A study of the effectiveness and safety of delayed release prednisone in patients with newly diagnosed Giant Cell Arteritis

• Conditions: Giant Cell Arteritis; MedDRA version: 14.1Level: LLTClassification code 10018250Term: Giant cell arteritisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2011-005090-22-GB
• Lead Sponsor: Southend Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-17
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age =50 years
New diagnosis of GCA within last 4 weeks
ESR >30 mm/h or CRP >10 mg/dl
Unequivocal clinical and laboratory picture of GCA either fulfilling American College of Rheumatology criteria or typical features (as assessed by clinician) including one or several of the following:
- New onset localised pain in the head after 50 years of age
- Jaw or tongue claudication
- Visual symptoms (amaurosis fugax, blurring and diplopia)
- Systemic symptoms not attributable to other causes
- Limb claudication
- Polymyalgia
- Abnormal temporal artery (tender, thickened, beading, decreased pulsation)
- Scalp tenderness
- Decreased visual acuity/visual field defect
- Anterior ischemic optic neuropathy (AION) or central retinal artery occlusion on fundoscopy
- Upper cranial nerve palsies
- Typical ischaemic complications of GCA (eg AION)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

GCA on steroid therapy longer than 4 weeks
Previous exposure to DMARD/biologic therapy
Serious or chronic infection in the last 3 months.
Diagnostic doubt
Failure to respond to high dose steroids within 5 days
Known other vasculitis
Patients with evolving ischemic symptoms requiring IV methylprednisolone
Malignancy
Patients unable to consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified