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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

NCT01709760 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2018-04-17

No results posted yet for this study

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

Conditions

Interventions

DRUG

Methotrexate

Methotrexate 15-25 mg/week

DRUG

ENIA11

ENIA11 25 mg, sc twice weekly

DRUG

Placebo

Placebo, sc twice weekly

Sponsors & Collaborators

  • Mycenax Biotech Inc.

    lead INDUSTRY

Principal Investigators

  • Joung-Liang Lan, PHD · China Medical University Hospital

  • Chung-Ming Huang, MD · China Medical University Hospital

  • Der-Yuan Chen, PHD · Taichung Veterans General Hospital

  • Ling-Ying Lu, PHD · Kaohsiung Veterans General Hospital.

  • Ning-Sheng Lai, PHD · Buddhist Tzu Chi General Hospital

  • Tien-Tsai Cheng, MD · Chang Gung Memorial Hospital

  • Gregory J Tsay, PHD · Chung Shan Medical University

  • Ying-Ming Chiu, MD · Changhua Christian Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-12-31
Completion
2019-12-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

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 NCT01709760 on ClinicalTrials.gov