Study of Long-Term Antibiotic Treatment in Reactive Arthritis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00621387

Enrollment

Registered

2008-02-22

Start date

1993-11-30

Completion date

1998-06-30

Last updated

2008-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reactive Arthritis

Keywords

reactive arthritis, antibiotics

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.

Interventions

DRUGofloxacin and roxithromycin

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients recovered from arthritis	6 months

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026