Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)
3. dubna 2014 aktualizováno: 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
Přehled studie
Postavení
Ukončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
644
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Pleven, Bulharsko
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Plovdiv, Bulharsko
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Ruse, Bulharsko
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Sevlievo, Bulharsko
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Sofia, Bulharsko
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Veliko Tarnovo, Bulharsko
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Amsterdam, Holandsko
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Cape Town, Jižní Afrika
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Durban, Jižní Afrika
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Pretoria, Jižní Afrika
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Stellenbosch, Jižní Afrika
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Gauteng
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Pretoria, Gauteng, Jižní Afrika
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Kwazulu Natal
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Durban, Kwazulu Natal, Jižní Afrika
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Western Cape
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Cape Town, Western Cape, Jižní Afrika
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Ontario
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Mississauga, Ontario, Kanada
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Balatonfured, Maďarsko
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Balatonfüred, Maďarsko
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Budapest, Maďarsko
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Debrecen, Maďarsko
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Zalaegerszeg, Maďarsko
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Dresden, Německo
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Hamburg, Německo
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Muenchen, Německo
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Bytom, Polsko
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Chelm Slaski, Polsko
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Grodzisk Mazowiecki, Polsko
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Sroda Wielkopolska, Polsko
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Warszawa, Polsko
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Wroclaw, Polsko
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Zyrardow, Polsko
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Łódź, Polsko
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Moscow, Ruská Federace
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Nizhny Novgorod, Ruská Federace
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Petrozavodsk, Ruská Federace
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Ryazan, Ruská Federace
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St. Petersburg, Ruská Federace
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Voronezh, Ruská Federace
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Yaroslavl, Ruská Federace
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Trebisov, Slovensko
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Trnava, Slovensko
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Basingstoke, Spojené království
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Eastbourne, Spojené království
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London, Spojené království
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Manchester, Spojené království
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Wolverhampton, Spojené království
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Berkshire
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Reading, Berkshire, Spojené království
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Greater London
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London, Greater London, Spojené království
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Sussex
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Eastbourne, Sussex, Spojené království
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Alabama
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Birmingham, Alabama, Spojené státy
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Arizona
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Glendale, Arizona, Spojené státy
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Mesa, Arizona, Spojené státy
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Phoenix, Arizona, Spojené státy
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Scottsdale, Arizona, Spojené státy
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California
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Huntington Beach, California, Spojené státy
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Long Beach, California, Spojené státy
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Colorado
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Colorado Springs, Colorado, Spojené státy
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Connecticut
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Bridgeport, Connecticut, Spojené státy
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Florida
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Daytona Beach, Florida, Spojené státy
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Jacksonville, Florida, Spojené státy
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Miami, Florida, Spojené státy
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Ocala, Florida, Spojené státy
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Palm Harbor, Florida, Spojené státy
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Pinellas Park, Florida, Spojené státy
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Venice, Florida, Spojené státy
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Illinois
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Chicago, Illinois, Spojené státy
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Indiana
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South Bend, Indiana, Spojené státy
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Kentucky
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Bowling Green, Kentucky, Spojené státy
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Elizabethtown, Kentucky, Spojené státy
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Maryland
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Oxon Hill, Maryland, Spojené státy
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Michigan
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Kalamazoo, Michigan, Spojené státy
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Missouri
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Richmond Heights, Missouri, Spojené státy
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Montana
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Kalispell, Montana, Spojené státy
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New Hampshire
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Nashua, New Hampshire, Spojené státy
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New Mexico
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Albuquerque, New Mexico, Spojené státy
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Las Cruces, New Mexico, Spojené státy
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New York
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Brooklyn, New York, Spojené státy
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North Carolina
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Charlotte, North Carolina, Spojené státy
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Ohio
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Perrysburg, Ohio, Spojené státy
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Pennsylvania
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Duncansville, Pennsylvania, Spojené státy
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South Carolina
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Greenville, South Carolina, Spojené státy
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Tennessee
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Jackson, Tennessee, Spojené státy
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Knoxville, Tennessee, Spojené státy
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Memphis, Tennessee, Spojené státy
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Texas
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Austin, Texas, Spojené státy
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Houston, Texas, Spojené státy
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Mesquite, Texas, Spojené státy
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Plano, Texas, Spojené státy
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San Antonio, Texas, Spojené státy
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Donetsk, Ukrajina
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Ivano-frankivsk, Ukrajina
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Kharkiv, Ukrajina
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Kyiv, Ukrajina
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Lutsk, Ukrajina
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Lviv, Ukrajina
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Odessa, Ukrajina
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Simferopol, Ukrajina
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Zaporyzhzhya, Ukrajina
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Brno, Česká republika
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Bruntal, Česká republika
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Hlucin, Česká republika
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Liberec, Česká republika
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Ostrava, Česká republika
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Ostrava - Poruba, Česká republika
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Ostrava - Trebovice, Česká republika
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Praha, Česká republika
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Praha 11, Česká republika
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Praha 2, Česká republika
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Praha 4, Česká republika
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Zlin, Česká republika
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Experimentální: 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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Experimentální: 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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Aktivní komparátor: 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.
Ostatní jména:
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Komparátor placeba: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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DAS28 EULAR Response at Week 6
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Neil MacKillop, MD PhD, AstraZeneca
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2011
Primární dokončení (Aktuální)
1. října 2012
Dokončení studie (Aktuální)
1. srpna 2013
Termíny zápisu do studia
První předloženo
17. prosince 2010
První předloženo, které splnilo kritéria kontroly kvality
21. prosince 2010
První zveřejněno (Odhad)
22. prosince 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
6. května 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. dubna 2014
Naposledy ověřeno
1. dubna 2014
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- D4300C00004
- 2010-023692-26 (Číslo EudraCT)
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