Methotrexate 2.5mg tablets (DrugBank: Methotrexate)
1 disease| 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 | 22 |
| 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 | EUCTR2016-001825-15-IT (EUCTR) | 28/06/2017 | 16/02/2018 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION - A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREAT | Rheumatoid Arthritis MedDRA version: 20.0;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 Name: Tofacitinb Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE | PFIZER INC | NULL | Not Recruiting | Female: yes Male: yes | 580 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Germany;Italy | ||
| 2 | EUCTR2016-001825-15-GB (EUCTR) | 03/04/2017 | 01/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;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 Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3;Phase 4 | Korea, Republic of;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Poland;Australia;South Africa;Bulgaria;Germany | ||
| 3 | EUCTR2016-001825-15-PL (EUCTR) | 29/03/2017 | 08/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;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 Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3;Phase 4 | Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 4 | EUCTR2015-003376-75-BG (EUCTR) | 02/08/2016 | 18/07/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) 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] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand | ||
| 5 | EUCTR2015-003376-75-CZ (EUCTR) | 27/07/2016 | 03/06/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) 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] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;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 | EUCTR2015-003376-75-HU (EUCTR) | 06/07/2016 | 09/06/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;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 Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand | ||
| 7 | EUCTR2015-003376-75-PL (EUCTR) | 28/06/2016 | 08/06/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) 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] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Belgium;Poland;Australia;Bulgaria;Japan;New Zealand | ||
| 8 | EUCTR2015-003334-27-LV (EUCTR) | 17/06/2016 | 08/06/2016 | A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis | Moderately to Severely Active Rheumatoid Arthritis (RA) 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 Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: MTX HEXAL 2,5mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 975 | Phase 3 | Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;European Union;Mexico;Canada;Argentina;Brazil;Kazakhstan;New Zealand;Japan;United States | ||
| 9 | EUCTR2015-003376-75-PT (EUCTR) | 17/06/2016 | 09/06/2016 | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) 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] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand | ||
| 10 | EUCTR2015-003376-75-AT (EUCTR) | 10/06/2016 | 28/06/2016 | A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;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 |
| 11 | EUCTR2015-003376-75-BE (EUCTR) | 07/06/2016 | 06/06/2016 | A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;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 Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand | ||
| 12 | EUCTR2012-002324-32-SE (EUCTR) | 27/03/2013 | 20/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active 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] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 13 | EUCTR2012-002324-32-BE (EUCTR) | 25/02/2013 | 19/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active 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: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 14 | EUCTR2012-002324-32-DE (EUCTR) | 23/01/2013 | 21/12/2012 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active 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] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 15 | EUCTR2012-002324-32-PT (EUCTR) | 18/01/2013 | 02/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis 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] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;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 |
| 16 | EUCTR2012-002324-32-AT (EUCTR) | 14/01/2013 | 09/01/2013 | A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN | Moderately to severely active rheumatoid arthritis 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] - Musculoskeletal Diseases [C05] | Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden | ||
| 17 | EUCTR2008-002623-85-SE (EUCTR) | 28/04/2010 | 04/03/2010 | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE | Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium Tablets 2.5mg Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company, Philadelphia,PA-19101,USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | United Kingdom;Netherlands;France;Spain;Ireland;Italy;Sweden | |||
| 18 | EUCTR2008-002623-85-DE (EUCTR) | 16/12/2009 | 12/06/2009 | Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE | Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). 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] | Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium Tablets 2.5mg Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Poland;Romania;Germany;Netherlands;Sweden;Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France | |||
| 19 | EUCTR2008-002623-85-IE (EUCTR) | 06/11/2009 | 15/09/2009 | Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE | Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). 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] | Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium Tablets 2.5mg Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France;Poland;Romania;Germany;Netherlands;Sweden | |||
| 20 | EUCTR2008-002623-85-FR (EUCTR) | 18/08/2009 | 04/06/2009 | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE | Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium tablets 2.5mg Product Name: Methotrexate INN or Proposed INN: methotrexate | Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | United Kingdom;Netherlands;France;Spain;Ireland;Italy;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 | EUCTR2008-002623-85-NL (EUCTR) | 27/07/2009 | 01/05/2009 | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE | Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Enbrel 25mg PFS Product Name: Enbrel (Etanercept) Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel 50mg PFS Product Name: Enbrel (Etanercept) Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden | |||
| 22 | EUCTR2008-002623-85-ES (EUCTR) | 27/07/2009 | 19/02/2010 | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE Estudio en 3 fases para evaluar el mantenimiento de la remisión y los parámetros de productividad en sujetos con artritis reumatoide en fase inicial que comiencen tratamiento con etanercept más metotrexato. | A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE Estudio en 3 fases para evaluar el mantenimiento de la remisión y los parámetros de productividad en sujetos con artritis reumatoide en fase inicial que comiencen tratamiento con etanercept más metotrexato. | Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate | Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | United Kingdom;Netherlands;France;Ireland;Spain;Italy;Sweden |