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Efficacy and Safety Study as Monotherapy of Satralizumab (SA237) to Treat NMO and NMOSD

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ClinicalTrials.gov Identifier: NCT02073279
Recruitment Status : Active, not recruiting
First Posted : February 27, 2014
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD

Condition or disease Intervention/treatment Phase
Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) Drug: satralizumab (SA237) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SA237 as Monotherapy in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
Actual Study Start Date : August 5, 2014
Actual Primary Completion Date : October 12, 2018
Estimated Study Completion Date : March 31, 2021


Arm Intervention/treatment
Experimental: satralizumab (SA237)
Subcutaneous satralizumab (SA237)
Drug: satralizumab (SA237)
Placebo Comparator: Placebo
Subcutaneous placebo
Drug: Placebo



Primary Outcome Measures :
  1. Time to first relapse [ Time Frame: up to approximately 38 months from first patient in ]

Secondary Outcome Measures :
  1. Annualized relapse rate [ Time Frame: up to approximately 38 months from first patient in ]


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. NMO or NMOSD
  • 2. Age 18 to 74 years, inclusive at the time of informed consent.

Exclusion Criteria:

  • 1. Pregnancy or lactation.
  • 2. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML).
  • 3. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073279


  Show 77 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Chugai Pharmaceutical
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02073279     History of Changes
Other Study ID Numbers: BN40900
SA-309JG ( Other Identifier: Chugai Pharmaceutical )
2015-005431-41 ( EudraCT Number )
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Neuromyelitis Optica
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases