Triple therapy in early active rheumatoid arthritis - TEAR

Conditions: Rheumatoid arthritis

Registration Number: EUCTR2004-002006-30-GB

Lead Sponsor: orth Glasgow NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 96

Inclusion Criteria

Rheumatoid arthritis
Active disease (measured using the validated disease activity score)
Disease duration < 5 years
Age 18-80 years

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 use of disease modifying drugs (other than hydroxychloroquine)
AST >80
ALP > 700
Creatinine > 160
White cell count <4
Platelet count < 150
Pregnancy, planned pregnancy, unwillingness to use contraception

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the trial is to test the hypothesis that improved, sustained disease contol (with acceptable toxicity) will result from early triple therapy with methotrexate, hydroxychloroquine and sulfasalazine. The specific research questions that will be addressed are:<br>1) Does early triple therapy in the treatment of early active rheumatoid arthritis confer significant benfits in terms of disease control when compared to a 'step up' strategy for the use of disease odifying drug therapy?;Secondary Objective: 2) Does early triple therapy in the treatment of early active rheumatoid arthritis result in improved physical function, quality of life and reduced radiological damage?<br><br>3) Is there excess toxicity associated with the use of early triple therapy?;Primary end point(s): Mean change in disease activity score (DAS28)<br>Proportion of patients with a 'good response' (EULAR definition)

Secondary Outcome Measures