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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

Tracking Information
First Submitted Date January 30, 2017
First Posted Date February 1, 2017
Results First Submitted Date January 9, 2018
Results First Posted Date September 19, 2018
Last Update Posted Date September 19, 2018
Actual Study Start Date October 2, 2014
Actual Primary Completion Date October 4, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2018)
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.
Original Primary Outcome Measures
 (submitted: January 30, 2017)
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.
Change History
Current Secondary Outcome Measures
 (submitted: January 9, 2018)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: January 30, 2017)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients suffering from SpA based on the opinion of the treating rheumatologist initiating a TNF alpha blocker.
Condition
  • Axial Spondyloarthritis
  • Fibromyalgia
Intervention Other: Follow-up after 12 weeks after TNF alpha blockers initiation
Study Groups/Cohorts
  • Fibromyalgia patients
    Intervention: Other: Follow-up after 12 weeks after TNF alpha blockers initiation
  • Not fibromyalgia patients
    Intervention: Other: Follow-up after 12 weeks after TNF alpha blockers initiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 30, 2017)
527
Original Actual Enrollment Same as current
Actual Study Completion Date October 4, 2016
Actual Primary Completion Date October 4, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03039088
Other Study ID Numbers 2014-A01288-39
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Association de Recherche Clinique en Rhumatologie
Original Responsible Party Same as current
Current Study Sponsor Association de Recherche Clinique en Rhumatologie
Original Study Sponsor Same as current
Collaborators RCTs
Investigators Not Provided
PRS Account Association de Recherche Clinique en Rhumatologie
Verification Date January 2018