Rheumatoid ArthritisPhase 3OSKIRA-XNCT01242514

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

A Phase 3 study testing Fostamatinib in people with Rheumatoid Arthritis, run by AstraZeneca at 308 sites in 31 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Fostamatinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,917 participants
Where: 308 sitesin 31 countries
Study dates: Jan 2011to Jan 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).

Who cannot join

Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
Females who are pregnant or breast feeding
Poorly controlled hypertension
Significant liver function test abnormalities or physical symptoms of hepatotoxicity
Significant infection
Gastrointestinal intolerance
Cancer

Trial locations and contacts

308 sites in 31 countries.

Country

City, postcode or hospital

308 sites in 31 countries

United States116 sites

Research Site
Albany, New York
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Albuquerque, New Mexico
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Amarillo, Texas
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Anaheim, California
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Anniston, Alabama
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Asheville, North Carolina
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Atlanta, Georgia
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Austin, Texas
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Birmingham, Alabama
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Boca Raton, Florida
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Boston, Massachusetts
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Bowling Green, Kentucky
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Brandon, Florida
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Bridgeport, Connecticut
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Brooklyn, New York
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Canton, Georgia
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Cedar Rapids, Iowa
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Charleston, South Carolina
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Charlotte, North Carolina
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Chesapeake, Virginia
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Chicago, Illinois
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Colorado Springs, Colorado
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Cooperstown, New York
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Cumberland, Maryland
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Dallas, Texas
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Danbury, Connecticut
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Dayton, Ohio
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Daytona Beach, Florida
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Decatur, Georgia
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Duncansville, Pennsylvania
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Durham, North Carolina
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Eagan, Minnesota
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Elizabethtown, Kentucky
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Erie, Pennsylvania
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Fall River, Massachusetts
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Florissant, Missouri
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Flowood, Mississippi
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Fort Lauderdale, Florida
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Fountain Valley, California
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Frederick, Maryland
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Freehold, New Jersey
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Glendale, Arizona
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Greensboro, North Carolina
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Greenville, South Carolina
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Hagerstown, Maryland
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Hixson, Tennessee
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Hot Springs, Arkansas
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Houston, Texas
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Huntington Beach, California
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Huntsville, Alabama
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Idaho Falls, Idaho
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Indianapolis, Indiana
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Jackson, Tennessee
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Jacksonville, Florida
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Kalamazoo, Michigan
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Kalispell, Montana
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Katy, Texas
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Knoxville, Tennessee
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La Jolla, California
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Lake Oswego, Oregon
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Lansing, Michigan
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Las Cruces, New Mexico
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Las Vegas, Nevada
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Lawrenceville, Georgia
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Lewes, Delaware
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Long Beach, California
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Lubbock, Texas
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Macon, Georgia
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Marietta, Georgia
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Mayfield Village, Ohio
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Memphis, Tennessee
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Mesa, Arizona
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Mesquite, Texas
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Miami, Florida
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Nashville, Tennessee
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Nassau Bay, Texas
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Ocala, Florida
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Oklahoma City, Oklahoma
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Olean, New York
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Omaha, Nebraska
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Orangeburg, South Carolina
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Orlando, Florida
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Oxon Hill, Maryland
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Palm Harbor, Florida
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Palo Alto, California
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Perrysburg, Ohio
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pinellas Park, Florida
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Rapid City, South Dakota
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Research Triangle Park, North Carolina
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Richmond Heights, Missouri
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Roseville, California
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Roslyn, New York
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Saint Clair Shores, Michigan
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San Antonio, Texas
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Santa Maria, California
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Santa Monica, California
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Scottsdale, Arizona
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Smithtown, New York
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Upland, California
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Venice, Florida
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West Reading, Pennsylvania
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Worcester, Massachusetts
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Zephyrhills, Florida

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Lviv
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Port Elizabeth, E Cape
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About this study

Official title: (OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

Conditions: Rheumatoid Arthritis
Being tested: Fostamatinib
Keywords: Rheumatoid Arthritis, OSKIRA, Fostamatinib
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FostamatinibDrug
Fostamatinib 100mg twice daily
FostamatinibDrug
Fostamatinib 150mg once daily
FostamatinibDrug
Fostamatinib 100mg once daily

