Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

This study has been terminated.
(AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01264770
First received: December 17, 2010
Last updated: April 3, 2014
Last verified: April 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 and placebo injections
Drug: Adalimumab and placebo of fostamatinib
Drug: Placebo of fostamatinib, fostamatinib, and placebo injections

  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
452 patients were enrolled into the main study, with 198 patients enrolled into a separate MRI sub-study. Synovitis results for the MRI sub-study were reported later due to study delays and so are presented entirely separately.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 173 patients failed screening to the main study.

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
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO Dosing Group C
ADALIMUMAB 40 MG SC Dosing Group D
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO Dosing Group F
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO Dosing Group G

Participant Flow:   Overall Study
    FOSTA 100 MG BID PO     FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO     FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO     ADALIMUMAB 40 MG SC     PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO     PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO  
STARTED     54 [1]   48 [1]   57 [1]   54 [1]   27 [1]   25 [1]
Randomised But Did Not Receive Treatment     2 [2]   5 [2]   2 [2]   3 [2]   2 [2]   0 [2]
COMPLETED     36 [3]   38 [3]   41 [3]   48 [3]   19 [3]   19 [3]
NOT COMPLETED     18     10     16     6     8     6  
Not reported                 0                 0                 1                 0                 0                 0  
e.g., change in circumstances                 8                 3                 3                 3                 4                 4  
Severe non-compliance to protocol                 0                 0                 1                 1                 0                 0  
Lack of therapeutic response                 1                 0                 2                 1                 1                 0  
Dev. of study specific discont. criteria                 2                 0                 0                 0                 1                 1  
Lost to Follow-up                 0                 0                 1                 1                 0                 0  
Adverse Event                 7                 7                 8                 0                 2                 1  
[1] Patients who received treatment
[2] Eligibility criteria not fulfilled/subject decision/other
[3] 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
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO Dosing Group C
ADALIMUMAB 40 MG SC Dosing Group D
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO Dosing Group F
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO Dosing Group G
Total Total of all reporting groups

Baseline Measures
    FOSTA 100 MG BID PO     FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO     FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO     ADALIMUMAB 40 MG SC     PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO     PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO     Total  
Number of Participants  
[units: participants]
  54     48     57     54     27     25     265  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 11.5     50  ± 12.6     50  ± 11.0     48  ± 12.4     50  ± 12.7     53  ± 10.8     50  ± 11.8  
Gender  
[units: Participants]
             
Female     38     39     48     45     20     20     210  
Male     16     9     9     9     7     5     55  
Race/Ethnicity, Customized  
[units: Participants]
             
White     48     47     48     51     23     23     240  
Black or African American     5     0     6     1     3     1     16  
Asian     1     1     0     1     0     1     4  
American Indian or Alaska Native     0     0     1     0     0     0     1  
Indian or Pakistani     0     0     1     1     0     0     2  
Other     0     0     1     0     1     0     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo   [ Time Frame: Baseline and 6 weeks ]

2.  Primary:   DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab   [ Time Frame: Baseline and 24 weeks ]

3.  Secondary:   DAS28 EULAR Response at Week 6   [ Time Frame: 6 weeks ]

4.  Secondary:   DAS28 EULAR Response at Week 24   [ Time Frame: 24 weeks ]

5.  Secondary:   Proportion of Patients Achieving ACR20 up to Week 24   [ Time Frame: 6 and 24 weeks ]

6.  Secondary:   Proportion of Patients Achieving ACR50 up to Week 24   [ Time Frame: 6 and 24 weeks ]

7.  Secondary:   Proportion of Patients Achieving ACR70 up to Week 24   [ Time Frame: 6 and 24 weeks ]

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

9.  Secondary:   ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24   [ Time Frame: Baseline and 24 weeks ]

10.  Secondary:   HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6   [ Time Frame: Baseline and 6 weeks ]

11.  Secondary:   HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24   [ Time Frame: Baseline and 24 weeks ]

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

13.  Secondary:   SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab 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 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 (0)1625 512415
e-mail: dave.goldstraw@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01264770     History of Changes
Other Study ID Numbers: D4300C00004, 2010-023692-26
Study First Received: December 17, 2010
Results First Received: November 22, 2013
Last Updated: April 3, 2014
Health Authority: Argentina: National Administration of Drugs, Food & Medical Technology (ANMAT)
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Public Health Institute
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration