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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: 8 February 2021
Main ID:  NCT04625153
Date of registration: 06/11/2020
Prospective Registration: Yes
Primary sponsor: RemeGen
Public title: RC18 in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial
Scientific title: RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial
Date of first enrolment: March 2021
Target sample size: 18
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT04625153
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Contacts
Name:     Wei Qiu, MD.
Address: 
Telephone: 02085253032
Email: qiuwei120@vip.163.com
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with relapsing remitting multiple sclerosis meet the diagnostic criteria of
McDonald 2017.

- 18-55 years old, male or female

- At least 2 recurrences (including clinical recurrence and imaging recurrence) were
recorded within 1 year before randomization.

- Gadolinium enhanced T1 lesions (= 1) in the brain at the screening stage

- EDSS score = 5.5

- Informed consent signed voluntarily

Exclusion Criteria:

- Patients with multiple sclerosis over 5 years

- Those who are unable to perform MRI or who are allergic to gadolinium contrast agent
during the test

- In addition to multiple sclerosis, patients with chronic active immune system disease
or stable condition but requiring immunotherapy (glucocorticoids and / or
immunosuppressants) (such as rheumatoid arthritis, scleroderma, Sjogren's syndrome,
Crohn's disease, ulcerative colitis, etc.) or known immune deficiency syndrome (AIDS,
genetic immune deficiency and drug-induced immunity) Patients who used glucocorticoid
maintenance therapy before randomization could participate in the trial after
discontinuation of the drug

- Patients with Aquaporin 4 (AQP4) antibody positive and / or Myelin oligodendrocyte
glycoprotein(MOG) antibody positive within 1 year before randomization

- Patients who have received the following treatment:

1. Interferon, pegylated interferon, galatirel acetate, dimethyl fumarate were used
within 4 weeks before randomization.

2. Fengomod, IV immunoglobulin or plasma exchange within 12 weeks before
randomization.

3. Alemtuzumab, daclizumab and ocrelizumab were used within 24 weeks before
randomization.

4. Before randomization, azathioprine (AZA, half-life t1/2 = 6hrs), mycophenolate
mofetil (t1/2 = 16hrs), leflunomide (LEF, t1/2 = 14.7hrs), tacrolimus (t1/2 =
43hrs), teriflunomide (t1/2 = 18 days), cyclosporin, In addition to leflunomide
and telifluoramine, immunosuppressants such as CSA, t1/2 = 27 hrs, methotrexate
(MTX, t1/2 = 14 HRS), cyclophosphamide (CTX, t1/2 = 6 hrs) can be added to the
group after the interval of withdrawal is more than 5 times of half-life.
Leflunomide and tertiazem need to be eluted with coleridine. The drug can be
stopped and the following measures can be taken: Take 8 g of coleridine three
times a day for 11 days. If the dose of 8 g can not be tolerated, it can be
changed to 4 g each time. The time and times are the same as before.

5. Cladribine or mitoxantrone was used within 1 year before randomization.

6. Lymphoid irradiation and bone marrow transplantation were received before
randomization.

- Patients were participated in any clinical trial 28 days before randomization or
within 5 times half-life of study drug participating in clinical trial (whichever is
longer).

- Patients with any persistent or chronic active infection or serious infection history
in the screening period, such as shingles; active tuberculosis (patients with latent
tuberculosis can participate in the test if they are given isoniazid and / or rifampin
at the same time); HIV infection; syphilis antibody positive; HCV antibody positive;
HBsAg positive; HBsAg negative but HBcAb positive, the HBV-DNA quantitative test is
needed. If the HBV-DNA is positive, the patient should be excluded. If the HBV-DNA is
negative, the patient can not be excluded.

- The results of abnormal laboratory tests to be excluded include but are not limited
to: Leukocyte count < 3 × 10~9 / L; neutrophil < 1.5 × 10~9 / L; hemoglobin < 85g / L;
platelet count < 80 × 10~9 / L; serum creatinine > 1.5 × ULN, accompanied by
creatinine clearance < 50ml / min (measured value, or calculated by Cockcroft Gault
formula); total bilirubin > 1.5 × ULN; ALT > 3 × ULN; AST > 3 × ULN; alkaline
phosphatase > 2 × ULN; IgG < lower limit of normal value; IgM < lower limit of normal
value;

- Cancer patients

- Pregnant women, lactating women and patients with family planning during the trial

- Patients with other mental disorders

- Patients who experienced any of the following events within 12 weeks before
randomization: myocardial infarction, unstable ischemic heart disease, stroke, or NYHA
class IV heart failure

- The researchers believe that the patients are compliant insufficiently or not suitable
to participate in this study.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis, Relapsing-Remitting
Intervention(s)
Biological: RC18 160mg
Biological: RC18 240mg
Primary Outcome(s)
Number changes of gadolinium enhanced T1 lesions in the brain [Time Frame: At 12, 24, 36, and 48 weeks]
Secondary Outcome(s)
Number changes of new / increased T2 lesions in the brain [Time Frame: At 12, 24, 36 and 48 weeks]
Number changes of new low signal T1 lesions [Time Frame: At week 12, 24, 36, and 48 weeks]
Proportion of patients who did not recur [Time Frame: Between 0 and 48 weeks]
Recurrence rate [Time Frame: 0-48weeks]
Volume changes of gadolinium enhanced T1 lesions [Time Frame: At 12, 24, 36 and 48 weeks]
Volume changes of T2 lesions in brain [Time Frame: At 12, 24, 36 and 48 weeks]
Secondary ID(s)
18C013
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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