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Ann Rheum Dis ; 69(2): 364-7, 2010 Feb.
Article in English | MEDLINE | ID: mdl-19357113

ABSTRACT

OBJECTIVE: To determine the efficacy and safety of pamapimod in adult patients with active rheumatoid arthritis (RA) who had an inadequate clinical response to methotrexate (MTX). METHODS: Patients receiving stable doses of MTX were randomised to one of six dose groups and received 12 weeks of double-blind pamapimod (up to 300 mg once daily) or matching placebo. The primary efficacy measure was the proportion of patients with > or =20% improvement in RA based on the American College of Rheumatology criteria (ACR20) at 12 weeks. Secondary measures were ACR50, Disease Activity Score (DAS)/European League Against Rheumatism (EULAR) responses and the individual ACR core set of parameters. Safety measures included adverse events (AEs), laboratory testing and immunology assessments. RESULTS: On a background of MTX, the percentage of patients with an ACR20 response at week 12 in the pamapimod groups (31% to 43%) was not significantly different from placebo (34%). Secondary efficacy end points showed a similar pattern. AEs were typically mild and included infections, gastrointestinal disturbances, dizziness and rashes; AEs resulting in discontinuation of study drug were primarily attributed to infections. CONCLUSION: In patients with active RA receiving stable doses of MTX, pamapimod showed non-significant improvement in efficacy outcomes compared to placebo.


Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Methotrexate/therapeutic use , Pyridones/therapeutic use , Pyrimidines/therapeutic use , Adolescent , Adult , Aged , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/blood , Biomarkers/blood , C-Reactive Protein/metabolism , Double-Blind Method , Drug Therapy, Combination , Humans , Methotrexate/adverse effects , Middle Aged , Protein Kinase Inhibitors/adverse effects , Protein Kinase Inhibitors/therapeutic use , Pyridones/adverse effects , Pyrimidines/adverse effects , Severity of Illness Index , Treatment Outcome , Young Adult , p38 Mitogen-Activated Protein Kinases/antagonists & inhibitors
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