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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 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
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Drug; Fostamatinib and placebo injections; Fostamatinib 100mg twice daily and placebo injection once every two weeks; Dosing Group A; Drug; Fostamatinib and placebo injections; Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks; Dosing Group B; Drug; Fostamatinib and placebo injections; Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.; Dosing Group C; Drug; Adalimumab and placebo of fostamatinib; Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.; Dosing Group D; Humira®; Drug; Placebo of fostamatinib, fostamatinib, and placebo injections; Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily / fostamatinib 150mg once daily. Placebo injection once every two weeks.; Dosing Group E
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Primary aim
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DAS28 score change from baseline to week 6 compared to placebo (DAS28 = Disease Activity Score based on a 28 joint count); DAS28 score change from baseline to week 24 compared to adalimumab
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Secondary Aim
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Review of efficacy based on the following criteria: DAS28, DAS28 response criteria, ACR20, ACR50, ACR70, ACR-N; 24 weeks; No; (ACR20 = American College of Rheumatology 20% response criteria) ACR50 = American College of Rheumatology 50% response criteria, ACR70 = American College of Rheumatology 70% response criteria, ACR N = numeric index of the ACR response); Health Assessment Questionnaire - Disability Index (HAQ-DI).; 24 weeks; No; 36-item Short Form Health Survey (SF-36) questionnaire; 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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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Reading, London, Eastbourne, Basingstoke, Manchester, Wolverhampton
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