Clinical trial NCT01197534: 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.
Official title: (OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to DMARDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 913
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the 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. The study will last for 1 year.

Detailed description: Sub-study:

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

Eligibility criteria: Inclusion Criteria:

* Active rheumatoid arthritis (RA) diagnosed after the age of 16
* 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:

* 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
* Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent
* Severe renal impairment
* Neutropenia

Primary outcomes:
measure: Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1
timeFrame: 1 week
measure: Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24
timeFrame: 24 weeks
measure: Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24
timeFrame: 24 weeks
measure: ACRn - Comparison Between Fostamatinib and Placebo at Week 24
timeFrame: Baseline and 24 weeks
measure: Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo
timeFrame: 12 weeks
measure: Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo
timeFrame: 24 weeks
measure: Proportion of Patients Achieving DAS28 EULAR Response at Week 24
timeFrame: 24 weeks
measure: HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24
timeFrame: Baseline and 24 weeks
measure: Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo
timeFrame: Baseline and 24 weeks
measure: SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24
timeFrame: Baseline and 24 weeks
measure: SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Hot Springs
country: United States
facility: Research Site
state: Arkansas
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Trumbull
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Brandon
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
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state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Venice
country: United States
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state: Florida
city: Zephyr Hills
country: United States
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state: Florida
city: Canton
country: United States
facility: Research Site
state: Georgia
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
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state: Georgia
city: Boise
country: United States
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state: Idaho
city: South Bend
country: United States
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state: Indiana
city: Elizabethtown
country: United States
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state: Kentucky
city: Crofton
country: United States
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state: Maryland
city: Cumberland
country: United States
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state: Maryland
city: Hagerstown
country: United States
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state: Maryland
city: Kalamazoo
country: United States
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state: Michigan
city: Flowood
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state: Mississippi
city: St. Louis
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state: Missouri
city: Kalispell
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state: Montana
city: Omaha
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city: Manalapan
country: United States
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city: Las Cruces
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state: New Mexico
city: Brooklyn
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city: Rochester
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city: Roslyn
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state: New York
city: Syracuse
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city: Charlotte
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state: North Carolina
city: Durham
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city: Dayton
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city: Duncansville
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city: Philadelphia
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city: West Reading
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city: Orangeburg
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city: Amarillo
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city: Austin
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city: Mesquite
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city: Edmonton
country: Canada
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city: Winnipeg
country: Canada
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state: Manitoba
city: Bowmanville
country: Canada
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city: Hamilton
country: Canada
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city: Mississauga
country: Canada
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city: Ottawa
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city: Toronto
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city: Montreal
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city: Trois-rivieres
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state: Quebec
city: Quebec
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city: Reading
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city: Brno
country: Czech Republic
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city: Bruntal
country: Czech Republic
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city: Ceska Lipa
country: Czech Republic
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city: Ceske Budejovice
country: Czech Republic
facility: Research Site
city: Hlucin
country: Czech Republic
facility: Research Site
city: Liberec
country: Czech Republic
facility: Research Site
city: Ostrava - Trebovice
country: Czech Republic
facility: Research Site
city: Praha 11
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
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city: Praha 4
country: Czech Republic
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city: Praha
country: Czech Republic
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city: Sokolov
country: Czech Republic
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city: Terezin
country: Czech Republic
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city: Zlin
country: Czech Republic
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Gandhinagar
country: India
facility: Research Site
state: Gujarat
city: Vadodara
country: India
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state: Gujarat
city: Bangalore
country: India
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state: Karnataka
city: Mangalore
country: India
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state: Karnataka
city: Mumbai
country: India
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state: Maharashtra
city: Pune
country: India
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state: Maharashtra
city: Coimbatore
country: India
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state: Tamil Nadu
city: Madurai
country: India
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state: Tamil Nadu
city: Lucknow
country: India
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city: Ashkelon
country: Israel
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city: Beer Yaakov
country: Israel
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city: Haifa
country: Israel
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city: Kfar-saba
country: Israel
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country: Israel
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city: Ramat Gan
country: Israel
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city: Ramat-gan
country: Israel
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city: Rehovot
country: Israel
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city: Tel Aviv
country: Israel
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city: Jesi
country: Italy
facility: Research Site
state: AN
city: Legnano
country: Italy
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state: MI
city: Udine
country: Italy
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state: UD
city: Varese
country: Italy
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state: VA
city: Liepaja
country: Latvia
facility: Research Site
city: Riga
country: Latvia
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city: Valmiera
country: Latvia
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city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Siauliai
country: Lithuania
facility: Research Site
city: Aveiro
country: Portugal
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city: Lisboa
country: Portugal
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city: Porto
country: Portugal
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city: Baia Mare
country: Romania
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city: Brailari
country: Romania
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city: Bucharest
country: Romania
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city: Bucuresti
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Niska Banja
country: Serbia
facility: Research Site
city: Novi Sad
country: Serbia
facility: Research Site
city: Kempron Park
country: South Africa
facility: Research Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Research Site
state: Gauteng
city: Durban
country: South Africa
facility: Research Site
state: Kz-natal
city: Cape Town
country: South Africa
facility: Research Site
state: W Cape
city: Port Elizabeth
country: South Africa
facility: Research Site
city: Stellenbosch
country: South Africa
facility: Research Site
city: La Laguna (tenerife)
country: Spain
facility: Research Site
state: Canarias
city: Merida
country: Spain
facility: Research Site
state: Extremadura
city: Barcelona
country: Spain
facility: Research Site
city: Getafe
country: Spain
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lutsk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Simferopol
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
city: Zaporyzhzhya
country: Ukraine
facility: Research Site
city: Maidstone
country: United Kingdom
facility: Research Site
state: Kent
city: Eastbourne
country: United Kingdom
facility: Research Site
state: Sussex
city: Solihull
country: United Kingdom
facility: Research Site
state: West Midlands
city: Basingstoke
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
city: Stoke on Trent
country: United Kingdom
facility: Research Site
city: Swindon
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Neil MacKillop, MD PhD
role: STUDY_DIRECTOR
References: