Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients
- Registration Number
- NCT02997605
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- Patients ≥ 18 years old.
- Fulfilling the 2010 American College of Rheumatology (ACR)/EULAR criteria for RA.
- Treated with a stable dose of Synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARD) or Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) for at least 3 months.
- Who have been treated with prednisone or prednisolone for at least 6 months.
- With a stable dose of prednisone or prednisolone of 5mg/day for at least 3 months.
- With a DAS28 ≤3.2 for at least 3 months.
- Patients with health insurance
- Patients who have signed a written informed consent form.
- Any chronic condition that would need long term corticoid use (e.g. chronic lung diseases).
- Evidence of a flare within the last 3 months.
- Evidence of an allergy or intolerance to hydrocortisone or prednisone.
- Chronic idiopathic, or autoimmune clinical adrenal insufficiency.
- GC joint injections within the last 3 months or scheduled in the next 3 months.
- Any GC intake expected more than >5mg/day within the next 12 months.
- Association with sultopride and with live vaccines
- Significant trauma or major surgery within the 3 months prior to the baseline visit.
- Scheduled surgery in the next 12 months.
- Fibromyalgia.
- Foreseeable poor compliance with the strategy.
- Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.
- Alcohol and/or drug misuse as determined by the investigator.
- Pregnancy or breastfeeding.
- Patient is not willing to sign the informed consent.
- Juridical Protection
- DAS28>3.2 after one month of a stable dose of prednisone 5 mg/day.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glucocorticoid (GC) tapering GlucoCorticoid "GC tapering group": patients will be asked to taper prednisone taken every morning at 8.00 AM by decreasing the daily dose by 1 mg every month as soon as they are in remission or Low Disease Activity (LDA). In addition they will receive a placebo of 20 mg/day of hydrocortisone (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg/day (at 8.00 AM) of hydrocortisone placebo for 3 months before discontinuing the hydrocortisone placebo. Hydrocortisone replacer GlucoCorticoid "Hydrocortisone replacer group": patients will replace prednisone with 20 mg of hydrocortisone on a daily basis (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg daily (at 8.00 AM) for 3 months then stop as soon as they are in remission or LDA, as well as a prednisone placebo (at 8.00 AM) with a schedule to taper the prednisone placebo by 1mg/day every month until discontinuation.
- Primary Outcome Measures
Name Time Method proportion of patients who could withdraw from prednisone and hydrocortisone at one year one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement 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.
- Secondary Outcome Measures
Name Time Method proportion of patients who have at least one flare confirmed by the investigator during the protocol. one year To compare the proportion of patients who have at least one flare confirmed by the investigator during the protocol.
proportion of patients in DAS28 remission and in DAS28 low disease activity 7 and 12 months To compare the proportion of patients in DAS28 remission and in DAS28 low disease activity at 7 and 12 months between the groups.
proportion of patients needing extra prednisone to control flares one year To compare the proportion of patients needing extra prednisone to control flares
area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis) one year 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.
medians of Health Assessment Questionnaire (HAQ) 4, 7 months and 1 year To compare the medians of HAQ at 4, 7 months and one year between the groups.
medians of EuroQol 5-dimensional Descriptive system (EQ-5D) 4, 7 months and 1 year To compare the medians of EQ-5D at 4, 7 months and one year between the groups.
medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F) 4, 7 months and 1 year To compare the medians of FACIT-F at 4, 7 months and one year between the groups.
proportion of patients with Serious Adverse events 1 year To compare the proportion of patients with Serious Adverse events at one year between the groups.
proportion of patients who could withdraw from prednisone one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement To compare the proportion of patients who could withdraw from prednisone whatever the additional hydrocortisone associated treatment.
proportion of patients with acute adrenal insufficiency one year To compare the proportion of patients with acute adrenal insufficiency at one year between the two groups.
proportion of patients with biological adrenal insufficiency one year To compare the proportion of patients with biological adrenal insufficiency at one year between the two groups.
medians of Rheumatoid Arthritis Impact of Disease (RAID) 4, 7 months and 1 year To compare the medians of RAID at 4, 7 months and one year between the groups.
Trial Locations
- Locations (17)
Brest University Hospital
🇫🇷Brest, France
Bordeaux University Hospital
🇫🇷Bordeaux, France
Clermont-Ferrand Hospital
🇫🇷Clermont-Ferrand, France
Pasteur Hospital
🇫🇷Nice, France
Saint-Etienne Hospital
🇫🇷Saint-Étienne, France
Strasbourg Hospital
🇫🇷Strasbourg, France
Orléans Hospital
🇫🇷Orléans, France
Hospital Pierre-Paul Riquet
🇫🇷Toujouse, France
Lille Hospital
🇫🇷Lille, France
La Pitié-Salpétrière
🇫🇷Paris, France
Bichat Hospital
🇫🇷Paris, France
Cochin Hospital
🇫🇷Paris, France
Jean Rougier Hospital
🇫🇷Cahors, France
Bicêtre Hospital
🇫🇷Le Kremlin-Bicêtre, France
Lyon Sud Hopsital
🇫🇷Pierre-Bénite, France
Limoges Hospital
🇫🇷Limoges, France
Montpellier Hospital
🇫🇷Montpellier, France