46. 悪性関節リウマチ
［臨床試験数：4,183，薬物数：2,538（DrugBank：401），標的遺伝子数：183，標的パスウェイ数：219］
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-004558-30-PT (EUCTR) | 03/02/2020 | 21/05/2019 | A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. | A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. | rheumatoid arthritis 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] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Ledertrexato Product Name: Metotrexato Product Code: Metotrexato INN or Proposed INN: metotrexato Other descriptive name: METHOTREXATE SODIUM Trade Name: Metex Pen Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 186 | Phase 4 | Portugal;Spain | ||
| 2 | EUCTR2011-004720-35-NO (EUCTR) | 04/05/2015 | 26/01/2015 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Metex INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Imurel INN or Proposed INN: IMUREL Other descriptive name: AZATHIOPRINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN INN or Proposed INN: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Plaquenil Other descriptive name: HYDROXYCHLOROQUINE SULFATE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 4 | Finland;Denmark;Norway;Sweden | ||
| 3 | EUCTR2012-005275-14-NO (EUCTR) | 19/03/2013 | 04/02/2013 | Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs | Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs in a non-inferiority design - ARCTIC REWIND | Rheumatoid arthritis (RA) 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] - Musculoskeletal Diseases [C05] | Trade Name: Methotrexate Pfizer 2,5 mg tabletter Trade Name: Methotrexate Pfizer 2,5 mg tabletter Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Trade Name: Salazopyrin EN 500 mg enterotabletter Trade Name: Salazopyrin EN 500 mg enterotabletter Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Trade Name: Arava 20 mg filmdrasjerte tabletter Trade Name: Arava 20 mg filmdrasjerte tabletter Trade Name: ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Trade Name: Cimzia 200 mg injeksjonsvæske, oppløsning Trade Name: Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning. Trade Name: Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte | Diakonhjemmet Hospital AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Norway | |||
| 4 | EUCTR2012-000222-21-DE (EUCTR) | 31/05/2012 | 16/03/2012 | Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection. | An open-label, randomized, two-period cross-over study of repeated subcutaneous injections of methotrexate 50mg/ml solution either by a pre-filled syringe (reference) or by a disposable pre-filled pen (test) to assess patient’s preference and self-injection experience and to compare the local tolerability in patients with active rheumatoid arthritis - Preference MTX pre-filled syringe vs pre-filled pen in RA | Rheumatoid Arthritis 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] | Trade Name: metex® 50 mg/ml Injektionslösung, Fertigspritze Product Name: metex® 50 mg/ml Injektionslösung, Fertigspritze Product Code: 70930.00.00 INN or Proposed INN: Methotrexate disodium Product Name: methotrexate pre-filled pen INN or Proposed INN: Methotrexate disodium | medac Gesellschaft für klinische Spezialpräparate mbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 5 | EUCTR2009-015740-42-DE (EUCTR) | 12/05/2010 | 12/01/2010 | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Metex 2,5mg INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Metex 2,5mg | Universitätsklinkum Erlangen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Germany | |||
| 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 | EUCTR2009-012953-39-PL (EUCTR) | 19/10/2009 | 31/07/2009 | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SC12267 Product Code: SC12267 Trade Name: Metex 2,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 7,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 10mg Tabletten INN or Proposed INN: METHOTREXATE | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Czech Republic;Bulgaria;Poland | ||
| 7 | EUCTR2009-012953-39-BG (EUCTR) | 11/09/2009 | 18/09/2009 | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SC12267 Product Code: SC12267 INN or Proposed INN: Vidofludimus Trade Name: Metex 2,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 7,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 10mg Tabletten INN or Proposed INN: METHOTREXATE | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Czech Republic;Bulgaria;Poland | ||
| 8 | EUCTR2009-012953-39-CZ (EUCTR) | 02/09/2009 | 03/07/2009 | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SC12267 Product Code: SC12267 Trade Name: Metex 2,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 7,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 10mg Tabletten INN or Proposed INN: METHOTREXATE | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Czech Republic;Bulgaria;Poland | ||
| 9 | EUCTR2006-004139-31-NO (EUCTR) | 16/09/2008 | 19/12/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden | |||
| 10 | EUCTR2006-004139-31-NL (EUCTR) | 02/12/2007 | 26/04/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2006-004139-31-HU (EUCTR) | 05/09/2007 | 17/05/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 12 | EUCTR2006-004139-31-DE (EUCTR) | 30/08/2007 | 24/04/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Czech Republic;United Kingdom;Germany;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 13 | EUCTR2006-004139-31-CZ (EUCTR) | 08/08/2007 | 15/02/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Germany;United Kingdom;Czech Republic;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 14 | EUCTR2006-004139-31-SE (EUCTR) | 02/05/2007 | 12/02/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 15 | EUCTR2006-004139-31-ES (EUCTR) | 23/04/2007 | 25/01/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis.Estudio multicéntrico, aleatorizado, doble ciego, en dos periodos, para determinar el protocolo óptimo de inicio del tratamiento combinado de metotrexato y adalimumab en pacientes con Artritis Reumatoide Temprana. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis.Estudio multicéntrico, aleatorizado, doble ciego, en dos periodos, para determinar el protocolo óptimo de inicio del tratamiento combinado de metotrexato y adalimumab en pacientes con Artritis Reumatoide Temprana. - OPTIMA | Rheumatoid Arthritis. Artritis Reumatoide MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;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 | EUCTR2006-004139-31-BE (EUCTR) | 03/04/2007 | 19/12/2006 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | |||
| 17 | EUCTR2006-004139-31-FR (EUCTR) | 12/03/2007 | 12/02/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 18 | EUCTR2006-003146-41-DE (EUCTR) | 08/03/2007 | 23/11/2006 | A CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY - HIT HARD | A CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY - HIT HARD | Musculoskeletal disorders MedDRA version: 8.1;Level: LLT;Classification code 10048592;Term: Musculoskeletal disorder | Trade Name: Humira Product Name: HUMIRA INN or Proposed INN: Adalimumab Trade Name: Metex Product Name: Metex | Charité-Universitätsmedizin Berlin; Department of Rheumatology and Clinical Immunology | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 19 | EUCTR2006-004139-31-GB (EUCTR) | 06/03/2007 | 02/01/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 20 | EUCTR2006-004139-31-SK (EUCTR) | 15/02/2007 | 19/01/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | Slovakia;Greece;Spain;Austria;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Norway;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 | EUCTR2006-004139-31-AT (EUCTR) | 13/02/2007 | 06/02/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 22 | EUCTR2007-003591-19-DE (EUCTR) | 05/09/2007 | AN OPEN, COMPARATIVE, WITHIN PATIENT CONTROLLED MULTICENTRE STUDY OF REPEATED SUBCUTANEOUS INJECTIONS OF METHOTREXATE 50MG/ML AND 10MG/ML TO COMPARE PATIENT SATISFACTION AND LOCAL TOLERABILITY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - MTX 50 versus 10mg/ml | AN OPEN, COMPARATIVE, WITHIN PATIENT CONTROLLED MULTICENTRE STUDY OF REPEATED SUBCUTANEOUS INJECTIONS OF METHOTREXATE 50MG/ML AND 10MG/ML TO COMPARE PATIENT SATISFACTION AND LOCAL TOLERABILITY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - MTX 50 versus 10mg/ml | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Methotrexate 50mg/ml solution for injection, pre-filled syringe INN or Proposed INN: Methotrexate disodium Other descriptive name: Methotrexate disodium Trade Name: Metex 10 mg/ml Injektionslösung, Fertigspritze INN or Proposed INN: methotrexate disodium Other descriptive name: Methotrexate disodium | medac Gesellschaft für klinische Spezialpräparate mbH | NULL | Not Recruiting | Female: yes Male: yes | Germany |