Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared... | Completed
Evaluation of Effectiveness of Two ... | 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

Location not identified by Google services

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

Medical Conditions
  • Rheumatoid Arthritis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01197755
Primary Trial ID Number

We need your help to advance medical research

You can help accelerate the discovery of cures of medical conditions by signing up and creating a profile. By doing so you can register your interest in clinical trials and researchers will be able to get in touch about trials that are suitable for you.

This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Cambridge
Cambridgeshire
Local Institution
London
Greater London
Greenwood Medical Center
Nottingham
Reading Clinical Research Centre
Reading
Research Site
Warrington
Cheshire
Research Site
Christchurch
Research Site
Ipswich
Research Site
Southend-on-Sea
Research Site
Wirral
Maidstone Hospital and The Tunbridge Wells Hospital
Maidstone
Investigative site
Eastbourne
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Mexico, Portugal, South Africa, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 added to source

08 Sep 2010

Date updated in source

27 Feb 2014