Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial

Phase 4

• Conditions: M05; Seropositive rheumatoid arthritis

• Registration Number: DRKS00004774
• Lead Sponsor: Ruhr-Universität Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-12
• Study Completion: 2018-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

• Diagnosis of RA according to the ACR/EULAR 2010 criteria (Aletaha et al. 2010),
• disease duration < 3 years,
• active disease: DAS 28 ESR > 4 plus = 3 swollen joints.
• adequate compliance related to medication and paticipating in examinations in assessment of the physician
• legal capacity
• sufficient German language skills to fill in the questioning forms
• written informed consent

Exclusion Criteria

- age < 18 years
- pregnancy or planned pregnancy,
- presence or history of severe infections,
- systemic corticoid-therapy 2 weeks before study start,
- Prior treatment with DMARDs (except for hydroxychloroquin or sulfasalazine or methotrexate during the last four weeks before screening,
-intolarance or known of inefficacy of Methotrexat (MTX),
- 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,
- uncontrolled arterial hypertension,
- relevant immunodeficiency incl. HIV-infection,
- clinically significant pulmonary fibrosis,
- history of malignant melanoma,
- complicated or refractory gastrointestinal ulcers,
- uncontrolled increased intraocular pressure,

- non-compliance,

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of radiographic damage after one year as quantified by the van der Heijde modification of the Sharp score (SHS). Determined at basline and after one year.