NCT04192617

A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: SinoMab BioScience Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the safety and efficacy of SM03 compared to placebo in patients with active rheumatoid arthritis(RA) receiving methotrexate

Conditions

• Rheumatoid Arthritis

Interventions

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

Timeline

• Start date: 2014-12-31
• Primary completion: 2016-02-03
• Completion: 2016-02-03
• First posted: 2019-12-10
• Last updated: 2019-12-10

Locations

1 site across 1 country: China