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

NCT04178850 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2019-11-27

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Genor Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhanguo Li, Ph.D · Peking University People Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2020-12-31
Completion
2021-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178850 on ClinicalTrials.gov