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

(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Fostamatinib; Drug: Fostamatinib; Drug: Fostamatinib

• Study Type: Interventional
• Enrollment (Actual): 1917
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba Buenos Aires, Argentina
    • Research Site
  • Ciudad Autonoma Bs As, Argentina
    • Research Site
  • Ciudad de Buenos Aires, Argentina
    • Research Site
  • Quilmes, Argentina
    • Research Site
  • San Juan, Argentina
    • Research Site
  • CBA
    • Ciudad Autonoma Bs As, CBA, Argentina
      • Research Site
  • CRD
    • Cordoba, CRD, Argentina
      • Research Site
  • Caba
    • Buenos Aires, Caba, Argentina
      • Research Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina
      • Research Site
  • TUC
    • San Miguel de Tucuman, TUC, Argentina
      • Research Site
• Australia
  • Cairns, Australia
    • Research Site
  • New South Wales
    • Camperdown, New South Wales, Australia
      • Research Site
  • Queensland
    • Southport, Queensland, Australia
      • Research Site
• Belgium
  • Brussels, Belgium
    • Research Site
  • Gent, Belgium
    • Research Site
  • Gilly, Belgium
    • Research Site
  • Liege, Belgium
    • Research Site
  • Yvoir, Belgium
    • Research Site
• Brazil
  • Rio de Janeiro, Brazil
    • Research Site
  • GO
    • Goiania, GO, Brazil
      • Research Site
  • PE
    • Recife, PE, Brazil
      • Research Site
  • PR
    • Curitiba, PR, Brazil
      • Research Site
  • SP
    • Sao Paulo, SP, Brazil
      • Research Site
• Bulgaria
  • Pleven, Bulgaria
    • Research Site
  • Plovdiv, Bulgaria
    • Research Site
  • Sevlievo, Bulgaria
    • Research Site
  • Sofia, Bulgaria
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Research Site
  • British Columbia
    • Victoria, British Columbia, Canada
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Research Site
  • Newfoundland and Labrador
    • St John's, Newfoundland and Labrador, Canada
      • Research Site
    • St. John's, Newfoundland and Labrador, Canada
      • Research Site
  • Ontario
    • Bowmanville, Ontario, Canada
      • Research Site
    • Etobicoke, Ontario, Canada
      • Research Site
    • Hamilton, Ontario, Canada
      • Research Site
    • Mississauga, Ontario, Canada
      • Research Site
    • Ottawa, Ontario, Canada
      • Research Site
    • Toronto, Ontario, Canada
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada
      • Research Site
    • Pointe-claire, Quebec, Canada
      • Research Site
    • Quebec City, Quebec, Canada
      • Research Site
    • Rimouski, Quebec, Canada
      • Research Site
    • Trois-rivieres, Quebec, Canada
      • Research Site
• Chile
  • Santiago, Chile
    • Research Site
  • X Region
    • Osorno, X Region, Chile
      • Research Site
• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia
      • Research Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Research Site
  • Santander
    • Bucaramanga, Santander, Colombia
      • Research Site
• Czech Republic
  • Brno, Czech Republic
    • Research Site
  • Bruntal, Czech Republic
    • Research Site
  • Ceska Lipa, Czech Republic
    • Research Site
  • Ceske Budejovice, Czech Republic
    • Research Site
  • Hlucin, Czech Republic
    • Research Site
  • Hostivice, Czech Republic
    • Research Site
  • Kladno, Czech Republic
    • Research Site
  • Liberec, Czech Republic
    • Research Site
  • Ostrava, Czech Republic
    • Research Site
  • Ostrava - Trebovice, Czech Republic
    • Research Site
  • Praha, Czech Republic
    • Research Site
  • Sokolov, Czech Republic
    • Research Site
  • Terezin, Czech Republic
    • Research Site
  • Zlin, Czech Republic
    • Research Site
• Estonia
  • Parnu, Estonia
    • Research Site
  • Tallinn, Estonia
    • Research Site
  • Tartu, Estonia
    • Research Site
• France
  • Orleans Cedex 1, France
    • Research Site
• Germany
  • Erlangen, Germany
    • Research Site
  • Frankfurt, Germany
    • Research Site
  • Hamburg, Germany
    • Research Site
  • Heidelberg, Germany
    • Research Site
  • Herne, Germany
    • Research Site
  • Koln, Germany
    • Research Site
  • Leipzig, Germany
    • Research Site
  • Muenchen, Germany
    • Research Site
  • Nordrhein Westfalen
    • Aachen, Nordrhein Westfalen, Germany
