Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients

Phase 1

• Conditions: glucocorticoid withdrawal in rheumatoid arthritis; MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-001618-18-FR
• Lead Sponsor: CHU Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-09
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

•Patients who have fulfilled the 2010 ACR/EULAR criteria for RA for at least 6 months.
•Aged 18 or over.
•Treated with a stable dose of synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARDs) and/or with a biological DMARD (bDMARD) for at least 3 months.
•Who have been treated with oral prednisone or prednisolone for more than 6 months.
•With a stable dose of 5mg/day of prednisone or prednisolone for at least 3 months.
•And in remission or low disease activity as defined by a DAS28 under 3.2 for at least 3 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 122
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

Exclusion Criteria

•Any chronic condition that would need long-term corticoid use (chronic lung diseases, etc.).
•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.
•Any GC joint injection within the last 3 months or scheduled in the next 3 months.
•Any disease with GC contraindication.
•Treatment with sultopride; injection of alive 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.
.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified