Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (OSKIRA - 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01197521
First received: September 8, 2010
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: November 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: fostamatinib
Drug: placebo, fostamatinib

  Participant Flow
  Hide Participant Flow

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 1475 patients were enrolled: 311, 306 & 306 were randomised to Groups A, B & C, respectively (310, 304 & 304 received at least 1 dose of IP).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 552 patients failed screening.

Reporting Groups
  Description
FOSTA 100 MG BID PO Dosing Group A
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO Dosing Group B
PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO Dosing Group C

Participant Flow:   Overall Study
    FOSTA 100 MG BID PO     FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO     PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO  
STARTED     310 [1]   304 [1]   304 [1]
Randomised But Did Not Receive Treatment     1 [2]   2 [3]   2 [4]
COMPLETED     207 [5]   191 [5]   161 [5]
NOT COMPLETED     103     113     143  
Not reported                 24                 25                 21  
Enrolment in long term extension                 42                 36                 87  
Severe non-compliance to protocol                 1                 3                 3  
Lack of therapeutic response                 2                 3                 4  
Dev. of study specific discont. criteria                 6                 16                 2  
Lost to Follow-up                 3                 2                 2  
Adverse Event                 25                 28                 24  
[1] Patients who received treatment
[2] Eligibility criteria not fulfilled
[3] Eligibility criteria not fulfilled/other
[4] Adverse event/eligibility criteria not fulfilled
[5] Number of patients who completed treatment includes patients who had a dose reduction.



  Baseline Characteristics
  Hide Baseline Characteristics

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 PO Dosing Group A
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO Dosing Group B
PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO Dosing Group C
Total Total of all reporting groups

Baseline Measures
    FOSTA 100 MG BID PO     FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO     PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO     Total  
Number of Participants  
[units: participants]
  310     304     304     918  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 12.2     52  ± 12.0     53  ± 11.9     52  ± 12.0  
Gender  
[units: Participants]
       
Female     263     254     253     770  
Male     47     50     51     148  
Race/Ethnicity, Customized  
[units: Participants]
       
White     218     213     209     640  
Black or African American     9     5     11     25  
Asian     3     10     5     18  
American Indian or Alaska Native     14     12     11     37  
Indian or Pakistani     20     14     19     53  
Other     46     50     49     145  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.   [ Time Frame: 24 weeks ]

2.  Primary:   Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.   [ Time Frame: Baseline and 24 weeks ]

3.  Secondary:   ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1   [ Time Frame: 1 week ]

4.  Secondary:   Proportion of Patients Achieving ACR50 up to Week 24   [ Time Frame: 24 weeks ]

5.  Secondary:   Proportion of Patients Achieving ACR70 up to Week 24   [ Time Frame: 24 weeks ]

6.  Secondary:   ACRn - Comparison Between Fostamatinib and Placebo at Week 24   [ Time Frame: 24 weeks ]

7.  Secondary:   Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12   [ Time Frame: 12 weeks ]

8.  Secondary:   Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24   [ Time Frame: 24 weeks ]

9.  Secondary:   Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24   [ Time Frame: 24 weeks ]

10.  Secondary:   HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24   [ Time Frame: Baseline and 24 weeks ]

11.  Secondary:   SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24   [ Time Frame: Baseline and 24 weeks ]

12.  Secondary:   SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24   [ Time Frame: Baseline and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dave Goldstraw
Organization: AstraZeneca
phone: +44 (0)1625 512415
e-mail: dave.goldstraw@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01197521     History of Changes
Other Study ID Numbers: D4300C00001, 2010-020743-12
Study First Received: September 8, 2010
Results First Received: November 22, 2013
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
India: Drugs Controller General of India
Argentina: National Administration of Drugs, Food & Medical Technology (ANMAT)
Brazil: National Health Surveillance Agency
Chile: Instituto de Salud Pública de Chile
Mexico: Federal Commission for Sanitary Risks Protection
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs