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)

• 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: Association de Recherche Clinique en Rhumatologie
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Fibromyalgia Patients	Not Fibromyalgia Patients
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

Baseline Characteristics

Arm/Group Title		Fibromyalgia Patients	Not Fibromyalgia Patients	Total
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
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%

Outcome Measures

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fibromyalgia Patients	Not Fibromyalgia Patients
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
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)
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.
Description	[Not Specified]
Time Frame	At baseline and at 12 weeks after TNF alpha blockers initiation

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Fibromyalgia Patients	Not Fibromyalgia Patients
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	--/--	--/--
Serious Adverse Events
	Fibromyalgia Patients	Not Fibromyalgia Patients
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/202 (0.00%)	0/324 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: anna.molto@aphp.fr

• Responsible Party: Association de Recherche Clinique en Rhumatologie
• ClinicalTrials.gov Identifier: NCT03039088
• 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