Trial Outcomes & Findings for PREDICT-SpA - French Epidemiological Study of the Evaluation of the Impact of Fibromyalgia in the TNF Alpha Treatment Effect in Axial Spondyloarthritis in Both Anti-TNF naïve and - Experienced Patients (NCT NCT03039088)
NCT ID: NCT03039088
Last Updated: 2018-09-19
Results Overview
The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.
COMPLETED
527 participants
At 12 weeks after TNF alpha blockers initiation
2018-09-19
Participant Flow
Participant milestones
| Measure |
Fibromyalgia Patients
202 (38.4%) according to the FiRST questionnaire.
|
Not Fibromyalgia Patients
324 (61.6%) according to the FiRST questionnaire
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
316
|
|
Overall Study
COMPLETED
|
192
|
316
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PREDICT-SpA - French Epidemiological Study of the Evaluation of the Impact of Fibromyalgia in the TNF Alpha Treatment Effect in Axial Spondyloarthritis in Both Anti-TNF naïve and - Experienced Patients
Baseline characteristics by cohort
| Measure |
Fibromyalgia Patients
n=202 Participants
According to the FiRST Questionnaire
Follow-up after 12 weeks after TNF alpha blockers initiation
|
Not Fibromyalgia Patients
n=324 Participants
According to the FiRST Questionnaire
Follow-up after 12 weeks after TNF alpha blockers initiation
|
Total
n=526 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
|
|
Age, Categorical
Between 18 and 65 years
|
202 Participants
n=5 Participants
|
324 Participants
n=7 Participants
|
526 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12 weeks after TNF alpha blockers initiationThe difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.
Outcome measures
| Measure |
Fibromyalgia Patients
n=192 Participants
192 (37.8%) according to the FiRST questionnaire.
|
Not Fibromyalgia Patients
n=316 Participants
|
|---|---|---|
|
To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire >= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers
|
87 participants
|
171 participants
|
SECONDARY outcome
Timeframe: At 12 weeks after TNF alpha blockers initiationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 weeks after TNF alpha blockers initiationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and at 12 weeks after TNF alpha blockers initiationOutcome measures
Outcome data not reported
Adverse Events
Fibromyalgia Patients
Not Fibromyalgia Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Doctor Anna MOLTO
Rheumatology department, Cochin Hospital, APHP
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place