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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 (PREDICT_SpA)

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ClinicalTrials.gov Identifier: NCT03039088
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
RCTs
Information provided by (Responsible Party):
Association de Recherche Clinique en Rhumatologie

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Axial Spondyloarthritis
Fibromyalgia
Intervention Other: Follow-up after 12 weeks after TNF alpha blockers initiation
Enrollment 527
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fibromyalgia Patients Not Fibromyalgia Patients
Hide Arm/Group Description 202 (38.4%) according to the FiRST questionnaire. 324 (61.6%) according to the FiRST questionnaire
Period Title: Overall Study
Started 192 316
Completed 192 316
Not Completed 0 0
Arm/Group Title Fibromyalgia Patients Not Fibromyalgia Patients Total
Hide Arm/Group Description

According to the FiRST Questionnaire

Follow-up after 12 weeks after TNF alpha blockers initiation

According to the FiRST Questionnaire

Follow-up after 12 weeks after TNF alpha blockers initiation

Total of all reporting groups
Overall Number of Baseline Participants 202 324 526
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 324 participants 526 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
202
 100.0%
324
 100.0%
526
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 202 participants 324 participants 526 participants
41.6  (10.7) 41.1  (12.1) 41.3  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 324 participants 526 participants
Female
111
  55.0%
134
  41.4%
245
  46.6%
Male
91
  45.0%
190
  58.6%
281
  53.4%
1.Primary Outcome
Title 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
Hide Description The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.
Time Frame At 12 weeks after TNF alpha blockers initiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fibromyalgia Patients Not Fibromyalgia Patients
Hide Arm/Group Description:
192 (37.8%) according to the FiRST questionnaire.
[Not Specified]
Overall Number of Participants Analyzed 192 316
Measure Type: Number
Unit of Measure: participants
87 171
2.Secondary Outcome
Title The Relative Attributable Risks of the Doctor’s Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy
Hide Description [Not Specified]
Time Frame At 12 weeks after TNF alpha blockers initiation
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease)
Hide Description [Not Specified]
Time Frame At 12 weeks after TNF alpha blockers initiation
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Evaluation of the Concordance Existing Between the Current Recommendations for the Initiation of Anti-TNF in Non-radiographic Axial SpA and the Daily Practice as Represented by This Study.
Hide Description [Not Specified]
Time Frame At baseline and at 12 weeks after TNF alpha blockers initiation
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fibromyalgia Patients Not Fibromyalgia Patients
Hide Arm/Group Description

According to the FiRST Questionnaire

Follow-up after 12 weeks after TNF alpha blockers initiation

According to the FiRST Questionnaire

Follow-up after 12 weeks after TNF alpha blockers initiation

All-Cause Mortality
Fibromyalgia Patients Not Fibromyalgia Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fibromyalgia Patients Not Fibromyalgia Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/202 (0.00%)   0/324 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fibromyalgia Patients Not Fibromyalgia Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/202 (0.00%)   0/324 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Doctor Anna MOLTO
Organization: Rheumatology department, Cochin Hospital, APHP
Phone: 0158412617
Responsible Party: Association de Recherche Clinique en Rhumatologie
ClinicalTrials.gov Identifier: NCT03039088     History of Changes
Other Study ID Numbers: 2014-A01288-39
First Submitted: January 30, 2017
First Posted: February 1, 2017
Results First Submitted: January 9, 2018
Results First Posted: September 19, 2018
Last Update Posted: September 19, 2018