR) | 18/07/2005 | 27/05/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: Celebrex 200 mg capsule, hard Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 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 |
| 61 | EUCTR2005-000158-61-DK (EUCTR) | 24/06/2005 | 02/06/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 62 | NCT00113308 (ClinicalTrials.gov) | June 2005 | 7/6/2005 | COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: GW406381 | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 2208 | Phase 3 | United States;Argentina;Austria;Belgium;Bulgaria;Canada;Chile;Costa Rica;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Latvia;Mexico;Netherlands;New Zealand;Norway;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;Estonia;Lithuania;Pakistan;Slovakia;Taiwan |
| 63 | NCT00157872 (ClinicalTrials.gov) | January 7, 2004 | 7/9/2005 | A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231) | A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Naproxen Table 500 mg Twice Daily in the Treatment of Chinese Patient With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MK0966; rofecoxib;Drug: Comparator: naproxen tablet 500 mg | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 150 | Phase 4 | China |
| 64 | NCT00195663 (ClinicalTrials.gov) | December 2000 | 13/9/2005 | Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis | A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFa Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER). | Early Rheumatoid Arthritis | Biological: Adalimumab;Drug: Methotrexate;Biological: Adalimumab placebo;Drug: Methotrexate placebo | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | N/A | All | 799 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Slovakia;Spain;Sweden;Switzerland;United Kingdom |