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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.

NCT03016013 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2024-09-26

No results posted yet for this study

Summary

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.

Conditions

  • Moderate and Severe RheumatoId Arthritis

Interventions

BIOLOGICAL

Placebo plus MTX

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.

BIOLOGICAL

RC18 160 mg plus MTX

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.

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fengchun Zhang · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2022-11-19
Completion
2022-12-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03016013 on ClinicalTrials.gov