CClinicalTrials.gg
Sign In
Status unknownNCT02357069Updated Jan 6, 2016

A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Phase 3 interventional study of Enbrel and LBEC0101 in Arthritis, Rheumatoid, sponsored by LG Life Sciences. Status unknown at 2 sites in 2 countries. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-06.

Sponsored by LG Life Sciences · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
372
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.

02

Conditions studied

  • Arthritis, Rheumatoid
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 372 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

LG Life Sciences is the lead sponsor of 75 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
  • Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
372 participants (estimated)

Study arms

  • Experimental
    LBEC0101

    Etanercept

    Drug: LBEC0101

  • Active comparator
    Enbrel

    Etanercept

    Drug: Enbrel

Interventions

  • DrugEnbrel

    Etanercept

  • DrugLBEC0101

    Etanercept

06

What researchers measure

Primary outcomes

  1. Disease activity score based on a 28 joint count (DAS28)

    Time frame: Week 24

07

Study locations

2 sites
  • Mochida Investigational site
    Tokyo, Japan
  • LGLS Investigational site
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Matsuno H, Tomomitsu M, Hagino A, Shin S, Lee J, Song YW. Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate. Ann Rheum Dis. 2018 Apr;77(4):488-494. doi: 10.1136/annrheumdis-2017-212172. Epub 2017 Dec 19. PubMed 29259050 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02357069
Lead sponsor
LG Life Sciences
Collaborators
Mochida Pharmaceutical Company, Ltd.
Responsible party
Sponsor
First posted
Feb 6, 2015
Start date
Feb 2015
Primary completion
Dec 2016 (estimated)
Last update
Jan 6, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Arthritis→

Other studies from this sponsor

LG Life Sciences

Start the discussion