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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 DMARDs versus DMARDs 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 DMARDs versus DMARDs 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 DMARDs versus DMARDs alone in patients with rheumatoid arthritis.

The study period for each patient will be 28 weeks, during which the patient will undergo screening for up to 14 days, followed by treatment of 24 weeks and follow-up period of 2 weeks. Each patient will be required to make a total of 9 visits. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01787149
Study type Interventional
Source Mycenax Biotech Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 2013
Completion date December 2019