Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or MethotrexateAddendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA

Phase 1

• Conditions: early rheumatoid arthritis; MedDRA version: 12.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditions

• Registration Number: EUCTR2010-019873-13-BE
• Lead Sponsor: CL Cliniques Universitaires Saint Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-14
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Diagnosis of RA (according to ACR criteria)
Disease duration < 2 years.
Age between 18 and 70 years old.
Active RA defined by a DAS28-CRP score > 3.2 with a swollen joint count = 4
MTX naive
Stable therapy with corticosteroïds or NSAIDs
Presence of knee arthralgia or synovitis (addendum protocol with synovial biopsy).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous MTX treatment.
Exclusion for severe physical handicap to perform CRE.
Exclusion for general safety (history of severe allergic reaction, sepsis, malignancy within 5 years, pregnancy, severe heart failure)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified