Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)
3 aprile 2014 aggiornato da: 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
Panoramica dello studio
Stato
Terminato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
644
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Ruse, Bulgaria
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Sevlievo, Bulgaria
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Sofia, Bulgaria
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Veliko Tarnovo, Bulgaria
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Ontario
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Mississauga, Ontario, Canada
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Moscow, Federazione Russa
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Nizhny Novgorod, Federazione Russa
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Petrozavodsk, Federazione Russa
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Ryazan, Federazione Russa
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St. Petersburg, Federazione Russa
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Voronezh, Federazione Russa
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Yaroslavl, Federazione Russa
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Dresden, Germania
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Hamburg, Germania
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Muenchen, Germania
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Amsterdam, Olanda
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Bytom, Polonia
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Chelm Slaski, Polonia
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Grodzisk Mazowiecki, Polonia
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Sroda Wielkopolska, Polonia
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Warszawa, Polonia
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Wroclaw, Polonia
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Zyrardow, Polonia
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Łódź, Polonia
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Basingstoke, Regno Unito
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Eastbourne, Regno Unito
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London, Regno Unito
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Manchester, Regno Unito
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Wolverhampton, Regno Unito
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Berkshire
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Reading, Berkshire, Regno Unito
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Greater London
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London, Greater London, Regno Unito
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Sussex
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Eastbourne, Sussex, Regno Unito
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Brno, Repubblica Ceca
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Bruntal, Repubblica Ceca
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Hlucin, Repubblica Ceca
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Liberec, Repubblica Ceca
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Ostrava, Repubblica Ceca
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Ostrava - Poruba, Repubblica Ceca
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Ostrava - Trebovice, Repubblica Ceca
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Praha, Repubblica Ceca
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Praha 11, Repubblica Ceca
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Praha 2, Repubblica Ceca
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Praha 4, Repubblica Ceca
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Zlin, Repubblica Ceca
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Trebisov, Slovacchia
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Trnava, Slovacchia
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Alabama
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Birmingham, Alabama, Stati Uniti
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Arizona
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Glendale, Arizona, Stati Uniti
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Mesa, Arizona, Stati Uniti
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Phoenix, Arizona, Stati Uniti
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Scottsdale, Arizona, Stati Uniti
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California
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Huntington Beach, California, Stati Uniti
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Long Beach, California, Stati Uniti
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Colorado
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Colorado Springs, Colorado, Stati Uniti
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Connecticut
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Bridgeport, Connecticut, Stati Uniti
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Florida
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Daytona Beach, Florida, Stati Uniti
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Jacksonville, Florida, Stati Uniti
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Miami, Florida, Stati Uniti
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Ocala, Florida, Stati Uniti
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Palm Harbor, Florida, Stati Uniti
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Pinellas Park, Florida, Stati Uniti
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Venice, Florida, Stati Uniti
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Illinois
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Chicago, Illinois, Stati Uniti
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Indiana
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South Bend, Indiana, Stati Uniti
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Kentucky
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Bowling Green, Kentucky, Stati Uniti
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Elizabethtown, Kentucky, Stati Uniti
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Maryland
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Oxon Hill, Maryland, Stati Uniti
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Michigan
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Kalamazoo, Michigan, Stati Uniti
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Missouri
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Richmond Heights, Missouri, Stati Uniti
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Montana
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Kalispell, Montana, Stati Uniti
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New Hampshire
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Nashua, New Hampshire, Stati Uniti
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New Mexico
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Albuquerque, New Mexico, Stati Uniti
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Las Cruces, New Mexico, Stati Uniti
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New York
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Brooklyn, New York, Stati Uniti
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North Carolina
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Charlotte, North Carolina, Stati Uniti
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Ohio
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Perrysburg, Ohio, Stati Uniti
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Pennsylvania
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Duncansville, Pennsylvania, Stati Uniti
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South Carolina
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Greenville, South Carolina, Stati Uniti
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Tennessee
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Jackson, Tennessee, Stati Uniti
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Knoxville, Tennessee, Stati Uniti
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Memphis, Tennessee, Stati Uniti
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Texas
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Austin, Texas, Stati Uniti
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Houston, Texas, Stati Uniti
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Mesquite, Texas, Stati Uniti
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Plano, Texas, Stati Uniti
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San Antonio, Texas, Stati Uniti
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Cape Town, Sud Africa
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Durban, Sud Africa
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Pretoria, Sud Africa
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Stellenbosch, Sud Africa
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Gauteng
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Pretoria, Gauteng, Sud Africa
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Kwazulu Natal
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Durban, Kwazulu Natal, Sud Africa
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Western Cape
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Cape Town, Western Cape, Sud Africa
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Donetsk, Ucraina
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Ivano-frankivsk, Ucraina
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Kharkiv, Ucraina
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Kyiv, Ucraina
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Lutsk, Ucraina
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Lviv, Ucraina
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Odessa, Ucraina
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Simferopol, Ucraina
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Zaporyzhzhya, Ucraina
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Balatonfured, Ungheria
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Balatonfüred, Ungheria
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Budapest, Ungheria
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Debrecen, Ungheria
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Zalaegerszeg, Ungheria
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Dosing Group A
Oral treatment and subcutaneous injection
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Fostamatinib 100mg twice daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
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Sperimentale: Dosing Group B
Oral treatment and subcutaneous injection
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Fostamatinib 100mg twice daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
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Sperimentale: Dosing Group C
Oral treatment and subcutaneous injection
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Fostamatinib 100mg twice daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
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Comparatore attivo: Dosing Group D
Oral treatment and subcutaneous injection
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Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
Altri nomi:
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Comparatore placebo: Dosing Group E
Oral treatment and subcutaneous injection
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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).
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
Lasso di tempo: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab
Lasso di tempo: Baseline and 24 weeks
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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.
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Baseline and 24 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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DAS28 EULAR Response at Week 6
Lasso di tempo: 6 weeks
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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.
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6 weeks
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DAS28 EULAR Response at Week 24
Lasso di tempo: 24 weeks
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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.
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24 weeks
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Proportion of Patients Achieving ACR20 up to Week 24
Lasso di tempo: 6 and 24 weeks
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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.
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6 and 24 weeks
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Proportion of Patients Achieving ACR50 up to Week 24
Lasso di tempo: 6 and 24 weeks
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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.
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6 and 24 weeks
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Proportion of Patients Achieving ACR70 up to Week 24
Lasso di tempo: 6 and 24 weeks
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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.
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6 and 24 weeks
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ACRn - Comparison Between Fostamatinib and Placebo at Week 6
Lasso di tempo: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24
Lasso di tempo: Baseline and 24 weeks
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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.
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Baseline and 24 weeks
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HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6
Lasso di tempo: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24
Lasso di tempo: Baseline and 24 weeks
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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.
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Baseline and 24 weeks
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SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24
Lasso di tempo: Baseline and 24 weeks
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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
|
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SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24
Lasso di tempo: 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.
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Baseline and 24 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Neil MacKillop, MD PhD, AstraZeneca
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2011
Completamento primario (Effettivo)
1 ottobre 2012
Completamento dello studio (Effettivo)
1 agosto 2013
Date di iscrizione allo studio
Primo inviato
17 dicembre 2010
Primo inviato che soddisfa i criteri di controllo qualità
21 dicembre 2010
Primo Inserito (Stima)
22 dicembre 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
6 maggio 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 aprile 2014
Ultimo verificato
1 aprile 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D4300C00004
- 2010-023692-26 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .