Eine Studie zu Ocrelizumab bei Teilnehmenden mit schubförmig remittierender Multipler Sklerose, die auf eine adäquate krankheitsmodifizierende Behandlung suboptimal angesprochen haben

A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

  • Autoimmunerkrankung
  • Multiple Sklerose (MS)
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
  • Augsburg
  • Berg
  • Berlin
  • Bochum
  • Bonn
  • Buchholz in der Nordheide
  • Böblingen
  • Dresden
  • Düsseldorf
  • Erbach
  • Frankfurt am Main
  • Freiburg im Breisgau
  • Hamburg
  • Hannover
  • Heidelberg
  • Hennigsdorf
  • Itzehoe
  • Kassel
  • Leipzig
  • Magdeburg
  • Mainz
  • Marburg
  • München
  • Münster
  • Neuruppin
  • Oldenburg in Holstein
  • Potsdam
  • Stuttgart
  • Tübingen
  • Ulm
  • Westerstede
Studien-ID:

NCT02861014 2015-005597-38 MA30005

      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

      The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02861014, MA30005, 2015-005597-38 Studien-ID
      Ocrelizumab Treatments
      Multiple Sclerosis, Relapsing-Remitting Condition
      Official Title

      An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment

      Einschlusskriterien

      All Gender
      ≥18 Years & ≤ 55 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
      • Have a length of disease duration, from first symptom, of less than (<) 10 years
      • Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
      • Suboptimal disease control while on a DMT
      • Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
      • For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
      Exclusion Criteria
      • Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
      • Inability to complete an Magnetic Resonance Imaging (MRI) procedure
      • Known presence of other neurological disorders
      • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
      • History or currently active primary or secondary immunodeficiency
      • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
      • History of opportunistic infections
      • History or known presence of recurrent or chronic infection
      • History of malignancy
      • Congestive heart failure
      • Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds

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