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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


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
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