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

March 23, 2012
April 23, 2014
April 2012
January 2013   (final data collection date for primary outcome measure)
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.
Mean change from baseline in 24-hour mean ambulatory systolic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01563978 on ClinicalTrials.gov Archive Site
  • 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.
  • Mean change from baseline in 24-hour mean ambulatory diastolic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in mean daytime (6am-10pm) systolic blood pressure and diastolic blood pressure, night time (10pm-6am) systolic blood pressure and diastolic blood pressure, awake and sleeping systolic blood pressure and diastolic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in clinic systolic blood pressure and diastolic blood pressure and in morning pre-dose and evening post-dose home systolic blood pressure and diastolic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Mean change from completion/discontinuation to follow-up in clinical measurement of systolic blood pressure and diastolic blood pressure [ Time Frame: week 4 to week 5 ] [ Designated as safety issue: Yes ]
  • Efficacy based on Disease Activity Score based on a 28 joint count (DAS28) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The DAS28 is based on a count of 28 swollen and tender joints, with a score ranging from 0 to 9.4, and can be used to objectively evaluate a patient's response to treatment.
Not Provided
Not Provided
 
Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis
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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: fostamatinib
    fostamatinib 100 mg twice daily
  • Drug: placebo
    placebo
  • Experimental: Dosing Regimen A
    Oral treatment
    Intervention: Drug: fostamatinib
  • Placebo Comparator: Dosing Regimen B
    Oral treatment
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Czech Republic,   Germany,   Poland,   South Africa,   Ukraine
 
NCT01563978
D4300C00033, 2011-006070-73
Yes
AstraZeneca
AstraZeneca
Not Provided
Study Director: Chris O'Brien, MD PhD AstraZeneca
AstraZeneca
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP