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Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis (Oskira ABPM)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fostamatinib
placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dosing Regimen A

Dosing Regimen B

Arm Description

Oral treatment

Oral treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 23, 2012
Last Updated
April 23, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01563978
Brief Title
Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis
Acronym
Oskira ABPM
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 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 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.
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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dosing Regimen A
Arm Type
Experimental
Arm Description
Oral treatment
Arm Title
Dosing Regimen B
Arm Type
Placebo Comparator
Arm Description
Oral treatment
Intervention Type
Drug
Intervention Name(s)
fostamatinib
Intervention Description
fostamatinib 100 mg twice daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change From Baseline in 24-hour Mean Ambulatory SBP
Description
ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in 24-hour Mean Ambulatory DBP
Description
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product.
Time Frame
4 weeks
Title
Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring
Description
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time Frame
4 weeks
Title
Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring
Description
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time Frame
4 weeks
Title
Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring
Description
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time Frame
4 weeks
Title
Mean Change From Baseline in Clinic SBP and DBP
Description
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.
Time Frame
4 weeks
Title
Mean Change From Baseline in Morning Pre-dose Home SBP and DBP
Description
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time Frame
4 weeks
Title
Mean Change From Baseline in Evening Post-dose Home SBP and DBP
Description
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time Frame
4 weeks
Title
Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP
Description
BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time Frame
Day 29 to Day 36
Title
DAS28-CRP Improvement
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris O'Brien, MD PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
Research Site
City
Santa Maria
State/Province
California
Country
United States
Facility Name
Research Site
City
Trumbull
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Brandon
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Venice
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Cumberland
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Frederick
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Hagerstown
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Florissant
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Richmond Heights
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Freehold
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Albuquerque
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
Greensboro
State/Province
North Carolina
Country
United States
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Research Site
City
Lake Oswego
State/Province
Oregon
Country
United States
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Research Site
City
Duncansville
State/Province
Pennsylvania
Country
United States
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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
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Lubbock
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Nassau Bay
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Sevlievo
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Hlucin
Country
Czech Republic
Facility Name
Research Site
City
Hostivice
Country
Czech Republic
Facility Name
Research Site
City
Kladno
Country
Czech Republic
Facility Name
Research Site
City
Ostrava-Trebovice
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
Aachen
Country
Germany
Facility Name
Research Site
City
Halle
Country
Germany
Facility Name
Research Site
City
Gdynia
Country
Poland
Facility Name
Research Site
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
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City
Kalisz
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
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Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Sroda Wielkopolska
Country
Poland
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Research Site
City
Wroclaw
Country
Poland
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Research Site
City
Łódź
Country
Poland
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Research Site
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Bloemfontein
Country
South Africa
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Research Site
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Cape Town
Country
South Africa
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Research Site
City
Durban
Country
South Africa
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City
Kempron Park
Country
South Africa
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Donetsk
Country
Ukraine
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Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
Country
Ukraine
Facility Name
Research Site
City
Zaporozhye
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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