Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

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

torstai 3. huhtikuuta 2014 päivittänyt: 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

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

644

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Alankomaat
      • Amsterdam, Alankomaat
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Ruse, Bulgaria
        • Research Site
      • Sevlievo, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Veliko Tarnovo, Bulgaria
        • Research Site
  • Etelä-Afrikka
      • Cape Town, Etelä-Afrikka
        • Research Site
      • Durban, Etelä-Afrikka
        • Research Site
      • Pretoria, Etelä-Afrikka
        • Research Site
      • Stellenbosch, Etelä-Afrikka
        • Research Site
    • Gauteng
      • Pretoria, Gauteng, Etelä-Afrikka
        • Research Site
    • Kwazulu Natal
      • Durban, Kwazulu Natal, Etelä-Afrikka
        • Research Site
    • Western Cape
      • Cape Town, Western Cape, Etelä-Afrikka
        • Research Site
  • Kanada
    • Ontario
      • Mississauga, Ontario, Kanada
        • Research Site
  • Puola
      • Bytom, Puola
        • Research Site
      • Chelm Slaski, Puola
        • Research Site
      • Grodzisk Mazowiecki, Puola
        • Research Site
      • Sroda Wielkopolska, Puola
        • Research Site
      • Warszawa, Puola
        • Research Site
      • Wroclaw, Puola
        • Research Site
      • Zyrardow, Puola
        • Research Site
      • Łódź, Puola
        • Research Site
  • Saksa
      • Dresden, Saksa
        • Research Site
      • Hamburg, Saksa
        • Research Site
      • Muenchen, Saksa
        • Research Site
  • Slovakia
      • Trebisov, Slovakia
        • Research Site
      • Trnava, Slovakia
        • Research Site
  • Tšekin tasavalta
      • Brno, Tšekin tasavalta
        • Research Site
      • Bruntal, Tšekin tasavalta
        • Research Site
      • Hlucin, Tšekin tasavalta
        • Research Site
      • Liberec, Tšekin tasavalta
        • Research Site
      • Ostrava, Tšekin tasavalta
        • Research Site
      • Ostrava - Poruba, Tšekin tasavalta
        • Research Site
      • Ostrava - Trebovice, Tšekin tasavalta
        • Research Site
      • Praha, Tšekin tasavalta
        • Research Site
      • Praha 11, Tšekin tasavalta
        • Research Site
      • Praha 2, Tšekin tasavalta
        • Research Site
      • Praha 4, Tšekin tasavalta
        • Research Site
      • Zlin, Tšekin tasavalta
        • 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
  • Unkari
      • Balatonfured, Unkari
        • Research Site
      • Balatonfüred, Unkari
        • Research Site
      • Budapest, Unkari
        • Research Site
      • Debrecen, Unkari
        • Research Site
      • Zalaegerszeg, Unkari
        • Research Site
  • Venäjän federaatio
      • Moscow, Venäjän federaatio
        • Research Site
      • Nizhny Novgorod, Venäjän federaatio
        • Research Site
      • Petrozavodsk, Venäjän federaatio
        • Research Site
      • Ryazan, Venäjän federaatio
        • Research Site
      • St. Petersburg, Venäjän federaatio
        • Research Site
      • Voronezh, Venäjän federaatio
        • Research Site
      • Yaroslavl, Venäjän federaatio
        • Research Site
  • Yhdistynyt kuningaskunta
      • Basingstoke, Yhdistynyt kuningaskunta
        • Research Site
      • Eastbourne, Yhdistynyt kuningaskunta
        • Research Site
      • London, Yhdistynyt kuningaskunta
        • Research Site
      • Manchester, Yhdistynyt kuningaskunta
        • Research Site
      • Wolverhampton, Yhdistynyt kuningaskunta
        • Research Site
    • Berkshire
      • Reading, Berkshire, Yhdistynyt kuningaskunta
        • Research Site
    • Greater London
      • London, Greater London, Yhdistynyt kuningaskunta
        • Research Site
    • Sussex
      • Eastbourne, Sussex, Yhdistynyt kuningaskunta
        • Research Site
  • Yhdysvallat
    • Alabama
      • Birmingham, Alabama, Yhdysvallat
        • Research Site
    • Arizona
      • Glendale, Arizona, Yhdysvallat
        • Research Site
      • Mesa, Arizona, Yhdysvallat
        • Research Site
      • Phoenix, Arizona, Yhdysvallat
        • Research Site
      • Scottsdale, Arizona, Yhdysvallat
        • Research Site
    • California
      • Huntington Beach, California, Yhdysvallat
        • Research Site
      • Long Beach, California, Yhdysvallat
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Yhdysvallat
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, Yhdysvallat
        • Research Site
    • Florida
      • Daytona Beach, Florida, Yhdysvallat
        • Research Site
      • Jacksonville, Florida, Yhdysvallat
        • Research Site
      • Miami, Florida, Yhdysvallat
        • Research Site
      • Ocala, Florida, Yhdysvallat
        • Research Site
      • Palm Harbor, Florida, Yhdysvallat
        • Research Site
      • Pinellas Park, Florida, Yhdysvallat
        • Research Site
      • Venice, Florida, Yhdysvallat
        • Research Site
    • Illinois
      • Chicago, Illinois, Yhdysvallat
        • Research Site
    • Indiana
      • South Bend, Indiana, Yhdysvallat
        • Research Site
    • Kentucky
      • Bowling Green, Kentucky, Yhdysvallat
        • Research Site
      • Elizabethtown, Kentucky, Yhdysvallat
        • Research Site
    • Maryland
      • Oxon Hill, Maryland, Yhdysvallat
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, Yhdysvallat
        • Research Site
    • Missouri
      • Richmond Heights, Missouri, Yhdysvallat
        • Research Site
    • Montana
      • Kalispell, Montana, Yhdysvallat
        • Research Site
    • New Hampshire
      • Nashua, New Hampshire, Yhdysvallat
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Yhdysvallat
        • Research Site
      • Las Cruces, New Mexico, Yhdysvallat
        • Research Site
    • New York
      • Brooklyn, New York, Yhdysvallat
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Yhdysvallat
        • Research Site
    • Ohio
      • Perrysburg, Ohio, Yhdysvallat
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Yhdysvallat
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Yhdysvallat
        • Research Site
    • Tennessee
      • Jackson, Tennessee, Yhdysvallat
        • Research Site
      • Knoxville, Tennessee, Yhdysvallat
        • Research Site
      • Memphis, Tennessee, Yhdysvallat
        • Research Site
    • Texas
      • Austin, Texas, Yhdysvallat
        • Research Site
      • Houston, Texas, Yhdysvallat
        • Research Site
      • Mesquite, Texas, Yhdysvallat
        • Research Site
      • Plano, Texas, Yhdysvallat
        • Research Site
      • San Antonio, Texas, Yhdysvallat
        • Research Site

