A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis
- Conditions
- Giant cell arteritisMedDRA version: 18.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-002778-38-IE
- Lead Sponsor
- Institut de Recherches Internationales Servier (IRIS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
- Relapsing GCA with systemic symptoms,
- Diagnosis of GCA according to modified ACR criteria,
- Oral CS therapy,
- Male or female, age = 50 years,
- Weight > 40 kg at selection,
- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
- Relapse of GCA with symptoms indicative of a risk of ischemic event,
- History of recent, permanent or transient visual loss due to GCA and the presence of any specific visual abnormality,
- History of major ischemic event, unrelated to GCA,
- History of fibromyalgia,
- Evidence of active pulmonary infection, active TB disease, or malignancy, or suspicion of active or latent TB, or exposition to TB,
- History of severe allergic or anaphylactic reactions to monoclonal antibodies,
- History of malignancy within 5 years prior to selection,
- Known immunodeficiency,
- Infectious disease,
- Pregnancy, breastfeeding or possibility to become pregnant during the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method