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

NCT03039088 | Completed Results

• 1 other identifier: 2014-A01288-39
• Study Type: observational
• Target: 527
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective observational national (France) study with 2 visits 3 months apart (baseline and 12 weeks after TNF alpha blockers initiation). The objective of recruitment is 500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF alpha blocker. The main objective of the study is to evaluate the impact of a concomitant fibromyalgia on the anti-TNF treatment effect in axial Spondyloarthritis in both anti-TNF naïve and pre-exposed patients.

Conditions

Axial Spondyloarthritis; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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

  The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.

  At 12 weeks after TNF alpha blockers initiation

Secondary Outcomes (3)

• The Relative Attributable Risks of the Doctor's Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy

  At 12 weeks after TNF alpha blockers initiation

• Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease)

  At 12 weeks after TNF alpha blockers initiation

• 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.

  At baseline and at 12 weeks after TNF alpha blockers initiation

Study Arms (2)

Fibromyalgia patients

Other: Follow-up after 12 weeks after TNF alpha blockers initiation

Not fibromyalgia patients

Other: Follow-up after 12 weeks after TNF alpha blockers initiation

Interventions

Follow-up after 12 weeks after TNF alpha blockers initiation OTHER

Fibromyalgia patients; Not fibromyalgia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from SpA based on the opinion of the treating rheumatologist initiating a TNF alpha blocker.

You may qualify if:

• Patients aged \> 18 years old and suffering from SpA based on the opinion of the treating rheumatologist
• Patients in whom the decision of initiating of switching an anti-TNF because of an axial involvement of SpA has been made by the treating rheumatologist. In case of previous exposure to antiTNF a washout period of at least 4 weeks be asked.

You may not qualify if:

• Patients unable to understand the questionnaire
• Patients not giving their informed written consent
• Patients with absolute contraindications to anti-TNF as per label

Sponsors & Collaborators

• Association de Recherche Clinique en Rhumatologie: lead
• RCTs: collaborator

Related Publications (1)

• Hamitouche F, Lopez-Medina C, Gossec L, Perrot S, Dougados M, Molto A. Evaluation of the agreement between the ACR 1990 fibromyalgia tender points and an enthesitis score in patients with axial spondyloarthritis. Rheumatology (Oxford). 2023 Aug 1;62(8):2757-2764. doi: 10.1093/rheumatology/keac683.

  PMID: 36573318 DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis; Fibromyalgia

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Muscular Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Doctor Anna MOLTO
• Organization: Rheumatology department, Cochin Hospital, APHP

anna.molto@aphp.fr

0158412617

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 1, 2017
• Study Start: October 2, 2014
• Primary Completion: October 4, 2016
• Study Completion: October 4, 2016
• Last Updated: September 19, 2018
• Results First Posted: September 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share