A study comparing LBEC0101 to Enbrel® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy

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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002163

Enrollment

372

Registered

2016-12-06

Start date

2015-04-02

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Test treatment: LBEC0101 50mg/mL subcutaneous injection, once a week, 52 weeks treatment Reference treatment: Enbrel® 50mg/mL subcutaneous injection, once a week, 52 weeks treatment

Eligibility

Sex/Gender

All

Inclusion 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 (American College of Rheumatology) criteria for at least 6 months prior to screening - Patients who have inadequate response to methotrexate 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-? 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

Design outcomes

Primary

Measure	Time frame
efficacy : DAS28-ESR	—

Secondary

Measure	Time frame
efficacy : ACR20;safety : immumogenicity tests (anti-drug antibody / neutralizing antiboty)	—

Countries

Korea, Republic of

Contacts

Public ContactYeong-Wook Song

Seoul National University Hospital

ysong@snu.kr+82-2-2072-2217

Outcome results