Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel

NCT04079374 | Unknown Phase 3

• 1 other identifier: FM-ENRT-17
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 10

Brief Summary

The Study objectives are:

1. 1.To compare the efficacy and safety of Etanercept, lyophilisate for solution for injection and Enbrel, lyophilisate for solution for subcutaneous injection, which are used as subcutaneous injections at a dose of 25 mg 2 times a week for 24 weeks in combination with methotrexate in patients with rheumatoid arthritis.
2. 2.To prove the therapeutic equivalence of Etanercept, lyophilisate for solution for injection and Enbrel, lyophilisate for solution for subcutaneous injection in patients with rheumatoid arthritis.
3. 3.To evaluate the immunogenicity of Etanercept, lyophilisate for solution for injection.

Conditions

Rheumatoid Arthritis

Keywords

Etanercept; Enbrel

Outcome Measures

Primary Outcomes (1)

• Number of patients with ACR20 (American College of Rheumatology 20 criteria) response

  ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1. Health Assessment Questionnaire-Disability Index (HAQ-DI), 2. C-reactive Protein (CRP), 3. Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4. Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5. Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)

  at 24 week of treatment.

Secondary Outcomes (5)

• Number of patients with ACR50 (American College of Rheumatology 50 criteria) response

  at 4, 8 and 12 weeks of treatment

• Number of patients with ACR70 (American College of Rheumatology 70 criteria)

  at 4, 8 and 12 weeks of treatment

• Number of patients who achieved remission (DAS28(Disease Activity Score 28)<2.6) and low disease activity (DAS28≤3.2)

  at 12 and 24 weeks of treatment

• Changes in activity index DAS28

  at 4, 8, 12 and 24 weeks of treatment

• Changes in functional state of patients according to questionnaire HAQ -(Health Assessment Questionnaire- data)

  at 4, 8, 12 and 24 weeks of treatment compared to baseline.

Study Arms (2)

Etanercept

EXPERIMENTAL

Patients receive Etanercept in the form of subcutaneous injections at a dose of 25 mg 2 times a week for 24 weeks.

Drug: Etanercept

Enbrel

ACTIVE COMPARATOR

Patients receive Enbrel in the form of subcutaneous injections at a dose of 25 mg 2 times a week for 24 weeks.

Drug: Enbrel

Interventions

Etanercept DRUG

Subcutaneous injections

Also known as: L04AB01

Etanercept

Enbrel DRUG

Subcutaneous injections

Also known as: L04AB01, etanercept

Enbrel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of both sexes, from 18 to 75 years old;
• body weight \> 45 kg;
• patients diagnosed with: rheumatoid arthritis (RA) of moderate and high activity, according to the classification of RA criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) of 2010;
• functional class I, II or III according to the Classification of the Functional Class of the RA of the American College of Rheumatology (ACR);
• number of painful joints (NPJ) ≥ 6 (68 joints examined), number of swollen joints (NSJ) ≥6 (66 joints examined);
• ESR (Erythrocyte sedimentation rate)≥ 28 mm/hour or СRP (C - reactive protein) \> 7.0 mg/dl;
• patient who receive methotrexate for at least 12 weeks at doses of 7.5-20 mg/week (orally or parenterally), and the dose and route of administration of methotrexate was not changed for 4 weeks before randomization;
• patient who stopped therapy with other basic antirheumatic drugs, except methotrexate, and completed the wash-out period for these drugs of at least five half-life periods, but not less than 2 weeks (whichever is longer);
• if a patient takes NSAIDs (Nonsteroidal anti-inflammatory drugs), the dose of the drug should be stable within 2 weeks before randomization;
• if a patient takes oral glucocorticosteroids, the dose should be ≤10 mg/day of prednisolone (or equivalent) and be stable for 2 weeks before randomization;
• women of childbearing age and men who have partners, who have agreed to use reliable contraceptive methods during the entire study period and within 3 months after its termination. Reliable methods of contraception include: intrauterine devices, double-barrier method or state after surgical sterilization and vasectomy;
• signed informed consent of participants to participate in this study, which was obtained before any screening procedures, including discontinuation of forbidden-drugs.

