NCT02357069

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

January 29, 2015

Last Update Submit

January 5, 2016

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

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

    Week 24

Study Arms (2)

LBEC0101

EXPERIMENTAL

Etanercept

Drug: LBEC0101

Enbrel

ACTIVE COMPARATOR

Etanercept

Drug: Enbrel

Interventions

EnbrelDRUG

Etanercept

Enbrel
LBEC0101DRUG

Etanercept

LBEC0101

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mochida Investigational site

Tokyo, Japan

Location

LGLS Investigational site

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29259050DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

EtanerceptLBEC0101

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 6, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2016

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

JP(1)KR(1)