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A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA — ENIA11  

Rheumatoid Arthritis Clinical Trial

Official title:
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

Clinical Trial Summary

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with Methotrexate versus Methotrexate Alone in Patients with Rheumatoid Arthritis

Clinical Trial Description

The objectives of the study are to evaluate the efficacy and safety of ENIA11 in combination with methotrexate versus methotrexate alone in patients with rheumatoid arthritis.

This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of ENIA11 in combination with methotrexate versus methotrexate alone in patients with rheumatoid arthritis.

Subject participation duration: A total of 28 weeks, including: 2 weeks of screening, 24 weeks of treatment and 2 weeks of follow-up ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01709760
Study type Interventional
Source Mycenax Biotech Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 2012
Completion date December 2019
View Details
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