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Dosing Group A
Oral treatment and subcutaneous injection
Lääke: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Lääke: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Lääke: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Kokeellinen: Dosing Group B
Oral treatment and subcutaneous injection
Lääke: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Lääke: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Lääke: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Kokeellinen: Dosing Group C
Oral treatment and subcutaneous injection
Lääke: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Lääke: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Lääke: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Active Comparator: Dosing Group D
Oral treatment and subcutaneous injection
Lääke: Adalimumab and placebo of fostamatinib
Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
Muut nimet:
  • Humira®
Placebo Comparator: Dosing Group E
Oral treatment and subcutaneous injection
Lääke: 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).

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
DAS28 EULAR Response at Week 6
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

AstraZeneca

Tutkijat

  • Opintojohtaja: Neil MacKillop, MD PhD, AstraZeneca

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Lauantai 1. tammikuuta 2011

Ensisijainen valmistuminen (Todellinen)

Maanantai 1. lokakuuta 2012

Opintojen valmistuminen (Todellinen)

Torstai 1. elokuuta 2013

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 17. joulukuuta 2010

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 21. joulukuuta 2010

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 22. joulukuuta 2010

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Tiistai 6. toukokuuta 2014

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 3. huhtikuuta 2014

Viimeksi vahvistettu

Tiistai 1. huhtikuuta 2014

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Nivelreuma

Kliiniset tutkimukset Fostamatinib and placebo injections

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Portugal

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

3
Tilaa