Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients

RheumatoId Arthritis Clinical Trial

— STAR  

Official title:

Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997605
• Other study ID #: RC31/15/7824
• Secondary ID: 2016-001618-18PH
• Status: Completed
• Phase: Phase 4
• Start date: January 31, 2017
• Est. completion date: January 27, 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• RheumatoId Arthritis

Intervention

Drug:
• GlucoCorticoid
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.

Locations

Country	Name	City	State
France	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-Étienne
France	Strasbourg Hospital	Strasbourg
France	Hospital Pierre-Paul Riquet	Toujouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	proportion of patients who could withdraw from prednisone	To compare the proportion of patients who could withdraw from prednisone whatever the additional hydrocortisone associated treatment.	one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
Secondary	proportion of patients with acute adrenal insufficiency	To compare the proportion of patients with acute adrenal insufficiency at one year between the two groups.	one year
Secondary	proportion of patients with biological adrenal insufficiency	To compare the proportion of patients with biological adrenal insufficiency at one year between the two groups.	one year
Secondary	proportion of patients needing extra prednisone to control flares	To compare the proportion of patients needing extra prednisone to control flares	one year
Secondary	proportion of patients who have at least one flare confirmed by the investigator during the protocol.	To compare the proportion of patients who have at least one flare confirmed by the investigator during the protocol.	one year
Secondary	area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis)	To compare the area under the curve of the means of the FLARE (Flare Assessment in Rheumatoid Arthritis) at one year with a self-assessment questionnaire.	one year
Secondary	proportion of patients in DAS28 remission and in DAS28 low disease activity	To compare the proportion of patients in DAS28 remission and in DAS28 low disease activity at 7 and 12 months between the groups.	7 and 12 months
Secondary	medians of Health Assessment Questionnaire (HAQ)	To compare the medians of HAQ at 4, 7 months and one year between the groups.	4, 7 months and 1 year
Secondary	medians of Rheumatoid Arthritis Impact of Disease (RAID)	To compare the medians of RAID at 4, 7 months and one year between the groups.	4, 7 months and 1 year
Secondary	medians of EuroQol 5-dimensional Descriptive system (EQ-5D)	To compare the medians of EQ-5D at 4, 7 months and one year between the groups.	4, 7 months and 1 year
Secondary	medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F)	To compare the medians of FACIT-F at 4, 7 months and one year between the groups.	4, 7 months and 1 year
Secondary	proportion of patients with Serious Adverse events	To compare the proportion of patients with Serious Adverse events at one year between the groups.	1 year