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Efficacy and Safety Study as Add-on Therapy of SA237 to Treat NMO and NMOSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02028884
Recruitment Status : Active, not recruiting
First Posted : January 7, 2014
Last Update Posted : December 5, 2018
Information provided by (Responsible Party):
Chugai Pharmaceutical

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) NMO Spectrum Disorder (NMOSD) Drug: satralizumab (SA237) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Addition to Baseline Treatment, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SA237 in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
Study Start Date : February 2014
Actual Primary Completion Date : June 6, 2018
Estimated Study Completion Date : June 2020

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 30 months from first patient in ]

Secondary Outcome Measures :
  1. Annualized relapse rate [ Time Frame: up to approximately 30 months from first patient in ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 74 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. NMO or NMOSD
  2. Age 12 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 identifier (NCT number): NCT02028884

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Sponsors and Collaborators
Chugai Pharmaceutical
Study Director: Yoshiaki Negi Chugai Pharmaceutical

Responsible Party: Chugai Pharmaceutical Identifier: NCT02028884     History of Changes
Other Study ID Numbers: SA-307JG
2013-003752-21 ( EudraCT Number )
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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