A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03330418|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuromyelitis Optica Spectrum Disorders||Biological: Placebo Biological: RC18 160 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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.|
|Actual Study Start Date :||September 21, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: Placebo Comparator
Participants received placebo weekly administered subcutaneously for 48 times in the double-blind treatment period.Once the participants relapse,they should advance to the open phase.All participants were treated with the test drugs.
Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.
Experimental: RC18 160 mg
Patients received the test group RC18 160mg weekly administered subcutaneously for 48 times.Starting with the forty-ninth dose,the trial went into the open phase . All participants were treated with the test drugs.
Biological: RC18 160 mg
In the Phase B,the researchers can adjust the dose of RC18 according to the subjects' willingness and recurrence, but the maximum dose of single dose should not exceed 320g.
- Time to first relapse after randomization [ Time Frame: 144 weeks ]
- 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 ]The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.
- 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 ]
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): NCT03330418
|Contact: Binghua Xiaofirstname.lastname@example.org|
|Beijing, Beijing, China|
|Contact: Xianhao Xu 010-65282171 email@example.com|
|Principal Investigator:||xianhao Xu||Beijing Hospital|