Clinical Trial: Study of Long-Term Antibiotic Treatment in Reactive Arthritis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis
Brief Summary: This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at regular intervals until 6 months. The main outcome measure is recovery from arthritis, and secondary outcome measures include swollen and tender joint counts, Ritchie index, joint pain, serum C-reactive protein level and blood erythrocyte sedimentation rate. The study will also address the safety and tolerability of long-term antibiotic treatment. 56 patients are enrolled and the enrollment of patients has been completed.
Detailed Summary:
Sponsor: Helsinki University
Current Primary Outcome: Proportion of patients recovered from arthritis [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Swollen joint count [ Time Frame: 6 months ]
- Tender joint count [ Time Frame: 6 months ]
- Ritchie index [ Time Frame: 6 months ]
- Joint pain (visual analogue scale) [ Time Frame: 6 months ]
- Serum C-reactive protein level [ Time Frame: 6 months ]
- Blood erythrocyte sedimentation rate [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Helsinki University
Dates:
Date Received: February 11, 2008
Date Started: November 1993
Date Completion:
Last Updated: February 11, 2008
Last Verified: November 2007
