NCT04178850

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

A Randomized, Double-blind, Multi-center Phase Ⅲ Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 568 (estimated)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	GB242	GB242: Dosing of 3 mg/kg, intravenous drip, to be completed over 120 minutes, dosing at weeks 0, 2, 6, 14 and 22, a total of 5 doses; MTX:Dosage and administration at enrollment are maintained (10\~15mg/week), oral administration, a total of 30 doses; Folic acid: 5-10mg/week, oral administration, a total of 30 doses
BIOLOGICAL	Infliximab	Infliximab: Dosing of 3 mg/kg, intravenous drip, to be completed over 120 minutes, dosing at weeks 0, 2, 6, 14 and 22, a total of 5 doses; MTX:Dosage and administration at enrollment are maintained (10\~15mg/week), oral administration, a total of 30 doses; Folic acid: 5-10mg/week, oral administration, a total of 30 doses

Timeline

• Start date: 2017-10-13
• Primary completion: 2020-12-01
• Completion: 2021-04-01
• First posted: 2019-11-26
• Last updated: 2019-11-27

Locations

1 site across 1 country: China