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
  • Berlin
  • Dresden
  • Erlangen
  • Esslingen am Neckar
  • Freiburg im Breisgau
  • Hannover
  • Herne
  • Jena
  • Mainz
  • München
  • Tübingen
Studien-ID:

NCT01791153 2011-006022-25 WA28119

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      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

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