A Phase III Study of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects with Poor Efficacy of MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.
Sponsor study identifier
interventional
479
1 country
1
Study Start
March 29, 2017
Actual (reported)Primary Completion
November 19, 2022
Actual (reported)Study Completion
December 29, 2022
Actual (reported)The purpose of this study is to initially access the safety and effectivity of RC18 combined with methotrexate (MTX) in comparison with the use of methotrexate alone in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response to MTX therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 29, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2017
Actual (reported)January 10, 2017
Actual (reported)March 29, 2017
Actual (reported)November 19, 2022
Actual (reported)December 29, 2022
Actual (reported)The proportion of patients in each group reached ACR20 at week 24
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）
Percentage of Participants Achieving American College of Rheumatology ACR50 and ACR70 Responses at week 24.
Week 24
Percentage of Participants Achieving Low Disease Activity and clinical remission. (DAS28 ≤3.20 and DAS28 < 2.6).
Week 24
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
Percentage of Participants With American College of Rheumatology 20% ,50% and 70% (ACR20, ACR50 and ACR70) Response
Week 4, Week 8, Week 12, Week 28, Week 32, Week 40, Week48
Patients received placebo SC plus MTX weekly administered subcutaneously for 24 times.All patients had a foundation MTX therapy, MTX dose should be stable, not to adjust the dose. All subjects received RC-18 treatment once a week from week 24 to week 48.
Patients received the test group RC18 160mg plus MTX weekly administered subcutaneously for 24 times. All patients had a foundation MTX therapy, MTX dose should be stable, not to adjust the dose.
The trial was divided into two groups: (1) placebo + MTX; (2) telitacicept 160 mg + MTX. MTX was used as the basic treatment, the dose of MTX was stable during the trial, and could not be adjusted. Telitacicept or placebo was administered once a week for the first 24 weeks. Beginning at week 24, subjects in the placebo group will enter the RC-18 treatment group. All subjects received RC-18 treatment once a week from week 24 to week 48.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Fengchun Zhang
Peking Union Medical College Hospital
479 participants (actual enrollment reported by the registry).
First Submitted
January 8, 2017
First Posted
January 10, 2017
Study Start
March 29, 2017
Actual (reported)The trial was divided into two groups: (1) placebo + MTX; (2) telitacicept 160 mg + MTX. MTX was used as the basic treatment, the dose of MTX was stable during the trial, and could not be adjusted. Telitacicept or placebo was administered once a week for the first 24 weeks. Beginning at week 24, subjects in the placebo group will enter the RC-18 treatment group. All subjects received RC-18 treatment once a week from week 24 to week 48.
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Primary Completion
November 19, 2022
Actual (reported)Study Completion
December 29, 2022
Actual (reported)Last Updated
September 26, 2024
Record last verified: 2023-09
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Source: ClinicalTrials.gov.
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