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Remission and Flare in Psoriatic Arthritis: a Prospective 6-month Study With a Double Perspective. (ReFlaP)

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ClinicalTrials.gov Identifier: NCT03119805
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Laure Gossec, Groupe Hospitalier Pitie-Salpetriere

Brief Summary:
The purpose of this study is to define cut-off values of the most widely used composite scores and patient-reported outcomes, for levels corresponding to remission/low disease activity and for changes in levels corresponding to flares, in PsA, when remission/low disease activity and flare are defined from the patient and physician perspective. The ReFlaP (Remission/Flare in PsA) study is a prospective, multicentric international, longitudinal, observational study.

Condition or disease
Psoriatic Arthritis

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 466 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Defining Cut-off Values for Widely-used Composite Scores and Patient-reported Outcome Measures in Psoriatic Arthritis Corresponding to Remission and Flare Assessed by the Physician and the Patient
Actual Study Start Date : May 18, 2017
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To determine the cutoff value of PsAID corresponding to flare [ Time Frame: 6 months ]

    For flare, the gold standard will be decision of treatment intensification. The primary outcome will be to determine the cutoff value of PsAID corresponding flare.

    The PsAID is a questionnaire (paper CRF) that can be used to calculate a score reflecting the impact of psoriatic arthritis (PsA) from the patients' perspective. (Gossec L et al., A patient-derived and patient-reported outcome measure for assessing psoriatic arthritis: elaboration and preliminary validation of the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, a 13-country EULAR initiative. Ann Rheum Dis. 2014;73(6):1012-9).


  2. To determine the cutoff value of PsAID corresponding to remission [ Time Frame: 6 months ]
    For remission, the gold standard will be Minimal Disease Activity. The primary outcome will be to determine the cutoff value of PsAID corresponding to remission. Patients are classified as achieving Minimal Disease Activity if they fulfill 5 of 7 outcome measures: tender joint count ≤1; swollen joint count ≤1; psoriasis activity and severity index ≤1 or body surface area ≤3; patient pain visual analog scale (VAS) score of ≤15; patient global disease activity VAS score of ≤20; Health Assessment Questionnaire (HAQ) score ≤0.5; and tender entheseal points ≤1. (L C Coates, J Fransen, P S Helliwell Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment Clinical and epidemiological research Ann Rheum Dis 2010;69:48-53.)



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
Over the 6 months recruitment period, all patients with definite PsA who satisfy the inclusion criteria, seen in outpatient visits in the participating centers by one of the investigators, will be asked to participate. It is planned to take place in 6 participating centres in France, 15 other European tertiary rheumatology centers (Germany, Hungary, Ireland, Italy, Norway, Romania, Spain, Turkey and the UK), 4 centers in the USA, 2 centers in Canada, 1 in Brazil, and 2 in Asia (Singapore and Russia).It is planned that in each center, 15-30 patients will be included. The first 15-30 consecutive patients will be selected in each center to reduce bias selection.
Criteria

Inclusion Criteria:

  • Age>18 years
  • Definite PsA according to the ClASsification of Psoriatic ARthritis (CASPAR) criteria and diagnosis confirmed by a rheumatologist. (Taylor2006)
  • Willingness to participate and signed informed consent.
  • There are no inclusion criteria based on disease activity or treatment
  • Patients with more than 2 years of disease duration will be included in the study for more homogeneity.

Patient will be included consecutively. A registry will be kept locally to note the age and gender of patients who have been proposed the study but refused to participate.

Exclusion Criteria:

  • No definite PsA or less than 2 years of disease duration
  • Patients who don't speak or read the local language or are not comfortable filling in a paper CRF in the local language.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119805


  Show 22 Study Locations
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
  Study Documents (Full-Text)

Documents provided by Laure Gossec, Groupe Hospitalier Pitie-Salpetriere:

Additional Information:

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Responsible Party: Laure Gossec, Professor, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03119805     History of Changes
Other Study ID Numbers: ongoing
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 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
Keywords provided by Laure Gossec, Groupe Hospitalier Pitie-Salpetriere:
composite scores
patient reported outcomes
patient perpective
physician perspective
cut-off values
flare
remission
minimal disease activity
low disease activity
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases