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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03330418
Date of registration: 31/10/2017
Prospective Registration: Yes
Primary sponsor: RemeGen
Public title: A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
Scientific title: A Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders.
Date of first enrolment: September 21, 2017
Target sample size: 118
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03330418
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
China
Contacts
Name:     Xianhao Xu
Address: 
Telephone: 010-65282171
Email: bjyyxcc@bjhmoh.cn
Affiliation: 
Name:     Binghua Xiao
Address: 
Telephone: 86-010-58076833
Email: xiaosir522@163.com
Affiliation: 
Name:     xianhao Xu
Address: 
Telephone:
Email:
Affiliation:  Beijing Hospital
Key inclusion & exclusion criteria

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 the group .If the patients taking leflunomide and teriflunomide,they should
need to take colestyramine for elution.

- Have participated in any clinical trial in the first 28 days of the initial screening
or 5 times half-life period of the study compound (taking shorter time ).

- The patients have severe psychiatric symptoms and are not compatible with clinical
studies

- Malignant tumor patients ;

- patients experienced any of the following events within 12 weeks before screening :
myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart
Association class IV heart failure

- Patients can't accept magnetic resonance imaging inspection during the trial.

- Infection with herpes zoster or HIV virus at the screening;

- The anti-hepatitis C virus (anti-HCV) of patients show positive;

- Investigator considers candidates not appropriating for the study.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Neuromyelitis Optica Spectrum Disorders
Intervention(s)
Biological: Placebo
Biological: RC18 160 mg
Primary Outcome(s)
Time to first relapse after randomization [Time Frame: 144 weeks]
Secondary Outcome(s)
Change from Baseline in Expanded Disability Status Scale (EDSS) Score at week 4,8,12,24,36,48,60,72,96,120,144 [Time Frame: 144 weeks]
Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144 [Time Frame: week 4,8,12,24,36,48,60,72,96,120,144]
Secondary ID(s)
C009NMOSDCLLI
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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