Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )

PHASE3UnknownINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

October 6, 2016

Primary Completion Date

September 30, 2018

Study Completion Date

October 31, 2018

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Etanercept

"Enerceptan®. Injectable Solution in prefilled syringes~Source: GEMABIOTECH S. A. Formulation per unit:~1,0 ml of Enerceptan® contains 50 mg solution of Etanercept /Once a week Methotrexate 15 to 25 mg / Once a week"

Trial Locations (1)

Unknown

Instituto Medico CER, Bs As

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

QUID Quality in Drugs and Devices Latin American Consulting SRL

OTHER

lead

Gema Biotech S.A.

INDUSTRY