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    The EU Clinical Trials Register currently displays   42886   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-006344-71
    Sponsor's Protocol Code Number:TSORA
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-04-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-006344-71
    A.3Full title of the trial
    Trichuris suis ova (TSO) as a additional therapy for rheumatoid arthritis patients with insufficient response to methotrexate. A prospective, double-blind, randomized, controlled monocenter study.
    Trichuris suis ova (TSO) als zusätzliche Therapie bei Patienten mit rheumatoider Arthritis, die nicht ausreichend auf eine Therapie mit Methotrexat ansprechen
    - eine monozentrische, prospektive, doppelblinde, randomisierte, placebokontrollierte Pilot-Studie -
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with eggs of pig whipworm for patients with rheumatoid arthritis, who are insufficiently treated with methotrexate
    Behandlung mit Eiern des Schweinepeitschenwurms bei Patientin mit rheumatoider Arthritis, die nicht ausreichend auf eine Therapie mit Methotrexat ansprechen
    A.4.1Sponsor's protocol code numberTSORA
    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 SponsorImmanuel Krankenhaus Berlin
    B.1.3.4CountryGermany
    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 supportImmanuel Krankenhaus Berlin
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportOvamed GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmanuel Krankenhaus Berlin
    B.5.2Functional name of contact pointStudiensekretariat Naturheilkunde
    B.5.3 Address:
    B.5.3.1Street AddressKönigstr. 63
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14109
    B.5.3.4CountryGermany
    B.5.4Telephone number00493080505691
    B.5.5Fax number00493080505692
    B.5.6E-mailg.loibl@immanuel.de
    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 Trichuris suis ova
    D.2.1.1.2Name of the Marketing Authorisation holderOvamed GmbH
    D.2.1.2Country which granted the Marketing AuthorisationThailand
    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 nameTrichuris suis ova
    D.3.2Product code TSO
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    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 INNTrichuris suis ova
    D.3.9.2Current sponsor codeTSO
    D.3.9.3Other descriptive namePig whipworm eggs
    D.3.9.4EV Substance CodeSUB29585
    D.3.10 Strength
    D.3.10.1Concentration unit thousand organisms thousand organisms
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral suspension
    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
    Rheumatoide Arthritis
    E.1.1.1Medical condition in easily understood language
    Inflammatory disease of the joints, rheumatoid arthritis
    entzündliche Gelenkerkrankung
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 effectiveness of trichuris suis ova (TSO) in rheumatoid arthritis patients in combination with methotrexate compared to methotrexate monotherapy ind patients with insufficient methotrexate monotherapy measured with the primary outcome parameter DAS 28 after 24 weeks.
    Die Studie vergleicht die Wirksamkeit einer Kombinationstherapie von Trichuris suis ova mit Methotrexat mit einer Methotrexat-Monotherapie über jeweils 24 Wochen bei Patienten mit rheumatoider Arthritis und insuffizientem Ansprechen unter Methotrexat-Monotherapie. Die Wirksamkeit wird mit dem primären Outcome-Parameter, dem DAS 28-Score in der Woche 24, bestimmt.
    E.2.2Secondary objectives of the trial
    Evaluation of
    - patients with low disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 24
    - patients with low disease activity (DAS 28 < 3,2) after Week 12
    - improvement of functional status measured by FFbH
    - ACR20, ACR50, ACR70 after week 24
    - ACR 20, ACR50, ACR70 after week 12
    descriptive analysis of change glucocorticoids, NSAID dosage
    - report of adverse events and serious adverse events (referring to ICH GCP / CPMP ICH E2)
    - changes of CRP and ESR
    - changes of immunological parameters after week 24
    - Anteil der Patienten mit niedriger Krankheitsaktivität (DAS 28 < 3,2) bzw. Remission (DAS 28 < 2,6) zur Woche 24
    - Anteil der Patienten mit niedriger Krankheitsaktivität (DAS 28 < 3,2) bzw. Remission (DAS 28 < 2,6) zur Woche 12
    - Funktionsverbesserung, gemessen mit dem FFbH
    - Bestimmung der ACR20, ACR50, ACR70 von der Baseline zur Woche 24
    - Bestimmung der ACR20, ACR50, ACR70 von der Baseline zur Woche 12
    - deskriptive Analyse der Veränderungen der Glukokortikoid- und NSAR-Dosierung
    - Erhebung der unerwünschten Nebenwirkungen und schweren unerwünschten Nebenwirkungen (ICH GCP/ CPMP ICH E2)
    - Veränderungen der Entzündungsparameter (CRP/ BSG)
    - Bestimmung Immunologische Parameter Woche 24
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - male and female patients aged between 18 and 70 years
    - capable of understanding and signed informed consent form (AMG §40(1) 3b)
    - patients with definite rheumatoid arthritis to the ACR/ EULAR Classification Criteria 2010
    - DAS 28 > 3,2
    - Tender-Joint-Count (TJC) ≥ 4, Swollen-Joint-Count (SJC) ≥ 2
    - CRP > 5mg/l oder ESR > 15 mm/h
    - stable methotrexate therapy with dosage between 10-30mg/ week parenteral (s.c.) or oral use
    - Männliche und weibliche Patienten zwischen 18 und 70 Jahren
    - durchgeführte Patientenaufklärung und schriftliche Einwilligung (Laut AMG §40(1) 3b)
    - gesicherte rheumatoide Arthritis nach ACR/EULAR-Klassifikationskriterien 2010
    - DAS 28 > 3,2
    - Tender-Joint-Count (TJC) ≥ 4, Swollen-Joint-Count (SJC) ≥ 2
    - CRP > 5mg/l oder BSG > 15 mm/h
    - laufende Methotrexat Therapie mit einer Dosierung von 10-30mg wöchentlich s.c. oder p.o.
    E.4Principal exclusion criteria
    - gastroinstinal disease like inflammatory bowel disease, peptic ulcer, divertikulitis
    - resection of parts of the small intenstine
    - active helminth infection
    - active infection
    - in treatment for cancer
    - clinical relevant liver disease (cancer, hepatitis B or C)
    - other rheumatologic diseases than RA
    - pregnancy or breast-feeding
    - participation in other trial/ study during the last 3 months
    - intramuscular, intravenous, intraarticular injektion of glucosteroids in the last 4 weeks
    - Gastrointestinale Erkrankung wie chronisch entzündliche Darmerkrankungen, akute Ulcera des Gas-trointestinaltrakts, Divertikulitis
    - partielle oder komplette Dünndarmentfernung
    - akute Wurmerkrankung
    - floride Infektionserkrankung
    - aktuell in Behandlung befindliche Tumorerkrankungen
    - klinisch relevante Lebererkrankung (Neoplasie, serologische Diagnose einer chron. aktiven Hepatitis B und C)
    - aktuell behandlungsbedürftige Autoimmunerkrankung (außer rheumatoider Arthritis)
    - Schwangerschaft oder Stillzeit
    - Teilnahme an einer anderen klinischen Studie nach dem AMG oder MPG innerhalb der letzten 3 Monate oder während der gesamten Studiendauer
    - intramuskuläre, intravenöse oder intra-artikuläre Glukokortikoidtherapie innerhalb der letzten 4 Wo-chen
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of DAS 28 after 24 weeks treatment
    Bestimmung des DAS 28 nach 24-wöchiger Behandlung
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 24 weeks of treatment
    nach 24-wöchiger Behandlung
    E.5.2Secondary end point(s)
    Evaluation of
    - patients with lox disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 24
    - patients with lox disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 12
    - improvement of functional status measured by FFbH
    - ACR20, ACR50, ACR70 after week 24
    - ACR20, ACR50, ACR70 after week 12
    descriptive analysis of change glucocorticoids, NSAID dosage
    - report of adverse events and serious adverse events (referring to ICH GCP / CPMP ICH E2)
    - changes of CRP and ESR
    - changes of immunological parameters after week 24
    Bestimmung des/der

    - Anteils der Patienten mit niedriger Krankheitsaktivität (DAS < 3,2) bzw. Remission (DAS < 2,6) zur Woche 24
    - Anteils der Patienten mit niedriger Krankheitsaktivität (DAS < 3,2) bzw. Remission (DAS < 2,6) zur Woche 12
    - Funktionsverbesserung, gemessen mit dem FFbH
    - ACR20, ACR50, ACR70 von der Baseline zur Woche 24
    - ACR20, ACR50, ACR70 von der Baseline zur Woche 12
    - deskriptive Analyse der Veränderungen der Glukokortikoid- und NSAR-Dosierung
    - unerwünschten Nebenwirkungen und schweren unerwünschten Nebenwirkungen (ICH GCP/ CPMP ICH E2)
    - Veränderungen der Entzündungsparameter (CRP/ BSG)
    - Immunologische Parameter Woche 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 24 weeks of treatment
    nach 24-wöchiger Behandlung
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    Early escape after week 12: possibility of open label treatment without unblinding
    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.8.2.4Number 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.8.4.1Number of sites anticipated in Member State concerned1
    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
    The trial can be stopped for safety reasons. This is the case:
    - if more than 30% of the patients have to drop out for safety reasons
    - increasing unexpected seroius adverse events
    - new scientific results, which could affect patients negatively
    Die Studie kann abgebrochen werden, wenn
    -mehr als 30% der Patienten einen vorzeitigen Abbruch (aus Sicherheitsgründen) hatten
    - gehäuftes Auftreten von unerwarteten schwerwiegenden Nebenwirkungen
    - neue (wissenschaftliche) Erkenntnisse, die während der Laufzeit der klinischen Prüfung bekannt werden, die die Sicherheit der Studienteilnehmer gefährden können
    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 months6
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    optional follow-up after 6 weeks with full examination and laboratory examination.
    Optionales follow-up 6 Wochen nach Ende der Studie mit vollständiger klinischer Untersuchung und Laboruntersuchungen.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation hospital Laborverbund Brandenburg-Berlin GmbH
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Deutsches Rheuma Forschungszentrum
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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