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    Summary
    EudraCT Number:2012-000222-21
    Sponsor's Protocol Code Number:MC-MTX.11/RA
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-000222-21
    A.3Full title of the trial
    An open-label, randomized, two-period cross-over study of repeated subcutaneous injections of methotrexate 50mg/ml solution either by a pre-filled syringe (reference) or by a disposable pre-filled pen (test) to assess patient’s preference and self-injection experience and to compare the local tolerability in patients with active rheumatoid arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection.
    A.3.2Name or abbreviated title of the trial where available
    Preference MTX pre-filled syringe vs pre-filled pen in RA
    A.4.1Sponsor's protocol code numberMC-MTX.11/RA
    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 Sponsormedac Gesellschaft für klinische Spezialpräparate mbH
    B.1.3.4CountryGermany
    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 supportmedac Gesellschaft für klinische Spezialpräparate mbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationmedac Gesellschaft für klinische Spezialpräparate mbH
    B.5.2Functional name of contact pointCécile Guimbal-Schmolck, PhD
    B.5.3 Address:
    B.5.3.1Street AddressTheaterstr. 6
    B.5.3.2Town/ cityWedel
    B.5.3.3Post code22880
    B.5.3.4CountryGermany
    B.5.4Telephone number004941038006434
    B.5.5Fax number004941038006422
    B.5.6E-mailc.guimbal-schmolck@medac.de
    D. IMP Identification
    D.IMP: 1
    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 metex® 50 mg/ml Injektionslösung, Fertigspritze
    D.2.1.1.2Name of the Marketing Authorisation holdermedac Gesellschalft fur Klinische Spezialpraparate GmbH, Hamburg, Germany
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namemetex® 50 mg/ml Injektionslösung, Fertigspritze
    D.3.2Product code 70930.00.00
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNMethotrexate disodium
    D.3.9.1CAS number 59-05-2
    D.3.9.4EV Substance CodeSUB08856MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 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 namemethotrexate pre-filled pen
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNMethotrexate disodium
    D.3.9.1CAS number 59-05-2
    D.3.9.4EV Substance CodeSUB08856MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    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 15.1
    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 is to assess the number of patients preferring the MTX pre-filled pen to the pre-filled syringe after 6 weeks of treatment.
    E.2.2Secondary objectives of the trial
    To assess the number of patients preferring the MTX pre-filled pen or the pre-filled syringe at the end of the study based on a 6-items questionnaire

    To compare the self-injection experience of the patients after each treatment period.

    To compare the local tolerability of subcutaneous injections injected with pre-filled syringes and disposable pre-filled pens at the injection site.

    To assess the incidence of adverse events during study

    To assess the number of study nurses and investigators preferring the MTX pre-filled pen at the end of study (last patient last visit).

    To document dysfunctions of the pre-filled pen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent
    - Age between 18 and 75 years
    - Diagnosis of definite rheumatoid arthritis according to the ACR Criteria (1987) or ACR/EULAR (2010)
    - Patient requiring initiation or intensification of MTX therapy due to remaining RA activity (DAS28 > 2.6)
    E.4Principal exclusion criteria
    - Prior or other current subcutaneous treatment with self-injection
    - Prior or concomitant treatment with biologics
    - Renal insufficiency (creatinine > 1.5 ULN)
    - History or acute signs of hepatic insufficiency (ALT or AST > 2 x ULN, bilirubin > 5 mg/dl)
    - Impaired haematopoiesis (platelets < 100 x 109/L, leukocytes < 3,5 x 109/L ), significant anaemia (haemoglobin < 10 g/dl)
    - Known severe, acute or chronic infection like hepatitis B or C, tuberculosis or HIV
    - Active ulcer of oral cavity or ulcer of gastrointestinal tract
    - History or diagnosis of a dermatological disease in the area of the injection-site which could interfere with a proper assessment
    - Malignant disease (except treated basal carcinoma and complete remission > 5 year for all other malignancies)
    - Known alcohol or drug addiction
    - Patients with a known history of any previous generalised allergic reactions or serious adverse reactions to the study medication or other components of the injection solution
    - Women with child-bearing potential who do not use a highly effective method of contraception (pearl index < 1%) such as combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide during the study and at least 6 months thereafter.
    - Men who have a partner with child-bearing potential and do not use a condom or a cervical cap / diaphragm with spermicide during the study and at least 6 months thereafter.
    - Pregnant or breast feeding women
    - Patients simultaneously participating or having participated in another clinical trial in the 8 weeks before study start
    - Patients with any form of psychiatric disorder or other conditions which, in the opinion of the investigator, might invalidate or complicate communication with the patient
    - Insufficient knowledge in German to understand perfectly the questionnaires
    - Concurrent vaccination with live vaccines
    E.5 End points
    E.5.1Primary end point(s)
    • To assess the number of aptients preferring the MTX pre-filled pen to the pre-filled syringe after 6 weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the study (after 6 weeks of treatment)
    E.5.2Secondary end point(s)
    • To assess the number of patients preferring the MTX pre-filled pen at the end of study based on a 6-item questionnaire related to the overall ease of use, acceptability and satisfaction
    • To compare the self-injection experience of the patients after each treatment period using the Self-Injection Assessment Questionnaire (SIAQ)
    • To compare the local tolerability of subcutaneous injections with pre-filled syringes and disposable pre-filled pens at the injection sites rated by the investigator 30 minutes after the 1st and 4th injection
    • To compare the local tolerability of subcutaneous injections with pre-filled syringes and disposable pre-filled pens at the injection sites rated by the patient 30 minutes (except 1st and 4th injection), 2 hours, 24 hours and 48 hours after injection.
    • To assess the incidence of adverse events during study
    • To assess the number of study nurses and investigators preferring the MTX pre-filled pen at the end of study (last patient last visit)
    • To document dysfunction of the pre-filled pen with respect to any information identifying and describing incidents in which the pre-filled pen was misused, broken, incapable of being activated, or did not deliver the appropriate dose
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the study (after 6 weeks of treatment)
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    local safety and usability of the device
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 No
    E.8.1.6Cross over Yes
    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 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 concerned13
    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 trial is defined as the database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state120
    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 study termination every patient should receive appropriate treatment for RA per the investigator’s discretion.
    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 Decision2012-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-02
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