Trial Outcomes & Findings for Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria (NCT NCT00351273)
NCT ID: NCT00351273
Last Updated: 2018-11-13
Results Overview
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.
COMPLETED
PHASE3
42 participants
Month 6
2018-11-13
Participant Flow
Participant milestones
| Measure |
Azithromycin & Rifampin
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
Participants will receive Doxycycline and Rifampin
|
Placebo
Participants will receive placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
12
|
15
|
|
Overall Study
COMPLETED
|
14
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
5
|
Reasons for withdrawal
| Measure |
Azithromycin & Rifampin
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
Participants will receive Doxycycline and Rifampin
|
Placebo
Participants will receive placebo
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
5
|
Baseline Characteristics
Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria
Baseline characteristics by cohort
| Measure |
Azithromycin & Rifampin
n=15 Participants
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
n=12 Participants
Participants will receive Doxycycline and Rifampin
|
Placebo
n=15 Participants
Participants will receive placebo
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 12 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
49 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
14 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: 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.
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.
Outcome measures
| Measure |
Azithromycin & Rifampin
n=14 Participants
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
n=10 Participants
Participants will receive Doxycycline and Rifampin
|
Placebo
n=10 Participants
Participants will receive placebo
|
|---|---|---|---|
|
Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment.
|
10 participants
|
7 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Months 6 and 9Population: Patients randomized to combination antibiotics who believed that their disease went into complete remission during the trial
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.
Outcome measures
| Measure |
Azithromycin & Rifampin
n=10 Participants
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
n=7 Participants
Participants will receive Doxycycline and Rifampin
|
Placebo
n=3 Participants
Participants will receive placebo
|
|---|---|---|---|
|
Number of Patients With a Complete Response (Resolution of All Symptoms)
|
5 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline Month 1, 3, 6 and 9Comparison of mean ESR rates of combination antibiotic group vs placebo group at Baseline, Month 1, 3, 6 and 9
Outcome measures
| Measure |
Azithromycin & Rifampin
n=27 Participants
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
n=15 Participants
Participants will receive Doxycycline and Rifampin
|
Placebo
Participants will receive placebo
|
|---|---|---|---|
|
Erythrocyte Sedimentation Rate (ESR)
Month 1
|
17.8 millimeters/hour
Interval 2.0 to 50.0
|
25.2 millimeters/hour
Interval 1.0 to 78.0
|
—
|
|
Erythrocyte Sedimentation Rate (ESR)
Month 3
|
17.7 millimeters/hour
Interval 1.0 to 72.0
|
19.8 millimeters/hour
Interval 4.0 to 42.0
|
—
|
|
Erythrocyte Sedimentation Rate (ESR)
Month 6
|
12.7 millimeters/hour
Interval 1.0 to 55.0
|
17.0 millimeters/hour
Interval 3.0 to 37.0
|
—
|
|
Erythrocyte Sedimentation Rate (ESR)
Month 9
|
14.0 millimeters/hour
Interval 1.0 to 47.0
|
18.4 millimeters/hour
Interval 4.0 to 45.0
|
—
|
|
Erythrocyte Sedimentation Rate (ESR)
Baseline
|
25.1 millimeters/hour
Interval 1.0 to 81.0
|
18.9 millimeters/hour
Interval 1.0 to 74.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, and 6Comparison of high sensitivity C-reactive protein measurement in combination antibiotic group vs placebo group at Baseline, Month 1, 3, and 6
Outcome measures
| Measure |
Azithromycin & Rifampin
n=27 Participants
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
n=15 Participants
Participants will receive Doxycycline and Rifampin
|
Placebo
Participants will receive placebo
|
|---|---|---|---|
|
hsCRP
Baseline
|
1.07 mg/litre
Interval 0.02 to 10.9
|
0.42 mg/litre
Interval 0.069 to 1.85
|
—
|
|
hsCRP
Month 1
|
0.56 mg/litre
Interval 0.02 to 3.65
|
0.27 mg/litre
