Institutional Review Board, Hospital for Special Surgery
April 02, 2014
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Robert F. Spiera, MD
Jessica K. Gordon, MD
Lindsay Lally, MD
Uzunma Udeh
Nina Paddu
Daniele Lerner
Jason Zheng, PharmD
Aisha Ali, PharmD
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with giant cell arteritis. Patients will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or every 2 weeks or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, patients in remission will stop study treatment and enter long-term follow-up, whereas patients with disease activity or flares will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly for a maximum period of 104 weeks at the discretion of the investigator. Anticipated time on study is 39 months. Six patients will be recruited from this site.
Inclusion Criteria:
• Diagnosis of giant cell arteritis classified according to the following criteria:
o Age >/= 50 years
o History of ESR >/= 50 mm/hour
o and at least one of the following:
Unequivocal cranial symptoms of giant cell arteritis
Symptoms of polymyalgia rheumatica
o and at least one of the following
Temporal artery biopsy revealing features of giant cell arteritis
Evidence of large-vessel vasculitis
• New onset active disease (diagnosis within 6 weeks of baseline) or refractory active disease (diagnosis > 6 weeks before baseline and previous treatment with >/= 40 mg/day prednisone (or equivalent) for at least 2 consecutive weeks at any time); active disease defined as presence of clinical signs and symptoms and ESR >/= 30 mm/hour or CRP >/= 1 mg/dl within 6 weeks of baseline
Exclusion Criteria:
• Recent or incoming major surgery
• Organ transplantation recipient (except corneas within 3 months prior to baseline visit)
• Major ischemic event, unrelated to giant cell arteritis, within 12 weeks of screening
• Prior treatment with any of the following:
o Investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening visit
o Cell-depleting agents (e.g. anti CD 20)
o Tocilizumab
o Tofacitinib
o Alkylating agents including CYC within 6 months of baseline
o HCQ, CsA, AZA, or MMF within 4 weeks of baseline
o Tumor necrosis factor inhibitors within 2-8 weeks of baseline
o Anakinra within 1 week of baseline
o Corticosteroids for conditions other than GCA
o IV corticosteroids within 6 weeks of baseline
• History of severe allergic reactions to monoclonal antibodies
• Evidence of serious uncontrolled concomitant disease (e.g. cardiovascular, respiratory, renal, endocrine)
• Current liver disease that could interfere with the trial as determined by the investigator
• History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract condition that might predispose to bowel perforation
• Infections:
o Active current or history of recurrent bacterial, viral fungal, mycobacterial, or other infection
o Prior episode of major infection
o Active TB requiring treatment within the previous 3 years
o Untreated latent TB infection (LTBI)
• Primary or secondary immunodeficiency
• Malignancy (except for basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured)
• Inadequate hematologic, renal or liver function
• Positive for hepatitis B or hepatitis C infection
Uzunma Udeh
udehu@hss.edu
212-774-2123