- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02882087
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
April 1, 2019 updated by: RemeGen Co., Ltd.
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 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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China
- Renji Hospital Shanghai Jiaotong University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 :
- liver function ≥2 ULN;
- Cr >135μmol/L;
- WBCs<3x 109/L;;
- hemoglobin<85g/L;
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Placebo Comparator
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.
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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.
Other Names:
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EXPERIMENTAL: Experimental: RC18 160 mg plus MTX
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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients in each group reached ACR20 24 weeks for visits
Time Frame: Week 24(Visit 9 )
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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)
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Week 24(Visit 9 )
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, erythrocyte sedimentation rate (ESR) (in millimeters [mm]/hour), and the participant's global assessment of disease activity (100 mm visual analog scale [VAS]: 0 mm=no disease activity to 100 mm=maximum disease activity).
The formula for calculating DAS28 score using ESR value is: 0.56*square root (√) of TJC + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS).
The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
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week 12 and week 24
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants Achieving American College of Rheumatology ACR50 and ACR70 Responses at week 12 or week 24.
Time Frame: week 12 and week 24
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week 12 and week 24
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Sharp score relative change from baseline at week 24
Time Frame: week 24
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week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chunde Bao, Renji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (ACTUAL)
February 25, 2019
Study Completion (ACTUAL)
February 25, 2019
Study Registration Dates
First Submitted
August 24, 2016
First Submitted That Met QC Criteria
August 26, 2016
First Posted (ESTIMATE)
August 29, 2016
Study Record Updates
Last Update Posted (ACTUAL)
April 3, 2019
Last Update Submitted That Met QC Criteria
April 1, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- C004 RACLLI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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