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Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis

NCT03522415 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2022-05-09

No results posted yet for this study

Summary

To compare the efficacy between the HLX01 group and the placebo group through the proportion of subjects meeting the ACR20 improvement criteria for remission

Conditions

  • Moderately to Severely Active Rheumatoid Arthritis

Interventions

DRUG

HLX01

HLX01,Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection is recombinant human-mouse chimeric anti-cd20 CD20 monoclonal antibody.

DRUG

Methotrexate（MTX）

Methotrexate is a slow-acting antirheumatic drug.

Sponsors & Collaborators

Principal Investigators

  • Xiaofeng Zeng · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2020-04-05
Completion
2020-09-11

Countries

  • China

Study Locations

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Entities

Companies

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 NCT03522415 on ClinicalTrials.gov