A Study Of The Safety And Effectiveness Of RoActemra/Actemra (Tocilizumab) For Patients With Giant Cell Arteritis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-004545
NCT ID: NCT01791153
Sponsor Protocol Number: WA28119
About this study
The purpose of this study is to evaluate the effectiveness and safety of RoActemra/Actemra (tocilizumab) for the treatment of patients who have giant cell arteritis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Diagnosis of giant cell arteritis classified according to
- Age ≥ 50 years
- History of ESR ≥ 50 mm/hour
- And at least one of the following
- Unequivocal cranial symptoms of giant cell arteritis
- Symptoms of polymyalgia rheumatica
- 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 with diagnosis within 6 weeks of baseline, or refractory active disease with 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 oncoming 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
- Investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening visit
- Cell-depleting agents (e.g. anti CD 20)
- Tocilizumab
- Tofacitinib
- Alkylating agents including CYC within 6 months of baseline
- HCQ, CsA, AZA, or MMF within 4 weeks of baseline
- Tumor necrosis factor inhibitors within 2-8 weeks of baseline
- Anakinra within 1 week of baseline
- Corticosteroids for conditions other than GCA
- 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
- Active current or history of recurrent bacterial, viral fungal, mycobacterial, or other infection
- Prior episode of major infection
- Active TB requiring treatment within the previous 3 years
- Untreated latent TB infection (LTBI)
- Primary or secondary immunodeficiency
- Malignancy, except for basal or 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kenneth Warrington, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available