drugset
drugset / Trial / NCT04178850

Clinical Comparative Study to Evaluate the Efficacy and Safety of Recombinant Anti-TNF-alpha Antibodies for Injection

NCT04178850 ↗

Phase 3 Unknown 568 enrolled Genor Biopharma Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This study compares the similarity of the proportion of subjects who achieved ACR20 at week 30 in the two groups.

Timeline

Start
2017-10-13
Primary completion
2020-12
Completion
2021-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Infliximab Monoclonal antibody 3 mg/kg Intravenous
Background folic acid Other / unclassified 3 mg/kg Intravenous
Background MTX Unknown 10 mg Oral
Background MTX Unknown 15 mg Oral
Background folic acid Other / unclassified 5 mg Oral
Background folic acid Other / unclassified 10 mg Oral

Indications

rheumatoid arthritis