Study of Long-Term Antibiotic Treatment in Reactive Arthritis

This study has been completed.
Sponsor:
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00621387
First received: February 11, 2008
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Reactive Arthritis
Drug: ofloxacin and roxithromycin
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Proportion of patients recovered from arthritis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Swollen joint count [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tender joint count [ Time Frame: 6 months ]
  • Ritchie index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Joint pain (visual analogue scale) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Serum C-reactive protein level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood erythrocyte sedimentation rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: November 1993
Study Completion Date: June 1998
Arms Assigned Interventions
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 Name: Tarivid and Surlid
Placebo Comparator: 2
placebo
Drug: placebo
placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621387

Locations
Finland
Division of Rheumatology, Department of Medicine
Helsinki, Finland, 00029
Peijas Hospital
Vantaa, Finland, 01400
Sponsors and Collaborators
Helsinki University
Investigators
Principal Investigator: Marjatta Leirisalo-Repo, MD Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00621387     History of Changes
Other Study ID Numbers: 121-853-93
Study First Received: February 11, 2008
Last Updated: February 11, 2008
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University:
reactive arthritis
antibiotics

Additional relevant MeSH terms:
Arthritis
Arthritis, Reactive
Joint Diseases
Musculoskeletal Diseases
Arthritis, Infectious
Infection
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Anti-Bacterial Agents
Ofloxacin
Levofloxacin
Roxithromycin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 31, 2014