      • Research Site
  • Sachsen
    • Halle, Sachsen, Germany
      • Research Site
• Hungary
  • Balatonfured, Hungary
    • Research Site
  • Bekescsaba, Hungary
    • Research Site
  • Budapest, Hungary
    • Research Site
  • Debrecen, Hungary
    • Research Site
  • Mako, Hungary
    • Research Site
  • Sopron, Hungary
    • Research Site
  • Szentes, Hungary
    • Research Site
  • Zalaegerszeg-pozva, Hungary
    • Research Site
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India
      • Research Site
    • Secunderabad, Andhra Pradesh, India
      • Research Site
  • Gujarat
    • Ahmedabad, Gujarat, India
      • Research Site
    • Gandhinagar, Gujarat, India
      • Research Site
    • Vadodara, Gujarat, India
      • Research Site
  • Karnataka
    • Bangalore, Karnataka, India
      • Research Site
    • Mangalore, Karnataka, India
      • Research Site
    • Udupi, Karnataka, India
      • Research Site
  • Maharashtra
    • Mumbai, Maharashtra, India
      • Research Site
    • Pune, Maharashtra, India
      • Research Site
  • Maharshtra
    • Nagpur, Maharshtra, India
      • Research Site
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India
      • Research Site
    • Madurai, Tamil Nadu, India
      • Research Site
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India
      • Research Site
• Israel
  • Ashkelon, Israel
    • Research Site
  • Haifa, Israel
    • Research Site
  • Kfar-saba, Israel
    • Research Site
  • Ramat-gan, Israel
    • Research Site
  • Rehovot, Israel
    • Research Site
• Italy
  • AN
    • Jesi, AN, Italy
      • Research Site
  • UD
    • Udine, UD, Italy
      • Research Site
  • VA
    • Varese, VA, Italy
      • Research Site
• Latvia
  • Liepaja, Latvia
    • Research Site
  • Riga, Latvia
    • Research Site
  • Valmiera, Latvia
    • Research Site
• Lithuania
  • Kaunas, Lithuania
    • Research Site
  • Klaipeda, Lithuania
    • Research Site
  • Siauliai, Lithuania
    • Research Site
• Mexico
  • Chihuahua, Mexico
    • Research Site
  • San Luis Potosi, Mexico
    • Research Site
  • Baja California
    • Mexicali, Baja California, Mexico
      • Research Site
  • Coahuila
    • Saltillo, Coahuila, Mexico
      • Research Site
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico
      • Research Site
  • JAL
    • Guadalajara, JAL, Mexico
      • Research Site
  • NL
    • Monterrey, NL, Mexico
      • Research Site
  • SON
    • Obrergon, SON, Mexico
      • Research Site
• Peru
  • Arequipa, Peru
    • Research Site
  • Lima, Peru
    • Research Site
  • Lima
    • Pueblo Libre, Lima, Peru
      • Research Site
    • San Borja, Lima, Peru
      • Research Site
    • San Isidro, Lima, Peru
      • Research Site
• Poland
  • Bytom, Poland
    • Research Site
  • Chelm Slaski, Poland
    • Research Site
  • Grodzisk Mazowiecki, Poland
    • Research Site
  • Kalisz, Poland
    • Research Site
  • Katowice, Poland
    • Research Site
  • Krakow, Poland
    • Research Site
  • Lodz, Poland
    • Research Site
  • Warszawa, Poland
    • Research Site
  • Wroclaw, Poland
    • Research Site
  • Zyrardow, Poland
    • Research Site
• Portugal
  • Aveiro, Portugal
    • Research Site
  • Coimbra, Portugal
    • Research Site
  • Lisboa, Portugal
    • Research Site
  • Porto, Portugal
    • Research Site
• Romania
  • Braila, Romania
    • Research Site
  • Prahova
    • Ploiesti, Prahova, Romania
      • Research Site
• Russian Federation
  • Moscow, Russian Federation
    • Research Site
  • Nizhniy Novgorod, Russian Federation
    • Research Site
  • Petrozavodsk, Russian Federation
    • Research Site
  • Ryazan, Russian Federation
    • Research Site
  • Sankt-peterburg, Russian Federation
    • Research Site
  • Voronezh, Russian Federation
    • Research Site
  • Yaroslavl, Russian Federation
    • Research Site
• Serbia
  • Belgrade, Serbia
    • Research Site
  • Kragujevac, Serbia
    • Research Site
  • Niska Banja, Serbia
    • Research Site
  • Novi Sad, Serbia
    • Research Site
• Slovakia
  • Bratislava, Slovakia
    • Research Site
  • Poprad, Slovakia
    • Research Site
  • Rimavska Sobota, Slovakia
    • Research Site
  • Ruzomberok, Slovakia
    • Research Site
  • Trnava, Slovakia
    • Research Site
  • Zilina, Slovakia
    • Research Site
• South Africa
  • Stellenbosch, South Africa
    • Research Site
  • Cape Town
    • Panorama, Cape Town, South Africa
      • Research Site
  • E Cape
    • Port Elizabeth, E Cape, South Africa
      • Research Site
  • Gauteng
    • Kempron Park, Gauteng, South Africa
      • Research Site
    • Pretoria, Gauteng, South Africa
      • Research Site
  • Kwazulu Natal
    • Durban, Kwazulu Natal, South Africa
      • Research Site
  • Western Cape
    • Cape Town, Western Cape, South Africa
      • Research Site
• Spain
  • Barcelona, Spain
    • Research Site
  • Extremadura
    • Merida, Extremadura, Spain
      • Research Site
• Ukraine
  • Donetsk, Ukraine
    • Research Site
  • Ivano-frankivsk, Ukraine
    • Research Site
  • Kharkiv, Ukraine
    • Research Site
  • Kyiv, Ukraine
    • Research Site
  • Lugansk, Ukraine
    • Research Site
  • Lutsk, Ukraine
    • Research Site
  • Lviv, Ukraine
    • Research Site
  • Odessa, Ukraine
    • Research Site
  • Simferopol, Ukraine
    • Research Site
  • Vinnytsia, Ukraine
    • Research Site
  • Vinnytsya, Ukraine
    • Research Site
  • Zaporizhzhya, Ukraine
    • Research Site
  • Zaporyzhzhya, Ukraine
    • Research Site
• United Kingdom
  • Basingstoke, United Kingdom
    • Research Site
  • Cambridge, United Kingdom
    • Research Site
  • Christchurch, United Kingdom
    • Research Site
  • Ipswich, United Kingdom
    • Research Site
  • Nottingham, United Kingdom
    • Research Site
  • Stoke on Trent, United Kingdom
    • Research Site
  • Westcliff-on-the Sea, United Kingdom
    • Research Site
  • Wirral, United Kingdom
    • Research Site
  • Berkshire
    • Bracknell, Berkshire, United Kingdom
      • Research Site
  • Cheshire
    • Warrington, Cheshire, United Kingdom
      • Research Site
  • Greater London
    • London, Greater London, United Kingdom
      • Research Site
  • Kent
    • Maidstone, Kent, United Kingdom
      • Research Site
  • Sussex
    • Eastbourne, Sussex, United Kingdom
      • Research Site
  • West Midlands
    • Solihull, West Midlands, United Kingdom
      • Research Site
• United States
  • Alabama
    • Anniston, Alabama, United States
      • Research Site
    • Birmingham, Alabama, United States
      • Research Site
    • Huntsville, Alabama, United States
      • Research Site
    • Tuscaloosa, Alabama, United States
      • Research Site
  • Arizona
    • Glendale, Arizona, United States
      • Research Site
    • Mesa, Arizona, United States
      • Research Site
    • Phoenix, Arizona, United States
      • Research Site
    • Scottsdale, Arizona, United States
      • Research Site
    • Tucson, Arizona, United States
      • Research Site
  • Arkansas
    • Hot Springs, Arkansas, United States
      • Research Site
  • California
    • Anaheim, California, United States
      • Research Site
    • Fountain Valley, California, United States
      • Research Site
    • Huntington Beach, California, United States
      • Research Site
    • La Jolla, California, United States
      • Research Site
    • Long Beach, California, United States
      • Research Site
    • Palo Alto, California, United States
      • Research Site
    • Roseville, California, United States
      • Research Site
    • Santa Maria, California, United States
      • Research Site
    • Santa Monica, California, United States
      • Research Site
    • Torrance, California, United States
      • Research Site
    • Upland, California, United States
      • Research Site
  • Colorado
    • Colorado Springs, Colorado, United States
      • Research Site
  • Connecticut
    • Bridgeport, Connecticut, United States
      • Research Site
    • Danbury, Connecticut, United States
      • Research Site
    • Trumbull, Connecticut, United States
      • Research Site
  • Delaware
    • Lewes, Delaware, United States
      • Research Site
  • Florida
    • Boca Raton, Florida, United States
      • Research Site
    • Brandon, Florida, United States
      • Research Site
    • Daytona Beach, Florida, United States
      • Research Site
    • Ft. Lauderdale, Florida, United States
      • Research Site
    • Jacksonville, Florida, United States
      • Research Site
    • Miami, Florida, United States
      • Research Site
    • Ocala, Florida, United States
      • Research Site
    • Orlando, Florida, United States
      • Research Site
    • Palm Harbor, Florida, United States
