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

Completed

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT03119805

Run by

Groupe Hospitalier Pitie-Salpetriere

People needed

466

Starts

2017-05-18

Expected to finish

2018-07-30

Last updated by the study team

2018-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ana- Maria Orbai — Baltimore, Maryland, United States
• Husni — Cleveland, Ohio, United States
• Smolen — Vienna, Austria
• Palominos — Porto Alegre, Brazil
• Aydin — Ottawa, Canada
• Sibel Aydin — Ottawa, Canada
• Eder — Toronto, Canada
• Talli — Tallinn, Estonia
• Soubrier — Clermont-Ferrand, France
• Dernis — Le Mans, France
• Laure Gossec — Paris, France
• Richette — Paris, France
• Ruyssen-Witrand — Toulouse, France
• Uta Kiltz — Herne, Germany
• Lubrano — Campobasso, Italy
• Rossana Scrivo — Roma, Italy
• Balanescu — Bucharest, Romania
• Inna Gaydukova — Saratov, Russia
• Katy Leung — Singapore, Singapore
• Juan Canete — Barcelona, Spain
• Kalyoncu — Ankara, Turkey (Türkiye)
• Laura Coates — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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