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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 aktualisiert von: 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

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

644

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • 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
  • Deutschland
      • Dresden, Deutschland
        • Research Site
      • Hamburg, Deutschland
        • Research Site
      • Muenchen, Deutschland
        • Research Site
  • Kanada
    • Ontario
      • Mississauga, Ontario, Kanada
        • Research Site
  • Niederlande
      • Amsterdam, Niederlande
        • 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
  • Russische Föderation
      • Moscow, Russische Föderation
        • Research Site
      • Nizhny Novgorod, Russische Föderation
        • Research Site
      • Petrozavodsk, Russische Föderation
        • Research Site
      • Ryazan, Russische Föderation
        • Research Site
      • St. Petersburg, Russische Föderation
        • Research Site
      • Voronezh, Russische Föderation
        • Research Site
      • Yaroslavl, Russische Föderation
        • Research Site
  • Slowakei
      • Trebisov, Slowakei
        • Research Site
      • Trnava, Slowakei
        • Research Site
  • Südafrika
      • Cape Town, Südafrika
        • Research Site
      • Durban, Südafrika
        • Research Site
      • Pretoria, Südafrika
        • Research Site
      • Stellenbosch, Südafrika
        • Research Site
    • Gauteng
      • Pretoria, Gauteng, Südafrika
        • Research Site
    • Kwazulu Natal
      • Durban, Kwazulu Natal, Südafrika
        • Research Site
    • Western Cape
      • Cape Town, Western Cape, Südafrika
        • Research Site
  • Tschechische Republik
      • Brno, Tschechische Republik
        • Research Site
      • Bruntal, Tschechische Republik
        • Research Site
      • Hlucin, Tschechische Republik
        • Research Site
      • Liberec, Tschechische Republik
        • Research Site
      • Ostrava, Tschechische Republik
        • Research Site
      • Ostrava - Poruba, Tschechische Republik
        • Research Site
      • Ostrava - Trebovice, Tschechische Republik
        • Research Site
      • Praha, Tschechische Republik
        • Research Site
      • Praha 11, Tschechische Republik
        • Research Site
      • Praha 2, Tschechische Republik
        • Research Site
      • Praha 4, Tschechische Republik
        • Research Site
      • Zlin, Tschechische Republik
        • Research Site
  • Ukraine
      • Donetsk, Ukraine
        • Research Site
      • Ivano-frankivsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lutsk, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
      • Simferopol, Ukraine
        • Research Site
      • Zaporyzhzhya, Ukraine
        • Research Site
  • Ungarn
      • Balatonfured, Ungarn
        • Research Site
      • Balatonfüred, Ungarn
        • Research Site
      • Budapest, Ungarn
        • Research Site
      • Debrecen, Ungarn
        • Research Site
      • Zalaegerszeg, Ungarn
        • Research Site
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten
        • Research Site
    • Arizona
      • Glendale, Arizona, Vereinigte Staaten
        • Research Site
      • Mesa, Arizona, Vereinigte Staaten
        • Research Site
      • Phoenix, Arizona, Vereinigte Staaten
        • Research Site
      • Scottsdale, Arizona, Vereinigte Staaten
        • Research Site
    • California
      • Huntington Beach, California, Vereinigte Staaten
        • Research Site
      • Long Beach, California, Vereinigte Staaten
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Vereinigte Staaten
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, Vereinigte Staaten
        • Research Site
    • Florida
      • Daytona Beach, Florida, Vereinigte Staaten
        • Research Site
      • Jacksonville, Florida, Vereinigte Staaten
        • Research Site
      • Miami, Florida, Vereinigte Staaten
        • Research Site
      • Ocala, Florida, Vereinigte Staaten
        • Research Site
      • Palm Harbor, Florida, Vereinigte Staaten
        • Research Site
      • Pinellas Park, Florida, Vereinigte Staaten
        • Research Site
      • Venice, Florida, Vereinigte Staaten
        • Research Site
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten
        • Research Site
    • Indiana
      • South Bend, Indiana, Vereinigte Staaten
        • Research Site
    • Kentucky
      • Bowling Green, Kentucky, Vereinigte Staaten
        • Research Site
      • Elizabethtown, Kentucky, Vereinigte Staaten
        • Research Site
    • Maryland
      • Oxon Hill, Maryland, Vereinigte Staaten
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, Vereinigte Staaten
        • Research Site
    • Missouri
      • Richmond Heights, Missouri, Vereinigte Staaten
        • Research Site
    • Montana
      • Kalispell, Montana, Vereinigte Staaten
        • Research Site
    • New Hampshire
      • Nashua, New Hampshire, Vereinigte Staaten
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Vereinigte Staaten
        • Research Site
      • Las Cruces, New Mexico, Vereinigte Staaten
        • Research Site
    • New York
      • Brooklyn, New York, Vereinigte Staaten
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Vereinigte Staaten
        • Research Site
    • Ohio
      • Perrysburg, Ohio, Vereinigte Staaten
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Vereinigte Staaten
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Vereinigte Staaten
        • Research Site
    • Tennessee
      • Jackson, Tennessee, Vereinigte Staaten
        • Research Site
      • Knoxville, Tennessee, Vereinigte Staaten
        • Research Site
      • Memphis, Tennessee, Vereinigte Staaten
        • Research Site
    • Texas
      • Austin, Texas, Vereinigte Staaten
        • Research Site
      • Houston, Texas, Vereinigte Staaten
        • Research Site
      • Mesquite, Texas, Vereinigte Staaten
        • Research Site
      • Plano, Texas, Vereinigte Staaten
        • Research Site
      • San Antonio, Texas, Vereinigte Staaten
        • Research Site
  • Vereinigtes Königreich
      • Basingstoke, Vereinigtes Königreich
        • Research Site
      • Eastbourne, Vereinigtes Königreich
        • Research Site
      • London, Vereinigtes Königreich
        • Research Site
      • Manchester, Vereinigtes Königreich
        • Research Site
      • Wolverhampton, Vereinigtes Königreich
        • Research Site
    • Berkshire
      • Reading, Berkshire, Vereinigtes Königreich
        • Research Site
    • Greater London
      • London, Greater London, Vereinigtes Königreich
        • Research Site
    • Sussex
      • Eastbourne, Sussex, Vereinigtes Königreich
        • Research Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Dosing Group A
Oral treatment and subcutaneous injection
Arzneimittel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Arzneimittel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Arzneimittel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Experimental: Dosing Group B
Oral treatment and subcutaneous injection
Arzneimittel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Arzneimittel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Arzneimittel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Experimental: Dosing Group C
Oral treatment and subcutaneous injection
Arzneimittel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Arzneimittel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Arzneimittel: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Aktiver Komparator: Dosing Group D
Oral treatment and subcutaneous injection
Arzneimittel: Adalimumab and placebo of fostamatinib
Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
Andere Namen:
  • Humira®
Placebo-Komparator: Dosing Group E
Oral treatment and subcutaneous injection
Arzneimittel: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
DAS28 EULAR Response at Week 6
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AstraZeneca

Ermittler

  • Studienleiter: Neil MacKillop, MD PhD, AstraZeneca

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2011

Primärer Abschluss (Tatsächlich)

1. Oktober 2012

Studienabschluss (Tatsächlich)

1. August 2013

Studienanmeldedaten

Zuerst eingereicht

17. Dezember 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Dezember 2010

Zuerst gepostet (Schätzen)

22. Dezember 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

6. Mai 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. April 2014

Zuletzt verifiziert

1. April 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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Bedingungen

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