临床试验Nct页

Summary
EudraCT Number:2005-001202-60
Sponsor's Protocol Code Number:09/05
National Competent Authority:Finland - Fimea
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2005-04-25
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
A. Protocol Information
A.1Member State ConcernedFinland - Fimea
A.2EudraCT number2005-001202-60
A.3Full title of the trial
Metotreksaatti aksiaalisen spondyloartropatian hoidossa
A.3.2Name or abbreviated title of the trial where available
MTX&SPA
A.4.1Sponsor's protocol code number09/05
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 SponsorOrganisation name was not entered
B.1.3.4CountryFinland
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 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 Information not present in EudraCT
D.2.1.1.1Trade name Trexan
D.2.1.1.2Name of the Marketing Authorisation holderOrion-yhtymä Oyj
D.2.1.2Country which granted the Marketing AuthorisationFinland
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 nameMetotreksaatti
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.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number2,5
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 Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
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
Aksiaalinen spondyloartropatia (varhainen selkärankareuma)
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
Selvittää metotreksaatin teho aksiaalisen spondyloartropatian oireiden hoidossa.
E.2.2Secondary objectives of the trial
Arvioida sairauden ennustetta eli mahdollista kehittymistä luokittelukriteerit täyttäväksi selkärankareumaksi. Arvioida magneettitutkimuksen roolia hoidon seurannassa, sytokiinien ja rusto-luumarkkereiden merkitystä ennusteen ja hoitovasteen kannalta, perimän osuutta ennusteen, sairastuvuuden ja hoitovasteen kannalta sekä metotreksaattihoidon vaikutusta iriittien esiintyvyyteen.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
18-50 vuotias mies tai nainen.
Tulehduksellinen selkäkipu, määritelmänä neljä seuraavista viidestä piirteestä toteutuu: 1)selkäkipu kestänyt vähintään 3 kuukautta 2)oire on alkanut alle 45 vuotiaana 3)oire on alkanut vähitellen 4)selkäkipu helpottuu liikkuessa 5)selän aamujäykkyys.
Hoitoyritys vähintään kahdella tulehduskipulääkkeellä ei ole lievittänyt riittävästi oireita.
Verikokeessa todettu positiivinen HLA-B27.
SI-nivelten magneettikuvauksessa radiologin toteama sakroiliitti.
Aktiivi ja oireinen tauti.
E.4Principal exclusion criteria
Raskaus tai imetys.
Yliherkkyys metotreksaatille.
Vakava infektio 4 viikon sisällä.
Merkittävä maksa, munuais, keuhko, hematologinen tai gastroenterologinen sairaus.
Muu tulehduksellinen reumasairaus kuin spondyloartropatia.
Fibromyalgia.
Sairastettu syöpäsairaus 5 vuoden sisällä.
Magneettikuvauksen vasta-aiheet (sydämentahdistin, metallinen välikorvaproteesi, insuliinipumppu tai metalliset leikkausklipsit aivoissa).
E.5 End points
E.5.1Primary end point(s)
Ensisijainen päätemuuttuja ASAS20.
Toissijaiset päätemuuttujat ASAS40, ASAS5/6, BASDAI, lääkärin kokonaisarvio tautiaktiivisuudesta, turvonneiden ja arkojen nivelten määrä, rangan liikkuvuus, lasko ja CRP, ASAS osittainen remissio.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Yes
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety No
E.6.5Efficacy No
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
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 Yes
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.8.5The 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 Information not present in EudraCT
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 years2
E.8.9.1In the Member State concerned months6
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 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) No
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 Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
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 state120
F.4.2 For a multinational trial
F.4.2.2In the whole clinical trial 120
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)
Hoito on vapaa tutkimusjakson jälkeen t.s. normaalin hoitokäytännön mukainen.
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 Decision2005-05-26
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-03-30
P. End of Trial
P.End of Trial StatusOngoing

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