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    Summary
    EudraCT Number:2007-003479-37
    Sponsor's Protocol Code Number:CER 06-167
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-10-11
    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 ConcernedIreland - HPRA
    A.2EudraCT number2007-003479-37
    A.3Full title of the trial
    Efficacy of Methotrexate on Chronic Chondrocalcinosis
    A.4.1Sponsor's protocol code numberCER 06-167
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospital of Geneva
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity Hospital Geneva, Switzerland
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Metoject
    D.2.1.1.2Name of the Marketing Authorisation holdermedac GmbH,
    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 nameMetoject
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Chondrocalcinosis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    There is currently no specific medication to slow or prevent progression of chronic chondrocalcinosis, and no randomized trials have established the efficacy of antirheumatic therapies in this condition. The primary objective will be to determine the efficacy and safety of methotrexate, a well tolerated anti-rheumatic drug prescribed for other rheumatic diseases. Outcomes measured will include, the level of disease activity, pain, and number of arthritis flares reported. Patients will be randomized to receive either methotrexate or placebo for three months, followed by a washout period of two months. The crossover treatment will then be prescribed for a futher three months.
    E.2.2Secondary objectives of the trial
    The secondary outcomes will include;
    Patients global assessment of disease activity
    The function of the targeted joints
    Erythrocyte sedimentation rate
    Serologic markers of inflammation
    Duration of morning stiffness
    Number of tender and swollen joints
    Number of Analgesic tablets taken during the course of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients recruited to participate in this trial will satisfy the following criteria;

    Patients must have a definite diagnosis of Crystal Pyrophosphate Dihydrate (CPPD) disease using the Mc Carty diagnostic criteria.

    Patients who have had an unsatisfactory response to at least one non steroidal anti-inflammatory medication (NSAID) or low dose steroid.

    Contraindications to the use of NSAID and glucocorticoid medication

    Recurrent mono or oligoarthritis (pseudogout) (experiencing at least three flares in 6 months) or persistent polyarthritis
    E.4Principal exclusion criteria
    Patients will be excluded from study participation for the following reasons;

    Any contraindication to Methotrexate (hepatic failure, alcohol consumption, severe renal failure, haematological diseases, or acute infection

    A diagnosis of Rheumatoid Arthritis, Connective Tissue Disease or Gout.

    Literacy difficulties which will compromise their ability to fill out the study questionnaires

    Patients whose ability to give informed consent may be compromised
    E.5 End points
    E.5.1Primary end point(s)
    No specific outcome measures have been validated for CPPD deposition disease. Instruments developed and validated for other rheumatic diseases will be utilized. The clinical presentation of complicated CPPD is similar to other common rheumatic diseases such as gout (hence the term “pseudogout”) or polyarthritis, which should make the use of outcome measures for these diseases good instruments for chondrocalcinosis as well. Patients level of disease activity will be measured using the DAS 44. This is a composite outcome measure which includes the numbe of swollen joints, the number of tender joints, and the erythrocyte sedimentation rate (ESR).
    Disease activity: The DAS44 is a validated assessment tool of disease activity in rheumatoid arthritis that has been used in many other chronic arthritides.

    The computation of the Disease Activity score with 44 joints:
    (DAS44)(10): DAS44 = 0.54∙√(Tender count) + 0.065∙(Swollen count) + 0.33∙ln(ESR) + 0.007∙(patient assessment)·

    The number of tender and swollen joints will be assessed by the physicians at the beginning and at the end of each treatment period during the medical examination.

    Erythrocyte sedimentation rates (ESR) will be measured monthly.
    General health will be evaluated using a Lickert scale ranging from 0 to 10 by the physician.

    Acute arthritis flares: Arthritis flares (“pseudogout flares”) are an important outcome as these are one the most easily recognized concerns of patients. However, flares have not yet been well defined in the arthritis literature (11). Therefore, the number of arthritis flares reported by patients will be recorded, with patients making the judgement as to what is or is not a ‘flare’ or an ‘attack’.

    Pain: Pain will be pain measured using a visual analog scale (VAS) of the target joints.
    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 Yes
    E.7.1.3.1Other trial type description
    Use of Metotrexate for a new indication
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 100
    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)
    Methotrexate is a licensed medication. It will be possible to prescribe it for patients with chronic chondrocalcinosis, if efficacy and safety is demonstrated in this clinical trial.
    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 Decision2007-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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