N/A
N=508
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
Axial Spondyloarthritis · Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT03039088 ↗Enrolled (actual)
508
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: 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; 171 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Follow-up after 12 weeks after TNF alpha blockers initiation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Association de Recherche Clinique en Rhumatologie
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 171 | — |
| SECONDARY The Relative Attributable Risks of the Doctor's Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy |
— | — |
| SECONDARY Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease) |
— | — |
| SECONDARY 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. |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03039088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.