Rheumatoid ArthritisPhase 2Oskira ABPMNCT01563978

Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis

A Phase 2 study testing fostamatinib in people with Rheumatoid Arthritis, run by AstraZeneca at 56 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a disease-modifying anti-rheumatic drug (DMARD). The study will last for 57 days. 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?: Yes, some participants may receive a placebo
How many people: 266 participants
Where: 56 sitesin 7 countries
Study dates: Apr 2012to Jan 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

Male and female patients aged 18 or over diagnosed with rheumatoid arthritis after the age of 16
Active rheumatoid arthritis defined as: ≥4 swollen joints and ≥4 tender/painful joints (from 28 joint count) and either erythrocyte sedimentation rate ≥28 mm/h, or C-reactive protein ≥10 mg/L.
Currently taking one of the following disease-modifying anti-rheumatic drugs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
Patients without essential hypertension or with essential hypertension if their blood pressure is controlled (<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.

Who cannot join

Females who are pregnant or breastfeeding.
Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
History of liver problems that have required previous investigations
Evidence of tuberculosis infection
Conditions that preclude or render difficult the 24-hour ambulatory blood pressure monitoring technique.

Trial locations and contacts

56 sites in 7 countries.

Country

City, postcode or hospital

56 sites in 7 countries

United States30 sites

Research Site
Albuquerque, New Mexico
Research Site
Austin, Texas
Research Site
Boca Raton, Florida
Research Site
Brandon, Florida
Research Site
Brooklyn, New York
Research Site
Charlotte, North Carolina
Research Site
Cumberland, Maryland
Research Site
Dallas, Texas
Research Site
Decatur, Georgia
Research Site
Duncansville, Pennsylvania
Research Site
Florissant, Missouri
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Frederick, Maryland
Research Site
Freehold, New Jersey
Research Site
Greensboro, North Carolina
Research Site
Hagerstown, Maryland
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Houston, Texas
Research Site
Huntington Beach, California
Research Site
Huntsville, Alabama
Research Site
Lake Oswego, Oregon
Research Site
Lubbock, Texas
Research Site
Memphis, Tennessee
Research Site
Nassau Bay, Texas
Research Site
Orlando, Florida
Research Site
Richmond Heights, Missouri
Research Site
Santa Maria, California
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South Bend, Indiana
Research Site
Tacoma, Washington
Research Site
Tampa, Florida
Research Site
Trumbull, Connecticut
Research Site
Venice, Florida

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Poland8 sites

Research Site
Gdynia
Research Site
Grodzisk Mazowiecki
Research Site
Kalisz
Research Site
Katowice
Research Site
Lodz
Research Site
Poznan
Research Site
Środa Wielkopolska
Research Site
Wroclaw

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Czechia6 sites

Research Site
Brno
Research Site
Hlučín
Research Site
Hostivice
Research Site
Kladno
Research Site
Ostrava-Trebovice
Research Site
Prague

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South Africa4 sites

Research Site
Bloemfontein
Research Site
Cape Town
Research Site
Durban
Research Site
Kempron Park

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Ukraine4 sites

Research Site
Donetsk
Research Site
Kyiv
Research Site
Vinnytsia
Research Site
Zaporizhzhya

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Bulgaria2 sites

Research Site
Sevlievo
Research Site
Sofia

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Germany2 sites

Research Site
Aachen
Research Site
Halle

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About this study

Official title: OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients With Rheumatoid Arthritis

The study will last for 57 days.

Read the detailed description

OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis

Conditions: Rheumatoid Arthritis
Being tested: fostamatinib, placebo
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 100 mg twice daily
placeboDrug
placebo

Study groups in NCT01563978
Study group	Role	What they receive
Dosing Regimen A	Experimental	Oral treatment Receives: Drug: fostamatinib
Dosing Regimen B	Placebo comparator	Oral treatment Receives: Drug: placebo

What is being measured

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

Change From Baseline in 24-hour Mean Ambulatory SBP
ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Measured: 4 weeks

Secondary outcomes (9)

