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Trial record 2 of 120 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 VU University Medical Center
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Prof. dr. M. Boers, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT02585258
First received: October 20, 2015
Last updated: July 20, 2016
Last verified: July 2016
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 VU University Medical Center:

Primary Outcome Measures:
  • Signs and symptoms: the time-averaged mean value of the DAS28; [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • WHO-ILAR core set of RA outcome measures [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Severity and duration of morning stiffness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Severity and duration of fatigue due to RA [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • SF36 - The Short Form 36-item Health Survey, a questionnaire about QoL [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire (HAQ) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Utility/Quality-adjusted life years (QALY): Euro-QoL in 5 dimensions (EQ-5D) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Vital signs (heart rate and blood pressure) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness and cost-utility Estimate of costs of treatment and monitoring [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Bone mass assessed by Dual-energy X-ray Absorptiometry (DXA) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Vertebral Fracture Analysis (by DXA OR lateral radiograph of thoracic and lumbar spine) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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 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.

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.
  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 ClinicalTrials.gov identifier: NCT02585258

Contacts
Contact: Maarten Boers, Prof. dr. gloria@vumc.nl
Contact: Leonie Middelink, MSc gloria@vumc.nl

Locations
Finland
KSSHP Not yet recruiting
Jyväskylä, Finland
Contact: Tuulikki Sokka, prof dr         
EKSOTE Not yet recruiting
Lappeenranta, Finland
Contact: Kari Puolakka, dr         
Germany
Charite Not yet recruiting
Berlin, Germany
Contact: Frank Buttgereit, Prof. dr.         
Struenseehaus Not yet recruiting
Hamburg, Germany
Contact: Aries, dr         
Facharztpraxis Not yet recruiting
Magdeburg, Germany
Contact: Sieburg, dr.         
Knappschaftsklinikum Saar Not yet recruiting
Puettlingen, Germany
Contact: Ulrich Prothmann, dr         
Hungary
University of Debrecen Not yet recruiting
Debrecen, Hungary
Contact: Zoltan Szekanecz, prof. dr.         
Italy
University of Genova Not yet recruiting
Genova, Italy
Contact: Maurizio Cutolo, prof. dr.         
Netherlands
Meander Not yet recruiting
Amersfoort, Netherlands
Contact: Ruth Klaassen, dr.         
VUmc Recruiting
Amsterdam, Netherlands
Contact: Willem Lems, Prof. dr.         
Gelre Not yet recruiting
Apeldoorn, Netherlands
Contact: Jan Maarten van Woerkom, dr.         
HAGA Not yet recruiting
Den Haag, Netherlands
Contact: Yvonne Ruiterman, dr.         
Zuyderland Not yet recruiting
Heerlen, Netherlands
Contact: Miriam Starmans, dr         
MCL Not yet recruiting
Leeuwarden, Netherlands
Contact: Reinhard Bos, dr         
LUMC Not yet recruiting
Leiden, Netherlands
Contact: Renee Allaart, dr.         
MC Zuiderzee Not yet recruiting
Lelystad, Netherlands
Contact: Bruyn, dr.         
MUMC Not yet recruiting
Maastricht, Netherlands
Contact: Annelies Boonen, prof dr         
Radboud UMC Not yet recruiting
Nijmegen, Netherlands
Contact: Frank van den Hoogen, prof dr         
Maasstad Not yet recruiting
Rotterdam, Netherlands
Contact: Marc Kok, dr.         
Antonius Ziekenhuis Not yet recruiting
Sneek, Netherlands
Contact: Ed Griep, dr.         
UMC Utrecht Not yet recruiting
Utrecht, Netherlands
Contact: Jaap van Laar, prof. dr.         
VieCurie MC Not yet recruiting
Venlo, Netherlands
Contact: Jansen, dr         
Portugal
CHU Coimbra Not yet recruiting
Coimbra, Portugal
Contact: Jose da Sliva, Prof. dr.         
Hospital de Egas Moniz Not yet recruiting
Lisboa, Portugal
Contact: Branco, dr         
Hospital de Santa Maria Not yet recruiting
Lisboa, Portugal
Contact: Saavedra, dr.         
Instituto Portugues de Reumatologia Not yet recruiting
Lisboa, Portugal
Contact: Micaelo         
Hospital de Ponte Lima Not yet recruiting
Ponte de Lima, Portugal
Contact: Sousa Neves, dr         
Romania
Carol Davila Not yet recruiting
Bucuresti, Romania
Contact: Daniela Opris, dr         
Slovakia
NURCH Not yet recruiting
Bratislava, Slovakia
Contact: Jozef Rovensky, prof dr         
Sponsors and Collaborators
VU University Medical Center
European Commission
Investigators
Principal Investigator: Maarten Boers, Prof. dr. VU University Medical Center
  More Information

Responsible Party: Prof. dr. M. Boers, Professor, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02585258     History of Changes
Other Study ID Numbers: VUMC-ARC-GLORIA 
Study First Received: October 20, 2015
Last Updated: July 20, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on September 23, 2016