Interval 0.106 to 0.651
|
—
|
|
hsCRP
Month 3
|
0.63 mg/litre
Interval 0.02 to 5.88
|
0.55 mg/litre
Interval 0.035 to 2.51
|
—
|
|
hsCRP
Month 6
|
0.41 mg/litre
Interval 0.02 to 2.34
|
0.34 mg/litre
Interval 0.02 to 0.796
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 1,3,6 and 9Comparison 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
Outcome measures
| Measure |
Azithromycin & Rifampin
n=27 Participants
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
n=15 Participants
Participants will receive Doxycycline and Rifampin
|
Placebo
Participants will receive placebo
|
|---|---|---|---|
|
HAQ DI Score
Baseline
|
0.84 score on a scale
Interval 0.0 to 3.0
|
1.1 score on a scale
Interval 0.0 to 3.0
|
—
|
|
HAQ DI Score
Month 1
|
0.79 score on a scale
Interval 0.0 to 3.0
|
0.92 score on a scale
Interval 0.0 to 3.0
|
—
|
|
HAQ DI Score
Month 3
|
0.68 score on a scale
Interval 0.0 to 3.0
|
0.87 score on a scale
Interval 0.0 to 3.0
|
—
|
|
HAQ DI Score
Month 6
|
0.71 score on a scale
Interval 0.0 to 3.0
|
0.99 score on a scale
Interval 0.0 to 3.0
|
—
|
|
HAQ DI Score
Month 9
|
0.57 score on a scale
Interval 0.0 to 3.0
|
0.92 score on a scale
Interval 0.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 1,3,6 and 9Comparison 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
Outcome measures
| Measure |
Azithromycin & Rifampin
n=27 Participants
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
n=15 Participants
Participants will receive Doxycycline and Rifampin
|
Placebo
Participants will receive placebo
|
|---|---|---|---|
|
PhGA Assessment
Baseline
|
63.9 units on a scale
Interval 44.0 to 91.0
|
60.2 units on a scale
Interval 3.0 to 85.0
|
—
|
|
PhGA Assessment
Month 1
|
35.2 units on a scale
Interval 2.0 to 70.0
|
52.9 units on a scale
Interval 24.0 to 77.0
|
—
|
|
PhGA Assessment
Month 3
|
23.2 units on a scale
Interval 0.0 to 51.0
|
49.4 units on a scale
Interval 5.0 to 74.0
|
—
|
|
PhGA Assessment
Month 6
|
16.3 units on a scale
Interval 0.0 to 49.0
|
45.7 units on a scale
Interval 0.0 to 72.0
|
—
|
|
PhGA Assessment
Month 9
|
17.7 units on a scale
Interval 0.0 to 50.0
|
43.8 units on a scale
Interval 2.0 to 72.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 1,3,6 and 9Comparison 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.
Outcome measures
| Measure |
Azithromycin & Rifampin
n=27 Participants
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
n=15 Participants
Participants will receive Doxycycline and Rifampin
|
Placebo
Participants will receive placebo
|
|---|---|---|---|
|
Swollen 76 Joint Count (SJC)
Baseline
|
4.1 Swollen Joints
Interval 0.0 to 12.0
|
4.5 Swollen Joints
Interval 0.0 to 9.0
|
—
|
|
Swollen 76 Joint Count (SJC)
Month 1
|
1.7 Swollen Joints
Interval 0.0 to 6.0
|
3.5 Swollen Joints
Interval 0.0 to 8.0
|
—
|
|
Swollen 76 Joint Count (SJC)
Month 3
|
0.9 Swollen Joints
Interval 0.0 to 4.0
|
4.3 Swollen Joints
Interval 0.0 to 13.0
|
—
|
|
Swollen 76 Joint Count (SJC)
Month 6
|
0.9 Swollen Joints
Interval 0.0 to 5.0
|
5.2 Swollen Joints
Interval 0.0 to 13.0
|
—
|
|
Swollen 76 Joint Count (SJC)
Month 9
|
0.5 Swollen Joints
Interval 0.0 to 4.0
|
5.1 Swollen Joints
Interval 0.0 to 12.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6 and 9Comparison 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.
Outcome measures
| Measure |
Azithromycin & Rifampin
n=27 Participants
Participants will receive Azithromycin and Rifampin
|
Doxycycline & Rifampin
n=15 Participants
Participants will receive Doxycycline and Rifampin
|
Placebo
Participants will receive placebo
|
|---|---|---|---|
|
78 Tender Joint Count (TJC)
Baseline
|
7.4 Tender Joints
Interval 1.0 to 20.0
|
9.6 Tender Joints
Interval 0.0 to 24.0
|
—
|
|
78 Tender Joint Count (TJC)
Month 1
|
5.0 Tender Joints
Interval 0.0 to 23.0
|
10.6 Tender Joints
Interval 0.0 to 25.0
|
—
|
|
78 Tender Joint Count (TJC)
Month 3
|
3.3 Tender Joints
Interval 0.0 to 17.0
|
10.8 Tender Joints
Interval 0.0 to 28.0
|
—
|
|
78 Tender Joint Count (TJC)
Month 6
|
2.0 Tender Joints
Interval 0.0 to 9.0
|
11.8 Tender Joints
Interval 0.0 to 37.0
|
—
|
|
78 Tender Joint Count (TJC)
Month 9
|
1.9 Tender Joints
Interval 0.0 to 9.0
|
10.9 Tender Joints
Interval 0.0 to 29.0
|
—
|
Adverse Events
Azithromycin & Rifampin
Doxycycline & Rifampin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place