Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21AR053646 | U.S. NIH Grant/Contract | View source | |
| 1R21AR053646-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin and Rifampin | Active Comparator | Participants received Azithromycin and Rifampin |
|
| Doxycycline and Rifampin | Active Comparator | Participants received Doxycycline and Rifampin |
|
| received placebo | Placebo Comparator | Participants received placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline and Rifampin | Drug | doxycycline 100mg daily; rifampin 300mg daily (both for 6 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With a Complete Response (Resolution of All Symptoms) | Patients who completed full 6 months of treatment that reported feeling complete resolution of symptoms at month 6 visit and had no worsening of condition at the month 9 follow up visit. | Months 6 and 9 |
| Erythrocyte Sedimentation Rate (ESR) |
Not provided
Inclusion Criteria:
Meet the following European Spondyloarthropathy Study Group Criteria:
inflammatory spinal pain OR
synovitis AND
one or more of the following:
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)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John D. Carter, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33612 | United States | ||
| Louisiana State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15468362 | Background | 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. | |
| 20155838 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin & Rifampin | Participants will receive Azithromycin and Rifampin |
| FG001 | Doxycycline & Rifampin | Participants will receive Doxycycline and Rifampin |
| FG002 | Placebo | Participants will receive placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin & Rifampin | Participants will receive Azithromycin and Rifampin |
| BG001 | Doxycycline & Rifampin | Participants will receive Doxycycline and Rifampin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Efficacy and safety analyses were performed on an intent to treat(ITT) basis. Subjects who prematurely withdrew or who were lose to follow up for any reason were included in the ITT population and were considered nonresponders. | Posted | Number | participants | Month 6 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azithromycin & Rifampin | Participants will receive Azithromycin and Rifampin |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D. Carter, M.D. | University of South Florida | (813) 974-2681 | jocarter@health.usf.edu |
| ID | Term |
|---|---|
| D016918 | Arthritis, Reactive |
| D002690 | Chlamydia Infections |
| ID | Term |
|---|---|
| D001170 | Arthritis, Infectious |
| D007239 | Infections |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
Not provided
Not provided
| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D012293 | Rifampin |
| D017963 | Azithromycin |
| D015990 | Placebo Effect |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Azithromycin and Rifampin | Drug | Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months) |
|
|
| Placebo | Drug | Methylcellulose |
|
|
Comparison of mean ESR rates of combination antibiotic group vs placebo group at Baseline, Month 1, 3, 6 and 9 |
| Baseline Month 1, 3, 6 and 9 |
| hsCRP | Comparison of high sensitivity C-reactive protein measurement in combination antibiotic group vs placebo group at Baseline, Month 1, 3, and 6 | Baseline, Month 1, 3, and 6 |
| HAQ DI Score | Comparison of HAQ-DI score of combination antibiotic group vs placebo group at Baseline, Month 1,3,6 and 9 The Health assessment questionnaire disability index (HAQ-DI) is a questionnaire for the assessment of Rheumatoid Arthritis. The questionnaire is a patient reported outcome (PRO) which is usually self-administered by the patient There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made. The 8 scores of the 8 sections are summed and divided | Baseline, Month 1,3,6 and 9 |
| PhGA Assessment | Comparison of Physician's global assessment of disease activity (PhGA) using 0-100mm visual analog scale (VAS) , where 0 indicates the best possible outcome and 100 indicates the worst possible outcome, in combination antibiotic vs placebo groups at Baseline, month 1,3,6 and 9 | Baseline, month 1,3,6 and 9 |
