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

PHASE3UnknownINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2019

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Methotrexate

Methotrexate 15-25 mg/week

DRUG

ENIA11

ENIA11 25 mg, sc twice weekly

DRUG

Placebo

Placebo, sc twice weekly

Trial Locations (8)

407

Taichung Veterans General Hospital, Taichung

Unknown

Changhua Christian Hospital, Changhua

Buddhist Tzu Chi General Hospital, Chiayi City

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

Kaohsiung Veterans General Hospital, Kaohsiung City

China Medical University Hospital, Taichung

Chung Shan Medical University Hospital, Taichung

Taipei City Hospital, Taipei

Sponsors
All Listed Sponsors
lead

Mycenax Biotech Inc.

INDUSTRY