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Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

Primary Purpose

Rheumatoid Arthritis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Fostamatinib and placebo injections

Adalimumab and placebo of fostamatinib

Placebo of fostamatinib, fostamatinib, and placebo injections

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, OSKIRA, fostamatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dosing Group A

Dosing Group B

Dosing Group C

Dosing Group D

Dosing Group E

Arm Description

Oral treatment and subcutaneous injection

Outcomes

Primary Outcome Measures

DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo

DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.

DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab

DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.

Secondary Outcome Measures

DAS28 EULAR Response at Week 6

Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.

DAS28 EULAR Response at Week 24

Proportion of Patients Achieving ACR20 up to Week 24

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 patient's 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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.

Proportion of Patients Achieving ACR50 up to Week 24

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 patient's 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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.

Proportion of Patients Achieving ACR70 up to Week 24

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 patient's 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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.

ACRn - Comparison Between Fostamatinib and Placebo at Week 6

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 in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 6. Treatment difference: difference between fostamatinib and placebo groups.

ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24

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 in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. 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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 24. Treatment difference: difference between fostamatinib and adalimumab groups.

HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6

HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.

HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24

SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24

SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.

SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24

Full Information

NCT ID

NCT01264770

First Posted

December 17, 2010

Last Updated

April 3, 2014

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01264770

Brief Title

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)

Acronym

OSKIRA -4

Official Title

(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.

Study Start Date

January 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

Sub-study: Full title: Optional Genetic Research Date: 10 September 2010 Version: 1 Objectives: To collect and store, with appropriate consent , DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or adalimumab; and/or susceptibility to, progression of and prognosis of RA The main study recruitment is complete, and sub study recruitment will continue until the target is reached, estimated to be June 2013 Sub-study: Full title: (Sub-study to OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study Date: 21 March 2011 Version: 1 Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by: Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, OSKIRA, fostamatinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

644 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dosing Group A

Arm Type

Experimental

Arm Description

Oral treatment and subcutaneous injection

Arm Title

Dosing Group B

Arm Type

Experimental

Arm Description

Oral treatment and subcutaneous injection

Arm Title

Dosing Group C

Arm Type

Experimental

Arm Description

Oral treatment and subcutaneous injection

Arm Title

Dosing Group D

Arm Type

Active Comparator

Arm Description

Oral treatment and subcutaneous injection

Arm Title

Dosing Group E

Arm Type

Placebo Comparator

Arm Description

Oral treatment and subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Fostamatinib and placebo injections

Intervention Description

Fostamatinib 100mg twice daily and placebo injection once every two weeks

Intervention Type

Drug

Intervention Name(s)

Fostamatinib and placebo injections

Intervention Description

Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks

Intervention Type

Drug

Intervention Name(s)

Fostamatinib and placebo injections

Intervention Description

Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.

Intervention Type

Drug

Intervention Name(s)

Adalimumab and placebo of fostamatinib

Other Intervention Name(s)

Humira®

Intervention Description

Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.

Intervention Type

Drug

Intervention Name(s)

Placebo of fostamatinib, fostamatinib, and placebo injections

Intervention Description

Placebo injection once every two weeks. Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily (Group F) / fostamatinib 100mg twice daily then 150mg once daily (Group G).

Primary Outcome Measure Information:

Title

DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo

Description

Time Frame

Baseline and 6 weeks

Title

DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab

Description

DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.

Time Frame

Baseline and 24 weeks

Secondary Outcome Measure Information:

Title

DAS28 EULAR Response at Week 6

Description

Time Frame

6 weeks

Title

DAS28 EULAR Response at Week 24

Description

Time Frame

24 weeks

Title

Proportion of Patients Achieving ACR20 up to Week 24

Description

Time Frame

6 and 24 weeks

Title

Proportion of Patients Achieving ACR50 up to Week 24

Description

Time Frame

6 and 24 weeks

Title

Proportion of Patients Achieving ACR70 up to Week 24

Description

Time Frame

6 and 24 weeks

Title

ACRn - Comparison Between Fostamatinib and Placebo at Week 6

Description

Time Frame

Baseline and 6 weeks

Title

ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24

Description

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 in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. 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, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 24. Treatment difference: difference between fostamatinib and adalimumab groups.

Time Frame

Baseline and 24 weeks

Title

HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6

Description

Time Frame

Baseline and 6 weeks

Title

HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24

Description

Time Frame

Baseline and 24 weeks

Title

SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24

Description

Time Frame

Baseline and 24 weeks

Title

SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24

Description

Time Frame

Baseline and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil MacKillop, MD PhD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

Research Site

City

Glendale

State/Province

Arizona

Country

United States

Facility Name

Research Site

City

Mesa

State/Province

Arizona

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

Research Site

City

Scottsdale

State/Province

Arizona

Country

United States

Facility Name

Research Site

City

Huntington Beach

State/Province

California

Country

United States

Facility Name

Research Site

City

Long Beach

State/Province

California

Country

United States

Facility Name

Research Site

City

Colorado Springs

State/Province

Colorado

Country

United States

Facility Name

Research Site

City

Bridgeport

State/Province

Connecticut

Country

United States

Facility Name

Research Site

City

Daytona Beach

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Ocala

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Palm Harbor

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Pinellas Park

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Venice

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Research Site

City

South Bend

State/Province

Indiana

Country

United States

Facility Name

Research Site

City

Bowling Green

State/Province

Kentucky

Country

United States

Facility Name

Research Site

City

Elizabethtown

State/Province

Kentucky

Country

United States

Facility Name

Research Site

City

Oxon Hill

State/Province

Maryland

Country

United States

Facility Name

Research Site

City

Kalamazoo

State/Province

Michigan

Country

United States

Facility Name

Research Site

City

Richmond Heights

State/Province

Missouri

Country

United States

Facility Name

Research Site

City

Kalispell

State/Province

Montana

Country

United States

Facility Name

Research Site

City

Nashua

State/Province

New Hampshire

Country

United States

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

Country

United States

Facility Name

Research Site

City

Las Cruces

State/Province

New Mexico

Country

United States

Facility Name

Research Site

City

Brooklyn

State/Province

New York

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

Country

United States

Facility Name

Research Site

City

Perrysburg

State/Province

Ohio

Country

United States

Facility Name

Research Site

City

Duncansville

State/Province

Pennsylvania

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

South Carolina

Country

United States

Facility Name

Research Site

City

Jackson

State/Province

Tennessee

Country

United States

Facility Name

Research Site

City

Knoxville

State/Province

Tennessee

Country

United States

Facility Name

Research Site

City

Memphis

State/Province

Tennessee

Country

United States

Facility Name

Research Site

City

Austin

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Mesquite

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Plano

State/Province

Texas

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Pleven

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

Country

Bulgaria

Facility Name

Research Site

City

Ruse

Country

Bulgaria

Facility Name

Research Site

City

Sevlievo

Country

Bulgaria

Facility Name

Research Site

City

Sofia

Country

Bulgaria

Facility Name

Research Site

City

Veliko Tarnovo

Country

Bulgaria

Facility Name

Research Site

City

Mississauga

State/Province

Ontario

Country

Canada

Facility Name

Research Site

City

Brno

Country

Czech Republic

Facility Name

Research Site

City

Bruntal

Country

Czech Republic

Facility Name

Research Site

City

Hlucin

Country

Czech Republic

Facility Name

Research Site

City

Liberec

Country

Czech Republic

Facility Name

Research Site

City

Ostrava - Poruba

Country

Czech Republic

Facility Name

Research Site

City

Ostrava - Trebovice

Country

Czech Republic

Facility Name

