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Study of Long-Term Antibiotic Treatment in Reactive Arthritis

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ClinicalTrials.gov Identifier: NCT00621387
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : February 22, 2008
Sponsor:
Information provided by:
Helsinki University

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.

Condition or disease Intervention/treatment Phase
Reactive Arthritis Drug: ofloxacin and roxithromycin Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : November 1993
Actual Study Completion Date : June 1998


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Proportion of patients recovered from arthritis [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Swollen joint count [ Time Frame: 6 months ]
  2. Tender joint count [ Time Frame: 6 months ]
  3. Ritchie index [ Time Frame: 6 months ]
  4. Joint pain (visual analogue scale) [ Time Frame: 6 months ]
  5. Serum C-reactive protein level [ Time Frame: 6 months ]
  6. Blood erythrocyte sedimentation rate [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00621387     History of Changes
Other Study ID Numbers: 121-853-93
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: February 22, 2008
Last Verified: November 2007

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
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors