An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)

Completed · Phase 3 · Has a placebo group

Conditions studied: Giant Cell Arteritis

In brief

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 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, participants in remission will stop study treatment and enter long-term follow-up, whereas participants with disease activity or flares will receive open-label tocilizumab or other treatment at the discretion of the investigator for a maximum period of 104 weeks.

Key facts

Study ID: NCT01791153
Run by: Hoffmann-La Roche
People needed: 251
Starts: 2013-07-22
Expected to finish: 2018-06-04
Last updated by the study team: 2020-02-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Cedars-Sinai Medical Center — Los Angeles, California, United States
Rheumatology Assoc. of S. Florida - Clinical Research Center — Boca Raton, Florida, United States
Sarasota Arthritis Res Center — Sarasota, Florida, United States
Four Rivers Clinical Research Inc. — Paducah, Kentucky, United States
Rheumatology Associates — Portland, Maine, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Shores Rheumatology — Saint Clair Shores, Michigan, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
Hospital For Special Surgery; Dept of Medicine - Rheumatology — New York, New York, United States
Asheville Arthritis & Osteoporosis Center, PA — Asheville, North Carolina, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
University of Utah; Division of Rheumatology — Salt Lake City, Utah, United States
Marshfield Clinic Wausau Ctr — Wausau, Wisconsin, United States
Hospital Erasme — Brussels, Belgium
UZ Leuven Gasthuisberg — Leuven, Belgium
Clin. de Rhumatologie — Trois-Rivières, Quebec, Canada
Nordsjællands Hospital - Hillerød;Department of Rheumatology 0731 — Hillerød, Denmark
Hopital Avicenne; Medecine Interne H5 — Bobigny, France
Hopital La Cavale Blanche; Rhumatologie — Brest, France
Hopital Claude Huriez; Internal Medicine — Lille, France
Hôpital de la Conception — Marseille, France
Hopital Emile Muller; Medecine Interne — Mulhouse, France
Hopital Cochin; Medecine Interne — Paris, France
Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie — Bad Abbach, Germany
Univ of Calif., Los Angeles; Rheumatology — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.