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 | Completed
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
OSKIRA - 3
Trial Source

Health Conditions
  • Rheumatoid Arthritis
Completed
Recruitment Status
NCT01197755
Primary Trial ID Number
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 methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.
Primary Outcome Measures
  • Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo; 24 weeks
Secondary Outcome Measures
  • Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo; 1 week; Proportion of Patients Achieving ACR50 at Week 24, Comparison Between Fostamatinib and Placebo; 24 weeks; Proportion of Patients Achieving ACR70 at Week 24, Comparison Between Fostamatinib and Placebo; 24 weeks; ACRn - Comparison Between Fostamatinib and Placebo at Week 24; Baseline and 24 weeks; Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo; 24 weeks; Proportion of Patients Achieving DAS28-CRP <=3.2 at Week 12, Comparison Between Fostamatinib and Placebo; 12 weeks; Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24, Comparison Between Fostamatinib and Placebo; 24 weeks; Proportion of Patients With a HAQ-DI Response at Week 24 - Comparison Between Fostamatinib and Placebo; 24 weeks; Change From Baseline to Week 24 in mTSS Score, Comparison Between Fostamatinib and Placebo; Baseline and 24 weeks; SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24; Baseline and 24 weeks; SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24; Baseline and 24 weeks
Research Question
  • 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 methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
United States; Argentina; Belgium; Brazil; Canada; Czech Republic; France; Germany; Hungary; Israel; Italy; Mexico; Portugal; South Africa; Spain; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Active rheumatoid arthritis (RA) diagnosed after the age of 16
  • - Currently taking methotrexate
  • - 6 or more swollen joints and 6 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 12months 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 anakinra or previous treatment with biological agent
  • (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)
  • - Severe renal impairment
  • - Neutropenia
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - Active rheumatoid arthritis (RA) diagnosed after the age of 16
  • - Currently taking methotrexate
  • - 6 or more swollen joints and 6 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 12months 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 anakinra or previous treatment with biological agent
  • (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)
  • - Severe renal impairment
  • - Neutropenia
Interventions
Drug; fostamatinib; fostamatinib 100 mg twice daily; [Dosing Regimen A]; Drug; fostamatinib; fostamatinib 100 mg twice daily/150 mg once daily; [Dosing Regimen B]; Drug; placebo; Placebo twice daily; [Dosing Regimen C]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
OSKIRA - 3
Scientific Title
(OSKIRA-3): 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 Inadequate Response to a TNF-alpha Antagonist
Secondary Trial Identifying Number
2010-020745-27
Website
http://www.oskirastudy.com; http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=419&filename=CSR-D8480C00030.pdf; http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1201&filename=CSR-D1700C00001.pdf
Study Funded By
AstraZeneca
Funder Type
Sorry, this information is not available
Study Sponsored By
AstraZeneca
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

08 Sep 2010

Last Updated

27 Feb 2014

Date Record Refreshed on UKCTG

31 Jul 2015