Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Cortisol succinate; Glucocorticoids; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Prednisone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.