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

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2015-002809-12-HU
• Date of registration: 26/08/2015
• Prospective Registration: Yes
• Primary sponsor: YL Biologics Ltd
• Public title: A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis
• Scientific title: A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis
• Date of first enrolment: 17/11/2015
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002809-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Czech Republic, Hungary, India, Japan, Latvia, Romania, Spain, Ukraine

Contacts

• Name: Head - Regulatory
• Affiliation: YL Biologics Ltd

• Name: Head - Regulatory
• Affiliation: YL Biologics Ltd

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis
MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

Product Name: YLB113
Product Code: YLB113
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Current Sponsor code: YLB113
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: 20% improvement according to American College of Rheumatology
criteria (ACR20) at Week 24 of dosing

Secondary Objective: 1. ACR20 response rate at Weeks 4, 8 and 12 of dosing
2. ACR50 and ACR70 response rate at Weeks 4, 8, 12 and 24 of dosing
3. Improvement in the DAS28 (Disease activity score using 28 tender
and swollen joint counts, C-Reactive Protein (CRP)/ Erythrocyte
Sedimentation Rate (ESR) and the subject's global assessment)
response rate at Weeks 4, 8, 12 and 24 of dosing
4. Adverse events, Physical examination, Vital signs, ECG, Clinical
laboratory examination and Injection site assessment
5. Immunogenicity at Weeks 4, 8, 12, 24, 36, 44 and 52 of dosing

Primary end point(s): Patients will be considered to have achieved an ACR20 , improvement if:
compared to baseline (Day 1), they achieve a 20% decrease in SJC, 20%
decrease in TJC and 20% improvement in 3 of the following 5 measures:
•Patient assessment of pain (VAS)
•Patient global assessment of disease activity (VAS)
•Physician global assessment of disease activity (VAS)
•CRP or ESR
•HAQ-DI
To assess ACR response for a patient, the same acute phase reactants
i.e. either ESR or CRP should be used throughout the study.

Timepoint(s) of evaluation of this end point: Stage A - week 24
Stage B - week 52
Stage C-week 52

Secondary Outcome(s)

Secondary end point(s): •ACR20 response rate at Weeks 4, 8 and 12 of dosing
•ACR50 response rate at Weeks 4, 8, 12 and 24 of dosing
•ACR70 response rate at Weeks 4, 8, 12 and 24 of dosing
An improvement in the DAS28 scores at Weeks 4, 8, 12 and 24 of dosing.
The DAS28 score is calculated using results from a 28 joint subset of the
66/68 SJC/TJC.
The DAS28 is a composite score (ranging from 0- 9.4) calculated using
the results of the 28 joint subset of the 66/68 SJC/TJC, CRP levels
(mg/L) or ESR levels (mm/hr), and the patient's global assessment of
diseases activity (0- 100 scale). The DAS28 is calculated using the
following formula , :
DAS28 based on CRP
0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*pt
global VAS + 0.96
DAS28 based on ESR
0.56*sqrt(TJC 28) + 0.28*sqrt(SJC28) + 0.70*Ln(ESR) + 0.014* pt
global VAS

To assess DAS28 scores for a patient, the same DAS assessment
parameters (based on either ESR or CRP) should be used throughout the
study.
The DAS28 scores indicating high disease activity are > 5.1; moderate
disease activity = 3.2 to = 5.1; low disease activity, < 3.2 and remission,
< 2.6.

Timepoint(s) of evaluation of this end point: Stage A - week 24
Stage B - week 52
Stage C-week 52

Secondary ID(s)

YLB113-002

Source(s) of Monetary Support

YL Biologics Ltd