Status:
COMPLETED
An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a...
Eligibility Criteria
Inclusion
- Diagnosis of GCA classified according to age \>/=50 years; history of ESR \>/=50 mm/hr or history of CRP \>/=2.45 mg/dL; and at least one of the following: unequivocal cranial symptoms of GCA or symptoms of polymyalgia rheumatica \[PMR\]; and at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large-vessel vasculitis by angiography or cross-sectional imaging
- New onset (diagnosis within 6 weeks of baseline) or refractory (diagnosis greater than \[\>\] 6 weeks before baseline and previous treatment with \>/= 40 milligrams per day prednisone \[or equivalent\] for at least 2 consecutive weeks at any time) GCA
- Active disease (presence of clinical signs and symptoms \[cranial or PMR\] and ESR \>/=30 mm/hour or CRP \>/=1 mg/dL) within 6 weeks of baseline visit
Exclusion
- Major surgery within 8 weeks prior to screening or planned within 12 months after randomization
- Transplanted organs (except corneas with transplant performed \>3 months prior to screening)
- Major ischemic event, unrelated to GCA, within 12 weeks of screening
- Prior treatment with any of the following: investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening; cell-depleting therapies including investigational agent; intravenous (IV) gamma globulin or plasmapheresis within 6 months of baseline; alkylating agents or with total lymphoid irradiation; tocilizumab; hydroxychloroquine, cyclosporine A, azathioprine, or mycophenolate mofetil within 4 weeks of baseline; etanercept within 2 weeks of baseline; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks of baseline; anakinra within 1 week of baseline; tofacitinib; cyclophosphamide within 6 months of baseline; \>100 milligrams of daily IV methylprednisolone within 6 weeks of baseline
- Participants requiring systemic glucocorticoids for conditions other than GCA, which, in the opinion of the investigator, would interfere with adherence to the fixed glucocorticoid taper regimen and/or to assessment of efficacy in response to the test article
- History of severe allergic reactions to monoclonal antibodies or to prednisone
- Evidence of serious uncontrolled concomitant disease (for example, cardiovascular, respiratory, renal, endocrine, psychiatric, corneal ulcers/injuries, or gastrointestinal \[GI\] disease)
- Current liver disease, as determined by the investigator
- History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract condition that might predispose to bowel perforation
- Known active or history of recurrent bacterial, viral fungal, mycobacterial, or other infection
- Primary or secondary immunodeficiency
- Evidence of malignancies diagnosed within previous 5 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured)
- Inadequate hematologic, renal or liver function
- Positive for hepatitis B or hepatitis C infection
Key Trial Info
Start Date :
July 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2018
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT01791153
Start Date
July 22 2013
End Date
June 4 2018
Last Update
February 6 2020
Active Locations (78)
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1
Univ of Calif., Los Angeles; Rheumatology
Los Angeles, California, United States, 90025
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Rheumatology Assoc. of S. Florida - Clinical Research Center
Boca Raton, Florida, United States, 33486
4
Sarasota Arthritis Res Center
Sarasota, Florida, United States, 34239