Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) | Stopped
Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)
OSKIRA -4
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
Stopped
Recruitment Status
NCT01264770
Primary Trial ID Number
Summary
The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The study will last for approximately six months
Research Details
  • Sub-study: Full title: Optional Genetic Research Date: 10 September 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 adalimumab; and/or susceptibility to, progression of and prognosis of RA The main study recruitment is complete, and sub study recruitment will continue until the target is reached, estimated to be June 2013 Sub-study: Full title: (Sub-study to OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study Date: 21 March 2011 Version: 1 Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by: - Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.
Phase
Phase 2
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 and placebo injections, Drug : Fostamatinib and placebo injections, Drug : Fostamatinib and placebo injections, Drug : Adalimumab and placebo of fostamatinib, Drug : Placebo of fostamatinib, fostamatinib, and placebo injections

Study Arm Groups : Dosing Group A, Dosing Group B, Dosing Group C, Dosing Group D, Dosing Group E

Intervention Type
See Interventions above
Primary Outcome Measures
  • DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo; Baseline and 6 weeks; DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab; Baseline and 24 weeks
Secondary Outcome Measures
  • DAS28 EULAR Response at Week 6; 6 weeks; DAS28 EULAR Response at Week 24; 24 weeks; Proportion of Patients Achieving ACR20 up to Week 24; 6 and 24 weeks; Proportion of Patients Achieving ACR50 up to Week 24; 6 and 24 weeks; Proportion of Patients Achieving ACR70 up to Week 24; 6 and 24 weeks; ACRn - Comparison Between Fostamatinib and Placebo at Week 6; Baseline and 6 weeks; ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24; Baseline and 24 weeks; HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6; Baseline and 6 weeks; HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24; Baseline and 24 weeks; SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24; Baseline and 24 weeks; SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab 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:
  • - Male or female aged 18 and over
  • - Active rheumatoid arthritis (RA) diagnosed after the age of 16 and diagnosis within 5
  • years prior to study visit 1 and inadequate response to treatment with a maximum 2
  • Disease-Modifying anti-rheumatic drug (DMARD) therapies, or diagnosis within 5 years
  • prior to study visit 1 and intolerance to DMARD therapy, or diagnosis within 2 years
  • prior to study visit 1 and no previous use of DMARDs
  • - 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 2 of the following: documented history or current presence of positive
  • 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
  • - Previously received treatment with a TNF alpha antagonist (including etanercept,
  • certolizumab, adalimumab, infliximab, golimumab) or anakinra or previous treatment
  • with other biological agent including rituximab, abatacept and tocilizumab
  • - Use of any DMARDs within 6 weeks before first study visit
  • - Severe renal impairment
  • - Neutropenia
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
London
Manchester
Research Site
Wolverhampton
Reading
Basingstoke Hospital
Basingstoke
Research Site
Eastbourne
East Sussex
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, Bulgaria, Canada, Czech Republic, Germany, Hungary, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Ukraine, United Kingdom
Scientific Title
(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
D4300C00004
Sponsor(s)
AstraZeneca
Key Dates

Recruitment Start Date

Jan 2011

Recruitment End Date

Oct 2012

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

17 Dec 2010

Last Updated

03 Apr 2014