A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.
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|ClinicalTrials.gov Identifier: NCT03016013|
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : April 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Moderate and Severe RheumatoId Arthritis||Biological: Placebo plus MTX Biological: RC18 160 mg plus MTX||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||March 2023|
Placebo Comparator: Placebo plus MTX
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.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.
Biological: Placebo plus MTX
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 Name: MTX=Methotrexate
Experimental: Experimental: RC18 160 mg+MTX
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.
Biological: RC18 160 mg plus MTX
- The proportion of patients in each group reached ACR20 at week 24 [ Time Frame: Week 24（Visit 9） ]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).
- Percentage of Participants Achieving American College of Rheumatology ACR50 and ACR70 Responses at week 24. [ Time Frame: Week 24 ]
- Percentage of Participants Achieving Low Disease Activity and clinical remission. (DAS28 ≤3.20 and DAS28 < 2.6). [ Time Frame: Week 24 ]Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.
- 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 ]
- Sharp Score Relative Change from Baseline at Week 24 [ Time Frame: Week 24 ]
- Percentage of Participants With American College of Rheumatology 20% ,50% and 70% (ACR20, ACR50 and ACR70) Response [ Time Frame: Week 4, Week 8, Week 12, Week 28, Week 32, Week 40, Week48 ]
- Change From Baseline in Joint Space Narrowing and Erosions at week 24 and week 48. [ Time Frame: Week 24,Week48 ]Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion).And Joint space narrowing score (a component of the modified TSS) also is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016013
|Contact: Fengchun Zhangemail@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Fengchun Zhang|
|Principal Investigator:||Fengchun Zhang||Peking Union Medical College Hospital|