EUCTR2012-004074-25-DEActive, not recruitingPhase 1
Comparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Ruhr-Universität Bochum
- Enrollment
- 450
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Diagnosis of rheumatoid arthritis based on expert opinion according to the ACR/EULAR 2009 criteria (Hawker 2009), disease duration < 3 years, active disease: DAS 28 ESR (Prevoo et al 1995) > 4 plus = 3 swollen joints
- •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 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
Exclusion Criteria
- •Prior treatment with DMARDs (except for hydroxychloroquin or sulfasalazine or methotrexate during the last four weeks before screening)
- •Clinically relevant comorbidity:
- •concurrent liver disease (ALT > 2 times upper limit of normal),
- •active hepatitis B or C viral infection,
- •renal disease (creatinine clearance < 30 ml/minute),
- •clinically relevant haematological disease due to the
- •judgement of the rheumatologist,
- •uncontrolled diabetes mellitus,
- •relevant immunodeficiency incl. HIV-infection,
- •clinically significant pulmonary fibrosis,
- •presence or history of severe infections,
- •pregnancy or planned pregnancy,
- •non-compliance,
- •age < 18 years.
Investigators
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