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    Summary
    EudraCT Number:2019-000660-25
    Sponsor's Protocol Code Number:CT-P17_3.2
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-000660-25
    A.3Full title of the trial
    A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberCT-P17_3.2
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCELLTRION, Inc.
    B.1.3.4CountryKorea, Republic of
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelltrion, Inc
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelltrion
    B.5.2Functional name of contact pointChangWoo Park
    B.5.3 Address:
    B.5.3.1Street Address23 Academy-ro, Yeonsu-gu
    B.5.3.2Town/ cityIncheon
    B.5.3.3Post code22014
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number'+82328505701
    B.5.6E-mailchangwoo.park@celltrion.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCT-P17
    D.3.2Product code CT-P17
    D.3.4Pharmaceutical form Solution for injection in pre-filled injector
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeCT-P17
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Active Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate usability of CT-P17 AI assessed by patients at Week 4.
    E.2.2Secondary objectives of the trial
    - To evaluate change in usability assessed by patients and observer over time up to Week 24.
    - To evaluate overall safety and efficacy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet all of the following criteria to be enrolled in this study:
    1. Male or female patient between 18 to 70 years of age, inclusive.
    2. Patient must be able and willing to self-administer subcutaneous (SC) injections via auto-injector (AI).
    3. Patient with a diagnosis of rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for at least 24 weeks prior to the first administration of the study drug (Day 1).
    4. Patient who has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed), 6 or more tender joints (of 68 assessed) and either an erythrocyte sedimentation rate (ESR) >28 mm/hour or a serum C-reactive protein (CRP) concentration >1.0 mg/dL (>10 mg/L) at Screening.
    5. Patient who has been receiving oral or intramuscular (IM) methotrexate (MTX) at a dose of between 12.5 to 25 mg/week, or 10 mg/week if intolerant to a higher dose, for at least 12 weeks and who has been on a stable dose and route of MTX for at least 4 weeks prior to the first administration of the study drug (Day 1).
    6. Patient has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
    • Serum creatinine ≤1.5 x upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula) (Système International d'Unités [SI] units: 0.84 mL/second).
    •Serum alanine aminotransferase ≤ 3.0 x ULN.
    •Serum aspartate aminotransferase ≤ 3.0 x ULN.
    • Serum total bilirubin ≤ 1.5 x ULN.
    7. Patient has the following hematology laboratory test results at Screening:
    • Hemoglobin >8.0 g/dL (SI units: >80 g/L or 4.96 mmol/L).
    • Absolute neutrophil count ≥ 1.5 x 10³ cells/μL.
    • Platelet count ≥ 75x 10³ cells/μL.
    8. Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side-effects, has the ability to cooperate with the Investigator and is given ample time and opportunity to read and understand verbal and/or written instructions, and signs the written informed consent form (ICF) with date prior to participation in the study.
    9. Patient and their partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 6 months after the last dose of the study drug. Examples include the following:
    • Hormonal contraceptives (combined or progestogen-only) associated with inhibition of ovulation.
    • Intrauterine devices.
    • Sexual abstinence (not periodically, but for the entire period of risk associated with the study drug).
    A man or woman is of childbearing potential if, in the opinion of the Investigator, he or she is biologically capable of having children and is sexually active. Male and female patients and their partners who have been surgically sterilized for less than 24 weeks prior to the date of informed consent must agree to use any medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential.
    E.4Principal exclusion criteria
    A patient meeting any of the following criteria will be excluded from the study:
    1. Patient who has previously received or plans to receive investigational or licensed product; biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of RA and/or a tumor necrosis factor (TNF) α inhibitor for any purposes.
    2. Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
    3. Patient who has previous or current use of other SC self-injected drugs.
    4. Patient who currently has, or has a history of, any of the following infections:
    o A known infection with hepatitis B (active or carrier of hepatitis B [HBV]), hepatitis C, or infection with human immunodeficiency virus (HIV). Patient will be enrolled based on HBV infection eligibility criteria.
    o Hospitalization for treatment of infection within 24 weeks prior to the first administration of the study drug (Day 1).
    o Symptomatic or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug (Day 1).
    o Past or current granulomatous infections or other severe or chronic infections. A patient who has a past diagnosis with sufficient documentation of complete resolution of the infection can be enrolled in the study.
