Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female aged 18 and over 2) Active Rheumatoid Arthritis (RA) diagnosed after the age of 16 3) Currently taking Methotrexate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Females who are pregnant or breast feeding 2) Poorly controlled blood pressure 3) History of liver problems that have required previous investigation 4) Certain Inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of 2 oral dosing regimens of fostamatinib disodium (FosD) (Regimen A - 100 mg twice daily (bid); Regimen B - induction with 100 mg bid for the first 4 weeks, 150 mg once daily (qd) maintenance thereafter) taken in combination with methotrexate, compared with placebo plus methotrexate, in patients with active rheumatoid arthritis (RA) by assessment of: • The signs and symptoms of RA, as measured by American College of Rheumatology 20% response criteria (ACR20) at Week 24. • The prevention of structural joint damage, as measured by change in radiographic modified total Sharp score (mTSS) at Week 24. ;Secondary Objective: The secondary objectives of the study assessed over the 52-week study period are: • To further assess the efficacy of FosD measured by ACR20, ACR 50% response criteria (ACR50), ACR 70% response criteria (ACR70), major clinical response, ACR-N and the individual components of the ACR score. • To assess physical function status of patients after administration of FosD using the Health Assessment Questionnaire - Disability Index (HAQ-DI). • To evaluate the efficacy of FosD as measured by Disease Activity Score based on a 28 joint count (DAS28) and DAS28 European League Against Rheumatism (EULAR) response criteria. • To further assess the efficacy of FosD in the prevention of structural joint damage, as measured by change in the components of modified Total Sharp Score (mTSS). • To investigate the effects of FosD on patient reported health outcomes measures.;Primary end point(s): There are 2 primary endpoints in this study: the proportion of patients achieving ACR20 at Week 24 and prevention of structural joint damage, as measured by change in radiographic modified total Sharp score mTSS at Week 24. These will be assessed for each dose regimen versus placebo. A hierarchical (fixed sequence) approach will be used within each dosing regimen (ACR20 and then mTSS), and the Hochb | — |
Countries
Belgium, Bulgaria, Estonia, France, Germany, Hungary, Poland, Slovakia, United Kingdom
Outcome results
None listed