A study of effectiveness and safety of delayed release prednisolone in patients with newly diagnosed Giant Cell Arteritis | Not Recruiting
A study of effectiveness and safety of delayed release prednisolone in patients with newly diagnosed Giant Cell Arteritis

Trial Source

Health Conditions
  • Giant cell arteritis (GCA)
Not Recruiting
Recruitment Status
ISRCTN40911426
Primary Trial ID Number
Summary
1. Determine whether delayed release prednisolone, in doses equivalent to standard of care immediate release prednisolone, can effectively maintain disease control in new cases of giant cell arteritis. 2. To investigate the duration of the observed clinical response and safety and tolerance of said treatment. Data from this study will support further phase 3 study of efficacy and corticosteroid adverse event sparing effect of MR prednisolone in GCA. The validation of outcome assessments used in this study, will guide protocol development for future international multi-centre clinical trials in GCA.
Primary Outcome Measures
  • Proportion of patients achieving persistent disease control (without features of active disease and remaining flare free at 26 weeks) in each arm.
  • Disease Control:
  • Primary response criteria for assessing remission in patients will be as follows:
  • 1. Patients maintaining a global improvement >70% (compared to pre-steroid state)
  • 2. Absence of signs and symptoms of new, recurrent, worsening features of GCA
  • 3. CRP< 10mg/L or ESR< 30mm/h
  • Complete control: patients fulfilling all three criteria items
  • Partial control: Fulfilling 2 out of 3
Secondary Outcome Measures
  • 1. Relapse free subjects in each arm at 26 weeks
  • 2. Time to the first flare
  • 3. Time to second flare
  • 4. Cumulative steroid dosage
  • 5. Patient global VAS of disease activity
  • 6. Reduction of ESR
  • 7. Reduction of CRP
  • 8. Improvement in HAQ and Euro QOL 5D
  • 9. Visual Function Questionnaire (VFQ-25) in patients with vision loss.
  • 10. Improvement in sleep and fatigue scores
  • 11. Proportion with steroid related toxicity in each arm with particular reference to weight gain, fluid retention, bruising, glucose tolerance, hypertension, dyspepsia
Research Question
  • 1. Determine whether delayed release prednisolone, in doses equivalent to standard of care immediate release prednisolone, can effectively maintain disease control in new cases of giant cell arteritis. 2. To investigate the duration of the observed clinical response and safety and tolerance of said treatment. Data from this study will support further phase 3 study of efficacy and corticosteroid adverse event sparing effect of MR prednisolone in GCA. The validation of outcome assessments used in this study, will guide protocol development for future international multi-centre clinical trials in GCA.
Design Type
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Ethics Approval
Not provided at time of registration
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
30
Participant Inclusion Criteria
  • 1. Age ≥50 years
  • 2. New diagnosis of Giant Cell Arteritis (GCA) within last 4 weeks
  • 3. Erythrocyte sedimentation rate (ESR) >30 mm/h or CRP > 10 mg/L
  • 4. Unequivocal clinical and laboratory picture of GCA either fulfilling American College of Rheumatology criteria (see below) or typical features, as assessed by a clinician, including one or several of the following:
  • 4.1. New onset localised pain in the head after 50 years of age
  • 4.2. Jaw or tongue claudication
  • 4.3. Visual symptoms (amaurosis fugax, blurring and diplopia)
  • 4.4. Systemic symptoms not attributable to other causes
  • 4.5. Limb claudication
  • 4.6. Polymyalgia
  • 4.7. Abnormal temporal artery (tender, thickened, beading, decreased pulsation)
  • 4.8. Scalp tenderness
  • 4.9. Decreased visual acuity/visual field defect
  • 4.10. Anterior ischemic optic neuropathy or central retinal artery occlusion
  • 4.11. Upper cranial nerve palsies
  • 5. Symptoms and signs of GCA with typical ischaemic complications (e.g. Anterior ischaemic optic neuropathy - AION)
  • The American College of Rheumatology classification criteria for GCA (3 out of 5 items fulfilled)
  • 1. Age ≥50 years at disease onset
  • 2. New onset of or new type of localized pain in the
  • 3. Temporal artery abnormality - tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries.
  • 4. Elevated erythrocyte sedimentation rate (ESR ≥50 mm/h by the Westergren method)
  • 5. Abnormal artery biopsy – showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells
Participant Exclusion Criteria
  • 1. GCA on steroid therapy longer than 4 weeks
  • 2. Previous exposure to DMARD/biologic therapy
  • 3. Serious or chronic infection in the last 3 months
  • 4. Diagnostic doubt
  • 5. Failure to respond to high dose steroids within 5 days
  • 6. Known other vasculitis
  • 7. Patients with evolving ischemic symptoms requiring IV methylprednisolone
  • 8. Malignancy
  • 9. Patients lacking capacity to consent
Interventions
New cases of GCA will be treated with high dose standard prednisolone (40 – 60 mg) daily for 4 weeks. Thereafter they will be randomised to 2 open arms with 15 cases in each arm to continue tapering steroid treatment with either standard (IR) or modified release (MR) prednisolone. A taper schedule will be followed and will only be instituted if the disease activity is controlled at each visit on symptoms review and laboratory assessment.
Design Details
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Study Design
Interventional feasibility study over 26 weeks using a randomised, open protocol with blinded evaluator in 2 centres using 30 subjects comparing delayed release prednisolone to standard prednisolone
Results Reporting
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Acronym
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Scientific Title
A study of efficacy and safety of delayed release prednisolone in newly diagnosed cases of Giant Cell Arteritis
Secondary Trial Identifying Number
001
Website
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Study Funded By
Napp Pharmaceuticals Limited (UK)
Funder Type
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Study Sponsored By
Southend Univeristy Hospital (UK)
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment

01 Dec 2011

Recruitment End Date

01 Dec 2012

Trial End Date

01 Dec 2012

Date added to Registry

13 Oct 2011

Last Updated

20 Jun 2012