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

Rheumatoid Arthritis Clinical Trial

— Oskira ABPM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563978
• Other study ID #: D4300C00033
• Secondary ID: 2011-006070-73
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2012
• Last updated: April 23, 2014
• Start date: April 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Bulgarian Drug Agency Ministry of Health (BDA)Czech Republic: The State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and BiocidesUkraine: Ministry of Public Health of Ukraine (MPHU)Germany: Federal Institute for Drugs and Medical Devices (BfArM)South Africa: Medicines Control CouncilArgentina: National Administration of Drugs, Food & Medical Technology (ANMAT)Mexico: Federal Commission for Protection Against Sanitary Risks (COFEPRIS)Peru: General Directorate of Medicines, Supplies and Drug (DIGEMID)Brazil: The National Health Surveillance Agency (ANVISA)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• fostamatinib
fostamatinib 100 mg twice daily
• placebo
placebo

Locations

Country	Name	City	State
Bulgaria	Research Site	Sevlievo
Bulgaria	Research Site	Sofia
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Hlucin
Czech Republic	Research Site	Hostivice
Czech Republic	Research Site	Kladno
Czech Republic	Research Site	Ostrava-Trebovice
Czech Republic	Research Site	Praha 11
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha 4
Germany	Research Site	Aachen
Germany	Research Site	Halle
Poland	Research Site	Gdynia
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Kalisz
Poland	Research Site	Katowice
Poland	Research Site	Lódz
Poland	Research Site	Poznan
Poland	Research Site	Sroda Wielkopolska
Poland	Research Site	Wroclaw
South Africa	Research Site	Bloemfontein
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Kempron Park
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Vinnytsia
Ukraine	Research Site	Zaporizhzhya
Ukraine	Research Site	Zaporozhye
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Austin	Texas
United States	Research Site	Boca Raton	Florida
United States	Research Site	Brandon	Florida
United States	Research Site	Brooklyn	New York
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Cumberland	Maryland
United States	Research Site	Dallas	Texas
United States	Research Site	Decatur	Georgia
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Florissant	Missouri
United States	Research Site	Frederick	Maryland
United States	Research Site	Freehold	New Jersey
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Hagerstown	Maryland
United States	Research Site	Houston	Texas
United States	Research Site	Huntington Beach	California
United States	Research Site	Huntsville	Alabama
United States	Research Site	Lake Oswego	Oregon
United States	Research Site	Lubbock	Texas
United States	Research Site	Memphis	Tennessee
United States	Research Site	Nassau Bay	Texas
United States	Research Site	Orlando	Florida
United States	Research Site	Richmond Heights	Missouri
United States	Research Site	Santa Maria	California
United States	Research Site	South Bend	Indiana
United States	Research Site	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Trumbull	Connecticut
United States	Research Site	Venice	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  Germany,  Poland,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in 24-hour Mean Ambulatory SBP	ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.	4 weeks	Yes
Secondary	Change From Baseline in 24-hour Mean Ambulatory DBP	ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product.	4 weeks	Yes
Secondary	Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring	ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.	4 weeks	Yes
Secondary	Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring	ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.	4 weeks	Yes
Secondary	Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring	ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.	4 weeks	Yes
Secondary	Mean Change From Baseline in Clinic SBP and DBP	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.	4 weeks	Yes
Secondary	Mean Change From Baseline in Morning Pre-dose Home SBP and DBP	ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.	4 weeks	Yes
Secondary	Mean Change From Baseline in Evening Post-dose Home SBP and DBP	ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.	4 weeks	Yes
Secondary	Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP	BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.	Day 29 to Day 36	Yes
Secondary	DAS28-CRP Improvement	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.	4 weeks	No