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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 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

644

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna
        • Research Site
    • Arizona
      • Glendale, Arizona, Förenta staterna
        • Research Site
      • Mesa, Arizona, Förenta staterna
        • Research Site
      • Phoenix, Arizona, Förenta staterna
        • Research Site
      • Scottsdale, Arizona, Förenta staterna
        • Research Site
    • California
      • Huntington Beach, California, Förenta staterna
        • Research Site
      • Long Beach, California, Förenta staterna
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Förenta staterna
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, Förenta staterna
        • Research Site
    • Florida
      • Daytona Beach, Florida, Förenta staterna
        • Research Site
      • Jacksonville, Florida, Förenta staterna
        • Research Site
      • Miami, Florida, Förenta staterna
        • Research Site
      • Ocala, Florida, Förenta staterna
        • Research Site
      • Palm Harbor, Florida, Förenta staterna
        • Research Site
      • Pinellas Park, Florida, Förenta staterna
        • Research Site
      • Venice, Florida, Förenta staterna
        • Research Site
    • Illinois
      • Chicago, Illinois, Förenta staterna
        • Research Site
    • Indiana
      • South Bend, Indiana, Förenta staterna
        • Research Site
    • Kentucky
      • Bowling Green, Kentucky, Förenta staterna
        • Research Site
      • Elizabethtown, Kentucky, Förenta staterna
        • Research Site
    • Maryland
      • Oxon Hill, Maryland, Förenta staterna
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, Förenta staterna
        • Research Site
    • Missouri
      • Richmond Heights, Missouri, Förenta staterna
        • Research Site
    • Montana
      • Kalispell, Montana, Förenta staterna
        • Research Site
    • New Hampshire
      • Nashua, New Hampshire, Förenta staterna
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Förenta staterna
        • Research Site
      • Las Cruces, New Mexico, Förenta staterna
        • Research Site
    • New York
      • Brooklyn, New York, Förenta staterna
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna
        • Research Site
    • Ohio
      • Perrysburg, Ohio, Förenta staterna
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Förenta staterna
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Förenta staterna
        • Research Site
    • Tennessee
      • Jackson, Tennessee, Förenta staterna
        • Research Site
      • Knoxville, Tennessee, Förenta staterna
        • Research Site
      • Memphis, Tennessee, Förenta staterna
        • Research Site
    • Texas
      • Austin, Texas, Förenta staterna
        • Research Site
      • Houston, Texas, Förenta staterna
        • Research Site
      • Mesquite, Texas, Förenta staterna
        • Research Site
      • Plano, Texas, Förenta staterna
        • Research Site
      • San Antonio, Texas, Förenta staterna
        • Research Site
  • Kanada
    • Ontario
      • Mississauga, Ontario, Kanada
        • Research Site
  • Nederländerna
      • Amsterdam, Nederländerna
        • 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
  • Ryska Federationen
      • Moscow, Ryska Federationen
        • Research Site
      • Nizhny Novgorod, Ryska Federationen
        • Research Site
      • Petrozavodsk, Ryska Federationen
        • Research Site
      • Ryazan, Ryska Federationen
        • Research Site
      • St. Petersburg, Ryska Federationen
        • Research Site
      • Voronezh, Ryska Federationen
        • Research Site
      • Yaroslavl, Ryska Federationen
        • Research Site
  • Slovakien
      • Trebisov, Slovakien
        • Research Site
      • Trnava, Slovakien
        • Research Site
  • Storbritannien
      • Basingstoke, Storbritannien
        • Research Site
      • Eastbourne, Storbritannien
        • Research Site
      • London, Storbritannien
        • Research Site
      • Manchester, Storbritannien
        • Research Site
      • Wolverhampton, Storbritannien
        • Research Site
    • Berkshire
      • Reading, Berkshire, Storbritannien
        • Research Site
    • Greater London
      • London, Greater London, Storbritannien
        • Research Site
    • Sussex
      • Eastbourne, Sussex, Storbritannien
        • 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
  • Tjeckien
      • Brno, Tjeckien
        • Research Site
      • Bruntal, Tjeckien
        • Research Site
      • Hlucin, Tjeckien
        • Research Site
      • Liberec, Tjeckien
        • Research Site
      • Ostrava, Tjeckien
        • Research Site
      • Ostrava - Poruba, Tjeckien
        • Research Site
      • Ostrava - Trebovice, Tjeckien
        • Research Site
      • Praha, Tjeckien
        • Research Site
      • Praha 11, Tjeckien
        • Research Site
      • Praha 2, Tjeckien
        • Research Site
      • Praha 4, Tjeckien
        • Research Site
      • Zlin, Tjeckien
        • Research Site
  • Tyskland
      • Dresden, Tyskland
        • Research Site
      • Hamburg, Tyskland
        • Research Site
      • Muenchen, Tyskland
        • Research Site
  • Ukraina
      • Donetsk, Ukraina
        • Research Site
      • Ivano-frankivsk, Ukraina
        • Research Site
      • Kharkiv, Ukraina
        • Research Site
      • Kyiv, Ukraina
        • Research Site
      • Lutsk, Ukraina
        • Research Site
      • Lviv, Ukraina
        • Research Site
      • Odessa, Ukraina
        • Research Site
      • Simferopol, Ukraina
        • Research Site
      • Zaporyzhzhya, Ukraina
        • Research Site
  • Ungern
      • Balatonfured, Ungern
        • Research Site
      • Balatonfüred, Ungern
        • Research Site
      • Budapest, Ungern
        • Research Site
      • Debrecen, Ungern
        • Research Site
      • Zalaegerszeg, Ungern
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Dosing Group A
Oral treatment and subcutaneous injection
Läkemedel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Läkemedel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Läkemedel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Experimentell: Dosing Group B
Oral treatment and subcutaneous injection
Läkemedel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Läkemedel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Läkemedel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Experimentell: Dosing Group C
Oral treatment and subcutaneous injection
Läkemedel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Läkemedel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Läkemedel: 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
Läkemedel: Adalimumab and placebo of fostamatinib
Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
Andra namn:
  • Humira®
Placebo-jämförare: Dosing Group E
Oral treatment and subcutaneous injection
Läkemedel: 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).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
DAS28 EULAR Response at Week 6
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Utredare

  • Studierektor: Neil MacKillop, MD PhD, AstraZeneca

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2011

Primärt slutförande (Faktisk)

1 oktober 2012

Avslutad studie (Faktisk)

1 augusti 2013

Studieregistreringsdatum

Först inskickad

17 december 2010

Först inskickad som uppfyllde QC-kriterierna

21 december 2010

Första postat (Uppskatta)

22 december 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 maj 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 april 2014

Senast verifierad

1 april 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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