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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00351273 |
Reactive arthritis, also known as Reiter's syndrome, is a form of arthritis that occurs as a reaction to an infection elsewhere in the body. It is characterized by inflammation of the joints, tendons, urogenital tract, and eyes. Pain and swelling in the knees, ankles, and feet are common. This study will determine the effectiveness of antibiotic therapy in treating people with chlamydia-induced reactive arthritis that has lasted for more than 6 months.
Condition | Intervention | Phase |
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Arthritis, Reactive Reiter Disease |
Drug: Doxycycline and Rifampin Drug: Azithromycin and Rifampin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase 3 Trial to Assess the Efficacy of Long-Term (6 Months) Combination Antibiotics as a Treatment for Chlamydia-Induced Reactive Arthritis |
Estimated Enrollment: | 42 |
Study Start Date: | May 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive Azithromycin and Rifampin
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Drug: Azithromycin and Rifampin
Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months)
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2: Active Comparator
Participants will receive Doxycycline and Rifampin
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Drug: Doxycycline and Rifampin
doxycycline 100mg daily; rifampin 300mg daily (both for 6 months)
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3: Placebo Comparator
Participants will receive placebo
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Drug: Placebo
Methylcellulose
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The initial infection that causes reactive arthritis is caused by one of two bacteria: Chlamydia trachomatis, which is usually acquired through sexual contact, or Chlamydia pneumoniae, which can cause respiratory infections. Most people recover fully from the initial flare of arthritis symptoms. However, about 20% of people with reactive arthritis experience long-lasting symptoms. In these individuals, the Chlamydia bacteria exist in a persistent metabolically active state within the joint tissue, even years after the initial exposure. The bacteria produce heat shock proteins (HSPs), which are thought to play a key role in the chronic persistent state of Chlamydia and which may stimulate the immune inflammatory response seen in reactive arthritis. This indicates the need for antimicrobial therapy that can reduce Chlamydia's HSP production and block its metabolism. The purpose of this study is to determine the effectiveness of long-term combination antibiotic therapy in treating people with chronic reactive arthritis. The study will use two different combinations of common antibiotics: doxycycline paired with rifampin and azithromycin paired with rifampin.
This study will entail 6 months of treatment followed by 3 months of follow-up. After screening, eligible participants will be randomly assigned to one of three treatment groups: rifampin once a day plus doxycycline twice a day; rifampin once a day plus azithromycin once a day for 5 days, then twice weekly; or placebo. Study visits will occur at baseline and Months 1, 3, 6, and 9. At all visits, participants will undergo an interview, a physical examination, and blood collection. They will also complete a questionnaire related to their symptoms and functional status. At screening and Month 6, a synovial biopsy may be performed. This will involve taking a sample of the tissue that lines the joints.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meet the following European Spondyloarthropathy Study Group Criteria:
one or more of the following:
Exclusion Criteria:
United States, Florida | |
University of South Florida | |
Tampa, Florida, United States, 33612 | |
United States, Louisiana | |
Louisiana State University | |
New Orleans, Louisiana, United States, 70112 | |
Canada, Ontario | |
University of Toronto | |
Toronto, Ontario, Canada, M5T 2S8 |
Principal Investigator: | John D. Carter, MD | University of South Florida |
Responsible Party: | University of South Florida ( John D. Carter, M.D./Principal Investigator ) |
Study ID Numbers: | R21 AR053646, 1R21AR053646-01 |
Study First Received: | July 10, 2006 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00351273 |
Health Authority: | United States: Federal Government |
Chlamydia |
Spinal Diseases Joint Diseases Spondylarthropathy Arthritis, Infectious Arthritis, Reactive Bone Diseases Rifampin Musculoskeletal Diseases |
Arthritis Azithromycin Chlamydia Infections Reiter's Syndrome Spondylarthritis Doxycycline Spondylarthropathies |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection Pharmacologic Actions Antibiotics, Antitubercular |
Anti-Bacterial Agents Antimalarials Antiparasitic Agents Therapeutic Uses Antitubercular Agents Nucleic Acid Synthesis Inhibitors Leprostatic Agents |