Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis

Summary

To compare the efficacy between the HLX01 group and the placebo group through the proportion of subjects meeting the ACR20 improvement criteria for remission

Timeline

Start

2018-05-28

Primary completion

2020-04-05

Completion

2020-09-11

Outcome

Met primary endpoint

paper ACR20 response was significantly greater in the HLX01 group compared with the placebo group in the intention-to-treat population (60.7% vs 35.9%; P < 0.001) PMID 35689239 ↗

release “HLX01 plus MTX showed significantly improved clinical outcomes and comparable safety profiles compared with placebo in Chinese patients with moderate to severe active RA” henlius.com ↗

release “this study has met the primary endpoints and demonstrated that HLX01 in combination with MTX is safe and effective in MTX-IR patients” henlius.com ↗

Publications

• Zeng X, Liu J, Liu X, Wu L, Liu Y, Liao X, Liu H, Hu J, Lu X, Chen L, Xu J, Jiang Z, Lu FA, Wu H, Li Y, Wang Q, Zhu J; HLX01-RA03 Investigators. Efficacy and safety of HLX01 in patients with moderate-to-severe rheumatoid arthritis despite methotrexate therapy: a phase 3 study. Arthritis Res Ther. 2022 Jun 10;24(1):136. doi: 10.1186/s13075-022-02821-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HLX01	Monoclonal antibody	1000 mg	Intravenous
Background	Methotrexate	Small molecule	—	—

Indications

No indication recorded.