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.)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01242514
First received: November 10, 2010
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242514

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01242514     History of Changes
Other Study ID Numbers: D4300C00005, 2010-020892-22
Study First Received: November 10, 2010
Results First Received: December 18, 2013
Last Updated: February 25, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
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
Israel: Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
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 Publica de Chile
Mexico: Federal Commission for Sanitary Risks Protection
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
South Africa: Medicines Control Council

Keywords provided by AstraZeneca:
Rheumatoid Arthritis
OSKIRA
Fostamatinib

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014