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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2013
• Main ID: NCT01197755
• Date of registration: 08/09/2010
• Primary sponsor: AstraZeneca
• Public title: 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
• 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
• Date of first enrolment: September 2010
• Target sample size: 322
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01197755
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Mexico, Portugal, South Africa, Spain, United Kingdom, United States

Contacts

• Name: Chris O'Brien, MD PhD
• Affiliation: AstraZeneca

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: fostamatinib

Drug: placebo

Primary Outcome(s)

Proportion of patients with ACR20 compared to placebo (ACR20 = American College of Rheumatology 20% response criteria) [Time Frame: 24 Weeks]

Secondary Outcome(s)

Health Assessment Questionnaire - Disability Index (HAQ-DI). [Time Frame: 24 Weeks]

Proportion of patients with ACR20, ACR50, ACR70, ACR-N compared to placebo (ACR50 = American College of Rheumatology 50% response criteria, ACR70 = American College of Rheumatology 70% response criteria, [Time Frame: 24 Weeks]

Proportion of patients with DAS28 and DAS28 EULAR response criteria compared to baseline (DAS28 = Disease Activity Score based on a 28 joint count; EULAR = European League Against Rheumatism) [Time Frame: 24 Weeks]

Secondary ID(s)

2010-020745-27

D4300C00003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors