Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis

• Conditions: Rheumatoid arthritis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2011-006070-73-BG
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-07
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Male and female patients aged 18 or over diagnosed with Rheumatoid Arthritis after the age of 16
2. Active Rheumatoid Arthritis
3. Currently taking one of the following DMARD treatments: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
4.Patients with essential hypertension may be included provided that their BP is controlled (<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 117
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

1. Females who are pregnant or breast feeding
2. Certain inflammatory conditions (other than RA), connective tissue diseases or chronic pain disorders
3. History of liver problems that have required previous investigations
4. Evidence of TB infection
5. Conditions that preclude or render difficult the 24-hour ABPM technique.
6. Known secondary causes of hypertension.
7. Evidence of recent significant CV disease.
8. Severely impaired renal function.
9. Evidence of recent or active infection.
10. Absolute neutrophil count (ANC) <1500/mm3 or 1.5 x 109/L.
11. Any other clinically significant disease or disorder, which in the opinion of the investigator (by its nature or by being inadequately controlled) might put the patient at risk due to participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified