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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate and Severe Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	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.
DRUG	RC18 160 mg plus MTX

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-02-25
• Completion: 2019-02-25
• First posted: 2016-08-29
• Last updated: 2019-04-03

Locations

1 site across 1 country: China