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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01563978
First received: March 23, 2012
Last updated: April 23, 2014
Last verified: April 2014
Results First Received: November 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: fostamatinib
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 266 patients were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 131 patients failed screening.

Reporting Groups
  Description
FOSTA 100 MG BID Fostamatinib 100 mg bid, oral treatment
PLACEBO Oral treatment

Participant Flow:   Overall Study
    FOSTA 100 MG BID     PLACEBO  
STARTED     68 [1]   67 [1]
Randomised But Did Not Receive Treatment     0     0  
COMPLETED     64     65  
NOT COMPLETED     4     2  
Physician Decision                 1                 0  
Lost to Follow-up                 1                 0  
Dev. of study specific discont. criteria                 1                 0  
Adverse Event                 1                 2  
[1] Patients who received treatment.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FOSTA 100 MG BID Fostamatinib 100 mg bid, oral treatment
PLACEBO Oral treatment
Total Total of all reporting groups

Baseline Measures
    FOSTA 100 MG BID     PLACEBO     Total  
Number of Participants  
[units: participants]
  68     67     135  
Age  
[units: Years]
Mean ± Standard Deviation
  54  ± 12.0     54  ± 13.0     54  ± 12.5  
Gender  
[units: Participants]
     
Female     57     57     114  
Male     11     10     21  
Race/Ethnicity, Customized  
[units: Participants]
     
White     63     58     121  
Black or African American     3     8     11  
Indian or Pakistani     2     1     3  



  Outcome Measures
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1.  Primary:   Change From Baseline in 24-hour Mean Ambulatory SBP   [ Time Frame: 4 weeks ]

2.  Secondary:   Change From Baseline in 24-hour Mean Ambulatory DBP   [ Time Frame: 4 weeks ]

3.  Secondary:   Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring   [ Time Frame: 4 weeks ]

4.  Secondary:   Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring   [ Time Frame: 4 weeks ]

5.  Secondary:   Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring   [ Time Frame: 4 weeks ]

6.  Secondary:   Mean Change From Baseline in Clinic SBP and DBP   [ Time Frame: 4 weeks ]

7.  Secondary:   Mean Change From Baseline in Morning Pre-dose Home SBP and DBP   [ Time Frame: 4 weeks ]

8.  Secondary:   Mean Change From Baseline in Evening Post-dose Home SBP and DBP   [ Time Frame: 4 weeks ]

9.  Secondary:   Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP   [ Time Frame: Day 29 to Day 36 ]

10.  Secondary:   DAS28-CRP Improvement   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dave Goldstraw
Organization: AstraZeneca Pharmaceuticals
phone: +44-1625-512415
e-mail: dave.goldstraw@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01563978     History of Changes
Other Study ID Numbers: D4300C00033, 2011-006070-73
Study First Received: March 23, 2012
Results First Received: November 8, 2013
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency Ministry of Health (BDA)
Czech Republic: The State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocides
Ukraine: Ministry of Public Health of Ukraine (MPHU)
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
South Africa: Medicines Control Council
Argentina: 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)