We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 127 for:    GLORIA

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

This study is currently recruiting participants.
Verified November 2017 by Prof. dr. M. Boers, VU University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02585258
First Posted: October 23, 2015
Last Update Posted: November 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
European Commission
Information provided by (Responsible Party):
Prof. dr. M. Boers, VU University Medical Center
  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
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
Actual Study Start Date: June 30, 2016
Estimated Study Completion Date: July 1, 2020
Estimated Primary Completion Date: May 1, 2020 (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

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.


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


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

Locations
Finland
KSSHP Withdrawn
Jyväskylä, Finland
EKSOTE Withdrawn
Lappeenranta, Finland
Germany
Charite Recruiting
Berlin, Germany
Contact: Frank Buttgereit, Prof. dr.         
Struenseehaus Withdrawn
Hamburg, Germany
Facharztpraxis Recruiting
Magdeburg, Germany
Contact: Sieburg, dr.         
Knappschaftsklinikum Saar Recruiting
Püttlingen, Germany
Contact: Ulrich Prothmann, dr         
Hungary
University of Debrecen Recruiting
Debrecen, Hungary
Contact: Zoltan Szekanecz, prof. dr.         
Italy
University of Genova Recruiting
Genova, Italy
Contact: Maurizio Cutolo, prof. dr.         
Netherlands
Meander 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 Recruiting
Den Haag, Netherlands
Contact: Yvonne Ruiterman, dr.         
Zuyderland Withdrawn
Heerlen, Netherlands
MCL Recruiting
Leeuwarden, Netherlands
Contact: Reinhard Bos, dr         
LUMC Recruiting
Leiden, Netherlands
Contact: Renee Allaart, dr.         
MC Zuiderzee Recruiting
Lelystad, Netherlands
Contact: Bruyn, dr.         
MUMC Not yet recruiting
Maastricht, Netherlands
Contact: Annelies Boonen, prof dr         
Radboud UMC Withdrawn
Nijmegen, Netherlands
Maasstad Recruiting
Rotterdam, Netherlands
Contact: Marc Kok, dr.         
Antonius Ziekenhuis Not yet recruiting
Sneek, Netherlands
Contact: Ed Griep, dr.         
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: Jaap van Laar, prof. dr.         
VieCurie MC Recruiting
Venlo, Netherlands
Contact: Jansen, dr         
Portugal
CHU Coimbra Recruiting
Coimbra, Portugal
Contact: Jose da Sliva, Prof. dr.         
Hospital de Egas Moniz Recruiting
Lisboa, Portugal
Contact: Branco, dr         
Hospital de Santa Maria Recruiting
Lisboa, Portugal
Contact: Saavedra, dr.         
Instituto Portugues de Reumatologia Recruiting
Lisboa, Portugal
Contact: Micaelo         
Hospital de Ponte Lima Recruiting
Ponte de Lima, Portugal
Contact: Sousa Neves, dr         
Romania
Carol Davila Recruiting
Bucuresti, Romania
Contact: Daniela Opris, dr         
Slovakia
NURCH 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

Publications:
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
First Submitted: October 20, 2015
First Posted: October 23, 2015
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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