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Study of Long-Term Antibiotic Treatment in Reactive Arthritis

Information source: Helsinki University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Reactive Arthritis

Intervention: ofloxacin and roxithromycin (Drug); placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Helsinki University

Official(s) and/or principal investigator(s):
Marjatta Leirisalo-Repo, MD, Principal Investigator, Affiliation: Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Proportion of patients recovered from arthritis

Secondary outcome:

Swollen joint count

Tender joint count

Ritchie index

Joint pain (visual analogue scale)

Serum C-reactive protein level

Blood erythrocyte sedimentation rate


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Division of Rheumatology, Department of Medicine, Helsinki 00029, Finland

Peijas Hospital, Vantaa 01400, Finland

Additional Information

Starting date: November 1993
Last updated: February 11, 2008

Page last updated: August 23, 2015

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