Status:
COMPLETED
Tocilizumab for Patients With Giant Cell Arteritis
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Bern
Roche Pharma AG
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Giant-cell arteritis (GCA) is an immune-mediated disease that mostly affects people older than 50 years of age. Glucocorticoid (GC) treatment dramatically alters the symptoms and course of GCA, reduci...
Detailed Description
Background Giant-cell arteritis (GCA) is an immune-mediated disease that mostly affects people older than 50 years of age. Glucocorticoid (GC) treatment dramatically alters the symptoms and course of...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with newly onset or relapsed GCA
- \> 50 years of age
- satisfying ACR criteria
- elevated sedimentation rate above 40 mm
- CRP \> 20 mg/L
- Patients with histologically proven GCA or with large vessel vasculitis assessed by MRI
- Exclusion Criteria
- Rheumatic diseases (except for CPPD/chondrocalcinosis) other than GCA/Takayasu disease or polymyalgia rheumatica (i.e., RA, autoimmune connectivitides, other systemic vasculitides, a.o.)
- Evidence of significant and/or uncontrolled concomitant disease
- Diagnosis of GCA \> 4 weeks before screening visit and beginning of GC treatment \> 4 weeks before screening (only valid for new onset GCA), or when a patient received treatment with tocilizumab or with other biological agents (such as TNFα-blockers) within 3 months before screening
- Any condition or general state of health which, in the Investigator's opinion, would preclude participation in the study
- Actual or recent myocardial infarction (within the last 3 months before screening visit)
- Significant cardiac disease (NYHA Class III and IV), known severe chronic obstructive pulmonary disease (COPD) (FEV1 \< 50% predicted or Functional dyspnoea \> Grade 3 on the MRC Dyspnoea Scale) or other significant pulmonary disease
- Uncontrolled disease (such as asthma, psoriasis or inflammatory bowel disease) where flares are commonly treated with oral or injectable corticosteroids
- Known active infection of any kind, or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or completion of oral anti-infectives within 2 weeks prior to baseline
- History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within 52 weeks prior to baseline
- Any surgical procedure, including bone/joint surgery within 8 weeks prior to baseline or planned within the duration of the study
- History of serious recurrent or chronic infection (for screening for a chest infection a chest radiograph will be performed at screening if not performed within 12 weeks prior to screening)
- Lack of peripheral venous access
- Body weight \> 150 kg or BMI \> 35
- Previous treatment with tocilizumab or any other biological agent
- Treatment with any investigational agent within 28 days of screening or 5 half-lives of the investigational drug (whichever is the longer)
- History of severe allergic or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of tocilizumab (RoActemra)
- Receipt of any vaccine within 28 days prior to baseline (a patient's vaccination record and need for immunization prior to receiving tocilizumab/placebo must be carefully investigated)
- Positive tests for hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HbcAb) or hepatitis C serology
- Positive Quantiferon-TB® test for latent Tb without subsequent INH prophylaxis
- Patients with active Tb which had to be treated for Tb within 2 years before the screening visit
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01450137
Start Date
September 1 2011
End Date
September 1 2015
Last Update
February 12 2019
Active Locations (1)
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1
Department of Rheumatology, Clinical Immunology Allergology, University Hospital, Inselspital
Bern, Switzerland, 3010