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    Summary
    EudraCT Number:2021-005287-21
    Sponsor's Protocol Code Number:Simon1234
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-10-07
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-005287-21
    A.3Full title of the trial
    Exercise-induced cardiac adaptions in rheumatoid arthritis patients during interleukin-6 vs. tumor necrosis factor antibody therapy: a randomised controlled study (RABEX).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Physiological effects of high intensity exercise training in rheumatoid arthritis patients in biologic anti-inflammatory treatment; A randomized controlled study
    Fysiologiske effekter af højintens træning hos leddegigt-patienter i biologisk behandling: et randomiseret kontrolleret studie.
    A.3.2Name or abbreviated title of the trial where available
    RABEX
    A.4.1Sponsor's protocol code numberSimon1234
    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 SponsorRigshospitalet, Center for Aktiv Sundhed, section 7641
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGangstedfonden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNovo Nordisk Fonden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion Hovedstadens Forskningsfond
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportTrygfonden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportKong Christian den Tiendes Fond
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet, Center for Aktiv Sundhed
    B.5.2Functional name of contact pointSimon Jønck
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.6E-mailsimon.joenck.04@regionh.dk
    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 Yes
    D.2.1.1.1Trade name Kevzara
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSarilumab
    D.3.9.3Other descriptive name.
    D.3.9.4EV Substance CodeSUB177914
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 200
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name AMGEVITA
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 40
    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
    Rheumatoid Athritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis is a chronic autoimmune disease in which the body attacks its own healthy tissue, primarily the joints.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10003268
    E.1.2Term Arthritis rheumatoid
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study (RABEX) is to investigative the physiological effects of the cytokines IL-6 and TNF on the adaptive changes to exercise in patients with rheumatoid arthritis.

    We will compare rheumatoid arthritis patients in treatment with either IL-6 or TNF blockage on exercise-induced cardiac adaptations as well as metabolic adaptations including oral glucose tolerance test (OGTT) and changes in adipose tissue mass.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >= 18 and <70 years
    • Informed consent
    • Diagnosed RA based on the 2010 American College of Rheumatology/ EULAR criteria and in biological treatment with either IL-6rB og TNFi over four months prior to enrollment
    • Low RA disease activity, based on the Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28) <=3.2
    • An electrocardiogram without features of left ventricular hypertrophy defined by the European Society of Cardiology
    • Females of childbearing potential have to use one or more of the following highly effective methods for contraception in order to be included:
    o Vasectomized partner
    o Bilateral tubal occlusion
    o Sexual abstinence
    o Intrauterine device
    o Hormonal contraception

    • Females who are considered to have no childbearing potential are
    o Bilateral tubal ligation
    o Bilateral oophorectomy
    o Complete hysterectomy
    o Postmenopausal defined as 12 months with no menses without an alternative medical cause
    E.4Principal exclusion criteria
    • Health conditions that prevent participating in the exercise intervention determined by the Project Coordinator
    • Subjects who cannot undergo MRI scans (metallic implants or claustrophobia)
    • Corticosteroid use per os > 10 mg/day within seven days of study enrollment
    • Intramuscular corticosteroid within 3 weeks of the study enrollment
    • Grade 2 hypertension (systolic BP > 160 mmHg and/or diastolic BP >100 mmHg) 32 despite the use of antihypertensive drugs.
    • Pregnancy
    • Subjects with insulin dependent Diabetes
    E.5 End points
    E.5.1Primary end point(s)
    To compare the physiological adaptations to exercise in reumatoid athritis patients in either IL-6 or TNF blockage. The following parameters will be measured:

    Primary
    Change in left ventricular mass (MRI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks (end of exercise intervention or control group (no exercise intervention)).
    E.5.2Secondary end point(s)
    To compare the physiological adaptations to exercise in reumatoid athritis patients in either IL-6 or TNF blockage. The following parameters will be measured:

    Secondary
    Visceral adipose tissue mass (MRI).
    Stroke volume, left ventricular and atrial end-diastolic volume, LVEF, GLS, E/A, E/e’ (MRI and echocardiography).
    Functional vascular parameters: aortic and pulmonary distensibility and pulse wave velocity (MRI).
    Subcutaneous, visceral and epicardial adipose tissue, intramyocardial triglyceride content (MRI and MR spectroscopy).
    Cardiorespiratory measurements (VO2 max).
    Body composition (DXA).
    Lung function (forced expired volume in 1 second, forced vital capacity, total lung capacity, residual volume, and diffusing capacity).
    Blood samples analyzed for markers related to exercise, metabolism, inflammation and cardiovascular function.
    RA disease specific outcomes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks (end of exercise intervention or control group (no exercise intervention)).
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    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) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Inclusion period will end 26 months after the first subject has been recruited or if at least 16 subjects in each group have been deemed fully compliant to intervention or control (as described in the protocol) and further inclusion rate is below 2 patients per month. 16 subjects in each group, will meet the recommended power of 0.8 and alpha-level of 0.05 for the primary endpoint and this deadline is within the scope of the PhD study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    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: 70
    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 state80
    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)
    Before, during and after the patients will undergo standard of care
    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 Decision2021-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-03
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