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NCT Number: NCT03039088

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

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.

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Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Fibromyalgia Joint Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up after 12 weeks after TNF alpha blockers initiation

Other

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

    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.

Secondary outcomes

  1. 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

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

    Time frame: At 12 weeks after TNF alpha blockers initiation

  3. 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

Sponsors and collaborators

Lead sponsor

Association de Recherche Clinique en Rhumatologie

Other

Collaborators

  • RCTs

Registry information

Acronym: PREDICT_SpA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 1, 2017
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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