A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2015-002809-12-CZ
• Lead Sponsor: YL Biologics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-02
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

(1) Male or female adults = 18 and = 75 years of age at the time of
informed consent.
(2) Patients diagnosed with RA according to the 2010 American College
of Rheumatology (ACR)/ European League Against Rheumatism (EULAR)
classification criteria for RA1 and are capable of providing written
informed consent to participate in the study.
(3) Patients with = 6 tender joints and = 6 swollen joints (based on the
Swollen Joint Count [SJC] using 66 joints and Tender Joint Count [TJC]
using 68 joints) and a DAS28 score = 3.2.
(4) Patients classified as Global Functional Assessment Class I, II, or III,
according to the revised ACR criteria.

Please refer to protocol for remaining criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

(1) Patients with known hypersensitivity to Etanercept or any other
components of the study drug.
(2) Patients allergic to latex (the needle cap on the Etanercept prefilled
syringe contains latex, which may cause allergic reactions in individuals
sensitive to latex).
(3) Patients suffering from acute or chronic, localized or disseminated
infections (bacterial/fungal/viral) or sepsis, or patients with a history of
recurring infections, or those who are at an increased risk of developing
infections or sepsis (and those with positive test results for ß-D-glucan
only for Japan) within 3 months prior to screening.
(4) Patients with active tuberculosis (TB), prior history of unsuccessfully
treated TB, latent TB, or those who are at risk of developing TB and
patients who are not negative for TB tests (e.g., T-SPOT® TB or
QuantiFERON®-TB Gold test/ appropriate test).
(5) Patients with a history of septic arthritis of native joints within 12
months prior to screening, or any prior history of septic arthritis of a
prosthetic joint.
(6) Patients diagnosed with other rheumatic diseases, autoimmune
disease, connective tissue disease, or immune deficiencies (e.g.,
psoriasis, psoriatic arthritis, primary Sjogren's syndrome, systemic lupus
erythematosus, or demyelinating diseases such as multiple sclerosis).
(7) Patients with active or prior history of malignancies (except for
successfully treated non-metastatic basal or squamous cell carcinoma of
the skin and carcinoma insitu of the cervix).
(8) Patients with a prior history of blood dyscrasias.
(9) Patients with a history of alcohol, drug, or chemical abuse in the past
2 years prior to screening.
(10) Patients who received any live or attenuated vaccines within 4
weeks of screening.
(11) Patients previously treated with any other biologic response
modifiers for any auto-immune indication (including but not limited to
tocilizumab, adalimumab, anakinra, abatacept, infliximab, rituximab,
golimumab, etanercept, certolizumab and tofacitinib).
(12) Patients with serious systemic infections (e.g., patients who test
positive for hepatitis B surface antigen [HBsAg], hepatitis B core
antibody [HBcAb], hepatitis C virus [HCV], or human immunodeficiency
virus [HIV]).

Please refer to protocol for remaining criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified