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Trial record 2 of 123 for:    GLORIA

The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (Gloria)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by Prof. dr. M. Boers, VU University Medical Center
European Commission
Information provided by (Responsible Party):
Prof. dr. M. Boers, VU University Medical Center Identifier:
First received: October 20, 2015
Last updated: July 20, 2016
Last verified: July 2016

Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis:

The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA)

Condition Intervention Phase
RheumatoId Arthritis Drug: Prednisolone Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Prof. dr. M. Boers, VU University Medical Center:

Primary Outcome Measures:
  • Signs and symptoms: the time-averaged mean value of the DAS28; [ Time Frame: 24 months ]
  • The total number of patients experiencing at least one AE of Special Interest (an SAE, or an AE on a prespecified list of clinically relevant AEs commonly associated with the disease and glucocorticoid use [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Damage progression: 2-year change in total Sharp/van der Heijde damage score of hands and forefeet radiographs. [ Time Frame: 24 months ]
  • WHO-ILAR core set of RA outcome measures [ Time Frame: 24 months ]
  • Severity and duration of morning stiffness [ Time Frame: 24 months ]
  • Severity and duration of fatigue due to RA [ Time Frame: 24 months ]
  • SF36 - The Short Form 36-item Health Survey, a questionnaire about QoL [ Time Frame: 24 months ]
  • 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 [ Time Frame: 24 months ]
  • Health Assessment Questionnaire (HAQ) [ Time Frame: 24 months ]
  • cost questionnaire, including o Activity limitation (part of cost questionnaire) o Work disability (for those holding a paid job, part of cost questionnaire) [ Time Frame: 24 months ]
  • Utility/Quality-adjusted life years (QALY): Euro-QoL in 5 dimensions (EQ-5D) [ Time Frame: 24 months ]
  • Vital signs (heart rate and blood pressure) [ Time Frame: 24 months ]
  • Cost-effectiveness and cost-utility Estimate of costs of treatment and monitoring [ Time Frame: 24 months ]
  • Medication adherence Adherence to trial drug is measured through the e-communicative packaging solution as the count of days in which the bottle is opened on the appropriate days, as measured by the adherence tool. [ Time Frame: 24 months ]
  • Bone mass assessed by Dual-energy X-ray Absorptiometry (DXA) [ Time Frame: 24 months ]
  • Vertebral Fracture Analysis (by DXA OR lateral radiograph of thoracic and lumbar spine) [ Time Frame: 24 months ]

Estimated Enrollment: 800
Study Start Date: March 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm A
prednisolone 5 mg per day
Drug: Prednisolone
capsules 5 mg / day
Placebo Comparator: arm B
placebo capsules once per day
Other: Placebo
capsules 1 / day

  Show Detailed Description


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 disease activity score of 28 joints calculated with erythrocyte sedimentation rate (DAS28) ≥3.20;
  • 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 three months 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);
  • 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.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02585258

Contact: Maarten Boers, Prof. dr.
Contact: Leonie Middelink, MSc

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Sponsors and Collaborators
VU University Medical Center
European Commission
Principal Investigator: Maarten Boers, Prof. dr. VU University Medical Center
  More Information

Responsible Party: Prof. dr. M. Boers, Professor, VU University Medical Center Identifier: NCT02585258     History of Changes
Other Study ID Numbers: VUMC-ARC-GLORIA
Study First Received: October 20, 2015
Last Updated: July 20, 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents processed this record on September 18, 2017