ISRCTN18445519
Completed
Not Applicable
Comparison of combination therapy with single-drug therapy in early rheumatoid arthritis: a multicentre randomised open parallel-group treatment strategy trial
Turku University Hospital (Finland)0 sites199 target enrollmentNovember 27, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Turku University Hospital (Finland)
- Enrollment
- 199
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. American Rheumatism Association criteria for rheumatoid arthritis
- •2\. Aged between 18 and 65 years, either sex
- •3\. Duration of symptoms of less than 2 years
- •4\. Active disease with three or more swollen joints and at least three of the following:
- •4\.1\. Erythrocyte sedimentation rate (ESR) at least 28 mm/h
- •4\.2\. C\-reactive protein (CRP) above 19 mg/l
- •4\.3\. Morning stiffness of 29 minutes or more
- •4\.4\. More than five swollen joints
- •4\.5\. More than ten tender joints
Exclusion Criteria
- •1\. Patients who had used DMARDs in the past
- •2\. Had undergone glucocorticoid therapy within the previous 2 weeks
- •3\. Patients with serious comorbidity
- •4\. Suspected inability to comply with the protocol
- •5\. Hypersensitivity to any study medication
- •6\. A history of cancer
- •7\. Pregnant women
- •8\. Women of childbearing age who were not using reliable methods of contraception
Outcomes
Primary Outcomes
Not specified
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