A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

• Register: EUCTR
• Last refreshed on: 12 April 2021
• Main ID: EUCTR2015-002729-21-SK
• Date of registration: 25/02/2016
• Prospective Registration: Yes
• Primary sponsor: VU University Medical Center
• Public title: A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis
• Scientific title: The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria
• Date of first enrolment: 22/04/2016
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002729-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; 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

Finland, Germany, Hungary, Portugal, Slovakia

Contacts

• Name: Project Coordinator
• Affiliation: VU medical Center

• Name: Project Coordinator
• Affiliation: VU medical Center

Key inclusion & exclusion criteria

Inclusion criteria:
RA according to the 1987 or 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) (Aletaha D 2010);

Inadequate disease control, as evidenced by a 28-joint disease activity score (DAS28) of = 2.60.
For eligibility, the DAS28 can be calculated with ESR or CRP, and also recalculated from the DAS of 44 joints. A DAS28 may be calculated with clinical and lab assessments obtained no more than 4 weeks before the baseline visit.

age = 65 years.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion criteria:
Change, stop or start of antirheumatic treatment in the last month prior to eligibility assessment, including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, azathioprine, intramuscular and oral gold, cyclosporine, biologic agents including anti-TNF, anakinra, abatacept, rituximab, tocilizumab (temporary exclusion);
Treatment with systemic GC: oral or parenteral GC with a cumulative prednisolone equivalent dose of 200 mg or higher in the last 3 months;
Treatment with any GC (oral, intra-articular, intravenous or intramuscular) in the last 30 days (temporary exclusion);
Exposure to investigational therapy in the last three months;
Current participation in another clinical trial;
Major surgery, donation or loss of approximately 500 ml blood within 4 weeks prior to the screening visit (temporary exclusion)
Absolute contraindication to low-dose prednisolone, as determined by the treating physician, such as: uncontrolled chronic infections, diabetes mellitus, hypertension, osteoporosis. When these conditions are under control (e.g. with antiosteoporosis drugs, antihypertensive drugs) these patients can enter;
Absolute contraindication to Calcium and/or Vitamin D supplement as determined by the treating physician, such as: hyperparathyroidism (when insufficiently treated);
Uncontrolled comorbid conditions, short life span, etc. as determined by the treating physician.
Absolute indication to start with oral or intravenous GC, according to the treating physician;
Inability to comply with medical instructions or inability to assess major outcomes at 6-monthly visits, in the assessment of the treating physician.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid artritis
MedDRA version: 20.0 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: prednisolone Labesfal
Product Name: prednisolone
Pharmaceutical Form: Capsule
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: a)To assess the effectiveness, safety and cost-effectiveness of 2 years of low-dose GC therapy (5 mg/day) compared to placebo as co-treatment for elderly RA patients in a pragmatic randomized trial
b)Study medication adherence through a medication packaging solution, and test the effectiveness of smart device technology to improve adherence

Secondary Objective: not applicable

Timepoint(s) of evaluation of this end point: Baseline, 3, 6, 12, 18 and 24 months

Primary end point(s): Signs and symptoms: the time-averaged mean value of the DAS28.
To measure safety, the primary endpoint is the total number of patients experiencing at least one serious adverse event, or one clinical event related to the disease or its therapy.
Other major outcomes are cost-effectiveness, cost-utility, and medication adherence.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months

Secondary end point(s): Damage progression: 2-year change in total Sharp/van der Heijde damage score of hands and forefeet radiographs.
WHO-ILAR core set of RA outcome measures, including pain, patient and physician global assessment, physical disability, joint counts (swollen joints and tender joints), acute phase reactants (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)), and radiographs of hands and forefeet at 0 and 2 years
Severity and duration of morning stiffness
Fatigue
SF36 - The Short Form 36-item Health Survey, a questionnaire about QoL
RA Impact of Disease (RAID) tool – The RAID is a validated questionnaire assessing the seven most important domains of impact of RA on the patients
Health Assessment Questionnaire (HAQ)
Cost questionnaire, including; Activity limitation (part of cost questionnaire); Work disability (for those holding a paid job, part of cost questionnaire)
Utility/Quality-adjusted life years (QALY): Euro-QoL in 5 dimensions (EQ-5D)

Secondary ID(s)

2015-002729-21-DE

NCT02585258

VUMC-ARC-GLORIA

Source(s) of Monetary Support

European Committee: Horizon 2020

Ethics review

Status: Approved
Approval date: 10/02/2016
Contact: