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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2012-004940-31
    Sponsor's Protocol Code Number:IMM-12-0074
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-04-03
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-004940-31
    A.3Full title of the trial
    Dermal inflammation in psoriatic arthritis, the association to molecular mass of hyaluronan and effect of adalimumab.
    A prospective, open-label, multi-center study of hyaluronan molecular mass distribution in psoriatic arthritis patients compared to healthy subjects.

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the molecular size distribution of hyaluronan and the effect of adalimumab treatment of psoriatic arthritis.
    A.4.1Sponsor's protocol code numberIMM-12-0074
    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 SponsorDept of medical sciences, Rheumatology
    B.1.3.4CountrySweden
    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 supportAbbVie
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital
    B.5.2Functional name of contact pointDept of medical sciences
    B.5.3 Address:
    B.5.3.1Street AddressEntr 40, 5th floor
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code751 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+46(0)704250919
    B.5.5Fax number+46(0)18509297
    B.5.6E-mailUlla.Lindqvist@medsci.uu.se
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 IMPSubcutaneous use
    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 typeequal
    D.3.10.3Concentration number40
    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) Yes
    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
    Active psoriatic arthritis according to CASPAR
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis is a painful joint condition connected to psoriasis.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    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
    To study the molecular mass of HA in skin and circulation and relate the molecular weight distribution of HA to the clinical and histological inflammatory picture in psoriatic arthritis (PsA) patients with active disease.
    E.2.2Secondary objectives of the trial
    To study the effect of anti-TNF-alpha treatment (adalimumab) after three months with regard to HA molecular weight distribution in psoriatic arthritis (PsA) patients with active disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (applies to patients only):
    1. Age 18 years or older
    2. Fulfil the classification criteria for psoriatic arthritis according to CASPAR
    3. RF (reumatoid factor) and ACPA (anticitrullinated protein/peptide antibody) negative
    4. Have a psoriatic plaque lesion with inflammation that can be biopsied/adapt suction blister on
    5. Have no other inflammatory joint or skin disease
    6. No previous treatment with anti-TNF-alpha
    7. Active psoriatic arthritis defined as fulfilling the criteria for treatment with anti-TNF in PsA according to Swedish Guidelines in Swedish Association for rheumatology;
    a/High activity with polyarthritis or dachtylitis and increased SR or CRP.
    b/Treatment failure on NSAID/local steroids and one DMARD (methotrexate, sulphasalazine, leflunomide, gold salts, cyclosporine)
    8. Stable dose of DMARD for at least 4 weeks prior to inclusion
    9. Stable dose of NSAIDs and oral corticosteroids for at least 2 weeks prior to inclusion
    E.4Principal exclusion criteria
    (applies to patients only) :
    1. Active or latent tuberculosis
    2. Chronic infections including hepatitis B and C
    3. Chronic liver diseases
    4. Malignancy
    5. Congestive heart failure
    6. Severe infections such as sepsis
    7. Opportunistic infections
    8. Positive pregnancy test at inclusion or at deviation of menstruation during study, and/or lactating woman of reproductive age
    9. Not able to use adequate contraception during treatment and five month after treatment with adalimumab in woman of reproductive age
    10. Other contraindication to adalimumab in accordance with Swedish SmPC
    11. Diabetes
    12. Metabolic syndrome
    13. Ongoing chondroitin or glucosamine medication
    14. Other reason as evaluated by the investigator


    E.5 End points
    E.5.1Primary end point(s)
    The proportion of low molecular mass of hyaluronan in skin biopsies from psoriatic arthritis patients compared to healthy subjects.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 2 weeks, 6 weeks and 3 months.
    E.5.2Secondary end point(s)
    - The proportion of LMM HA in suction blisters from psoriatic arthritis patients compared to healthy subjects.

    - Reversability of LMM HA in skin biopsies from psoriatic arthritis patients by adalimumab at three months compared to baseline.

    - Reversability of LMM HA in suction blister fluids from psoriatic arthritis patients by adalimumab at three months compared to baseline.

    - Potential correlations between LMM HA and disease activity measured as Composite Psoriatic Disease Activity Index (CPDAI) at baseline and at 3 months.

    - Potential correlation with radiographic score (according to Wassenberg) and LMM HA at baseline only. Radiography will only be performed once as 3 months is a too short period to expect progression.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and 3 months.
    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 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 No
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    10 healthy volunteers will be used for comparison.
    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 trial1
    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 concerned5
    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
    Last visit of the last subject.
    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 months
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state30
    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)
    Not different from the expected normal treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-26
    P. End of Trial
    P.End of Trial StatusOngoing
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