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

Phase 3

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Humira®; Drug: LBAL

• Registration Number: NCT02746380
• Lead Sponsor: LG Life Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-05
• Study Start: 2016-04-13
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Primary Completion: 2017-07-14
• Study Completion: 2018-02-23
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 383

Inclusion Criteria

• Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
• Diagnosed as having RA (Rheumatoid Arthritis) according to the revised 1987 ACR (American College of Rheumatology) criteria for at least 3 months prior to screening
• Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.

Exclusion Criteria

• patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
• patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
• patients with any seropositive result for hepatitis B or hepatitis C or HIV
• patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Humira®	Humira®	Adalimumab
LBAL	LBAL	Adalimumab

Primary Outcome Measures

Name	Time	Method
DAS28-ESR	Week 24	DAS is a combined index to measure the disease activity in patients with Rheumatoid Arthritis (RA).; DAS28-ESR is calculated by assessing the number of swollen and tender joints (among 28 joints) and measuring the ESR.

Trial Locations

Locations (2)

Mochida Investigational site; 🇯🇵 Tokyo, Japan

LGLS Investigational site; 🇰🇷 Seoul, Korea, Republic of