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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 15 June 2020
Main ID:  EUCTR2016-001618-18-FR
Date of registration: 09/06/2016
Prospective Registration: Yes
Primary sponsor: CHU Toulouse
Public title: Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients
Scientific title: STAR Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR
Date of first enrolment: 08/07/2016
Target sample size: 122
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001618-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
France
Contacts
Name: huguet    
Address:  2 rue Viguerie, TSA 80039 31059 Toulouse France
Telephone: +33661778490
Email:
Affiliation:  CHU Toulouse
Name: huguet    
Address:  2 rue Viguerie, TSA 80039 31059 Toulouse France
Telephone: +33661778490
Email:
Affiliation:  CHU Toulouse
Key inclusion & exclusion criteria
Inclusion criteria:
• Patients who have fulfilled the 2010 ACR/EULAR criteria for RA for at least 6 months.
• Aged 18 or over.
• Treated with a stable dose of synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARDs) and/or with a biological DMARD (bDMARD) for at least 3 months.
• Who have been treated with oral prednisone or prednisolone for more than 6 months.
• With a stable dose of 5mg/day of prednisone or prednisolone for at least 3 months.
• And in remission or low disease activity as defined by a DAS28 under 3.2 for at least 3 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 122
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

Exclusion criteria:
• Any chronic condition that would need long-term corticoid use (chronic lung diseases, etc.).
• 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.
• Any GC joint injection within the last 3 months or scheduled in the next 3 months.
• Any disease with GC contraindication.
• Treatment with sultopride; injection of alive 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.
.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
glucocorticoid withdrawal in rheumatoid arthritis
MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Prednisone
Product Name: prednisone 5 mg
Pharmaceutical Form: Capsule

Trade Name: Prednisone
Product Name: prednisone 4 mg
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Prednisone
Product Name: prednisone 3 mg
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Prednisone
Product Name: prednisone 2 mg
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Prednisone
Product Name: prednisone 1 mg
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Hydrocortisone 10mg
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: 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.
Primary end point(s): Proportion of patients who could withdraw from prednisone and hydrocortisone
Secondary Objective: To compare the proportion of patients :
-who could only withdraw from prednisone.
-with flares confirmed by the investigator.
To compare the area under the curves of the FLARE questionnaire for the whole protocol.
To compare the proportion of patients :
-needing extra prednisone to control flares.
-with intra-articular injections.
- acute adrenal insufficiency.
- a biological adrenal insufficiency.
- in remission (i.e. DAS28 < 2.6) and the proportion of patients in LDA (2.6=DAS28=3.2) at 7 and 12 months.
-with Severe “Serious” Adverse Events at 1, 4, 7 and 12 months.
To compare:
the HAQ medians between the two groups at 4, 7 and 12 months.
to compare the RAID medians between the two groups at 4, 7 and 12 months.
To compare the EQ-5D medians between the two groups at 4, 7 and 12 months.
To compare the FACIT medians between the two groups at 4, 7 and 12 months.

Timepoint(s) of evaluation of this end point: one year
Secondary Outcome(s)
Secondary end point(s): • Proportion of patients who could only withdraw from prednisone.
• Proportion of patients with flares confirmed by the investigator.
• Area under the curves of the FLARE questionnaire for the whole protocol.
• Proportion of patients needing extra prednisone to control flares.
• Proportion of patients with intra-articular injections.
• Proportion of patients with acute adrenal insufficiency.
• Proportion of patients with a biological adrenal insufficiency.
• Proportion of patients in remission (i.e. DAS28 < 2.6) and the proportion of patients in LDA (2.6=DAS28=3.2) at 7 and 12 months.
• HAQ medians between the two groups at 4, 7 and 12 months.
• RAID medians between the two groups at 4, 7 and 12 months.
• EQ-5D medians between the two groups at 4, 7 and 12 months.
• FACIT medians between the two groups at 4, 7 and 12 months.
• Proportion of patients with Severe “Serious” Adverse Events.
Timepoint(s) of evaluation of this end point: one month, 4 months, 6 months and one year
Secondary ID(s)
15782401
Source(s) of Monetary Support
Ministry of Health
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 10/06/2016
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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