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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-003486-34
    Sponsor's Protocol Code Number:39132
    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:2013-11-04
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-003486-34
    A.3Full title of the trial
    Systemic versus ultrasound-guided local glucocorticoid treatment, among rheumatoid arthritis patients with tenosynovitis - a randomized double blind study


    Systemisk versus ultralyds-guided lokal glucocorticoid behandling ved tenosynovit hos reumatoid artrit patienter – et randomiseret dobbeltblindet studie.

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Tenosynovitis among rheumatoid arthritis patients
    Seneskedehindebetændelses behandling hos leddegigt patienter.
    A.3.2Name or abbreviated title of the trial where available
    SULTAN
    SULTAN
    A.4.1Sponsor's protocol code number39132
    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 SponsorKnowledge Centre for Rheumatology and Back Diseases
    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 supportKnowledge Centre for Rheumatology and Back Diseases, Glostrup
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKnowledge Centre for Rheumatology and Back Diseases
    B.5.2Functional name of contact pointMads Ammitzbøll Danielsen
    B.5.3 Address:
    B.5.3.1Street AddressNordre Ringvej 57
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.6E-mailmads.ammitzboell.danielsen@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 Diprofos Depot
    D.2.1.1.2Name of the Marketing Authorisation holderOrifarm a/s
    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 Solution for 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 INNBETAMETHASONE ACIBUTATE
    D.3.9.1CAS number 5534-05-4
    D.3.9.2Current sponsor codeGlucocorticoid
    D.3.9.3Other descriptive nameBinyrebarkhormon
    D.3.9.4EV Substance CodeSUB05798MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3,5 to 14
    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 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 Natriumklorid 9mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    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 Solution for 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 INNSODIUM CHLORIDE
    D.3.9.2Current sponsor codeNatriumklorid
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4,5 to 18
    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
    E.1.1.1Medical condition in easily understood language
    Treatment of Tenosynovitis
    Behandling af seneskedehindebetændelse
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10042869
    E.1.2Term Synovitis and tenosynovitis
    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
    Explore whether ultrasound-guided glucocorticoid injection in the synovial sheath has better effect than intramuscularly glucocorticoid injection among patients with tenosynovitis, assessed by US examination, pain VAS-score and clinical evaluation.
    Belyse om ultralyd-guided glucocorticoid injektion i seneskeden har bedre effekt end intramuskulær glucocorticoid injektion hos patienter med tenosynovit, vurderet ved hjælp af ultralyd-undersøgelse, smerte VAS-score og klinisk vurdering.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Ultrasonic signs of treatment demanding tenosynovitis in flexor or extensor tendons in the hand (1st - 6th compatment) or flexor- , extensor-, or peroneus tendons in the ankle.

    Rheumatoid arthritis according to ACR/EULAR 2010 criteria

    Above 18 years of age

    Ultrasonisk tegn på behandlingskrævende tenosynovit i håndens flexor- eller ekstensorsener (1. – 6. kulisse) eller ankelens flexor-, ekstensor-, eller peroneussener.

    Reumatoid artrit I henhold til ACR/EULAR 2010 kriterier.

    Alder over 18 år.
    E.4Principal exclusion criteria
    Lack of ability to understand the information given about the study.

    Recent operation in hands or feet.

    Start of Disease-modifying anti-rheumatic drugs (DMARDs) / biological treatment within the last 12 weeks

    Change of DMARD / biological or glucocorticoid treatment within the last 6 weeks.

    Allergy to betamethasone.

    Start of Non-Steroidal Anti-Inflammatory Drugs (NSAID) treatment within the last 10 days.

    Systemic fungal infection

    Positive urine HCG among women in the age of fertility.

    Manglende evne til at forstå informationen om studiet.

    Nylig operation i hænder eller fødder.

    Opstart af Disease-modifying anti-rheumatic drugs (DMARD)/biologisk behandling indenfor de sidste 12 uger

    Ændring af DMARD/biologisk eller glucocorticoid behandlingen indenfor de seneste 6 uger.

    Allergi for betamethason.

    Opstart af Non-Steroidal Anti-Inflammatory Drugs (NSAID) behandling indenfor de sidste 10 dage.

    Systemisk svampeinfektion

    Positiv Urin HCG hos kvinder i den fertile alder.
    E.5 End points
    E.5.1Primary end point(s)
    Differences in the scoring of tenosynovitis evaluated by US, between treatment arm A and B (US-tenosynovitis scoring ≤ 1 4 weeks after the injektion), assessed by the Mann-Whitney U test.
    Forskelle i tenosynovit scoring, bestemt ved UL, mellem behandlings arm A og B (UL-tenosynovit scoring ≤ 1 ved tiden 4 uger efter injektion), bedømt ved Mann-Whitney U test.

    E.5.1.1Timepoint(s) of evaluation of this end point
    After the last visit of the last subject.
    Efter sidste besøg, af sidste deltager.
    E.5.2Secondary end point(s)
    Changes in the patient parameters (Clinical and US-sound assessment, as well as the participant’s own reporting and visual Analog Scale for tenosynovitis) assessed by Wilcoxon Pratt test after 2, 4 and 12 weeks.


    Correlation between findings (Clinical and US-sound assessment, as well as the participant’s own reporting and visual Analog Scale for tenosynovitis) , assessed by Spearman's correlation analysis after 2, 4 and 12 weeks.

    Differences in the scoring of tenosynovitis evaluated by US, between treatment arm A and B (US-tenosynovitis scoring ≤ 1 12 weeks after the injektion), assessed by the Mann-Whitney U test.

    Ændringer i patient parametre (klinisk og UL-mæssig vurdering samt deltagers egen rapportering og visuel Analog Skala for tenosynovitis), vurderet ved WilcoxonPratt test efter 2, 4 og 12 uger.

    Korrelation mellem fund (klinisk og UL-mæssig vurdering samt deltagers egen rapportering og visuel Analog Skala for tenosynovitis) vurderet ved Spearman’s korrelationsanalyse efter 2, 4 og 12 uger.

    Forskelle i scoring af tenosynovit bestemt ved UL, mellem behandlings arm A og B (UL-tenosynovit scoring ≤ 1 ved tiden 12 uger efter injektion), bedømt ved Mann-Whitney U test.

    E.5.2.1Timepoint(s) of evaluation of this end point
    After the last visit of the last subject
    Efter sidste besøg, af sidste deltager.
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    CS inj. in the synovial sheath and NaCL Solvens IM vs CS IM and NaCL Solvens inj.in synovial sheath
    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 Yes
    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
    LVLS
    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: 40
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-11-04. Yes
    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 state50
    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)
    None
    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 Decision2013-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-21
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