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Health Condition(s) or Problem
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Rheumatoid Arthritis
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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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
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Primary aim
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Proportion of patients with ACR20 compared to placebo (ACR20 = American College of Rheumatology 20% response criteria)
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Secondary Aim
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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,; 24 Weeks; No; 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); 24 Weeks; No; Health Assessment Questionnaire - Disability Index (HAQ-DI).; 24 Weeks; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://www.oskirastudy.com
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Recruitment Status
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Completed
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Nation
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England
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Location
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Reading, Warrington, Maidstone, Eastbourne, Cambridge, Christchurch, Ipswich, London, Nottingham, Ilminster, Wirral
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