NCT03478111

CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis

A Randomized, Double-blind, Methotrexate (MTX) Based, Parallel-group, Multicenter Phase III Study to Evaluate Efficacy and Safety of CMAB008 in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis, Compared to Remicade

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CMAB008 is an infliximab biosimilar candidate. The host cell of Remicade is mouse myeloma SP2/0 cell, however, the host cell of CMAB008 is CHO (Chinese hamster ovary cell). It seems that CMAB008 has lower immunogenicity and higher safety, because Remicade comprises more complex-type and hybrid-type glycans than CMAB008. However, it is not yet known whether CMAB008 is not inferior to Remicade. This randomized, double-blind trial investigates the efficacy and safety of CMAB008 for moderately to severely active rheumatoid arthritis, compared to Remicade.

Detailed description

This is a non-inferiority trial. The primary outcome is the percentage of subjects achieving ACR20. According to the global instruction of Remicade, the effective rate of Remicade is 50%, and the placebo is 20%. Calculate the critical value δ=（50%-20%）×50%=15%, one-side α=0.025, β=0.20, experimental group : control group = 1:1, the results are: CMAB008 group 175 participants, control group 175 participants, 350 participants in total. Take 10% drop-out into consideration, the finial sample sizes are: CMAB008 group 196 participants, control group 196 participants, 392 participants in total. During the entire duration of the study, all adverse events (AE) and all serious adverse events (SAEs) are collected, fully investigated and documented in source documents and case report forms (CRF). Study duration encompassed the time from when the participant sign the informed consent until the last protocol-specific procedure has been completed, including a safety follow up period. This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the guidelines of Good Clinical Practice (GCP) as well as all national legal and regulatory requirements.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	CMAB008	the study drug
DRUG	MTX	basic therapy drug
DRUG	Remicade	active comparator

Timeline

• Start date: 2018-03-30
• Primary completion: 2019-06-23
• Completion: 2019-08-27
• First posted: 2018-03-27
• Last updated: 2020-03-18

Locations

1 site across 1 country: China