An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy

Summary

This is a randomized, double-blind, multi-center, parallel-group study to evaluate the efficacy and safety of subcutaneous (SC) tocilizumab (162 milligrams \[mg\] every 2 weeks \[Q2W\]) given as monotherapy and in combination with MTX versus MTX given as monotherapy, in participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate response to current DMARD therapy. The study comprises a 24-week double-blind treatment phase, followed by a 24-week extension phase.

Timeline

Start

2017-08-02

Primary completion

2022-08-08

Completion

2022-08-08

Outcome

Met primary endpoint

paper The week 24 ACR20 response rate was significantly greater with tocilizumab-methotrexate and tocilizumab-placebo vs methotrexate-placebo PMID 40388166 ↗

paper difference, 27.9 percentage points [95% CI, 14.7-41.2 percentage points]; P < .001; PMID 40388166 ↗

paper subcutaneous tocilizumab, either as monotherapy or combined with methotrexate, demonstrated superior efficacy to methotrexate monotherapy PMID 40388166 ↗

Publications

• Liu T, Wang L, Zhang X, Chen L, Liu Y, Jiang Z, Shuai Z, Zhang M, Wei W, Liu H, Xu J, Zhang Z, Wang G, Wang X, Hu J, Li H, Zhang Z, Wang H, Lu F, Du Y, Xue Z, Zhao Y, Li Z. Tocilizumab Monotherapy or Combined With Methotrexate for Rheumatoid Arthritis: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511095. doi: 10.1001/jamanetworkopen.2025.11095.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methotrexate	Small molecule	10 mg	Oral
Subject	Methotrexate	Small molecule	25 mg	Oral
Subject	Tocilizumab	Monoclonal antibody	162 mg	Subcutaneous

Indications