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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Rheumatoid Arthritis
Unfortunately contact details are not available for this trial.
Primary Contact Details
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.
Research Details
  • 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
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : fostamatinib, Drug : fostamatinib, Drug : placebo

Study Arm Groups : Dosing Regimen A, Dosing Regimen B, Dosing Regimen C

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
London
Nottingham
Cambridge
Research Site
Ipswich
Reading
Research Site
Maidstone
Wirral
Research Site
Warrington
Cheshire
Research Site
Eastbourne
East Sussex
Research Site
Christchurch
Research Site
Westcliff-on-the Sea
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Argentina, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Mexico, Portugal, South Africa, Spain, United Kingdom
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
D4300C00003
Sponsor(s)
AstraZeneca
Key Dates

Recruitment Start Date

Sep 2010

Recruitment End Date

Feb 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

08 Sep 2010

Last Updated

27 Feb 2014