A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis… (NCT03330418) | Clinical Trial Compass
TerminatedPhase 3
A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
Stopped: Sponsor Strategic Priority Adjustment
China178 participantsStarted 2018-01-29
Plain-language summary
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Meet the 2015 international consensus diagnostic criteria for Neuromyelitis Optica Spectrum Disorders and astrocyte water channel aquaporin-4 (AQP4) antibody positivity.
* EDSS 0-7.5
* Clinical evidence of at least 2 relapses within the first two years of randomization and/ or 1 relapse within the first one year of randomization
* Consent to use effective contraception during the study period (women of childbearing age)
* Voluntarily signed informed consent
Exclusion Criteria:
* Abnormal laboratory parameters need to be excluded, including but not limited to:
* Currently suffering from active hepatitis or serious liver disease and medical history
* Patients were treated with rituximab or other monoclonal antibodies within 6 months prior to randomization .
* Any concomitant disease other than neuromyelitis optica(NMO)/ neuromyelitis optica Spectrum disorders(NMOSD)that required treatment with lucocorticoid.
* pregnant , lactating women and men or women who have birth plans during the research;
* Have a history of allergic reaction to contrast agent for parenteral administration and human biological medicines.
* Receipt of intravenous immune globulin ( IVIG) within 28 days prior to randomization.
* Receipt of any of the following prior to randomization: Azathioprine,Cyclosporin, Methotrexate Mitoxantrone,Cyclophosphamide,Tocilizumab,Tacrolimus,Mycophenolate,and Patients discontinued more than 5 times the half-life of the drug before they could get into …