| Swollen 76 Joint Count (SJC) | Comparison of modified Swollen Joint Counts between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of swelling in each of the 76 joints was determined by any swelling or absence of swelling. Each swollen joint receives a value of 1, ranging from 0-76 as a possible score. | Baseline, month 1,3,6 and 9 |
| 78 Tender Joint Count (TJC) | Comparison of modified 78 Tender Joint Count (TJC) between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of tender joing in each of the 78 joints was determined by examination. Each tender joint receives a value of 1, ranging from 0-78 as a possible score. | Baseline, Month 1, 3, 6 and 9 |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| University of Toronto | Toronto | Ontario | M5T 2S8 | Canada |
| BG002 | Placebo | Participants will receive placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants will receive Doxycycline and Rifampin |
| OG002 | Placebo | Participants will receive placebo |
|
|
|
| Secondary | Number of Patients With a Complete Response (Resolution of All Symptoms) | Patients who completed full 6 months of treatment that reported feeling complete resolution of symptoms at month 6 visit and had no worsening of condition at the month 9 follow up visit. | Patients randomized to combination antibiotics who believed that their disease went into complete remission during the trial | Posted | Count of Participants | Participants | Months 6 and 9 |
|
|
|
| Secondary | Erythrocyte Sedimentation Rate (ESR) | Comparison of mean ESR rates of combination antibiotic group vs placebo group at Baseline, Month 1, 3, 6 and 9 | Posted | Mean | Full Range | millimeters/hour | Baseline Month 1, 3, 6 and 9 |
|
|
|
| Secondary | hsCRP | Comparison of high sensitivity C-reactive protein measurement in combination antibiotic group vs placebo group at Baseline, Month 1, 3, and 6 | Posted | Mean | Full Range | mg/litre | Baseline, Month 1, 3, and 6 |
|
|
|
| Secondary | HAQ DI Score | Comparison of HAQ-DI score of combination antibiotic group vs placebo group at Baseline, Month 1,3,6 and 9 The Health assessment questionnaire disability index (HAQ-DI) is a questionnaire for the assessment of Rheumatoid Arthritis. The questionnaire is a patient reported outcome (PRO) which is usually self-administered by the patient There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made. The 8 scores of the 8 sections are summed and divided | Posted | Mean | Full Range | score on a scale | Baseline, Month 1,3,6 and 9 |
|
|
|
| Secondary | PhGA Assessment | Comparison of Physician's global assessment of disease activity (PhGA) using 0-100mm visual analog scale (VAS) , where 0 indicates the best possible outcome and 100 indicates the worst possible outcome, in combination antibiotic vs placebo groups at Baseline, month 1,3,6 and 9 | Posted | Mean | Full Range | units on a scale | Baseline, month 1,3,6 and 9 |
|
|
|
| Secondary | Swollen 76 Joint Count (SJC) | Comparison of modified Swollen Joint Counts between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of swelling in each of the 76 joints was determined by any swelling or absence of swelling. Each swollen joint receives a value of 1, ranging from 0-76 as a possible score. | Posted | Mean | Full Range | Swollen Joints | Baseline, month 1,3,6 and 9 |
|
|
|
| Secondary | 78 Tender Joint Count (TJC) | Comparison of modified 78 Tender Joint Count (TJC) between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of tender joing in each of the 78 joints was determined by examination. Each tender joint receives a value of 1, ranging from 0-78 as a possible score. | Posted | Mean | Full Range | Tender Joints | Baseline, Month 1, 3, 6 and 9 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Doxycycline & Rifampin | Participants will receive Doxycycline and Rifampin | 0 | 12 | 0 | 12 |
| EG002 | Placebo | Participants will receive placebo | 0 | 15 | 0 | 15 |
Not provided
Not provided
| D013166 |
| Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D015987 | Effect Modifier, Epidemiologic |
| D015981 | Epidemiologic Factors |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Month 3 |
|
| Month 6 |
|
| Month 9 |
|
| Month 3 |
|
| Month 6 |
|
| Month 3 |
|
| Month 6 |
|
| Month 9 |
|
| Month 3 |
|
| Month 6 |
|
| Month 9 |
|
| Month 3 |
|
| Month 6 |
|
| Month 9 |
|
| Month 3 |
|
| Month 6 |
|
| Month 9 |
|