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.

PHASE3CompletedINTERVENTIONAL
Enrollment

479

Participants

Timeline

Start Date

March 29, 2017

Primary Completion Date

November 19, 2022

Study Completion Date

December 29, 2022

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.

Trial Locations (1)

100730

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
lead

RemeGen Co., Ltd.

INDUSTRY

NCT03016013 - 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. | Biotech Hunter | Biotech Hunter