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A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

NCT02746380 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2021-03-15

No results posted yet for this study

Summary

This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

LBAL

Adalimumab

DRUG

Humira®

Adalimumab

Sponsors & Collaborators

  • Mochida Pharmaceutical Company, Ltd.

    collaborator INDUSTRY

  • LG Life Sciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-13
Primary Completion
2017-07-14
Completion
2018-02-23

Countries

  • Japan
  • South Korea

Study Locations

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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 NCT02746380 on ClinicalTrials.gov