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 |
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Recruitment Status :
Completed
First Posted : February 1, 2017
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Axial Spondyloarthritis Fibromyalgia | Other: Follow-up after 12 weeks after TNF alpha blockers initiation |
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 Type : | Observational |
| Actual Enrollment : | 527 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | 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 |
| Actual Study Start Date : | October 2, 2014 |
| Actual Primary Completion Date : | October 4, 2016 |
| Actual Study Completion Date : | October 4, 2016 |
| Group/Cohort | Intervention/treatment |
|---|---|
| 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 |
- 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 [ Time Frame: At 12 weeks after TNF alpha blockers initiation ]The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.
- The Relative Attributable Risks of the Doctor's Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy [ Time Frame: At 12 weeks after TNF alpha blockers initiation ]
- Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease) [ Time Frame: 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. [ Time Frame: At baseline and at 12 weeks after TNF alpha blockers initiation ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
| Responsible Party: | Association de Recherche Clinique en Rhumatologie |
| ClinicalTrials.gov Identifier: | NCT03039088 |
| Other Study ID Numbers: |
2014-A01288-39 |
| First Posted: | February 1, 2017 Key Record Dates |
| Results First Posted: | September 19, 2018 |
| Last Update Posted: | September 19, 2018 |
| Last Verified: | January 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Spondylitis Fibromyalgia Myofascial Pain Syndromes Spondylarthritis Axial Spondyloarthritis Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Bone Diseases, Infectious Infections |
Bone Diseases Spinal Diseases Arthritis Joint Diseases Spondylarthropathies Ankylosis Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |