Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients (STAR)

Toulouse University Hospital

Status and phase: Completed; Phase 4

Conditions: RheumatoId Arthritis

Treatments: Drug: GlucoCorticoid

Study type: Interventional

Funder types: Other

Identifiers

NCT02997605

RC31/15/7824

PHRC

2016-001618-18 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups

Glucocorticoid (GC) tapering

Active Comparator group

Description:

"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.

Treatment:

Drug: GlucoCorticoid

Hydrocortisone replacer

Active Comparator group

Description:

"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.

Treatment:

Drug: GlucoCorticoid