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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: fostamatinib; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563978

2011-006070-73

D4300C00033

Details and patient eligibility

About

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.

Full 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

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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266 participants in 2 patient groups, including a placebo group

Dosing Regimen A

Experimental group

Description:

Oral treatment

Treatment:

Drug: fostamatinib

Dosing Regimen B

Placebo Comparator group

Description:

Oral treatment

Treatment:

Drug: placebo