NCT01264770|TerminatedPhase 2ResultsDMC

Study Stopped

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

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

OSKIRA -4

(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

AstraZeneca ClinicalTrials.gov

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2 other identifiers

D4300C000042010-023692-26

Study Type

interventional

Target

644

Locations

13 countries

Sites

105

Timeline

RegisteredDec 2010

StartedJan 2011

CompletionAug 2013

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

644

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline

Completed

Started Jan 2011

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach

13 countries

105 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

December 17, 2010

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed

10 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed

9 months until next milestone

Results Posted

Study results publicly available

May 6, 2014

Completed

Last Updated

May 6, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

December 17, 2010

Results QC Date

November 22, 2013

Last Update Submit

April 3, 2014

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisOSKIRAfostamatinib

Outcome Measures

Primary Outcomes (2)

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.
Baseline and 6 weeks
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.
Baseline and 24 weeks

Secondary Outcomes (11)

DAS28 EULAR Response at Week 6
6 weeks
DAS28 EULAR Response at Week 24
24 weeks
Proportion of Patients Achieving ACR20 up to Week 24
6 and 24 weeks
Proportion of Patients Achieving ACR50 up to Week 24
6 and 24 weeks
Proportion of Patients Achieving ACR70 up to Week 24
6 and 24 weeks
+6 more secondary outcomes