Study of Long-Term Antibiotic Treatment in Reactive Arthritis

February 11, 2008 updated by: University of Helsinki

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Division of Rheumatology, Department of Medicine
      • Vantaa, Finland, 01400
        • Peijas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
placebo
Drug: placebo
placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months
Experimental: 1
ofloxacin and roxithromycin
Drug: ofloxacin and roxithromycin
150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months
Other Names:
  • Tarivid and Surlid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients recovered from arthritis
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1993

Study Completion (Actual)

June 1, 1998

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

February 22, 2008

Last Update Submitted That Met QC Criteria

February 11, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121-853-93

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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