Clinical trial NCT01569074: Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis
Official title: (OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 163
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 four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 12 weeks.

Detailed description: (OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients with Active Rheumatoid Arthritis who are Inadequate Responders to Methotrexate Therapy

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 and over
* Active rheumatoid arthritis (RA) diagnosed after the age of 16
* 6 or more swollen joints and 6 or more tender/painful joints from certain joints in the hands, wrists, arms and knees
* At least one of: positive result for rheumatoid factor test, either in the past or currently (blood test); x-ray showing bone erosion within the last 12 months; presence of certain antibodies in the blood (blood test)
* Currently taking methotrexate for at least 4 months (and on a stable dose for at least 6 weeks)

Exclusion Criteria:

* Females who are pregnant or breast feeding
* Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders.
* Previously taken, but not responded to, certain biological treatments for rheumatoid arthritis
* High blood pressure that is not controlled by medication
* Low levels of neutrophils in the blood (blood test).

Primary outcomes:
measure: Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo
timeFrame: 1 week
measure: Proportion of Patients Achieving ACR50 at Week 12, Comparison Between Fostamatinib and Placebo
timeFrame: 12 weeks
measure: Proportion of Patients Achieving ACR70 at Week 12, Comparison Between Fostamatinib and Placebo
timeFrame: 12 weeks
measure: ACRn - Comparison Between Fostamatinib and Placebo at Week 12
timeFrame: Baseline and 12 weeks
measure: Proportion of Patients Achieving DAS28-CRP<=3.2 at Week 12, Comparison Between Fostamatinib and Placebo
timeFrame: 12 weeks
measure: Proportion of Patients With DAS28-CRP EULAR Response at Week 12, Comparison Between Fostamatinib and Placebo
timeFrame: 12 weeks
measure: Proportion of Patients With HAQ-DI Response at Week 12, Comparison Between Fostamatinib and Placebo
timeFrame: 12 weeks
measure: SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 12
timeFrame: Baseline and 12 weeks
measure: SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 12
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: New Territories
country: Hong Kong
facility: Research Site
state: HK
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume
country: Japan
facility: Research Site
state: Fukuoka
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Kato-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kasama-shi
country: Japan
facility: Research Site
state: Ibaraki
city: Kumamoto-shi
country: Japan
facility: Research Site
state: Kumamoto
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Isahaya
country: Japan
facility: Research Site
state: Nagasaki
city: Nagasaki-shi
country: Japan
facility: Research Site
state: Nagasaki
city: Omura-shi
country: Japan
facility: Research Site
state: Nagasaki
city: Sasebo-shi
country: Japan
facility: Research Site
state: Nagasaki
city: Shibata
country: Japan
facility: Research Site
state: Niigata
city: Okayama-shi
country: Japan
facility: Research Site
state: Okayama
city: Tomigusuku-shi
country: Japan
facility: Research Site
state: Okinawa
city: Matsue-shi
country: Japan
facility: Research Site
state: Shimane
city: Hamamatsu-shi
country: Japan
facility: Research Site
state: Shizuoka
city: Itabashi
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokyo
city: Nagasaki
country: Japan
facility: Research Site
city: Anyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Chiayi
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Singapore
country: Thailand
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Neil - Mackillop, MD
role: STUDY_DIRECTOR
References:
citation: Tanaka Y, Millson D, Iwata S, Nakayamada S. Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study. Rheumatology (Oxford). 2021 Jun 18;60(6):2884-2895. doi: 10.1093/rheumatology/keaa732.