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Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

This study has been terminated.
(AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.)
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: November 10, 2010
Last updated: February 25, 2014
Last verified: February 2014
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Fostamatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: (OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage of Patients Who Had at Least 1 Adverse Event in Any Category [ Time Frame: Entry in extension to end of study (variable duration; maximum 109 weeks) ]
    AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event

Secondary Outcome Measures:
  • Mean DAS28-CRP Score [ Time Frame: Weeks 0, 12, 24, 36 and 52 ]
    DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily

  • Mean mTSS Score [ Time Frame: Weeks 0 and 52 ]
    mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily

  • Mean HAQ-DI Score [ Time Frame: Weeks 0, 12, 24, 36 and 52 ]
    HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily

Enrollment: 1917
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Oral treatment
Drug: Fostamatinib
Fostamatinib 100mg twice daily
Experimental: B
Oral treatment
Drug: Fostamatinib
Fostamatinib 150mg once daily
Experimental: C
Oral treatment
Drug: Fostamatinib
Fostamatinib 100mg once daily


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
  • Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).

Exclusion Criteria:

  • Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
  • Females who are pregnant or breast feeding
  • Poorly controlled hypertension
  • Significant liver function test abnormalities or physical symptoms of hepatotoxicity
  • Significant infection
  • Gastrointestinal intolerance
  • Cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01242514

  Show 310 Study Locations
Sponsors and Collaborators
Study Director: Chris O'Brien, MD PhD AstraZeneca
  More Information

Responsible Party: AstraZeneca Identifier: NCT01242514     History of Changes
Other Study ID Numbers: D4300C00005
2010-020892-22 ( EudraCT Number )
Study First Received: November 10, 2010
Results First Received: December 18, 2013
Last Updated: February 25, 2014

Keywords provided by AstraZeneca:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on May 25, 2017