NCT04312815

A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX

A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severely Active Rheumatoid Arthritis Receiving Methotrexate

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (estimated)
• Sponsor: SinoMab BioScience Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

* To demonstrate that SM03 added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Chinese RA participants with an inadequate response to MTX. * To assess the safety of SM03 added to MTX in Chinese RA participants with an inadequate response to MTX

Detailed description

The total duration of study was expected up to 58 weeks (screening period of 6 weeks, randomized treatment period of 24 weeks and open-label treatment extention period of 24 weeks , and a 4-week post treatment observation).

Conditions

• Rheumatoid Arthritis(RA)

Interventions

Type	Name	Description
DRUG	SM03	SM03: 600 mg intravenous (IV)
DRUG	Placebo	Placebo: 600 mg intravenous (IV)
DRUG	MTX	Methotrexate: 7.5-20 mg/wk oral

Timeline

• Start date: 2017-12-28
• Primary completion: 2021-12-01
• Completion: 2022-07-01
• First posted: 2020-03-18
• Last updated: 2021-01-08

Locations

1 site across 1 country: China