Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

January 27, 2022

Study Completion Date

January 27, 2022

Conditions
RheumatoId Arthritis
Interventions
DRUG

GlucoCorticoid

"After inclusion in the study, the first part is an open follow-up period where all patients will receive 5 mg of prednisone daily for one month. After one month, if patients still have a DAS28 ≤3.2, they will be randomized into two arms: Group 1: GC tapering group / Group 2: Hydrocortisone replacement group.~After randomisation, there are four scheduled visits: M4, M7, M9 and M12. Patients withdrawing from GC therapy will be instructed, that if they start feeling unwell during or after the GC tapering protocol they should not taper the steroid dose any further, but contact the centre responsible for the protocol. If GC induced adrenal insufficiency is confirmed or strongly suspected, GC replacement will be secured using hydrocortisone."

Trial Locations (17)

31059

Hospital Pierre-Paul Riquet, Toujouse

Unknown

Bordeaux University Hospital, Bordeaux

Brest University Hospital, Brest

Jean Rougier Hospital, Cahors

Clermont-Ferrand Hospital, Clermont-Ferrand

Bicêtre Hospital, Le Kremlin-Bicêtre

Lille Hospital, Lille

Limoges Hospital, Limoges

Montpellier Hospital, Montpellier

Pasteur Hospital, Nice

Orléans Hospital, Orléans

Bichat Hospital, Paris

Cochin Hospital, Paris

La Pitié-Salpétrière, Paris

Lyon Sud Hopsital, Pierre-Bénite

Saint-Etienne Hospital, Saint-Etienne

Strasbourg Hospital, Strasbourg

All Listed Sponsors
lead

University Hospital, Toulouse

OTHER

NCT02997605 - Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients | Biotech Hunter | Biotech Hunter