Clinical trial NCT02997605: Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients
Official title: Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: RheumatoId Arthritis
Keywords: low disease activity
remission
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: proportion of patients who could withdraw from prednisone and hydrocortisone at one year
timeFrame: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
Secondary outcomes:
measure: proportion of patients who could withdraw from prednisone
timeFrame: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
measure: proportion of patients with acute adrenal insufficiency
timeFrame: one year
measure: proportion of patients with biological adrenal insufficiency
timeFrame: one year
measure: proportion of patients needing extra prednisone to control flares
timeFrame: one year
measure: proportion of patients who have at least one flare confirmed by the investigator during the protocol.
timeFrame: one year
measure: area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis)
timeFrame: one year
measure: proportion of patients in DAS28 remission and in DAS28 low disease activity
timeFrame: 7 and 12 months
measure: medians of Health Assessment Questionnaire (HAQ)
timeFrame: 4, 7 months and 1 year
measure: medians of Rheumatoid Arthritis Impact of Disease (RAID)
timeFrame: 4, 7 months and 1 year
measure: medians of EuroQol 5-dimensional Descriptive system (EQ-5D)
timeFrame: 4, 7 months and 1 year
measure: medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F)
timeFrame: 4, 7 months and 1 year
measure: proportion of patients with Serious Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Cahors
country: France
facility: Jean Rougier Hospital
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand Hospital
city: Le Kremlin-Bicêtre
country: France
facility: Bicêtre Hospital
city: Lille
country: France
facility: Lille Hospital
city: Limoges
country: France
facility: Limoges Hospital
city: Montpellier
country: France
facility: Montpellier Hospital
city: Nice
country: France
facility: Pasteur Hospital
city: Orléans
country: France
facility: Orléans Hospital
city: Paris
country: France
facility: Bichat Hospital
city: Paris
country: France
facility: Cochin Hospital
city: Paris
country: France
facility: La Pitié-Salpétrière
city: Pierre-Bénite
country: France
facility: Lyon Sud Hopsital
city: Saint-Étienne
country: France
facility: Saint-Etienne Hospital
city: Strasbourg
country: France
facility: Strasbourg Hospital
city: Toujouse
country: France
facility: Hospital Pierre-Paul Riquet
Study officials:
affiliation: University Hospital of Toulouse, Rheumatology Center
name: Adeline RUYSSEN-WITRAND, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital of Toulouse, Rheumatology Center
name: Arnaud CONSTANTIN, MD, PhD
role: STUDY_CHAIR
References: