Please sign in to follow a disease.
Steroid-Free hope for arthritis patients?
NCT ID NCT02997605
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two methods to help people with rheumatoid arthritis stop taking steroids (prednisone) safely. 102 adults with low disease activity or remission were given either a gradual dose reduction or a replacement with hydrocortisone. The goal was to see which approach allowed more patients to stop steroids completely after one year without causing adrenal gland problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prednisone and Hydrocortisone
- What this could lead to
- If successful, this could help rheumatoid arthritis patients stop taking steroids safely without causing adrenal insufficiency.
- What could go wrong
- This is a small Phase 4 trial with only 102 participants, so results may not apply to everyone. The strategies may not work for all patients, and there is a risk of adrenal insufficiency during withdrawal.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
102 people
The number who actually took part.
- Started
-
Jan 2017
- Finished
-
Jan 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Rheumatoid arthritis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Bichat Hospital
Paris, France
-
Bicêtre Hospital
Le Kremlin-Bicêtre, France
-
Bordeaux University Hospital
Bordeaux, France
-
Brest University Hospital
Brest, France
-
Clermont-Ferrand Hospital
Clermont-Ferrand, France
-
Cochin Hospital
Paris, France
-
Hospital Pierre-Paul Riquet
Toujouse, 31059, France
-
Jean Rougier Hospital
Cahors, France
-
La Pitié-Salpétrière
Paris, France
-
Lille Hospital
Lille, France
-
Limoges Hospital
Limoges, France
-
Lyon Sud Hopsital
Pierre-Bénite, France
-
Montpellier Hospital
Montpellier, France
-
Orléans Hospital
Orléans, France
-
Pasteur Hospital
Nice, France
-
Saint-Etienne Hospital
Saint-Etienne, France
-
Strasbourg Hospital
Strasbourg, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A new ankle? researchers track 400 people with an implant meant to restore movement
- Can a Job-Focused rehab program keep arthritis patients employed?
- Do rheumatic diseases quietly damage the Eye's oil glands?
- Hidden kidney damage may lurk in rheumatoid arthritis patients
- Can a new injection calm rheumatoid arthritis? an early trial puts ZB002 to the test
- Can a new knee implant design offer better Long-Term relief?