Clinical trial NCT01563978: Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in 24-hour Mean Ambulatory SBP
timeFrame: 4 weeks
Secondary outcomes:
measure: Change From Baseline in 24-hour Mean Ambulatory DBP
timeFrame: 4 weeks
measure: Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring
timeFrame: 4 weeks
measure: Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring
timeFrame: 4 weeks
measure: Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring
timeFrame: 4 weeks
measure: Mean Change From Baseline in Clinic SBP and DBP
timeFrame: 4 weeks
measure: Mean Change From Baseline in Morning Pre-dose Home SBP and DBP
timeFrame: 4 weeks
measure: Mean Change From Baseline in Evening Post-dose Home SBP and DBP
timeFrame: 4 weeks
measure: Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP
timeFrame: Day 29 to Day 36
measure: DAS28-CRP Improvement
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Santa Maria
country: United States
facility: Research Site
state: California
city: Trumbull
country: United States
facility: Research Site
state: Connecticut
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Brandon
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Venice
country: United States
facility: Research Site
state: Florida
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: South Bend
country: United States
facility: Research Site
state: Indiana
city: Cumberland
country: United States
facility: Research Site
state: Maryland
city: Frederick
country: United States
facility: Research Site
state: Maryland
city: Hagerstown
country: United States
facility: Research Site
state: Maryland
city: Florissant
country: United States
facility: Research Site
state: Missouri
city: Richmond Heights
country: United States
facility: Research Site
state: Missouri
city: Freehold
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Lake Oswego
country: United States
facility: Research Site
state: Oregon
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: Nassau Bay
country: United States
facility: Research Site
state: Texas
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Sevlievo
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Hlucin
country: Czech Republic
facility: Research Site
city: Hostivice
country: Czech Republic
facility: Research Site
city: Kladno
country: Czech Republic
facility: Research Site
city: Ostrava-Trebovice
country: Czech Republic
facility: Research Site
city: Praha 11
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Kalisz
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Sroda Wielkopolska
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Kempron Park
country: South Africa
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
city: Zaporozhye
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Chris O'Brien, MD PhD
role: STUDY_DIRECTOR
References: