Select Your Region
Americas
Europa
Afrika
Weltweit
Eine Studie zur Wirksamkeit und Sicherheit von Tocilizumab (RoActemra/Actemra) bei Teilnehmenden mit Riesenzellarteriitis (GCA)
An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)
- Autoimmunerkrankung
- Riesenzellarteriitis
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Bad Abbach
- Bad Bramstedt
- Baden-Baden
- Berlin
- Dresden
- Erlangen
- Frankfurt am Main
- Freiburg
- Hannover
- Herne
- Jena
- Kiel
- Mainz
- München
- Plochingen
- Stuttgart
- Tübingen
Studien-ID:
NCT01791153 2011-006022-25 WA28119
Studienzusammenfassung
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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01791153,WA28119,2011-006022-25
Studien-ID
Tocilizumab, Prednisone, Tocilizumab Placebo, Prednisone Placebo, Corticosteroids, Methotrexate
Treatments
Giant Cell Arteritis
Condition
Official Title
A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis
Einschlusskriterien
All
Gender
≥50 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- 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 Criteria
- 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
Um die aktuellste Version dieser Seite aufzurufen gehen Sie bitte auf www.Klinische-studien-für-patienten.de
