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Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

3. april 2014 opdateret af: AstraZeneca

(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis

The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The study will last for approximately six months

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Sub-study:

Full title: Optional Genetic Research

Date: 10 September 2010

Version: 1

Objectives: To collect and store, with appropriate consent , DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or adalimumab; and/or susceptibility to, progression of and prognosis of RA

The main study recruitment is complete, and sub study recruitment will continue until the target is reached, estimated to be June 2013

Sub-study:

Full title: (Sub-study to OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study

Date: 21 March 2011

Version: 1

Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by:

  • Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

644

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Bulgarien
      • Pleven, Bulgarien
        • Research Site
      • Plovdiv, Bulgarien
        • Research Site
      • Ruse, Bulgarien
        • Research Site
      • Sevlievo, Bulgarien
        • Research Site
      • Sofia, Bulgarien
        • Research Site
      • Veliko Tarnovo, Bulgarien
        • Research Site
  • Canada
    • Ontario
      • Mississauga, Ontario, Canada
        • Research Site
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
        • Research Site
      • Nizhny Novgorod, Den Russiske Føderation
        • Research Site
      • Petrozavodsk, Den Russiske Føderation
        • Research Site
      • Ryazan, Den Russiske Føderation
        • Research Site
      • St. Petersburg, Den Russiske Føderation
        • Research Site
      • Voronezh, Den Russiske Føderation
        • Research Site
      • Yaroslavl, Den Russiske Føderation
        • Research Site
  • Det Forenede Kongerige
      • Basingstoke, Det Forenede Kongerige
        • Research Site
      • Eastbourne, Det Forenede Kongerige
        • Research Site
      • London, Det Forenede Kongerige
        • Research Site
      • Manchester, Det Forenede Kongerige
        • Research Site
      • Wolverhampton, Det Forenede Kongerige
        • Research Site
    • Berkshire
      • Reading, Berkshire, Det Forenede Kongerige
        • Research Site
    • Greater London
      • London, Greater London, Det Forenede Kongerige
        • Research Site
    • Sussex
      • Eastbourne, Sussex, Det Forenede Kongerige
        • Research Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
        • Research Site
    • Arizona
      • Glendale, Arizona, Forenede Stater
        • Research Site
      • Mesa, Arizona, Forenede Stater
        • Research Site
      • Phoenix, Arizona, Forenede Stater
        • Research Site
      • Scottsdale, Arizona, Forenede Stater
        • Research Site
    • California
      • Huntington Beach, California, Forenede Stater
        • Research Site
      • Long Beach, California, Forenede Stater
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater
        • Research Site
    • Florida
      • Daytona Beach, Florida, Forenede Stater
        • Research Site
      • Jacksonville, Florida, Forenede Stater
        • Research Site
      • Miami, Florida, Forenede Stater
        • Research Site
      • Ocala, Florida, Forenede Stater
        • Research Site
      • Palm Harbor, Florida, Forenede Stater
        • Research Site
      • Pinellas Park, Florida, Forenede Stater
        • Research Site
      • Venice, Florida, Forenede Stater
        • Research Site
    • Illinois
      • Chicago, Illinois, Forenede Stater
        • Research Site
    • Indiana
      • South Bend, Indiana, Forenede Stater
        • Research Site
    • Kentucky
      • Bowling Green, Kentucky, Forenede Stater
        • Research Site
      • Elizabethtown, Kentucky, Forenede Stater
        • Research Site
    • Maryland
      • Oxon Hill, Maryland, Forenede Stater
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, Forenede Stater
        • Research Site
    • Missouri
      • Richmond Heights, Missouri, Forenede Stater
        • Research Site
    • Montana
      • Kalispell, Montana, Forenede Stater
        • Research Site
    • New Hampshire
      • Nashua, New Hampshire, Forenede Stater
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater
        • Research Site
      • Las Cruces, New Mexico, Forenede Stater
        • Research Site
    • New York
      • Brooklyn, New York, Forenede Stater
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
        • Research Site
    • Ohio
      • Perrysburg, Ohio, Forenede Stater
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Forenede Stater
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Forenede Stater
        • Research Site
    • Tennessee
      • Jackson, Tennessee, Forenede Stater
        • Research Site
      • Knoxville, Tennessee, Forenede Stater
        • Research Site
      • Memphis, Tennessee, Forenede Stater
        • Research Site
    • Texas
      • Austin, Texas, Forenede Stater
        • Research Site
      • Houston, Texas, Forenede Stater
        • Research Site
      • Mesquite, Texas, Forenede Stater
        • Research Site
      • Plano, Texas, Forenede Stater
        • Research Site
      • San Antonio, Texas, Forenede Stater
        • Research Site
  • Holland
      • Amsterdam, Holland
        • Research Site
  • Polen
      • Bytom, Polen
        • Research Site
      • Chelm Slaski, Polen
        • Research Site
      • Grodzisk Mazowiecki, Polen
        • Research Site
      • Sroda Wielkopolska, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
      • Wroclaw, Polen
        • Research Site
      • Zyrardow, Polen
        • Research Site
      • Łódź, Polen
        • Research Site
  • Slovakiet
      • Trebisov, Slovakiet
        • Research Site
      • Trnava, Slovakiet
        • Research Site
  • Sydafrika
      • Cape Town, Sydafrika
        • Research Site
      • Durban, Sydafrika
        • Research Site
      • Pretoria, Sydafrika
        • Research Site
      • Stellenbosch, Sydafrika
        • Research Site
    • Gauteng
      • Pretoria, Gauteng, Sydafrika
        • Research Site
    • Kwazulu Natal
      • Durban, Kwazulu Natal, Sydafrika
        • Research Site
    • Western Cape
      • Cape Town, Western Cape, Sydafrika
        • Research Site
  • Tjekkiet
      • Brno, Tjekkiet
        • Research Site
      • Bruntal, Tjekkiet
        • Research Site
      • Hlucin, Tjekkiet
        • Research Site
      • Liberec, Tjekkiet
        • Research Site
      • Ostrava, Tjekkiet
        • Research Site
      • Ostrava - Poruba, Tjekkiet
        • Research Site
      • Ostrava - Trebovice, Tjekkiet
        • Research Site
      • Praha, Tjekkiet
        • Research Site
      • Praha 11, Tjekkiet
        • Research Site
      • Praha 2, Tjekkiet
        • Research Site
      • Praha 4, Tjekkiet
        • Research Site
      • Zlin, Tjekkiet
        • Research Site
  • Tyskland
      • Dresden, Tyskland
        • Research Site
      • Hamburg, Tyskland
        • Research Site
      • Muenchen, Tyskland
        • Research Site
  • Ukraine
      • Donetsk, Ukraine
        • Research Site
      • Ivano-frankivsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lutsk, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
      • Simferopol, Ukraine
        • Research Site
      • Zaporyzhzhya, Ukraine
        • Research Site
  • Ungarn
      • Balatonfured, Ungarn
        • Research Site
      • Balatonfüred, Ungarn
        • Research Site
      • Budapest, Ungarn
        • Research Site
      • Debrecen, Ungarn
        • Research Site
      • Zalaegerszeg, Ungarn
        • Research Site

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

Beskrivelse

Inclusion Criteria:

  • Male or female aged 18 and over
  • Active rheumatoid arthritis (RA) diagnosed after the age of 16 and diagnosis within 5 years prior to study visit 1 and inadequate response to treatment with a maximum 2 Disease-Modifying anti-rheumatic drug (DMARD) therapies, or diagnosis within 5 years prior to study visit 1 and intolerance to DMARD therapy, or diagnosis within 2 years prior to study visit 1 and no previous use of DMARDs
  • 4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
  • At least 2 of the following: documented history or current presence of positive rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)

Exclusion Criteria:

  • Females who are pregnant or breast feeding
  • Poorly controlled hypertension
  • Liver disease or significant liver function test abnormalities
  • Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
  • Recent or significant cardiovascular disease
  • Significant active or recent infection including tuberculosis
  • Previously received treatment with a TNF alpha antagonist (including etanercept, certolizumab, adalimumab, infliximab, golimumab) or anakinra or previous treatment with other biological agent including rituximab, abatacept and tocilizumab
  • Use of any DMARDs within 6 weeks before first study visit
  • Severe renal impairment
  • Neutropenia

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dosing Group A
Oral treatment and subcutaneous injection
Medicin: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Medicin: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Medicin: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Eksperimentel: Dosing Group B
Oral treatment and subcutaneous injection
Medicin: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Medicin: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Medicin: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Eksperimentel: Dosing Group C
Oral treatment and subcutaneous injection
Medicin: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Medicin: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Medicin: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Aktiv komparator: Dosing Group D
Oral treatment and subcutaneous injection
Medicin: Adalimumab and placebo of fostamatinib
Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
Andre navne:
  • Humira®
Placebo komparator: Dosing Group E
Oral treatment and subcutaneous injection
Medicin: Placebo of fostamatinib, fostamatinib, and placebo injections
Placebo injection once every two weeks. Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily (Group F) / fostamatinib 100mg twice daily then 150mg once daily (Group G).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
Tidsramme: Baseline and 6 weeks
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
Baseline and 6 weeks
DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab
Tidsramme: Baseline and 24 weeks
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
Baseline and 24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
DAS28 EULAR Response at Week 6
Tidsramme: 6 weeks
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.
6 weeks
DAS28 EULAR Response at Week 24
Tidsramme: 24 weeks
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.
24 weeks
Proportion of Patients Achieving ACR20 up to Week 24
Tidsramme: 6 and 24 weeks
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
6 and 24 weeks
Proportion of Patients Achieving ACR50 up to Week 24
Tidsramme: 6 and 24 weeks
ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
6 and 24 weeks
Proportion of Patients Achieving ACR70 up to Week 24
Tidsramme: 6 and 24 weeks
ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
6 and 24 weeks
ACRn - Comparison Between Fostamatinib and Placebo at Week 6
Tidsramme: Baseline and 6 weeks
ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 6. Treatment difference: difference between fostamatinib and placebo groups.
Baseline and 6 weeks
ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24
Tidsramme: Baseline and 24 weeks
ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 24. Treatment difference: difference between fostamatinib and adalimumab groups.
Baseline and 24 weeks
HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6
Tidsramme: Baseline and 6 weeks
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Baseline and 6 weeks
HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24
Tidsramme: Baseline and 24 weeks
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Baseline and 24 weeks
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24
Tidsramme: Baseline and 24 weeks
SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.
Baseline and 24 weeks
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24
Tidsramme: Baseline and 24 weeks
SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.
Baseline and 24 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

  • Studieleder: Neil MacKillop, MD PhD, AstraZeneca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. januar 2011

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

17. december 2010

Først indsendt, der opfyldte QC-kriterier

21. december 2010

Først opslået (Skøn)

22. december 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D4300C00004
  • 2010-023692-26 (EudraCT nummer)

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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