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

NCT04312815 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2021-01-08

No results posted yet for this study

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

Conditions

  • Rheumatoid Arthritis(RA)

Interventions

DRUG

SM03

SM03: 600 mg intravenous (IV)

DRUG

Placebo

Placebo: 600 mg intravenous (IV)

DRUG

MTX

Methotrexate: 7.5-20 mg/wk oral

Sponsors & Collaborators

  • SinoMab BioScience Ltd

    lead INDUSTRY

Principal Investigators

  • Xiaofeng Zeng, MD · Department of Rheumatology and Immunology, Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-28
Primary Completion
2021-12-31
Completion
2022-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04312815 on ClinicalTrials.gov