CompletedNCT00621387Updated Feb 22, 2008

Study of Long-Term Antibiotic Treatment in Reactive Arthritis

An interventional study of ofloxacin and roxithromycin and placebo in Reactive Arthritis, sponsored by University of Helsinki. Completed at 2 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-02-22.

Sponsored by University of Helsinki · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 56
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Reactive Arthritis

Keywords

reactive arthritis
antibiotics

In context

Lead sponsor

University of Helsinki is the lead sponsor of 132 studies on the registry; 19 are open to participants now.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 56 participants (actual)

Study arms

Experimental
1
ofloxacin and roxithromycin
Drug: ofloxacin and roxithromycin
Placebo comparator
2
placebo
Drug: placebo

Interventions

Drugofloxacin and roxithromycin
Drug pages: Ofloxacin · Roxithromycin
150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months
Also known as: Tarivid and Surlid
Drugplacebo
placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months

What researchers measure

Primary outcomes

Proportion of patients recovered from arthritis
Time frame: 6 months

Secondary outcomes

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

Study locations

2 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00621387
Lead sponsor: University of Helsinki
First posted: Feb 22, 2008
Start date: Nov 1993
Completion: Jun 1998
Last update: Feb 22, 2008

Study contacts

Marjatta Leirisalo-Repo, MD

principal investigator · Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Ofloxacin · Roxithromycin

Other studies in this condition

Arthritis, Reactive

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