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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Fostamatinib and placebo injections (Drug); Fostamatinib and placebo injections (Drug); Fostamatinib and placebo injections (Drug); Adalimumab and placebo of fostamatinib (Drug); Placebo of fostamatinib, fostamatinib, and placebo injections (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Neil MacKillop, MD PhD, Study Director, Affiliation: AstraZeneca

Summary

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

Clinical Details

Official title: (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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo

DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab

Secondary outcome:

DAS28 EULAR Response at Week 6

DAS28 EULAR Response at Week 24

Proportion of Patients Achieving ACR20 up to Week 24

Proportion of Patients Achieving ACR50 up to Week 24

Proportion of Patients Achieving ACR70 up to Week 24

ACRn - Comparison Between Fostamatinib and Placebo at Week 6

ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24

HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6

HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24

SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24

SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, 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, Brno, Czech Republic

Research Site, Bruntal, Czech Republic

Research Site, Hlucin, Czech Republic

Research Site, Liberec, Czech Republic

Research Site, Ostrava - Poruba, Czech Republic

Research Site, Ostrava - Trebovice, Czech Republic

Research Site, Ostrava, Czech Republic

Research Site, Praha 11, Czech Republic

Research Site, Praha 2, Czech Republic

Research Site, Praha 4, Czech Republic

Research Site, Praha, Czech Republic

Research Site, Zlin, Czech Republic

Research Site, Dresden, Germany

Research Site, Hamburg, Germany

Research Site, Muenchen, Germany

Research Site, Balatonfured, Hungary

Research Site, Balatonfüred, Hungary

Research Site, Budapest, Hungary

Research Site, Debrecen, Hungary

Research Site, Zalaegerszeg, Hungary

Research Site, Amsterdam, Netherlands

Research Site, Bytom, Poland

Research Site, Chelm Slaski, Poland

Research Site, Grodzisk Mazowiecki, Poland

Research Site, Sroda Wielkopolska, Poland

Research Site, Warszawa, Poland

Research Site, Wroclaw, Poland

Research Site, Zyrardow, Poland

Research Site, Łódź, Poland

Research Site, Moscow, Russian Federation

Research Site, Nizhny Novgorod, Russian Federation

Research Site, Petrozavodsk, Russian Federation

Research Site, Ryazan, Russian Federation

Research Site, St. Petersburg, Russian Federation

Research Site, Voronezh, Russian Federation

Research Site, Yaroslavl, Russian Federation

Research Site, Trebisov, Slovakia

Research Site, Trnava, Slovakia

Research Site, Cape Town, South Africa

Research Site, Durban, South Africa

Research Site, Pretoria, South Africa

Research Site, Stellenbosch, South Africa

Research Site, 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, Basingstoke, United Kingdom

Research Site, Eastbourne, United Kingdom

Research Site, London, United Kingdom

Research Site, Manchester, United Kingdom

Research Site, Wolverhampton, United Kingdom

Research Site, Birmingham, Alabama, United States

Research Site, Glendale, Arizona, United States

Research Site, Mesa, Arizona, United States

Research Site, Phoenix, Arizona, United States

Research Site, Scottsdale, Arizona, United States

Research Site, Reading, Berkshire, United Kingdom

Research Site, Huntington Beach, California, United States

Research Site, Long Beach, California, United States

Research Site, Colorado Springs, Colorado, United States

Research Site, Bridgeport, Connecticut, United States

Research Site, Daytona Beach, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Miami, Florida, United States

Research Site, Ocala, Florida, United States

Research Site, Palm Harbor, Florida, United States

Research Site, Pinellas Park, Florida, United States

Research Site, Venice, Florida, United States

Research Site, Pretoria, Gauteng, South Africa

Research Site, London, Greater London, United Kingdom

Research Site, Chicago, Illinois, United States

Research Site, South Bend, Indiana, United States

Research Site, Bowling Green, Kentucky, United States

Research Site, Elizabethtown, Kentucky, United States

Research Site, Durban, Kwazulu Natal, South Africa

Research Site, Oxon Hill, Maryland, United States

Research Site, Kalamazoo, Michigan, United States

Research Site, Richmond Heights, Missouri, United States

Research Site, Kalispell, Montana, United States

Research Site, Nashua, New Hampshire, United States

Research Site, Albuquerque, New Mexico, United States

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Research Site, Perrysburg, Ohio, United States

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Research Site, Eastbourne, Sussex, United Kingdom

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Research Site, Knoxville, Tennessee, United States

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Research Site, Houston, Texas, United States

Research Site, Mesquite, Texas, United States

Research Site, Plano, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Cape Town, Western Cape, South Africa

Additional Information

Starting date: January 2011
Last updated: April 3, 2014

Page last updated: August 23, 2015

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