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Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy (PRINT)

31. januar 2013 opdateret af: TcLand Expression S.A.

Validation Study of RA-INF-Dx as a Multigene Molecular Test Intended to Aid in the Identification of Patients With Rheumatoid Arthritis Who Are Unlikely to Show an Initial Response to Infliximab and Methotrexate Combination Therapy

Study Design & Objectives:

Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks.

To determine the performances of the RA-INF-Dx blood test intended to aid in the identification of patients with rheumatoid arthritis who are unlikely to show an initial response to infliximab and methotrexate combination therapy evaluated according to EULAR response criteria.

Ancillary study objective:

To constitute a biocollection of samples associated with all clinical and biological data collected at inclusion and at the evaluation visit.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The RA-INF-Dx test is a non invasive in vitro blood test intended to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.

The RA-INF-Dx test is indicated for use in patients:

  • 18 years of age or older,
  • Eligible for a first line biologic therapy with infliximab. The RA-INF-Dx test is indicated for use by rheumatologists as a biological basis for guiding infliximab treatment prior to its initiation.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

123

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
      • Mississauga - Chow, Canada
        • Location n°31
      • Ontario, Canada
        • Location n°36
      • Rimouski, Canada
        • Location n°34
      • Saskatchewan, Canada
        • Location n°33
      • Toronto, Canada
        • Location n°35
  • Frankrig
      • Amiens, Frankrig
        • Location n°41
      • Bobigny, Frankrig
        • Location n°13
      • Dreux, Frankrig
        • Location n°39
      • Grenoble, Frankrig
        • Location n°14
      • Meaux, Frankrig
        • Location n°40
      • Paris, Frankrig
        • Location n°25
      • Paris (Hop Bichat), Frankrig
        • Location n°37
      • Strasbourg, Frankrig
        • Location n°38
  • Italien
      • Messina, Italien
        • Location n°15
      • Milano, Italien
        • Location n°16
      • Pisa, Italien
        • Location n°17
  • Litauen
      • Kaunas, Litauen
        • Location n°27
      • Klaipeda, Litauen
        • Location n°29
      • Panevezys, Litauen
        • Location n°30
      • Vilnius, Litauen
        • Location n°28
  • Rumænien
      • Bucharest, Rumænien
        • Location n° 19
      • Bucharest, Rumænien
        • Location n°20
      • Bucharest, Rumænien
        • Location n°22
      • Bucharest, Rumænien
        • Location n°23
      • Cluj Napoca, Rumænien
        • Location n°21
      • Iasi, Rumænien
        • Location n°24
      • Iasi, Rumænien
        • Location n°26
      • Timisoara, Rumænien
        • Location n°18
  • Slovakiet
      • Banska Bystrica, Slovakiet
        • Location n°12
      • Piestany, Slovakiet
        • Location n°11
  • Spanien
      • Malaga, Spanien
        • Location n°3
      • Oviedo, Spanien
        • Location n°5
  • Ungarn
      • Budapest, Ungarn
        • Location n°6
      • Budapest, Ungarn
        • Location n°8
      • Debrecen, Ungarn
        • Location n°7
      • Eger, Ungarn
        • Location n°10
      • Kistarcsa, Ungarn
        • Location n°9

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients suffering from RA eligible to a first biologic therapy for whom the treating rheumatologist envisages infliximab therapy will be included in this study.

Beskrivelse

Inclusion Criteria:

Diagnosis of Rheumatoid Arthritis

  1. Patient with a confirmed Rheumatoid Arthritis according the American College of Rheumatology (ACR) classification criteria.

    Disease Activity

  2. Patient with a DAS28 greater than 3.2.

    Treatment

  3. Patient eligible for a first line TNFα blocking agent treatment with infliximab according to the "Summary of Product Characteristics",
  4. Patient refractory to treatment with at least one classical DMARDs (one of which has to be MTX) prescribed according to the international recommendations, i.e. for at least 12 weeks at the maximal tolerated dose prior to infliximab treatment and with doses which must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy (patients may be included if they have undergone a wash-out period using cholestyramine or equivalent subsequent to leflunomide treatment),

  5. Use of oral steroids (≤ 10mg/day of prednisone or equivalent dose of another molecule) and/or NSAIDs will be permitted; doses must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy,

    Other criteria

  6. Patient (male or female) at 18 years of age or older at inclusion,
  7. Negative β-HCG pregnancy test, when appropriate according to the patient's age and contraceptive method,
  8. Informed consent signed.

Exclusion Criteria:

  1. Patient having received previous courses of other biologic therapy (TNF blocking agents, anti-CD20, anti-CTLA4, IL1 blockers, IL6 blockers and other molecules in development),
  2. Patient non eligible to infliximab therapy according to the "Summary of Product Characteristics",
  3. Patient with clinically significant, severe and uncontrolled infectious diseases,
  4. Patient with symptoms of a significant somatic or psychiatric/mental illness,
  5. Patient with other auto-immune diseases (i.e. Inflammatory Bowel Diseases, Systemic Lupus Erythematosus, vasculitis, uncontrolled asthma, etc...),
  6. Patient with evidence of cardiac, pulmonary, metabolic, renal, hepatic, gastro-intestinal conditions, which, in the opinion of the investigator, may interfere with the study,
  7. Pregnancy,
  8. Patient that is participating in a clinical trial or that participated in a previous one within 10 weeks prior to study entry.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
a single group of patients -200 expected
polyarthrite rhumatoid patients

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To determine the performances of the RA-INF-Dx test to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.
Tidsramme: Performed at inclusion : blood samples will be taken before the infliximab infusion.
Statistical relationship between the RA-INF-Dx blood test results and the non-response (evaluated according to EULAR criteria) to infliximab and methotrexate combination therapy will be analyzed.
Performed at inclusion : blood samples will be taken before the infliximab infusion.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Non-response to infliximab and methotrexate combination therapy based on American College of Rheumatology (ACR) criteria
Tidsramme: at the time of the first response evaluation (between the 12th and the 14th week)
A statistical analysis will be performed in order to evaluate the predictive performances of the test validated in the study primary objective in relation to the non-response to infliximab and methotrexate combination therapy evaluated according to ACR criteria.
at the time of the first response evaluation (between the 12th and the 14th week)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

TcLand Expression S.A.

Samarbejdspartnere

Premier Research Group plc
Theradis pharma
Medpharmgene, Inc.

Efterforskere

  • Ledende efterforsker: Sara MARSAL, MD, University Hospital Val d'Hebron (Barcelona, Spain)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2011

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

16. februar 2011

Først indsendt, der opfyldte QC-kriterier

16. februar 2011

Først opslået (Skøn)

18. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. februar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2010-A01046-33

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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