Study of Long-Term Antibiotic Treatment in Reactive Arthritis - Full Text View

Sponsor:	Helsinki University
Collaborator:	Helsinki University Central Hospital research funds
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00621387

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:

MedlinePlus related topics: Antibiotics

Drug Information available for: Roxithromycin Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

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:

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.

Contacts and Locations

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

Helsinki University Central Hospital research funds

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
Roxithromycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on February 09, 2012