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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
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
RCTs
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Axial Spondyloarthritis Fibromyalgia Other: Follow-up after 12 weeks after TNF alpha blockers initiation

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Spondylarthritis
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Spondylitis
Spinal Diseases
Bone Diseases
Arthritis
Joint Diseases
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs