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    Summary
    EudraCT Number:2015-005309-35
    Sponsor's Protocol Code Number:CL04041024
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-02-02
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2015-005309-35
    A.3Full title of the trial
    A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis
    Multicentrikus, nyílt, III. fázisú vizsgálat az olokizumab hatásosságának és biztonságosságának értékelésére mérsékelten súlyos és súlyos, aktív rheumatoid arthritisben szenvedő betegek esetében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis
    A.3.2Name or abbreviated title of the trial where available
    Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4
    A.4.1Sponsor's protocol code numberCL04041024
    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 SponsorR-Pharm
    B.1.3.4CountryRussian Federation
    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 supportR-Pharm
    B.4.2CountryRussian Federation
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJSC R-Pharm
    B.5.2Functional name of contact pointMedical Department
    B.5.3 Address:
    B.5.3.1Street AddressLeninsky pr, 111B
    B.5.3.2Town/ cityMoscow
    B.5.3.3Post code119421
    B.5.3.4CountryRussian Federation
    B.5.4Telephone number+7 495 956 7937
    B.5.5Fax number+7 495 956 7938
    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 nameOlokizumab
    D.3.2Product code (CDP6038; L04041)
    D.3.4Pharmaceutical form Solution for injection
    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 INNOlokizumab
    D.3.9.3Other descriptive nameCDP6038
    D.3.9.4EV Substance CodeSUB32350
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 No
    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
    Moderately to Severely Active Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Moderately to Severely Active 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 19.1
    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
    The primary objective of this study is to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) in subjects with moderately to severely active rheumatoid arthritis (RA) who previously completed 24 weeks of double blind treatment in Study CL04041022, CL04041023, or CL04041025 (core studies).
    E.2.2Secondary objectives of the trial
    • To evaluate the long-term efficacy of OKZ
    • To evaluate the long-term immunogenicity of OKZ
    • To evaluate the physical function and quality of life of subjects receiving long-term treatment with OKZ
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be willing and able to sign informed consent
    2. Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3 core studies (CL04041022, CL04041023, or CL04041025).
    3. Subject must have maintained their stable dose (and route) of MTX 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) during the core study and plan to maintain the same dose and route of administration for ≥12 additional weeks.
    4.Subjects must be willing to take folic acid or equivalent throughout the study.
    E.4Principal exclusion criteria
    1. Subject with any medically important condition in the core study (e.g., clinically significant laboratory values, frequent AEs or SAEs, infection SAEs, and/or other concurrent severe and/or uncontrolled medical condition) which would make this subject unsuitable for inclusion in the OLE study in the Investigator’s judgement.
    2. Subject has evidence of active TB
    3. Subject with a positive or repeated indeterminate interferon-gamma release assay (IGRA) result at Week 22 of the core study
     Subjects may be enrolled in the OLE study if they fulfill all 3 of the following criteria prior to the first dose of study treatment:
    a. Active TB is ruled out by a certified TB specialist or pulmonologist who is familiar with diagnosing and treating TB (as acceptable per local practice);
    b. The subject starts prophylaxis for LTBI according to country-specific/Centers for Disease Control and Prevention (CDC) guidelines (treatment with isoniazid for 6 months is not an appropriate prophylactic regime for this study and it should not be used); and
    c. The subject is willing to complete the entire course of recommended LTBI therapy
    4. Subject has planned surgery during the first 12 weeks of the OLE study
    5. Female subjects who are pregnant or lactating, or who are planning to become pregnant during the study or within 6 months of the last dose of study treatment
    6. Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status [e.g., correlative age] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels >40 mIU/mL and estradiol <20 pg/mL) who are not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment
    OR
    Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study treatment.
    7. Subject is unwilling or unable to follow the procedures outlined in the protocol
    8. Other medical or psychiatric conditions, or laboratory abnormalities that may increase the potential risk associated with study participation and administration of the study treatment, or that may affect study results interpretation and, as per Investigator’s judgement, make the subject ineligible.
    E.5 End points
    E.5.1Primary end point(s)
    -The nature, incidence, severity, and outcome of adverse events (AEs), including serious adverse events (SAEs) and AEs of special interest (AESIs)
    -Follow-up- adjusted incidence and event rates (per 100 subject-years of follow-up) for SAEs and AESIs
    -Proportions of subjects with clinically significant laboratory abnormalities
    -Assessment of changes over time in clinical laboratory parameters, vital sign measurements, and physical examination findings
    -Time from first exposure to OKZ to the first occurrence of any major adverse cardiac event (MACE)
    -Incidence and titer of antidrug antibodies (ADAs) to OKZ, incidence of neutralizing antibodies, and the time course of antibodies
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various time points throughout the study - please refer to the detailed
    'Schedule of Events' table in the protocol for full details.
    E.5.2Secondary end point(s)
    -Proportion of subjects achieving an American College of Rheumatology 20% (ACR20), American College of Rheumatology 50% (ACR50), and American College of Rheumatology 70% (ACR70) response who remain on randomized open-label treatment and in the study, assessed at all applicable time points
    -Evaluating the impact of ADAs to OKZ on subject safety and efficacy
    -Proportion of subjects with Simplified Disease Activity Index (SDAI) ≤3.3 remission, who remain on randomized open-label treatment and in the study, assessed at all applicable time points
    -Proportion of subjects with Disease Activity Score 28-joint count (DAS28) low disease activity (based on DAS28 C-reactive protein [CRP] <3.2), who remain on randomized open-label treatment and in the study, assessed at all applicable time points
    -Change from baseline over time in DAS28 (CRP), assessed at all applicable time points
    -Change from baseline over time in the measure of physical ability based on Health Assessment Questionnaire-Disability Index (HAQ-DI), assessed at all applicable time points
    -Proportion of subjects with improvement from baseline in HAQ-DI score ≥0.22, who remain on randomized open-label treatment and in the study, assessed at all applicable time points
    -Change from baseline over time in the scores for the following patient-reported outcomes (PRO) measures, assessed at all applicable time points:
    o Short Form-36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) total scores
    o European Quality of Life-5 Dimensions (EQ-5D)
    o Work Productivity Survey-Rheumatoid Arthritis (WPS-RA)
    o Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue)
    -Change from baseline over time in SDAI and Clinical Disease Activity Index (CDAI), assessed at all applicable time points
    -Proportion of subjects with moderate to good responses for European League Against Rheumatism (EULAR) based on DAS28 (CRP), who remain on randomized open-label treatment and in the study, assessed at all applicable time points, where a moderate response is defined as either DAS28 (CRP) ≤5.1 with an improvement from baseline in DAS28 (CRP) >0.6 and ≤1.2, or DAS28 (CRP) >3.2 with an improvement from baseline in DAS28 (CRP) >1.2, and a good response is defined as DAS28 (CRP) ≤3.2 with an improvement from baseline in DAS28 (CRP) >1.2
    -Change from baseline to all time points in the components of the ACR response criteria
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various time points throughout the study - please refer to the detailed
    'Schedule of Events' table in the protocol for full details.
    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 No
    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 Yes
    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 trial2
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA92
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belarus
    Brazil
    Bulgaria
    Colombia
    Czech Republic
    Estonia
    Georgia
    Germany
    Hungary
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    Poland
    Romania
    Russian Federation
    Taiwan
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 1576
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 304
    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 state68
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 726
    F.4.2.2In the whole clinical trial 1880
    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)
    After completion of the 82-week, open-label Treatment Period, or after premature discontinuation of study drug, subjects will enter the Safety Follow-Up Period. It is the responsibility of the Investigator to choose adequate treatment.
    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 Decision2017-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-01
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