The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.
French multicenter double-blind controlled parallel-group randomized clinical trial Phase IV assessing whether a hydrocortisone replacement therapy could increase the success rate of GC withdrawal at one year, in patients with Rheumatoid Arthritis in low disease activity or remission, in comparison to progressive decrease of GC (GC tapering).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
102
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.
Bordeaux University Hospital
Bordeaux, France
Brest University Hospital
Brest, France
Jean Rougier Hospital
Cahors, France
proportion of patients who could withdraw from prednisone and hydrocortisone at one year
To compare a prednisone tapering strategy to a hydrocortisone replacement strategy on the success rate of prednisone and hydrocortisone withdrawal at one year in Rheumatoid Arthritis patients in low disease activity or remission.
Time frame: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
proportion of patients who could withdraw from prednisone
To compare the proportion of patients who could withdraw from prednisone whatever the additional hydrocortisone associated treatment.
Time frame: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
proportion of patients with acute adrenal insufficiency
To compare the proportion of patients with acute adrenal insufficiency at one year between the two groups.
Time frame: one year
proportion of patients with biological adrenal insufficiency
To compare the proportion of patients with biological adrenal insufficiency at one year between the two groups.
Time frame: one year
proportion of patients needing extra prednisone to control flares
To compare the proportion of patients needing extra prednisone to control flares
Time frame: one year
proportion of patients who have at least one flare confirmed by the investigator during the protocol.
To compare the proportion of patients who have at least one flare confirmed by the investigator during the protocol.
Time frame: one year
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Clermont-Ferrand Hospital
Clermont-Ferrand, France
Bicêtre Hospital
Le Kremlin-Bicêtre, France
Lille Hospital
Lille, France
Limoges Hospital
Limoges, France
Montpellier Hospital
Montpellier, France
Pasteur Hospital
Nice, France
Orléans Hospital
Orléans, France
...and 7 more locations
area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis)
To compare the area under the curve of the means of the FLARE (Flare Assessment in Rheumatoid Arthritis) at one year with a self-assessment questionnaire.
Time frame: one year
proportion of patients in DAS28 remission and in DAS28 low disease activity
To compare the proportion of patients in DAS28 remission and in DAS28 low disease activity at 7 and 12 months between the groups.
Time frame: 7 and 12 months
medians of Health Assessment Questionnaire (HAQ)
To compare the medians of HAQ at 4, 7 months and one year between the groups.
Time frame: 4, 7 months and 1 year
medians of Rheumatoid Arthritis Impact of Disease (RAID)
To compare the medians of RAID at 4, 7 months and one year between the groups.
Time frame: 4, 7 months and 1 year
medians of EuroQol 5-dimensional Descriptive system (EQ-5D)
To compare the medians of EQ-5D at 4, 7 months and one year between the groups.
Time frame: 4, 7 months and 1 year
medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F)
To compare the medians of FACIT-F at 4, 7 months and one year between the groups.
Time frame: 4, 7 months and 1 year
proportion of patients with Serious Adverse events
To compare the proportion of patients with Serious Adverse events at one year between the groups.
Time frame: 1 year