A Study Comparing LBEC0101 to Enbrel® in Subjects With Ac... | NCT02357069

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

NCT02357069

Sponsor

LG Life Sciences

Status

Unknown status

Last Update Posted

Jan 6, 2016Estimated

Enrollment

372Estimated

Phase

Phase 3

Conditions

Arthritis, Rheumatoid

Interventions

Enbrel
LBEC0101

Countries

Japan
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Not provided

First Submitted Date

Jan 29, 2015

First Submission Date that Met QC Criteria

Feb 2, 2015

First Posted Date

Feb 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2016

Last Update Posted Date

Jan 6, 2016Estimated

Name	Class
Mochida Pharmaceutical Company, Ltd.	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

372Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LBEC0101	Experimental	Etanercept	Drug: LBEC0101
Enbrel	Active Comparator	Etanercept	Drug: Enbrel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enbrel	Drug	Etanercept	Enbrel
LBEC0101

Measure	Description	Time Frame
Disease activity score based on a 28 joint count (DAS28)		Week 24

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Mochida Investigational site		Tokyo			Japan
LGLS Investigational site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29259050	Derived	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.

Type	Date	Date Unknown
Release	Apr 11, 2018
Reset	Nov 8, 2018

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides