Lack of trial population, unable to recruit subjects
A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-α Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis
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-α Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis
This date has not been verified as actual or estimated.
Primary Completion
February 25, 2019
Actual (reported)
Study Completion
February 25, 2019
Actual (reported)
Brief Summary
This is a phase Ⅱ, placebo-controlled, multicenter, dynamic randomized, double blind study of the efficacy and safety of RC18, a recombinant human B lymphocyte stimulating factor receptor-antibody fusion protein in subjects with inadequate response of TNF-α antagonists due to treat moderate and severe rheumatoid arthritis.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
terminated
Estimated enrollment
60 participants
Study completion date
February 25, 2019
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
October 2015
Date type not reported
This date has not been verified as actual or estimated.
The proportion of patients in each group reached ACR20 24 weeks for visits
ACR20 response: Patients with tenderness and swollen joint counts and 20% improvement,At least 3 20% improvement in the following 5:a.Health Assessment Questionnaire;b.Subjects assessed pain VAS score;c.Assess the overall situation of the disease subject VAS score;d.Researchers assessed the overall situation of the disease in the VAS score;e.Acute phase reactants(ESR or CRP)
Week 24（Visit 9 ）
Secondary Outcomes (1)
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28)at week 12 and week 24.
week 12 and week 24
Other Outcomes (2)
Percentage of Participants Achieving American College of Rheumatology ACR50 and ACR70 Responses at week 12 or week 24.
week 12 and week 24
Sharp score relative change from baseline at week 24
week 24
Study Arms (2)
Placebo Comparator
EXPERIMENTAL
Placebo SC plus MTX. Patients received placebo SC weekly administered subcutaneously for 24 times.All patients had a foundation MTX therapy, MTX dose should be stable, not to adjust the dose.The researchers evaluated the efficacy of the patient in 12 week.Evaluation of efficacy in patients if not get the ACR20 response, adjust the treatment plan given the test drug.Test group continue to the test drug,placebo group switch to the test drug.
Drug: Placebo plus MTX
Experimental: RC18 160 mg plus MTX
EXPERIMENTAL
Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times. All patients had a foundation MTX therapy, MTX dose should be stable, not to adjust the dose.
Drug: RC18 160 mg plus MTX
Interventions
Placebo plus MTXDrug
All patients had a foundation MTX therapy.The researchers evaluated the efficacy of the patient in 12 week.study investigator evaluate the patients of curative effect . The researchers evaluated the efficacy of the patient in 12 week.Evaluation of efficacy in patients if not get the ACR20 response, adjust the treatment plan given the test drug.Test group continue to the test drug,placebo group switch to the test drug.
Also known as: MTX=Methotrexate
Placebo Comparator
RC18 160 mg plus MTXDrug
Eligibility Criteria
Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
You may qualify if:
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
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Lymphoma, FollicularArthritis, Rheumatoid
Interventions
MethotrexateRC-18
Condition Hierarchy (Ancestors)
Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesArthritis
Study Officials
Chunde Bao
RenJi Hospital
PRINCIPAL INVESTIGATOR
Study Design
Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Study Record Dates
First Submitted
August 24, 2016
First Posted
August 29, 2016
Study Start
October 2015
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
February 25, 2019
Also known as: RC18, MTX=Methotrexate
Experimental: RC18 160 mg plus MTX
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
You may not qualify if:
There are serious heart, liver, kidney and other important organs and blood, endocrine system diseases and medical history;
Evaluation criteria for severity :
liver function ≥2 ULN;
Cr \>135μmol/L;
WBCs\<3x 109/L;;
hemoglobin\<85g/L;
platelet count\<80x 109/L.
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;
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Source: ClinicalTrials.gov.
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