Study of Long-Term Antibiotic Treatment in Reactive Arthritis

Reactive Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621387
• Other study ID #: 121-853-93
• Status: Completed
• Phase: N/A
• First received: February 11, 2008
• Last updated: February 11, 2008
• Start date: November 1993
• Est. completion date: June 1998

Study information

• Verified date: November 2007
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Reactive
• Reactive Arthritis

Intervention

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

Locations

Country	Name	City	State
Finland	Division of Rheumatology, Department of Medicine	Helsinki
Finland	Peijas Hospital	Vantaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients recovered from arthritis		6 months	No
Secondary	Swollen joint count		6 months	No
Secondary	Tender joint count		6 months
Secondary	Ritchie index		6 months	No
Secondary	Joint pain (visual analogue scale)		6 months	No
Secondary	Serum C-reactive protein level		6 months	No
Secondary	Blood erythrocyte sedimentation rate		6 months	No