Research Site

City

Ostrava

Country

Czech Republic

Facility Name

Research Site

City

Praha 11

Country

Czech Republic

Facility Name

Research Site

City

Praha 2

Country

Czech Republic

Facility Name

Research Site

City

Praha 4

Country

Czech Republic

Facility Name

Research Site

City

Praha

Country

Czech Republic

Facility Name

Research Site

City

Zlin

Country

Czech Republic

Facility Name

Research Site

City

Dresden

Country

Germany

Facility Name

Research Site

City

Hamburg

Country

Germany

Facility Name

Research Site

City

Muenchen

Country

Germany

Facility Name

Research Site

City

Balatonfured

Country

Hungary

Facility Name

Research Site

City

Balatonfüred

Country

Hungary

Facility Name

Research Site

City

Budapest

Country

Hungary

Facility Name

Research Site

City

Debrecen

Country

Hungary

Facility Name

Research Site

City

Zalaegerszeg

Country

Hungary

Facility Name

Research Site

City

Amsterdam

Country

Netherlands

Facility Name

Research Site

City

Bytom

Country

Poland

Facility Name

Research Site

City

Chelm Slaski

Country

Poland

Facility Name

Research Site

City

Grodzisk Mazowiecki

Country

Poland

Facility Name

Research Site

City

Sroda Wielkopolska

Country

Poland

Facility Name

Research Site

City

Warszawa

Country

Poland

Facility Name

Research Site

City

Wroclaw

Country

Poland

Facility Name

Research Site

City

Zyrardow

Country

Poland

Facility Name

Research Site

City

Łódź

Country

Poland

Facility Name

Research Site

City

Moscow

Country

Russian Federation

Facility Name

Research Site

City

Nizhny Novgorod

Country

Russian Federation

Facility Name

Research Site

City

Petrozavodsk

Country

Russian Federation

Facility Name

Research Site

City

Ryazan

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Voronezh

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

Country

Russian Federation

Facility Name

Research Site

City

Trebisov

Country

Slovakia

Facility Name

Research Site

City

Trnava

Country

Slovakia

Facility Name

Research Site

City

Pretoria

State/Province

Gauteng

Country

South Africa

Facility Name

Research Site

City

Durban

State/Province

Kwazulu Natal

Country

South Africa

Facility Name

Research Site

City

Cape Town

State/Province

Western Cape

Country

South Africa

Facility Name

Research Site

City

Cape Town

Country

South Africa

Facility Name

Research Site

City

Durban

Country

South Africa

Facility Name

Research Site

City

Pretoria

Country

South Africa

Facility Name

Research Site

City

Stellenbosch

Country

South Africa

Facility Name

Research Site

City

Donetsk

Country

Ukraine

Facility Name

Research Site

City

Ivano-frankivsk

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

Country

Ukraine

Facility Name

Research Site

City

Kyiv

Country

Ukraine

Facility Name

Research Site

City

Lutsk

Country

Ukraine

Facility Name

Research Site

City

Lviv

Country

Ukraine

Facility Name

Research Site

City

Odessa

Country

Ukraine

Facility Name

Research Site

City

Simferopol

Country

Ukraine

Facility Name

Research Site

City

Zaporyzhzhya

Country

Ukraine

Facility Name

Research Site

City

Reading

State/Province

Berkshire

Country

United Kingdom

Facility Name

Research Site

City

London

State/Province

Greater London

Country

United Kingdom

Facility Name

Research Site

City

Eastbourne

State/Province

Sussex

Country

United Kingdom

Facility Name

Research Site

City

Basingstoke

Country

United Kingdom

Facility Name

Research Site

City

Eastbourne

Country

United Kingdom

Facility Name

Research Site

City

London

Country

United Kingdom

Facility Name

Research Site

City

Manchester

Country

United Kingdom

Facility Name

Research Site

City

Wolverhampton

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25074688

Citation

Taylor PC, Genovese MC, Greenwood M, Ho M, Nasonov E, Oemar B, Stoilov R, Vencovsky J, Weinblatt M. OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy. Ann Rheum Dis. 2015 Dec;74(12):2123-9. doi: 10.1136/annrheumdis-2014-205361. Epub 2014 Jul 29.

Results Reference

derived

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Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)

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Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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