The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study

• Register: ClinicalTrials.gov
• Last refreshed on: 25 July 2023
• Main ID: NCT02585258
• Date of registration: 20/10/2015
• Prospective Registration: Yes
• Primary sponsor: Amsterdam UMC, location VUmc
• Public title: The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Gloria
• 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
• Date of first enrolment: June 30, 2016
• Target sample size: 451
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02585258
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Finland, Germany, Hungary, Italy, Netherlands, Portugal, Romania, Slovakia

Contacts

• Name: Maarten Boers, Prof. dr.
• Affiliation: Amsterdam UMC, location VUmc

Key inclusion & exclusion criteria

Population (base) RA patients of 65 years of age and older requiring antirheumatic therapy.

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the
following criteria:

- RA according to the 1987 or the 2010 classification criteria of the American College
of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) (Aletaha D et
al, Ann Rheum Dis 2010;69:1580);

- inadequate disease control, as evidenced by a disease activity score of 28 joints
calculated with erythrocyte sedimentation rate (DAS28) =2.60;

- age = 65 years.

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from
participation in this study:

Lower probability of benefit:

- 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-tumor necrosis factor (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);

- Note: as this is a pragmatic trial, patients who require start of (other)
antirheumatic treatment at baseline or during the trial can still be eligible (see
7.1).

Higher probability of harm:

- 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.

Difficulty to measure harm/benefit:

- 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.

Subjects/patients not capable or willing to provide informed consent.

Substudy

Additional exclusion criteria for subjects participating in the substudy to measure the
effect of a reminder via smart device on adherence:

Inability/difficulty to measure benefit:

- Not in the possession of a smart device;

- Premature discontinuation of study medication within or at 3 months of the main trial.



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

RheumatoId Arthritis

Intervention(s)

Drug: Prednisolone

Drug: Placebo

Primary Outcome(s)

The Total Number of Patients Experiencing at Least One Adverse Event (AE) of Special Interest (AESI) [Time Frame: 24 months]

Signs and Symptoms: Mean DAS28 Post Baseline [Time Frame: 0,3,6,12,18,24 months]

Secondary Outcome(s)

Joint Damage Progression [Time Frame: 0, 24 months]

Secondary ID(s)

VUMC-ARC-GLORIA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European Commission

Results

• Results available: Yes
• Date Posted: 18/07/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02585258