Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients
STAR
3 other identifiers
interventional
102
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 rheumatoid-arthritis
Started Jan 2017
Longer than P75 for phase_4 rheumatoid-arthritis
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedStudy Start
First participant enrolled
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2022
CompletedNovember 28, 2025
February 1, 2022
5 years
December 15, 2016
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
Secondary Outcomes (12)
proportion of patients who could withdraw from prednisone
one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
proportion of patients with acute adrenal insufficiency
one year
proportion of patients with biological adrenal insufficiency
one year
proportion of patients needing extra prednisone to control flares
one year
proportion of patients who have at least one flare confirmed by the investigator during the protocol.
one year
- +7 more secondary outcomes
Study Arms (2)
Glucocorticoid (GC) tapering
ACTIVE COMPARATOR"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
ACTIVE COMPARATOR"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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Bordeaux University Hospital
Bordeaux, France
Brest University Hospital
Brest, France
Jean Rougier Hospital
Cahors, France
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
Bichat Hospital
Paris, France
Cochin Hospital
Paris, France
La Pitié-Salpétrière
Paris, France
Lyon Sud Hopsital
Pierre-Bénite, France
Saint-Etienne Hospital
Saint-Etienne, France
Strasbourg Hospital
Strasbourg, France
Hospital Pierre-Paul Riquet
Toujouse, 31059, France
Related Publications (1)
Ruyssen-Witrand A, Brusq C, Masson M, Bongard V, Salliot C, Poiroux L, Nguyen M, Roux CH, Richez C, Saraux A, Vergne-Salle P, Morel J, Flipo RM, Piperno M, Gottenberg JE, Marotte H, Soubrier M, Gossec L, Dieude P, Lassoued S, Zabraniecki L, Couture G, Boyer JF, Jamard B, Degboe Y, Constantin A. Comparison of two strategies of glucocorticoid withdrawal in patients with rheumatoid arthritis in low disease activity (STAR): a randomised, placebo- controlled, double-blind trial. Ann Rheum Dis. 2025 Jan;84(1):49-59. doi: 10.1136/ard-2024-226620. Epub 2025 Jan 2.
PMID: 39874233RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Adeline RUYSSEN-WITRAND, MD, PhD
University Hospital of Toulouse, Rheumatology Center
- STUDY CHAIR
Arnaud CONSTANTIN, MD, PhD
University Hospital of Toulouse, Rheumatology Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2016
First Posted
December 20, 2016
Study Start
January 31, 2017
Primary Completion
January 27, 2022
Study Completion
January 27, 2022
Last Updated
November 28, 2025
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share