Rheumatoid arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Fostamatinib disodium
Product Code: previously known as R935788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib disodium
CAS Number: 914295-16-2
Other descripti
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provision of informed consent, prior to any study-specific procedures. 2) Male or female aged 18 and over. 3) Diagnosis of RA, after the age of 16 according to the revised (1987) criteria of the American College of Rheumatology and one of the following: -diagnosis within 5 years prior to Visit 1 and inadequate response to treatment with a maximum of 2 of the following DMARD therapies: methotrexate, leflunomide, sulfasalazine, azathioprine, cyclosporine, gold, penacillamine, minocycline, mycophenolate, cyclophosphamide, tacrolimus or doxycycline or -diagnosis within 5 years prior to Visit 1 and intolerance to DMARD therapy or -diagnosis within 2 years prior to Visit 1 and no previous use of DMARDs. 4) Active RA defined as: - =4 swollen joints and =4 tender/painful joints (from 28 joint count) and either: - ESR =28 mm/h, or - CRP =10 mg/L 5) At least 2 of the following: -Documented history or current presence of positive rheumatoid factor (RF) -Radiographic erosion within 12 months prior to enrolment -Presence of serum anti-cyclic citrullinated peptide antibodies (anti CCP). 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 252 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: 1) Use of any DMARDs within 6 weeks prior to Visit 1 2) Patients who have 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 3) Females who are pregnant or lactating 4) Any systemic inflammatory conditions (other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data. 5) Poorly controlled blood pressure 6) History of liver problems that have required previous investigation 7) Evidence of recent or significant CV disease, active or recent infection or evidence of tuberculosis infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: •To evaluate the efficacy of 3 oral dosing regimens of fostamatinib compared with placebo when used as monotherapy in patients with active rheumatoid arthritis (RA) by assessment of: The signs and symptoms of RA, as measured by Disease Activity Score based on a 28 joint count (DAS28) at Week 6. •To evaluate whether the efficacy of 3 oral dosing regimens of fostamatinib are non-inferior to that of adalimumab (Humira®) when used as monotherapy in patients with active RA by assessment of: The signs and symptoms of RA, as measured by DAS28 at Week 24. ;Secondary Objective: The secondary objectives of the study are: •To further assess the efficacy of fostamatinib measured by DAS28, DAS28 response criteria, American College of Rheumatology 20% response criteria (ACR20), ACR 50% response criteria (ACR50), ACR 70% response criteria (ACR70), ACR-N and the individual components of the ACR score. •To assess physical function status of patients after administration of fostamatinib using the Health Assessment Questionnaire - Disability Index (HAQ-DI). •To investigate the effects of fostamatinib on health-related quality of life using the 36-item Short Form Health Survey (SF-36) questionnaire.;Primary end point(s): The primary endpoints in this study are the signs and symptoms of RA, as measured by DAS28 at Week 6 and DAS28 at Week 24.;Timepoint(s) of evaluation of this end point: Week 6 and 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome variables: - DAS28 score, DAS28 response criteria, DAS low disease activity, DAS28 remission, clinically important change in DAS28 score - ACR20, ACR50, ACR70, ACR-N, individual components of ACR (swollen joint count, tender joint count, patient’s assessment of pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, patient’s assessment of physical function, as measured by the HAQ-DI, C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]) - HAQ-DI score; HAQ-DI response, individual dimensions of HAQ-DI.;Timepoint(s) of evaluation of this end point: Secondary timepoints are: Screening plus week 0 to 6, 12, 18 and 24. | — |
Countries
Bulgaria, Canada, Czech Republic, Germany, Hungary, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Ukraine, United Kingdom, United States
Contacts
Public ContactInformation Centre
AstraZeneca AB
Outcome results
None listed