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NCT Number: NCT02746380

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

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.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mochida Investigational site, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBAL

Drug

Adalimumab

Humira®

Drug

Adalimumab

Primary outcomes

  1. DAS28-ESR

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Collaborators

  • Mochida Pharmaceutical Company, Ltd.

Registry information

Official study title

Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 21, 2016
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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