We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01563978
Recruitment Status : Completed
First Posted : March 27, 2012
Results First Posted : April 14, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: fostamatinib Drug: placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563978


  Show 59 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Chris O'Brien, MD PhD AstraZeneca
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01563978     History of Changes
Other Study ID Numbers: D4300C00033
2011-006070-73
First Posted: March 27, 2012    Key Record Dates
Results First Posted: April 14, 2014
Last Update Posted: May 8, 2014
Last Verified: April 2014

Keywords provided by AstraZeneca:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases