A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-a Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02882087
• Date of registration: 24/08/2016
• Prospective Registration: No
• Primary sponsor: RemeGen
• Public title: A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-a Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis
• Scientific title: A Phase II, Placebo-Controlled, Multicenter, Dynamic Randomized, Double Blind Trial of RC18, a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Inadequate Response of TNF-a Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis
• Date of first enrolment: October 2015
• Target sample size: 60
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02882087
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Chunde Bao
• Affiliation: RenJi Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of adult onset RA by a physician as defined by the 1987 and/or 2010 ACR
criteria.and ESR or C - reaction protein ( CRP ) is greater than the normal range

- Aged 18-65 years old;

- Consent to use effective contraception during the study period (women of childbearing
age)

- Patients with an inadequate response to existing therapies at least one anti-TNFs
Infliximab (Remicade ) at least three times, adalimumab (Humira), at least four times,
etanercept ( Enbrel) use at least 8 weeks, etanercept use at least 8 weeks .And Last
medication time to randomization more than 12 weeks .

- Voluntarily signed informed consent ;

- Patients have been taking MTX for at least 12 weeks at the screening and maintaining
dose stability =7.5mg/ weeks (or equivalent dose) 4weeks before randomization .

- If the subjects are taking DMARDs (except MTX) at screening, the test was discontinued
for at least 4 weeks before randomization.

- If subjects are receiving treatment of corticosteroid ,must stabilize dose (dose of
prednisone) at least equal to or less than 10mg / day for 4 weeks (before
randomization);

- If subjects are receiving treatment of NSAIDs ,must stabilize dose (dose of
prednisone) at least 4 weeks (before randomization).

- When the patient's condition to achieve moderate to severe active RA at the screening
, defined as at least 6/68 tenderness joints and at least 6/66 swollen joints.

Exclusion Criteria:

-There are serious heart, liver, kidney and other important organs and blood, endocrine
system diseases and medical history;

Evaluation criteria for severity :

1. liver function =2 ULN;

2. Cr >135µmol/L;

3. WBCs<3x 109/L;;

4. hemoglobin<85g/L;

5. platelet count<80x 109/L.

- Have a historically active hepatitis or active hepatitis or medical
history;HBsAg- surface antigen positive patients are not allowed to be selected,
but only anti HBC single positive is added to do HBV-DNA quantitative detection,
if the HBV-DNA quantity is negative can not be regarded as the exclusion;

- Immune deficiency, uncontrolled severe infection and patients with active or
recurrent peptic ulcer;

- pregnant , lactating women and men or women who have birth plans in the past 6
months ;

- Have a history of allergic reaction to contrast agent for parenteral
administration and human biological medicines.

- Receipt of live vaccine within 1 month(excepting for herpes zoster vaccine)

- 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 the time for
the elderly).

- Patients with using of biological agents for the treatment of DMARDs within three
months

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

- Active TB at screening.Exception for patients with PPD=15mm.But Patients with
anti tuberculosis treatment for 3 years without relapse are allowed to
participate in the trial;

- Malignant tumor patients :the patients who suffering from malignant tumor has
been removed and no recurrence or who with cervical carcinoma in situ have
evidence of metastatic disease and with basal cell or squamous cell carcinoma had
been completely removed and at least 3 years without recurrence can participate
in .

- there was a history of long-term alcohol abuse, intravenous drug abuse or other
illicit drug abuse within 6 months

- Planning to have surgery for RA or other significant surgery during the period of
the study.

- 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 received interferon treatment (such as interferon alpha, intron alpha,
peg-intron, double talon, intergen, Pegasys etc.) within 4 weeks before screening
, or are expected to test period will need to accept interferon therapy.

- The combined use of immunosuppressive agents associated with organ
transplantation is not allowed during the study period.

- Combined with non RA any other systemic inflammatory diseases, including but not
limiting to, juvenile chronic arthritis, vertebral arthrosis, limited enteritis
(Crohn's disease), ulcerative colitis, psoriatic arthritis, activity of
vasculitis or gout. But with secondary drying syndrome of patients need not be
excluded.

- 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

Moderate and Severe Rheumatoid Arthritis

Intervention(s)

Drug: RC18 160 mg plus MTX

Drug: Placebo plus MTX

Primary Outcome(s)

The proportion of patients in each group reached ACR20 24 weeks for visits [Time Frame: Week 24(Visit 9 )]

Secondary Outcome(s)

Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28)at week 12 and week 24. [Time Frame: week 12 and week 24]

Secondary ID(s)

C004 RACLLI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors