EUCTR2012-004074-25-DE
Active, not recruiting
Phase 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ruhr-Universität Bochum
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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,
Outcomes
Primary Outcomes
Not specified
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