Change From Baseline in 24-hour Mean Ambulatory DBP
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product.
Measured: 4 weeks
Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Measured: 4 weeks
Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Measured: 4 weeks
Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Measured: 4 weeks
Mean Change From Baseline in Clinic SBP and DBP
Blood pressure was measured in the clinic using an automated blood pressure machine (oscillometric method). Three separate measurements were taken 2 to 5 minutes apart and the mean of the 2nd and 3rd measurements calculated. ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Measured: 4 weeks
Mean Change From Baseline in Morning Pre-dose Home SBP and DBP
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Measured: 4 weeks
Mean Change From Baseline in Evening Post-dose Home SBP and DBP
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Measured: 4 weeks
Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP
BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Measured: Day 29 to Day 36
DAS28-CRP Improvement
ANCOVA=analysis of covariance, BID=twice daily, DAS28-CRP=Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (C-reactive protein [CRP]) and the patient's own assessment, FAS=full analysis set, IP=investigational product. Scores can take any positive value with a lower value indicative of 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 indicating a better clinical condition.
Measured: 4 weeks

Timeline

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

Apr 2012Jan 2013

First posted27 Mar 2012 (estimated)
Study startApr 2012
Primary completionJan 2013
Study completionJan 2013

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 266 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01563978
Sponsor's protocol ID: D4300C00033
Other IDs: 2011-006070-73
Acronym: Oskira ABPM
Status last verified: Apr 2014
First submitted: 23 Mar 2012
Last updated: 8 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01563978
Acronym / sponsor ID: Oskira ABPM / D4300C00033
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 266 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 27 Mar 2012 (estimated)
Results: Posted 14 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 study will last for 57 days.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dosing Regimen A	Experimental	Drug: fostamatinibOral treatment
Dosing Regimen B	Placebo comparator	Drug: placeboOral treatment

Who may qualify

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

Key inclusion criteria (4 listed)

Male and female patients aged 18 or over diagnosed with rheumatoid arthritis after the age of 16
Active rheumatoid arthritis defined as: ≥4 swollen joints and ≥4 tender/painful joints (from 28 joint count) and either erythrocyte sedimentation rate ≥28 mm/h, or C-reactive protein ≥10 mg/L.
Currently taking one of the following disease-modifying anti-rheumatic drugs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
Patients without essential hypertension or with essential hypertension if their blood pressure is controlled (<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.

Key exclusion criteria (5 listed)

Females who are pregnant or breastfeeding.
Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
History of liver problems that have required previous investigations
Evidence of tuberculosis infection
Conditions that preclude or render difficult the 24-hour ambulatory blood pressure monitoring technique.

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 100 mg twice daily	Drug	Dosing Regimen A
placeboplacebo	Drug	Dosing Regimen B

Primary outcome

Change From Baseline in 24-hour Mean Ambulatory SBP
Time frame: 4 weeks
ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.

9 secondary outcomes

Change From Baseline in 24-hour Mean Ambulatory DBP
Time frame: 4 weeks
Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring
Time frame: 4 weeks
Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring
Time frame: 4 weeks
Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring
Time frame: 4 weeks
Mean Change From Baseline in Clinic SBP and DBP
Time frame: 4 weeks
Mean Change From Baseline in Morning Pre-dose Home SBP and DBP
Time frame: 4 weeks
Mean Change From Baseline in Evening Post-dose Home SBP and DBP
Time frame: 4 weeks
Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP
Time frame: Day 29 to Day 36
DAS28-CRP Improvement
Time frame: 4 weeks

Results and safety

Results posted to the registry on 14 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
FOSTA 100 MG BID	68	64
PLACEBO	67	65

Primary outcome: Change From Baseline in 24-hour Mean Ambulatory SBP

Time frame: 4 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	FOSTA 100 MG BID n = 64	PLACEBO n = 62
Value	4.3 (7.34)	1.3 (7.87)

FOSTA 100 MG BID vs PLACEBO: Least squares mean treatment difference: 2.93 (95% CI 0.40 to 5.45), p = 0.023, ANCOVA

Population analysed: The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.

9 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	0 of 68 (0%)	2 of 68 (2.9%)	Not reported
PLACEBO	0 of 67 (0%)	4 of 67 (6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 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
Recruiting
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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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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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

56 sites in 7 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 56 sites in 7 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Poland, Czechia, South Africa, Ukraine and 2 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. Some participants in this study may receive a placebo. 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 14 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?

Change From Baseline in 24-hour Mean Ambulatory SBP (time frame: 4 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 NCT01563978.

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 8 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.