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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: fostamatinib; Drug: placebo

• Registration Number: NCT01563978
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Study Start: 2012-04
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2013-11-08
• Results First Submitted QC: 2014-03-13
• Status Verified: 2014-04
• Results First Posted: 2014-04-14
• Last Update Submitted: 2014-04-23
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dosing Regimen A	fostamatinib	Oral treatment
Dosing Regimen B	placebo	Oral treatment

Primary Outcome Measures

Name	Time	Method
Change From Baseline in 24-hour Mean Ambulatory SBP	4 weeks	ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in 24-hour Mean Ambulatory DBP	4 weeks	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	4 weeks	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	4 weeks	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	4 weeks	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	4 weeks	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	4 weeks	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	Day 29 to Day 36	BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
DAS28-CRP Improvement	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.
Mean Change From Baseline in Clinic SBP and DBP	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.

Trial Locations

Locations (1)

Research Site; 🇺🇦 Zaporozhye, Ukraine