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Rheumatoid ArthritisPhase 3NCT04079374

Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel

A Phase 3 study testing Etanercept and Enbrel in people with Rheumatoid Arthritis, run by Joint Stock Company "Farmak" at 10 sites in Ukraine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Study objectives are: 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Etanercept and Enbrel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
10 sitesUkraine
Study dates
3 Sep 2018to 3 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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);
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  • 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;
  • ASТ (Aspartate aminotransferase), АLТ (Alanine aminotransferase) 3 and more times higher than the upper limit of normal and serum total bilirubin 2 and more times higher than the upper limit of normal;
  • serum creatinine 2 times or higher than the upper limit of normal;
  • history of clinically significant or uncontrolled diseases of the respiratory system, liver, kidney, blood, gastrointestinal tract, endocrine system, immune system, skin, nervous system (including demyelinating disorders), cardiovascular system, or history of an autoimmune or mental disorder, or any condition which, in the opinion of the Investigator, can pose a threat to the safety of a patient, affect the study results or prevent a patient from completing the study;
  • hepatitis В, С;
  • scheduled surgical intervention including joint replacement during the study;
  • recent chickenpox;
  • oral and gastrointestinal ulcers;
  • pregnancy, breastfeeding;
  • history of alcohol or drug abuse;
  • vaccination with live or attenuated vaccines within 4 weeks before the screening, or scheduled vaccination during the study, or within 3 months after the last dose of the study/reference drug;
  • previous treatment with any other GEBD (genetically engineered biological drugs) (GEBD) for rheumatoid arthritis (including, tocilizumab, adalimumab, anakinra, abatacept, infliximab, rituximab, golimumab, Etanercept, certolizumab) or tofacitinib;
  • use of systemic or intraarticular corticosteroids, except prednisolone at a dose of≤10 mg/day orally, or equivalent to GCS (Glucocorticosteroids) within 2 weeks before randomization;
  • use of alkylating agents (e.g. cyclophosphamide, chlorambucil) within 6 months before randomization;
  • use of intravenous or oral antimicrobial agents 4 weeks before randomization; simultaneous participation in any other clinical study, or participation in a clinical study within 3 months before screening.

Trial locations and contacts

10 sites in 1 country.

Vladislav Udovitskiy contact

+380664227113

v.udovitskiy@farmak.ua

Anna Kopchyshyn contact

+ 380674643106

h.kopchyshyn@farmak.ua

10 sites in 1 country

Ukraine10 sites, 10 recruiting

  • Ivano-Frankivsk Central City Clinical Hospital

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Nataliia Virstyuk, MD, PhD, if_dermven@gmail.com

    Zoryana Mysliborska

    Recruiting

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

    Kharkiv, Kharkiv Oblast, 61019

    Oleksyi Oparin, MD, PhD, oparinaa@ukr.net

    Nataliya Lavrova, PhD, nata.lav12345@gmail.com

    Recruiting

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

    Kharkiv, Kharkiv Oblast, 61029

    Olena Grishina, PhD, olena.grishyna@gmail.com

    Olena Menkus, olena.menkus@gmail.com

    Recruiting

  • Khmelnytskyi Regional Hospital

    Khmelnytskyi, Khmelnytskyi Oblast, 29000

    Nataliya Ursol, PhD, ursol.nataliya@gmail.com

    Marina Tarasyuk, tarasukmar@gmail.com

    Recruiting

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

    Kryvyi Rih, Dnipropetrovsk Oblast, 50056

    Ganna Kuzmіna, MD, Revmatologymed@bigmir.net

    Olena Markova, a.markova@bigmir.net

    Recruiting

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

    Kryvyi Rih, Dnipropetrovsk Oblast, 50082

    Svitlana Sheiko, MD, PhD, doctor.sheyko@gmail.com

    Natalyia Kolb

    Recruiting

  • Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

    Lviv, Lviv Oblast, 81555

    Orest Abrahamovych, MD, PhD, doctorest@gmail.com

    Ulyana Abrahamovych, PhD, doculyana@i.ua

    Recruiting

  • Ternopil University Hospital

    Ternopil, Ternopil Oblast, 46002

    Svitlana Smiyan, MD, PhD, smiyans@ukr.net

    Ulyana Slaba, PhD, ulyana_slm@ukr.net

    Recruiting

  • Vinnitsa Regional Clinical Hospital Named After N.I.Pirogov

    Vinnitsa, Vinnitsa Region, 21018

    Mykola Stanyslavchuk, MD, mstanislav53@yahoo.com

    Katherine Zaichko, zaichkok@yahoo.com

    Recruiting

  • Municipal Institution O.Herbachevskiy Regional State Clinical Hospital

    Zhytomyr, Zhytomyr Oblast, 10002

    Konstantin Rudoi, rukott@gmail.com

    Svitlana Kuskalo, svetakus@ukr.net

    Recruiting

Other trials in Ukraine

About this study

Official title: Open, Randomized, Comparative, Multicenter Study in Parallel Groups of the Efficacy, Safety, Immunogenicity of Etanercept and Enbrel, Lyophilisates for Solution for Subcutaneous Injection, in Patients With Rheumatoid Arthritis

The Study objectives are:

  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. 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. To evaluate the immunogenicity of Etanercept, lyophilisate for solution for injection.
Read the detailed description

This is an open-label, randomized, comparative, multicentre study in parallel groups of the efficacy, safety and immunogenicity of Etanercept, lyophilisate for solution for injection and Enbrel, lyophilisate for solution for subcutaneous injection, in patients with rheumatoid arthritis.

Total duration of patient participation in the study will be 49-52 weeks. Of these: screening - up to 4 weeks, treatment - 24 weeks, follow-up after treatment - 4 weeks, evaluation of the study drug immunogenicity - 52 weeks after the treatment initiation.

Patients receive Etanercept or Enbrel (depending on the group) in the form of subcutaneous injections at a dose of 25 mg 2 times a week for 24 weeks.

Being tested
Etanercept, Enbrel
Keywords
Etanercept, Enbrel
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtanerceptDrug

    Also called L04AB01

    Subcutaneous injections

  • EnbrelDrug

    Also called L04AB01, etanercept

    Subcutaneous injections

Study groups in NCT04079374
Study groupRoleWhat they receive
EtanerceptExperimentalPatients receive Etanercept in the form of subcutaneous injections at a dose of 25 mg 2 times a week for 24 weeks.
Receives: Drug: Etanercept
EnbrelActive comparatorPatients receive Enbrel in the form of subcutaneous injections at a dose of 25 mg 2 times a week for 24 weeks.
Receives: Drug: Enbrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: at 24 week of treatment.

Secondary outcomes (5)

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

    ACR50 responders are subjects with at least 50% 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)

    Measured: at 4, 8 and 12 weeks of treatment

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

    ACR70 responders are subjects with at least 70% 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)

    Measured: at 4, 8 and 12 weeks of treatment

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

    The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm).

    DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count.

    The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission

    Measured: at 12 and 24 weeks of treatment

  4. Changes in activity index DAS28

    Changes in activity index compared to baseline. The DAS28 index takes into account information on safety and swelling of 28 joints, ESR and patients' global health assessment according to VAS.

    Calculate DAS28 from the expression:

    DAS28 = 0.56√NPJ + 0.28√NSJ + 70lnESR + 0.014PGAH, where NPJ - number of painful joints at palpation (28 examined), NSJ - number of swollen joints (28 examined), PGAH - patient's global assessment of health in millimetres in 100 mm Visual Analog Scale (VAS), ESR - rate of erythrocyte sedimentation in mm/h, ln - natural logarithm.

    According to the ACR criteria, the levels of the disease activity depending on the values of DAS28, are ranked as:

    remission - DAS28 <2.6; low - DAS28 ≤3.2; moderate - DAS28 3.3-5.1; high - DAS28 >5.1.

    To calculate DAS28, use the official online calculator: http://www.das-score.nl/das28/DAScalculators/dasculators.html and https://www.das-score.nl/das28/DAScalculators/dasculators.html

    Measured: at 4, 8, 12 and 24 weeks of treatment

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

    Changes in functional state of patients according to questionnaire HAQ DI -(Health Assessment Questionnaire Disability Index) compared to baseline. It includes the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. It asks patients about the amount of difficulty they experience in these activities as well as the use of aids and/or devices. The HAQ has a numeric rating scale (NRS) (13) to assess pain on a scale from 0 to 10.Grades to evaluate the treatment efficacy using the HAQ DI. The minimal clinically significant change in the HAQ DI, which corresponds to the difference in parameters before and after treatment, is equal to 0.22. НАQ < 0.22 points - no effect; 0.22 ≤ ∆ НАQ ≤ 0.36 - lowest effect (20% improvement according to ACR criterion); 0.36 ≤ ∆ HAQ < 0.80 - satisfactory effect (50% improvement according to ACR criterion); HAQ ≥ 0.80 points - highest effect (70% improvement according to ACR criterion).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start3 Sep 2018
  3. Primary completion3 Dec 2021 (estimated)
  4. Study completion3 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04079374
Sponsor's protocol ID
FM-ENRT-17
Status last verified
Jan 2021
First submitted
3 Sep 2019
Last updated
3 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etanercept and Enbrel in people with Rheumatoid Arthritis, run by Joint Stock Company "Farmak" at 10 sites in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vladislav Udovitskiy (+380664227113, v.udovitskiy@farmak.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with ACR20 (American College of Rheumatology 20 criteria) response (time frame: at 24 week of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04079374.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

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