Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020744-35-GB

Enrollment

900

Registered

2010-07-05

Start date

2010-10-26

Completion date

Unknown

Last updated

2013-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Fostamatinib disodium Product Code: FosD Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fostamatinib disodium CAS Number: 914295-16-2 Current Sponsor code: FosD Other desc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Male or female aged 18 and over 2. A diagnosis of RA after the age of 16 3. Currently taking 1 of the following traditional DMARDs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine. 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 810 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: 1.Females who are pregnant/lactating 2.Any systemic inflammatory conditions(other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data 3. Poorly controlled blood pressure 4.History of liver function abnormality requiring investigation, drug induced liver injury, chronic liver disease, excessive alcohol consumption/chronic alcohol induced disease

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 (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 a disease-modifying anti-rheumatic drug (DMARD), compared with placebo plus a DMARD, in patients with active rheumatoid arthritis (RA).;Secondary Objective: The secondary objectives of the study assessed over the 52-week study period are: •To assess the efficacy of fostamatinib in the prevention of structural joint damage, as measured by change in radiographic modified Total Sharp Score (mTSS) and the components of mTSS at Week 24 and Week 52. •To further assess the efficacy of fostamatinib 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 fostamatinib using the Health Assessment Questionnaire - Disability Index (HAQ-DI). •To evaluate the efficacy of fostamatinib as measured by Disease Activity Score based on a 28 joint count (DAS28) and DAS28 European League Against Rheumatism (EULAR) response criteria. •To investigate the effects of fostamatinib on patient reported health outcomes measures.;Primary end point(s): The primary endpoint in this study is the proportion of patients achieving ACR20 at Week 24.;Timepoint(s) of evaluation of this end point: Week 24	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the efficacy of 2 oral dosing regimens of fostamatinib (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 a disease-modifying anti-rheumatic drug (DMARD), compared with placebo plus a DMARD, in patients with active rheumatoid arthritis (RA).;Secondary Objective: The secondary objectives of the study assessed over the 52-week study period are: •To assess the efficacy of fostamatinib in the prevention of structural joint damage, as measured by change in radiographic modified Total Sharp Score (mTSS) and the components of mTSS at Week 24 and Week 52. •To further assess the efficacy of fostamatinib 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 fostamatinib using the Health Assessment Questionnaire - Disability Index (HAQ-DI). •To evaluate the efficacy of fostamatinib as measured by Disease Activity Score based on a 28 joint count (DAS28) and DAS28 European League Against Rheumatism (EULAR) response criteria. •To investigate the effects of fostamatinib on patient reported health outcomes measures.;Primary end point(s): The primary endpoint in this study is the proportion of patients achieving ACR20 at Week 24.;Timepoint(s) of evaluation of this end point: Week 24

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Secondary

Measure	Time frame
Secondary end point(s): - mTSS, radiographic erosion score (ES) and joint space narrowing (JSN). - ACR20, ACR50, ACR70, major clinical response, 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 - DAS28 response, DAS28 EULAR response criteria, DAS low disease activity, DAS28 remission, clinically important change in DAS28 score.;Timepoint(s) of evaluation of this end point: Secondary timepoints are: Screening plus week 0-6, 12, 24, 28, 36 and 52. For mTSS JSN (X-ray) timepoints 0, 12, 24 and 52	—

Measure

Time frame

Secondary end point(s): - mTSS, radiographic erosion score (ES) and joint space narrowing (JSN). - ACR20, ACR50, ACR70, major clinical response, 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 - DAS28 response, DAS28 EULAR response criteria, DAS low disease activity, DAS28 remission, clinically important change in DAS28 score.;Timepoint(s) of evaluation of this end point: Secondary timepoints are: Screening plus week 0-6, 12, 24, 28, 36 and 52. For mTSS JSN (X-ray) timepoints 0, 12, 24 and 52

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Countries

Canada, Czech Republic, Germany, India, Israel, Italy, Latvia, Lithuania, Portugal, Romania, Serbia, South Africa, Spain, Ukraine, United Kingdom, United States

Contacts

Public ContactInformation Centre

AstraZeneca AB

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026