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Trial record 1 of 216 for:    gloria
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The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (Gloria)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02585258
Recruitment Status : Active, not recruiting
First Posted : October 23, 2015
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Prof. dr. M. Boers, VU University Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
RheumatoId Arthritis Drug: Prednisolone Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Actual Study Start Date : June 30, 2016
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Signs and symptoms: the time-averaged mean value of the DAS28; [ Time Frame: 24 months ]
    DAS28

  2. 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 ]
    AEs


Secondary Outcome Measures :
  1. Damage progression: 2-year change in total Sharp/van der Heijde damage score of hands and forefeet radiographs. [ Time Frame: 24 months ]
  2. WHO-ILAR core set of RA outcome measures [ Time Frame: 24 months ]
  3. Severity and duration of morning stiffness [ Time Frame: 24 months ]
  4. Severity and duration of fatigue due to RA [ Time Frame: 24 months ]
  5. SF36 - The Short Form 36-item Health Survey, a questionnaire about QoL [ Time Frame: 24 months ]
  6. 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 ]
  7. Health Assessment Questionnaire (HAQ) [ Time Frame: 24 months ]
  8. 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 ]
  9. Utility/Quality-adjusted life years (QALY): Euro-QoL in 5 dimensions (EQ-5D) [ Time Frame: 24 months ]
  10. Vital signs (heart rate and blood pressure) [ Time Frame: 24 months ]
  11. Cost-effectiveness and cost-utility Estimate of costs of treatment and monitoring [ Time Frame: 24 months ]
  12. 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 ]
  13. Bone mass assessed by Dual-energy X-ray Absorptiometry (DXA) [ Time Frame: 24 months ]
  14. Vertebral Fracture Analysis (by DXA OR lateral radiograph of thoracic and lumbar spine) [ Time Frame: 24 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 2010);
  • 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-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585258


Locations
Show Show 29 study locations
Sponsors and Collaborators
VU University Medical Center
European Commission
Investigators
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Principal Investigator: Maarten Boers, Prof. dr. VU University Medical Center
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. dr. M. Boers, Professor, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02585258    
Other Study ID Numbers: VUMC-ARC-GLORIA
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents