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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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