Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria

NCT00351273 | Completed Phase 3 Results

• 2 other identifiers: R21AR0536461R21AR053646-01
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Arthritis, Reactive; Reiter Disease

Keywords

Chlamydia

Outcome Measures

Primary Outcomes (1)

• Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment.

  The outcome measure was a composite endpoint. Participants had to meet 4/6 clinical criteria. 17/24 subjects randomized to combination antibiotics did respond to treatment when compared to 3/10 randomized to placebo.

  Month 6

Secondary Outcomes (7)

• Number of Patients With a Complete Response (Resolution of All Symptoms)

  Months 6 and 9

• Erythrocyte Sedimentation Rate (ESR)

  Baseline Month 1, 3, 6 and 9

• hsCRP

  Baseline, Month 1, 3, and 6

• HAQ DI Score

  Baseline, Month 1,3,6 and 9

• PhGA Assessment

  Baseline, month 1,3,6 and 9

Study Arms (3)

Azithromycin and Rifampin

ACTIVE COMPARATOR

Participants received Azithromycin and Rifampin

Drug: Azithromycin and Rifampin

Doxycycline and Rifampin

ACTIVE COMPARATOR

Participants received Doxycycline and Rifampin

Drug: Doxycycline and Rifampin

received placebo

PLACEBO COMPARATOR

Participants received placebo

Drug: Placebo

Interventions

Doxycycline and Rifampin DRUG

doxycycline 100mg daily; rifampin 300mg daily (both for 6 months)

Also known as: Atridox and Rifadin

Doxycycline and Rifampin

Azithromycin and Rifampin DRUG

Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months)

Also known as: Zithromax and Rifadin

Azithromycin and Rifampin

Placebo DRUG

Methylcellulose

Also known as: Placebo effect

received placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the following European Spondyloarthropathy Study Group Criteria:
• inflammatory spinal pain OR
• synovitis AND
• one or more of the following:
• positive family history
• urethritis or cervicitis within 1 month prior to onset of arthritis
• buttock pain
• enthesopathy
• sacroiliitis
• Disease duration of at least 6 months
• Negative pregnancy test at study baseline and willing to use an effective method of contraception other than combined oral contraceptives for the duration of the study (for women of childbearing age)

You may not qualify if:

• Sensitivity or history of allergic reaction to rifampin, doxycycline, or azithromycin
• Currently taking any medications that may interact with the study medications, specifically rifampin
• Liver transaminases greater than or equal to two times the normal level
• Significant abnormalities in the complete blood count (CBC)
• Pregnant
• Current psoriasis
• Diagnosis of inflammatory bowel disease
• Diagnosis of ankylosing spondylitis
• Previous prolonged exposure to antibiotics (more than 2 weeks) as a potential treatment for reactive arthritis

Sponsors & Collaborators

• University of South Florida: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (3)

University of South Florida

Tampa, Florida, 33612, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

University of Toronto

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (2)

• Carter JD, Valeriano J, Vasey FB. Doxycycline versus doxycycline and rifampin in undifferentiated spondyloarthropathy, with special reference to chlamydia-induced arthritis. A prospective, randomized 9-month comparison. J Rheumatol. 2004 Oct;31(10):1973-80.

  PMID: 15468362 BACKGROUND

• Carter JD, Espinoza LR, Inman RD, Sneed KB, Ricca LR, Vasey FB, Valeriano J, Stanich JA, Oszust C, Gerard HC, Hudson AP. Combination antibiotics as a treatment for chronic Chlamydia-induced reactive arthritis: a double-blind, placebo-controlled, prospective trial. Arthritis Rheum. 2010 May;62(5):1298-307. doi: 10.1002/art.27394.

  PMID: 20155838 DERIVED

MeSH Terms

Conditions

Arthritis, Reactive; Chlamydia Infections

Interventions

Doxycycline; Rifampin; Azithromycin; Placebo Effect

Condition Hierarchy (Ancestors)

Arthritis, Infectious; Infections; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: John D. Carter, M.D.
• Organization: University of South Florida

jocarter@health.usf.edu

(813) 974-2681

Study Officials

• John D. Carter, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2006
• First Posted: July 12, 2006
• Study Start: May 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 13, 2018
• Results First Posted: August 10, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)