Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis

Launched by PROF. DR. RER. NAT. H.J. TRAMPISCH · Dec 3, 2013

Keywords

ClinConnect Summary

BACKGROUND: Although glucocorticoids (GCs) are widely used in the treatment of patients with early rheumatoid arthritis (RA), the best dosage for GCs, related to both, efficacy and safety, is not known.

OBJECTIVE: To compare two standard p.o. GC starting dosages and the non-use of GCs in the treatment of patients with early active RA on the background of the established 'anchor' therapy with methotrexate (MTX).

METHODS: Randomised double-blind placebo-controlled trial with two treatment arms (starting with 10 or 60 mg of p.o. prednisolone (P), tapered down to 5 mg P per day within 8 weeks...

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Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of rheumatoid arthritis based on expert opinion according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2009 criteria (Hawker 2009)
• • disease duration \< 3 years
• • active disease: disease activity score (DAS) 28 erythrocyte sedimentation rate (ESR) (Prevoo et al 1995) \> 4 plus ≥ 3 swollen joints
• Exclusion Criteria:
• • Prior treatment with disease-modifying antirheumatic drugs (DMARDs) (except for hydroxychloroquine 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,
• • uncontrolled arterial hypertension,
• • relevant immunodeficiency incl. HIV-infection,
• • clinically significant pulmonary fibrosis,
• • history of malignant melanoma,
• • complicated or refractory gastrointestinal ulcers,
• • presence or history of severe infections,
• • uncontrolled increased intraocular pressure,
• • pregnancy or planned pregnancy,
• • non-compliance,
• • age \< 18 years