Official Title: “Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: ofloxacin and roxithromycin
  • 150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months
• Drug: placebo
  • placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • ofloxacin and roxithromycin
• Placebo Comparator: 2
  • placebo

Primary Measures

• Proportion of patients recovered from arthritis
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Swollen joint count
  • Time Frame: 6 months
    Safety Issue?: No
• Tender joint count
  • Time Frame: 6 months
    
• Ritchie index
  • Time Frame: 6 months
    Safety Issue?: No
• Joint pain (visual analogue scale)
  • Time Frame: 6 months
    Safety Issue?: No
• Serum C-reactive protein level
  • Time Frame: 6 months
    Safety Issue?: No
• Blood erythrocyte sedimentation rate
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• 1. Diagnosis of acute reactive arthritis
• 2. Preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months
• 3. Age 18 or older

Exclusion Criteria:

• 1. Allergy to quinolones or macrolides
• 2. Treatment with systemic corticosteroids within 2 weeks
• 3. Serum creatinine level elevated over the reference limit
• 4. Alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit
• 5. Current or planned pregnancy, or lack of contraception
• 6. Known HIV positivity
• 7. Blood leukocyte count less than 4.0x109/l
• 8. Blood platelet count less than 100x109/l
• 9. Lack of co-operation.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Helsinki University

Overall Clinical Trial Officials and Contacts

Marjatta Leirisalo-Repo, MD Principal Investigator Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00621387

Study ID Number: 121-853-93

ClinicalTrials.gov Identifier: NCT00621387

Health Authority: Finland: National Agency for Medicines