Rheumatoid ArthritisPhase 2OSKIRA-Asia-1XNCT01640054

A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis

A Phase 2 study testing Fostamatinib in people with Rheumatoid Arthritis, run by AstraZeneca at 26 sites in 6 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 in Asia 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: 115 participants
Where: 26 sitesin 6 countries
Study dates: Jul 2012to Jul 2013
Phase: Phase 2
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

Provision of informed consent prior to any study-specific procedures.
Patients who have successfully completed study D4300C00008 and whose disease is adequately controlled, in the opinion of the Investigator.

Who cannot join

Premature withdrawal from study D4300C00008 or in the opinion of the Investigator the patient's disease is not adequately controlled on current treatment.
Development of any of the withdrawal criteria from study D4300C00008
Females who are pregnant or breast feeding
Any other clinically significant disease or disorder, which in the opinion of the Investigator might put the patient at risk due to participation in the study, or may influence the results of the study

Trial locations and contacts

26 sites in 6 countries.

Country

City, postcode or hospital

26 sites in 6 countries

Japan13 sites

Research Site
Fukuoka, Fukuoka
Research Site
Hamamatsu, Shizuoka
Research Site
Kato-shi, Hyōgo
Research Site
Kitakyushu-shi, Fukuoka
Research Site
Nagasaki, Nagasaki
Research Site
Okayama, Okayama-ken
Research Site
Omura-shi, Nagasaki
Research Site
Sapporo, Hokkaido
Research Site
Sasebo-shi, Nagasaki
Research Site
Sendai, Miyagi
Research Site
Shinjuku-ku, Tokyo
Research Site
tabashi City, Tokyo
Research Site
Tomigusuku-shi, Okinawa

Other trials in Japan

South Korea4 sites

Research Site
Anyang-si, Gyeonggi-do
Research Site
Gwangju
Research Site
Incheon
Research Site
Seoul

Other trials in South Korea

Taiwan3 sites

Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Taipei

Other trials in Taiwan

Hong Kong2 sites

Research Site
Hong Kong, Shatin
Research Site
Hong Kong

Other trials in Hong Kong

Thailand2 sites

Research Site
Bangkok
Research Site
Singapore, Singapore

Other trials in Thailand

Vietnam2 sites

Research Site
Hanoi
Research Site
Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: (OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

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

Read the detailed description

(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Conditions: Rheumatoid Arthritis
Being tested: Fostamatinib
Keywords: Rheumatoid Arthritis
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 once daily

Study groups in NCT01640054
Study group	Role	What they receive
Dosing regimen	Experimental	Open label Oral treatment 100mg once daily 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, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event
Measured: Entry in extension to study termination (variable duration; maximum 52 weeks)

Secondary outcomes (4)

Components of ACR Response Criteria Over Time
ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily
Measured: Every 12 weeks for one year then every 24 weeks until study end
DAS28-CRP Score Over Time
CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily
Measured: Every 12 weeks for one year then every 24 weeks until study end
HAQ-DI Score Over Time
HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily
Measured: Every 12 weeks for one year then every 24 weeks until study end
SF-36 Score Over Time
n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey
Measured: Every 12 weeks for one year then yearly until study end

Timeline

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

Jul 2012Jul 2013

First posted13 Jul 2012 (estimated)
Study startJul 2012
Primary completionJul 2013
Study completionJul 2013

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.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01640054
Sponsor's protocol ID: D4300C00029
Acronym: OSKIRA-Asia-1X
Status last verified: Feb 2014
First submitted: 2 Jul 2012
Last updated: 28 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Tanaka Y, Millson D, Iwata S, Nakayamada S. Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study. Rheumatology (Oxford). 2021 Jun 18;60(6):2884-2895. doi: 10.1093/rheumatology/keaa732.
PubMed 33254235

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

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Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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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
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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 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: (OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia
ClinicalTrials.gov ID: NCT01640054
Acronym / sponsor ID: OSKIRA-Asia-1X / D4300C00029
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.
Enrolment: 115 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 13 Jul 2012 (estimated)
Results: Posted 9 Jan 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 in Asia with rheumatoid arthritis (RA).

Detailed description

(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dosing regimen	Experimental	Drug: FostamatinibOpen label Oral treatment 100mg once daily

Who may qualify

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

Key inclusion criteria (2 listed)

Provision of informed consent prior to any study-specific procedures.
Patients who have successfully completed study D4300C00008 and whose disease is adequately controlled, in the opinion of the Investigator.

Key exclusion criteria (4 listed)

Premature withdrawal from study D4300C00008 or in the opinion of the Investigator the patient's disease is not adequately controlled on current treatment.
Development of any of the withdrawal criteria from study D4300C00008
Females who are pregnant or breast feeding
Any other clinically significant disease or disorder, which in the opinion of the Investigator might put the patient at risk due to participation in the study, or may influence the results of the study

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 once daily	Drug	Dosing regimen

Primary outcome

Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Time frame: Entry in extension to study termination (variable duration; maximum 52 weeks)
AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event

4 secondary outcomes

Components of ACR Response Criteria Over Time
Time frame: Every 12 weeks for one year then every 24 weeks until study end
DAS28-CRP Score Over Time
Time frame: Every 12 weeks for one year then every 24 weeks until study end
HAQ-DI Score Over Time
Time frame: Every 12 weeks for one year then every 24 weeks until study end
SF-36 Score Over Time
Time frame: Every 12 weeks for one year then yearly until study end

Results and safety

Results posted to the registry on 9 Jan 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
FOSTA 100 MG QD PO	115	109

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

Time frame: Entry in extension to study termination (variable duration; maximum 52 weeks). Number. Unit: Percentage of patients

Measure	FOSTA 100 MG QD PO n = 115
Any AE	62.6
Any AE with outcome of death	0
Any SAE (including events with outcome of death)	3.5
Any AE leading to discontinuation of IP	2.6

Population analysed: The full analysis set was the primary population for reporting efficacy and safety data, and comprised all patients who received at least 1 dose of investigational product.

4 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 QD PO	4 of 115 (3.5%)	29 of 115 (25.2%)	Not reported

Limitations and caveats (from the sponsor): Insufficient efficacy data was available for analysis due to sparse data collection and the early termination of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33254235Tanaka Y, Millson D, Iwata S, Nakayamada S. Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study. Rheumatology (Oxford). 2021 Jun 18;60(6):2884-2895. doi: 10.1093/rheumatology/keaa732.

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.

Neil - MacKillop, MD study director

AstraZeneca

26 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fostamatinib in people with Rheumatoid Arthritis, run by AstraZeneca at 26 sites in 6 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 4 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 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Japan, South Korea, Taiwan, Hong Kong, Thailand and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 9 Jan 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 study termination (variable duration; maximum 52 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 NCT01640054, which also lists 1 linked publication.

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 28 Mar 2014.