drugset / Trial / NCT03403140
Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )
Phase 3
Unknown
141 enrolled
Gema Biotech S.A.
QUID Quality in Drugs and Devices Latin American Consulting SRL · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to asses the long term efficacy, safety and immunogenicity of ENERCEPTAN® in combination with Methotrexate for the treatment of patients with rheumatoid arthritis up to 104 weeks
Timeline
- Start
- 2016-10-06
- Primary completion
- 2018-09-30
- Completion
- 2018-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etanercept | Protein / enzyme biologic | 50 mg | — |
| Background | Methotrexate | Small molecule | 15 mg | — |
| Background | Methotrexate | Small molecule | 25 mg | — |