Study of Long-Term Antibiotic Treatment in Reactive Arthritis

Not Applicable

Completed

• Conditions: Reactive Arthritis
• Interventions: Drug: ofloxacin and roxithromycin; Drug: placebo

• Registration Number: NCT00621387
• Lead Sponsor: University of Helsinki

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 Description

Not available

Study Timeline

• Study Start: 1993-11
• Study Completion: 1998-06
• Status Verified: 2007-11
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Last Update Submitted: 2008-02-11
• Study First Posted: 2008-02-22
• Last Update Posted: 2008-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ofloxacin and roxithromycin	ofloxacin and roxithromycin
2	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Proportion of patients recovered from arthritis	6 months

Secondary Outcome Measures

Name	Time	Method
Swollen joint count	6 months
Tender joint count	6 months
Ritchie index	6 months
Joint pain (visual analogue scale)	6 months
Serum C-reactive protein level	6 months
Blood erythrocyte sedimentation rate	6 months

Trial Locations

Locations (2)

Peijas Hospital; 🇫🇮 Vantaa, Finland

Division of Rheumatology, Department of Medicine; 🇫🇮 Helsinki, Finland