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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01563978
First received: March 23, 2012
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: fostamatinib
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change From Baseline in 24-hour Mean Ambulatory SBP [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 29 to Day 36 ] [ Designated as safety issue: Yes ]
    BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.

  • DAS28-CRP Improvement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 266
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing Regimen A
Oral treatment
Drug: fostamatinib
fostamatinib 100 mg twice daily
Placebo Comparator: Dosing Regimen B
Oral treatment
Drug: placebo
placebo

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563978

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01563978     History of Changes
Other Study ID Numbers: D4300C00033, 2011-006070-73
Study First Received: March 23, 2012
Results First Received: November 8, 2013
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency Ministry of Health (BDA)
Czech Republic: The State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocides
Ukraine: Ministry of Public Health of Ukraine (MPHU)
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
South Africa: Medicines Control Council
Argentina: National Administration of Drugs, Food & Medical Technology (ANMAT)
Mexico: Federal Commission for Protection Against Sanitary Risks (COFEPRIS)
Peru: General Directorate of Medicines, Supplies and Drug (DIGEMID)
Brazil: The National Health Surveillance Agency (ANVISA)

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

ClinicalTrials.gov processed this record on August 21, 2014