A 2 year follow up to assess the effectiveness in daily practice of different treatment strategies for early Rheumatoid Arthritis patients.

Phase 1

• Conditions: early active Rheumatoid Arthritis, previously untreated with DMARDS; MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2008-007225-39-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-12
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

-Age = 18 years
-Diagnosis of RA as defined by the 1987-revised ACR classification criteria or the new ACR/Eular 2010 criteria for early RA
-Early RA defined by a disease duration of = 1 year
-Use of a reliable method of contraception for women of childbearing potential
-Able and willing to give written informed consent and participate in the study

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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

-Previous treatment with methotrexate or leflunomide
-Previous treatment with cyclophosfamide, azathioprine or cyclosporine
-Previous treatment with sulphasalazine for more than 3 weeks
-Previous treatment with hydroxychloroquine for more than 6 weeks
-Previous treatment with corticoids or intra-articular glucocorticoïds within 4 weeks before treatment start or for more than 4 weeks
-Previous treatment with an investigational drug for the treatment/prevention of RA
-Contraindications for corticosteroids
-Contraindications for methotrexate, sulphasalazine or leflunomide
?known chronic hepatic disease (alcoholic, fibrosis, …)
?known pulmonary interstitial disease or fibrosis
?known chronic renal failure
?history of malignant neoplasm within 5 years
?hematologic problems at the discretion of the investigator
-Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
-Pregnancy, breastfeeding or no use of a reliable method of contraception
-Alcohol or drug abuse

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To study in patients with severe RA, the efficacy and effectiveness of a classic COBRA scheme (with 15mg MTX) versus two modified COBRA schemes respectively slim” (without SSZ and with half dose steroids) and avant-garde” (leflunomide instead of SSZ and half dose steroids) in daily practice.<br><br>To study in patients with less severe RA, the daily practice efficacy and effectiveness of a tight step up regimen (with 15mg MTX) versus a modified COBRA slim scheme (without SSZ and with half dose steroids). <br>;Secondary Objective: A superiority analysis will be performed: in the high risk arm, COBRA classic and COBRA avant-garde vs. COBRA slim and in the low risk arm, COBRA slim vs. Tight Step Up.;Primary end point(s): •Proportion in remission (DAS28CRP < 2.6) ;Timepoint(s) of evaluation of this end point: at week 16, 52 and 104