None listed
Conditions
Interventions
Group 1 Type of group
fostamatinib 100 mg twice daily
Group name:Group 3 Type of group
Placebo for 24 weeks followed by fostamatinib 100 mg twice daily
Sponsors
AstraZeneca AB,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Provide informed consent, before any specific study procedure. • Men or women 18 years of age or older with a diagnosis of RA after 16 years of age, according to the modified criteria (1987) of the North American College of Rheumatology. • AR active • Documented history of positive rheumatoid factor • Current presence of rheumatoid factor • Radiographic erosion in the 12 months prior to enrollment • Presence of cyclic citrullinated anti-peptide (anti-CCP) antibodies in serum. • Treatment with oral, subcutaneous or intramuscular methotrexate for at least 6 months before randomization. The dose and route of administration of methotrexate should have been stable between 7.5 mg and 25 mg per week for at least 6 weeks before randomization. Patients receiving lower doses of methotrexate (7.5 mg and 10 mg) should receive them as a result of a documented history of intolerance at higher doses of methotrexate.
Exclusion criteria
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 a TNF alpha antagonist, anakinra or previous treatment with other biological agent • Severe renal impairment • Neutropenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patients own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day. Measure:Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo Timepoints:24 weeks ; Outcome name:mTSS: modified total Sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day. Measure:Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo Timepoints:Baseline and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patients own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally. Measure:ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1 Timepoints:Week 1 ; Outcome name:ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patients own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day. Measure:Proportion of Patients Achieving ACR50 up to Week 24 Timepoints:Week 24 ; Outcome name:ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patients own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day. Measure:Proportion of Patients Achieving ACR70 up to Week 24 Timepoints:24 weeks ; Outcome name:ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or | — |
Countries
Bulgaria, Estonia, France, Germany, Hungaria, Peru, Poland, United Kindgdom
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed