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

April 23, 2014 updated by: AstraZeneca

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sevlievo, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Hlucin, Czech Republic
        • Research Site
      • Hostivice, Czech Republic
        • Research Site
      • Kladno, Czech Republic
        • Research Site
      • Ostrava-Trebovice, Czech Republic
        • Research Site
      • Praha 11, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
      • Praha 4, Czech Republic
        • Research Site
  • Germany
      • Aachen, Germany
        • Research Site
      • Halle, Germany
        • Research Site
  • Poland
      • Gdynia, Poland
        • Research Site
      • Grodzisk Mazowiecki, Poland
        • Research Site
      • Kalisz, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Sroda Wielkopolska, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
      • Łódź, Poland
        • Research Site
  • South Africa
      • Bloemfontein, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Kempron Park, South Africa
        • Research Site
  • Ukraine
      • Donetsk, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Vinnytsia, Ukraine
        • Research Site
      • Zaporizhzhya, Ukraine
        • Research Site
      • Zaporozhye, Ukraine
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States
        • Research Site
    • California
      • Huntington Beach, California, United States
        • Research Site
      • Santa Maria, California, United States
        • Research Site
    • Connecticut
      • Trumbull, Connecticut, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
      • Brandon, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • Venice, Florida, United States
        • Research Site
    • Georgia
      • Decatur, Georgia, United States
        • Research Site
    • Indiana
      • South Bend, Indiana, United States
        • Research Site
    • Maryland
      • Cumberland, Maryland, United States
        • Research Site
      • Frederick, Maryland, United States
        • Research Site
      • Hagerstown, Maryland, United States
        • Research Site
    • Missouri
      • Florissant, Missouri, United States
        • Research Site
      • Richmond Heights, Missouri, United States
        • Research Site
    • New Jersey
      • Freehold, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
      • Greensboro, North Carolina, United States
        • Research Site
    • Oregon
      • Lake Oswego, Oregon, United States
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Lubbock, Texas, United States
        • Research Site
      • Nassau Bay, Texas, United States
        • Research Site
    • Washington
      • Tacoma, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dosing Regimen A
Oral treatment
Drug: fostamatinib
fostamatinib 100 mg twice daily
Placebo Comparator: Dosing Regimen B
Oral treatment
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in 24-hour Mean Ambulatory DBP
Time Frame: 4 weeks
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product.
4 weeks
Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring
Time Frame: 4 weeks
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
4 weeks
Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring
Time Frame: 4 weeks
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
4 weeks
Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring
Time Frame: 4 weeks
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
4 weeks
Mean Change From Baseline in Clinic SBP and DBP
Time Frame: 4 weeks
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.
4 weeks
Mean Change From Baseline in Morning Pre-dose Home SBP and DBP
Time Frame: 4 weeks
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
4 weeks
Mean Change From Baseline in Evening Post-dose Home SBP and DBP
Time Frame: 4 weeks
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
4 weeks
Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP
Time Frame: Day 29 to Day 36
BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Day 29 to Day 36
DAS28-CRP Improvement
Time Frame: 4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4300C00033
  • 2011-006070-73

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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