You may not qualify if:

• known hypersensitivity to Etanercept or other components of the study drugs;
• other rheumatic diseases, autoimmune diseases, connective tissue diseases, immunodeficiency (e.g. psoriasis, psoriatic arthritis, primary Sjogren syndrome, systemic lupus erythematosus or demyelinating diseases such as multiple sclerosis);
• septic arthritis within 12 months before screening; purulent arthritis of prosthetic joints;
• acute or frequent recurrent chronic, local or generalized infections (bacterial/fungal/viral) or sepsis, or history of recurrent infections, or increased risk of developing infections or sepsis;
• an active form of tuberculosis; the history of the ineffective treatment of tuberculosis; latent tuberculosis or risk of developing tuberculosis (e.g., contact with patients who have an active form of tuberculosis, shortly before screening);
• severe interstitial lung diseases (bronchial asthma, chronic obstructive pulmonary disease, bronchiectasis, fibrosis);
• malignant diseases, including history (except successfully treated non-metastatic basal cell or squamous cell skin cancer or cervical cancer);
• congestive heart failure of class III or IV, according to New York Heart Association criteria, or unstable angina;
• uncontrolled diabetes mellitus, uncontrolled arterial hypertension;
• abnormal laboratory parameters at screening:
• haemoglobin \< 100.0 g/L;
• platelets \< 125 \*10\^9 cell/L;
• leukocytes \< 3.5 \*10\^9 cell/L,
• absolute neutrophil count \< 1.5 \*10\^9 cell/L;
• absolute lymphocyte count \< 0.8 \*10\^9 cell/L;

Sponsors & Collaborators

• Joint Stock Company "Farmak": lead
• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: collaborator

Study Sites (10)

PU Kryvyi Rih City Clinical Hospital №2 of the Dnipropetrovsk regional council

Kryvyi Rih, Dnipropetrovsk Oblast, 50056, Ukraine

RECRUITING

PU Kryvyi Rih City Clinical Hospital №8 of the Dnipropetrovsk regional council

Kryvyi Rih, Dnipropetrovsk Oblast, 50082, Ukraine

RECRUITING

Ivano-Frankivsk Central City Clinical Hospital

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

RECRUITING

Communal non-commercial enterprise of Kharkiv Regional Council Regional Hospital of the war veterans

Kharkiv, Kharkivs’ka Oblast’, 61019, Ukraine

RECRUITING

Municipal nonprofit enterprise City Multidisciplinary Hospital № 18 of Kharkiv City Council

Kharkiv, Kharkivs’ka Oblast’, 61029, Ukraine

RECRUITING

Khmelnytskyi Regional Hospital

Khmelnytskyi, Khmelnytskyi Oblast, 29000, Ukraine

RECRUITING

Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

Lviv, Lviv Oblast, 81555, Ukraine

RECRUITING

Ternopil University Hospital

Ternopil, Ternopil Oblast, 46002, Ukraine

RECRUITING

Vinnitsa Regional Clinical Hospital Named After N.I.Pirogov

Vinnitsa, Vinnitsa Region, 21018, Ukraine

RECRUITING

Municipal Institution O.Herbachevskiy Regional State Clinical Hospital

Zhytomyr, Zhytomyr Oblast, 10002, Ukraine

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Mykola Stanislavchuk, MD, PhD

  Vinnitsa Regional Clinical Hospital Named after N.I.Pirogov

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladislav Udovitskiy

CONTACT

+380664227113; v.udovitskiy@farmak.ua

Anna Kopchyshyn

CONTACT

+ 380674643106; h.kopchyshyn@farmak.ua

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: September 3, 2018
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2023
• Last Updated: February 3, 2021

Record last verified: 2021-01

Locations

UA (10)