Rheumatoid Arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
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
Concent
Sponsors
YL Biologics Ltd
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Bulgaria, Czech Republic, Hungary, India, Japan, Latvia, Romania, Spain, Ukraine
Contacts
Public ContactHead - Regulatory
YL Biologics Ltd
Outcome results
None listed