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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
56
150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months
placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months
Division of Rheumatology, Department of Medicine
Helsinki, Finland
Peijas Hospital
Vantaa, Finland
Proportion of patients recovered from arthritis
Time frame: 6 months
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
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