Remission and Flare in Psoriatic Arthritis: a Prospective 6-month Study With a Double Perspective. (ReFlaP)
|ClinicalTrials.gov Identifier: NCT03119805|
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : October 17, 2018
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||466 participants|
|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|
- 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).
- 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.)
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