    5. Patient is ineligible according to the following tuberculosis (TB) screening criteria:
    o Patient who has a history or a current diagnosis of active TB.
    o Patient who has had exposure to a person with active TB such as first-degree family members or co-workers.
    o Patient who has an indeterminate result for interferon-γ release assay (IGRA) or latent TB at Screening. A patient who has a previous diagnosis of latent TB cannot be enrolled despite sufficient documentation of completed TB prophylaxis. If the result of the IGRA is indeterminate at Screening, 1 retest will be possible during the Screening Period.
    o Any other investigational device or medical product within 4 weeks prior to the first administration of the study drug (Day 1) or 5 half-lives, whichever is longer.
    6. Patient who has current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled. Including one or more of the following:
    o Classified as Class II or III obese by World Health Organization classification.
    o Uncontrolled diabetes mellitus, even after an appropriate treatment.
    o Uncontrolled hypertension.
    o Any other inflammatory or rheumatic diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, systemic lupus erythematosus, Lyme disease, or fibromyalgia, that may confound the evaluation of the effect of the study drug.
    o Significant systemic RA involvement (e.g., Sjögren’s syndrome, vasculitis, pulmonary fibrosis), which would put the patient at risk if they are enrolled.
    o A known malignancy within the previous 5 years prior to the first administration of the study drug (Day 1) except completely excised and cured squamous carcinoma in situ of the uterine cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
    o A vaccination (live or live-attenuated) within 4 weeks prior to enrollment or Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to enrollment, or a live or attenuated vaccination planned during the course of the study.
    7. Patient who has received or plans to receive any of the following prohibited medications or treatment:
    o Intra-articular (IA) corticosteroids within 4 weeks prior to the first administration of the study drug (Day 1).
    o Conventional DMARDs, other than MTX, including hydroxychloroquine, chloroquine, or sulfasalazine within 4 weeks prior to the first administration of the study drug (Day 1).
    o A vaccination (live or live-attenuated) within 4 weeks prior to enrollment or Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to enrollment, or a live or attenuated vaccination planned during the course of the study.
    o Any surgical procedure, including bone or joint surgery or synovectomy (including joint fusion or replacement) within 12 weeks prior to the first administration of the study drug (Day 1).
    8. Severe physical incapacitation.
    9. Female patient who is currently pregnant or breastfeeding or plans to become pregnant or breastfeed within 6 months after the last dose of the study drug.
    10. Patient who has current drug or alcohol abuse or dependence, or a history of alcohol or drug abuse within 2 years from the first administration of the study drug (Day 1).
    11. Patient who, in the opinion of their general practitioner or the Investigator, should not participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The usability as assessed by patients rating using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Weeks 0, 2, 4.
    E.5.2Secondary end point(s)
    The usability as assessed by patients rating using PRE- and POST-SIAQ at Weeks 0, 2 and 24.
    The observer rating of successful self-injection using self-injection assessment checklist at Weeks 0, 2, 4 and 24.
    Mean change from baseline in disease activity score (DAS)28 (C-reactive protein [CRP]) and DAS28 (erythrocyte sedimentation rate [ESR]) up to Week 24.
    Adverse events (AEs) (including serious AEs [SAEs]), AEs of special interest (AESIs) (injection site reactions, hypersensitivity/allergic reactions, infections, and malignancies), hypersensitivity monitoring (via monitoring of vital signs ), vital signs measurements, ECGs, physical examination findings, interferon-γ release assay (IGRA), chest X-ray, pregnancy testing, clinical laboratory analyses, signs and symptoms of tuberculosis (TB), and prior and concomitant medications monitored throughout the study. Hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) status will be tested for the patient’s eligibility determination
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Usability as assessed by patients - at Weeks 0, 2, 4 and 24
    • Evaluation of overall efficacy - Up to Week 24
    • Evaluation of overall safety - up to Week 24 and Follow Up.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date of final database lock. An EOS visit will occur 4 weeks after the last dose (at Week 24) is received or prior to the start of new RA therapy, whichever comes earlier.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The Sponsor will not be providing the study drug after the end of the study and the Investigator is responsible for ensuring that consideration for the post-study care of the patient has been given.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-25
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