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

Completed

• Conditions: Axial Spondyloarthritis; Fibromyalgia
• Interventions: Other: Follow-up after 12 weeks after TNF alpha blockers initiation

• Registration Number: NCT03039088
• Lead Sponsor: Association de Recherche Clinique en Rhumatologie

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.

Detailed Description

Background: Diagnosis of SpA in the absence of objective signs of inflammation or structural damage can be challenging, and especially difficult to differentiate from Fibromyalgia. Furthermore, such patients can easily be classified as active and refractory to NSAIDs, and inappropriately receive TNF alpha blockers.

Objective: Primary objective: To evaluate the impact of fibromyalgia in the TNF alpha treatment effect in axial Spondyloarthritis in both anti-TNF naïve and - experienced patients.

Methods: Design: Prospective observational national (France) study with 2 visits 3 months apart (baseline and 12 weeks after TNF alpha blockers initiation). Patients: 500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF alpha blocker. Data collection: items permitting the calculation of the ASAS criteria, the FIRST questionnaire (Fibromyalgia Rapid Screen Test), patients and disease characteristics, disease activity and severity items, and the domain leading the doctor's decision for initiating the TNF alpha blocker (CRP/Imaging/Symptoms) will be collected at baseline. Effectiveness measures (e.g. BASDAI and patient's global) and the doctor's decision to continue/discontinue the TNF alpha blocker will be collected during the second visit. Statistical analysis: for the main objective, evaluation of the predictive factors of a TNF alpha response in real life, and the impact of Fibromyalgia in such response (e.g. logistic regression to estimate BASDAI reduction of 50%). For the secondary objectives: evaluation of the relative attributable risks of the doctor's domains leading the TNF alpha blocker initiation (Imaging/CRP/Symptoms) in order to explain the anti-TNF therapy response; evaluation of the concordance existing between the current recommendations and the daily practice.

Expected results: A positive finding might results into a change in the way of managing patients (e.g. carefully checking for the co-existence of fibromyalgia before confirming a spondyloarthritis diagnosis, an active disease and also before initiating a specific therapy such as biologics.

Study Timeline

• Study Start: 2014-10-02
• Primary Completion: 2016-10-04
• Study Completion: 2016-10-04
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Status Verified: 2018-01
• Results First Submitted: 2018-01-09
• Results First Submitted QC: 2018-01-09
• Last Update Submitted: 2018-01-09
• Results First Posted: 2018-09-19
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibromyalgia patients	Follow-up after 12 weeks after TNF alpha blockers initiation	-
Not fibromyalgia patients	Follow-up after 12 weeks after TNF alpha blockers initiation	-

Primary Outcome Measures

Name	Time	Method
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	At 12 weeks after TNF alpha blockers initiation	The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.

Secondary Outcome Measures

Name	Time	Method
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
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