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Completed

NCT Number: NCT00621387

Study of Long-Term Antibiotic Treatment in 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.

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Key information

Conditions

Reactive Arthritis Arthritis Arthritis, Infectious Arthritis, Reactive Bone Diseases Chronic Disease Disease Attributes Infections Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Infectious Disorders Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Rheumatology, Department of Medicine, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of acute reactive arthritis
  • Preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months
  • Age 18 or older

Exclusion criteria

  • Allergy to quinolones or macrolides
  • Treatment with systemic corticosteroids within 2 weeks
  • Serum creatinine level elevated over the reference limit
  • Alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit
  • Current or planned pregnancy, or lack of contraception
  • Known HIV positivity
  • Blood leukocyte count less than 4.0x109/l
  • Blood platelet count less than 100x109/l
  • Lack of co-operation.

Treatment and study plan

ofloxacin and roxithromycin

Drug

150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months

Other names: Tarivid and Surlid

Placebo

Drug

placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months

Primary outcomes

  1. Proportion of patients recovered from arthritis

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Official study title

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

Important dates

Study start
1993
Study completion
1998
First posted
Feb 22, 2008
Registry last updated
Feb 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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