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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-003508-36
    Sponsor's Protocol Code Number:NP01-007
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-29
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-003508-36
    A.3Full title of the trial
    A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis
    A.3.2Name or abbreviated title of the trial where available
    CAPRA-2
    A.4.1Sponsor's protocol code numberNP01-007
    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 SponsorNitec Pharma AG
    B.1.3.4CountrySwitzerland
    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 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 No
    D.2.1.1.1Trade name Lodotra®
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisone
    D.3.9.1CAS number 53-03-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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) No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 if 12 weeks of treatment with 5 mg Lodotra® administered in the evening is superior to placebo in terms of the ACR20 responder rate.
    E.2.2Secondary objectives of the trial
    The key secondary objective of this study is to evaluate if 12 weeks of treatment with 5 mg MR prednisone (Lodotra®) administered in the evening is superior to placebo in terms of the relative reduction of morning stiffness.
    Additional secondary objectives of this study are to compare 12 weeks of treatment with 5 mg Lodotra® administered in the evening with placebo in terms of efficacy, quality of life and safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Provide written informed consent
    •Have a documented history of RA (sero-negative or sero-positive) in agreement with the ACR criteria including the symptoms morning stiffness, joint pain, tender and swollen joints, inflammatory state with elevated erythrocyte sedimentation rate (ESR) or C reactive protein (CRP)
    •Be on disease modifying anti-rheumatic drugs (DMARD) treatment for RA for at least 6 months, with a stable dose for at least 6 weeks prior to screening visit (Visit 0)
    •Have duration of morning stiffness of at least 45 minutes
    •Have swollen joint count of 4 or more out of 28
    •Have tender joint count of 4 or more out of 28
    •Aged 18 to 80 years
    •Female patients of childbearing potential must be using a medically accepted contraceptive regimen
    •Able to perform the required study procedures including handling of medication containers and diaries
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a patient from study enrolment:
    •Suffering from another disease, which requires glucocorticoid treatment during the study period, e.g. asthma, neurodermatitis
    •Synovectomy within 4 months prior to study start
    •Use of glucocorticoids:
    - Continued use of systemic glucocorticoids within 4 weeks prior to screening visit (Visit 0)
    - Intermittent use of glucocorticoids within 2 weeks prior to screening visit (Visit 0). (Intermittent is defined as a maximum of 7 days treatment with a cumulative dose of < or equal to 100mg prednisone or equivalent within 6 weeks prior to Visit 0)
    - Joint injections within 6 weeks prior to screening visit (Visit 0)
    - Topical glucocorticoids, e.g. intra-nasal or inhaled glucocorticoids must be stopped at screening visit (Visit 0)
    •Use of biologicals such as: tumour necrosis factor a (TNFα) inhibitors and other compounds within 5 serum half lives prior to screening visit (Visit 0)
    •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
    •Pregnancy or nursing
    •Participation in another clinical study (use of an investigational product) within 30 days preceding visit (Visit 0)
    •Re-entry of patients previously enrolled in this trial
    •Suspected inability or unwillingness to comply with study procedures
    •Alcohol or drug abuse
    •Requirement of nonpermitted concomitant medication
    •Known hypersensitivity to prednisone or predniso(lo)ne
    •Any contraindication for low dose prednisone treatment
    •Significant renal impairment (serum creatinine > 150 µmol/L)
    •Significant hepatic impairment (investigator’s opinion)
    •Any uncontrolled concomitant disease requiring further clinical evaluation (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the ACR20 responder rate after 12 weeks of double-blind treatment with the study medication. Responders will be defined as those whose improvement from baseline to endpoint (12 weeks) fulfill all three of the following criteria:
    •= to or >20% reduction in the tender joint count (0–28)
    •= to or >20% reduction in the swollen joint count (0–28)
    •= to or >20% reduction in 3 of 5 of the following additional measures:
    -Patient assessment of pain (VAS)
    -Patient’s global assessment of disease activity (VAS)
    -Physician’s global assessment of disease activity (VAS)
    -HAQ-DI
    -CRP or ESR as acute-phase reactant. CRP will be used if the CRP value at baseline (Visit 1; Week 0) is above the ULN; otherwise the ESR value will be used to calculate the ACR20 responder status.
    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 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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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 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
    End of trial is August 2009.
    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 months4
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 350
    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 Decision2008-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-13
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