Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.
NCT ID: NCT01197534
Last Updated: 2014-04-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
913 participants
INTERVENTIONAL
2010-09-30
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.
NCT01197521
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist
NCT01197755
Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)
NCT01264770
Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis
NCT01569074
Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
NCT01242514
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Full title: Optional Genetic Research
Date: 18 June 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 methotrexate; and/or susceptibility to, progression of and prognosis of RA
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dosing Regimen A
Oral Treatment
fostamatinib
fostamatinib 100 mg twice daily
Dosing Regimen B
Oral Treatment
fostamatinib
fostamatinib 100 mg twice daily/ 150 mg once daily
Dosing Regimen C
Oral Treatment
placebo, fostamatinib
Placebo for 24 weeks followed by fostamatinib 100 mg twice daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fostamatinib
fostamatinib 100 mg twice daily
fostamatinib
fostamatinib 100 mg twice daily/ 150 mg once daily
placebo, fostamatinib
Placebo for 24 weeks followed by fostamatinib 100 mg twice daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine
* 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 one of the following: documented history of positive rheumatoid factor (blood test), current presence of 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
* 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
* Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent
* Severe renal impairment
* Neutropenia
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neil MacKillop, MD PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Tucson, Arizona, United States
Research Site
Hot Springs, Arkansas, United States
Research Site
Huntington Beach, California, United States
Research Site
Torrance, California, United States
Research Site
Trumbull, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Boca Raton, Florida, United States
Research Site
Brandon, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Venice, Florida, United States
Research Site
Zephyrhills, Florida, United States
Research Site
Canton, Georgia, United States
Research Site
Decatur, Georgia, United States
Research Site
Macon, Georgia, United States
Research Site
Boise, Idaho, United States
Research Site
South Bend, Indiana, United States
Research Site
Elizabethtown, Kentucky, United States
Research Site
Crofton, Maryland, United States
Research Site
Cumberland, Maryland, United States
Research Site
Hagerstown, Maryland, United States
Research Site
Kalamazoo, Michigan, United States
Research Site
Flowood, Mississippi, United States
Research Site
St Louis, Missouri, United States
Research Site
Kalispell, Montana, United States
Research Site
Omaha, Nebraska, United States
Research Site
Manalapan, New Jersey, United States
Research Site
Las Cruces, New Mexico, United States
Research Site
Brooklyn, New York, United States
Research Site
Rochester, New York, United States
Research Site
Roslyn, New York, United States
Research Site
Syracuse, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
Research Site
Dayton, Ohio, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
West Reading, Pennsylvania, United States
Research Site
Greenville, South Carolina, United States
Research Site
Orangeburg, South Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Amarillo, Texas, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Lubbock, Texas, United States
Research Site
Mesquite, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Chesapeake, Virginia, United States
Research Site
Tacoma, Washington, United States
Research Site
Edmonton, Alberta, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Bowmanville, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Trois-Rivières, Quebec, Canada
Research Site
Reading, , Canada
Research Site
Brno, , Czechia
Research Site
Bruntál, , Czechia
Research Site
Česká Lípa, , Czechia
Research Site
České Budějovice, , Czechia
Research Site
Hlučín, , Czechia
Research Site
Liberec, , Czechia
Research Site
Ostrava - Trebovice, , Czechia
Research Site
Prague, , Czechia
Research Site
Sokolov, , Czechia
Research Site
Terezín, , Czechia
Research Site
Zlín, , Czechia
Research Site
Erlangen, , Germany
Research Site
Hamburg, , Germany
Research Site
München, , Germany
Research Site
Hyderabad, Andhra Pradesh, India
Research Site
Ahmedabad, Gujarat, India
Research Site
Gandhinagar, Gujarat, India
Research Site
Vadodara, Gujarat, India
Research Site
Bangalore, Karnataka, India
Research Site
Mangalore, Karnataka, India
Research Site
Mumbai, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
Coimbatore, Tamil Nadu, India
Research Site
Madurai, Tamil Nadu, India
Research Site
Lucknow, , India
Research Site
Ashkelon, , Israel
Research Site
Beer Yaakov, , Israel
Research Site
Haifa, , Israel
Research Site
Kfar Saba, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Ramat Gan, , Israel
Research Site
Rehovot, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Iesi, AN, Italy
Research Site
Legnano, MI, Italy
Research Site
Udine, UD, Italy
Research Site
Varese, VA, Italy
Research Site
Liepāja, , Latvia
Research Site
Riga, , Latvia
Research Site
Valmiera, , Latvia
Research Site
Kaunas, , Lithuania
Research Site
Klaipėda, , Lithuania
Research Site
Šiauliai, , Lithuania
Research Site
Aveiro, , Portugal
Research Site
Lisbon, , Portugal
Research Site
Porto, , Portugal
Research Site
Baia Mare, , Romania
Research Site
Brailari, , Romania
Research Site
Bucharest, , Romania
Research Site
Ploieşti, , Romania
Research Site
Belgrade, , Serbia
Research Site
Kragujevac, , Serbia
Research Site
Niška Banja, , Serbia
Research Site
Novi Sad, , Serbia
Research Site
Kempron Park, Gauteng, South Africa
Research Site
Pretoria, Gauteng, South Africa
Research Site
Durban, Kz-natal, South Africa
Research Site
Cape Town, W Cape, South Africa
Research Site
Port Elizabeth, , South Africa
Research Site
Stellenbosch, , South Africa
Research Site
La Laguna (tenerife), Canary Islands, Spain
Research Site
Mérida, Extremadura, Spain
Research Site
Barcelona, , Spain
Research Site
Getafe, , Spain
Research Site
Kharkiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Lutsk, , Ukraine
Research Site
Lviv, , Ukraine
Research Site
Simferopol, , Ukraine
Research Site
Vinnytsia, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Research Site
Zaporyzhzhya, , Ukraine
Research Site
Maidstone, Kent, United Kingdom
Research Site
Eastbourne, Sussex, United Kingdom
Research Site
Solihull, West Midlands, United Kingdom
Research Site
Basingstoke, , United Kingdom
Research Site
Cambridge, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Newcastle upon Tyne, , United Kingdom
Research Site
Stoke-on-Trent, , United Kingdom
Research Site
Swindon, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-020744-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4300C00002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.