Study groups in NCT01242514
Study group	Role	What they receive
A	Experimental	Oral treatment Receives: Drug: Fostamatinib
B	Experimental	Oral treatment Receives: Drug: Fostamatinib
C	Experimental	Oral treatment Receives: Drug: Fostamatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Measured: Entry in extension to end of study (variable duration; maximum 109 weeks)

Secondary outcomes (3)

Mean DAS28-CRP Score
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. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily
Measured: Weeks 0, 12, 24, 36 and 52
Mean mTSS Score
mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily
Measured: Weeks 0 and 52
Mean HAQ-DI Score
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then 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. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily
Measured: Weeks 0, 12, 24, 36 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Jan 2015

First posted17 Nov 2010 (estimated)
Study startJan 2011
Primary completionJan 2015 (estimated)
Study completionJan 2015 (estimated)

Why it stopped: AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,917 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01242514
Sponsor's protocol ID: D4300C00005
Other IDs: 2010-020892-22
Acronym: OSKIRA-X
Status last verified: Feb 2014
First submitted: 10 Nov 2010
Last updated: 4 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: (OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01242514
Acronym / sponsor ID: OSKIRA-X / D4300C00005
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, OSKIRA, Fostamatinib
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.
Enrolment: 1,917 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Jan 2015 (estimated)
Study completion: Jan 2015 (estimated)
First posted: 17 Nov 2010 (estimated)
Results: Posted 4 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
A	Experimental	Drug: FostamatinibOral treatment
B	Experimental	Drug: FostamatinibOral treatment
C	Experimental	Drug: FostamatinibOral treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).

Key exclusion criteria (7 listed)

Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
Females who are pregnant or breast feeding
Poorly controlled hypertension
Significant liver function test abnormalities or physical symptoms of hepatotoxicity
Significant infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FostamatinibFostamatinib 100mg twice daily	Drug	A
FostamatinibFostamatinib 150mg once daily	Drug	B
FostamatinibFostamatinib 100mg once daily	Drug	C

Primary outcome

Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Time frame: Entry in extension to end of study (variable duration; maximum 109 weeks)
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event

3 secondary outcomes

Mean DAS28-CRP Score
Time frame: Weeks 0, 12, 24, 36 and 52
Mean mTSS Score
Time frame: Weeks 0 and 52
Mean HAQ-DI Score
Time frame: Weeks 0, 12, 24, 36 and 52

Results and safety

Results posted to the registry on 4 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fostamatinib 100 mg Bid	1,343	0
Fostamatinib 150 mg qd	357	0
Fostamatinib 100 mg qd	212	0

Primary outcome: Percentage of Patients Who Had at Least 1 Adverse Event in Any Category

Time frame: Entry in extension to end of study (variable duration; maximum 109 weeks). Number. Unit: Percentage of patients

Measure	Fostamatinib 100 mg Bid n = 1343	Fostamatinib 150 mg qd n = 357	Fostamatinib 100 mg qd n = 212
Any AE	74.4	70.3	69.8
Any AE with outcome of death	0.7	0.3	0.5
Any SAE (including events with outcome of death)	11.4	8.7	5.7
Any AE leading to discontinuation of IP	10.5	5.9	9.9

Population analysed: The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FOSTA 100 MG BID	153 of 1,343 (11.4%)	466 of 1,343 (34.7%)	Not reported
FOSTA 100 MG QD	12 of 212 (5.7%)	68 of 212 (32.1%)	Not reported
FOSTA 150 MG QD	31 of 357 (8.7%)	98 of 357 (27.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chris O'Brien, MD PhD study director

AstraZeneca

308 sites in 31 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fostamatinib in people with Rheumatoid Arthritis, run by AstraZeneca at 308 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 308 sites in United States, Canada, Czechia, India, United Kingdom and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Who Had at Least 1 Adverse Event in Any Category (time frame: Entry in extension to end of study (variable duration; maximum 109 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01242514.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014.