      • Research Site
    • Pinellas Park, Florida, United States
      • Research Site
    • Tampa, Florida, United States
      • Research Site
    • Tavares, Florida, United States
      • Research Site
    • Venice, Florida, United States
      • Research Site
    • Zephyr Hills, Florida, United States
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States
      • Research Site
    • Canton, Georgia, United States
      • Research Site
    • Decatur, Georgia, United States
      • Research Site
    • Lawrenceville, Georgia, United States
      • Research Site
    • Macon, Georgia, United States
      • Research Site
    • Marietta, Georgia, United States
      • Research Site
  • Idaho
    • Idaho Falls, Idaho, United States
      • Research Site
  • Illinois
    • Chicago, Illinois, United States
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States
      • Research Site
    • South Bend, Indiana, United States
      • Research Site
  • Iowa
    • Cedar Rapids, Iowa, United States
      • Research Site
  • Kentucky
    • Bowling Green, Kentucky, United States
      • Research Site
    • Elizabethtown, Kentucky, United States
      • Research Site
  • Maryland
    • Cumberland, Maryland, United States
      • Research Site
    • Frederick, Maryland, United States
      • Research Site
    • Hagerstown, Maryland, United States
      • Research Site
    • Oxon Hill, Maryland, United States
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States
      • Research Site
    • Fall River, Massachusetts, United States
      • Research Site
    • Worcester, Massachusetts, United States
      • Research Site
  • Michigan
    • Kalamazoo, Michigan, United States
      • Research Site
    • Lansing, Michigan, United States
      • Research Site
    • St. Clair Shores, Michigan, United States
      • Research Site
  • Minnesota
    • Eagan, Minnesota, United States
      • Research Site
  • Mississippi
    • Flowood, Mississippi, United States
      • Research Site
  • Missouri
    • Florissant, Missouri, United States
      • Research Site
    • Richmond Heights, Missouri, United States
      • Research Site
    • St. Louis, Missouri, United States
      • Research Site
  • Montana
    • Kalispell, Montana, United States
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States
      • Research Site
  • New Jersey
    • Freehold, New Jersey, United States
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Research Site
    • Las Cruces, New Mexico, United States
      • Research Site
  • New York
    • Albany, New York, United States
      • Research Site
    • Brooklyn, New York, United States
      • Research Site
    • Cooperstown, New York, United States
      • Research Site
    • Olean, New York, United States
      • Research Site
    • Roslyn, New York, United States
      • Research Site
    • Smithtown, New York, United States
      • Research Site
    • Syracuse, New York, United States
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States
      • Research Site
    • Charlotte, North Carolina, United States
      • Research Site
    • Durham, North Carolina, United States
      • Research Site
    • Greensboro, North Carolina, United States
      • Research Site
    • Research Triangle Park, North Carolina, United States
      • Research Site
  • Ohio
    • Dayton, Ohio, United States
      • Research Site
    • Mayfield Village, Ohio, United States
      • Research Site
    • Perrysburg, Ohio, United States
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Research Site
  • Oregon
    • Lake Oswego, Oregon, United States
      • Research Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States
      • Research Site
    • Erie, Pennsylvania, United States
      • Research Site
    • Philadelphia, Pennsylvania, United States
      • Research Site
    • Waxford, Pennsylvania, United States
      • Research Site
    • West Reading, Pennsylvania, United States
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States
      • Research Site
    • Greenville, South Carolina, United States
      • Research Site
    • Orangeburg, South Carolina, United States
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States
      • Research Site
  • Tennessee
    • Hixson, Tennessee, United States
      • Research Site
    • Jackson, Tennessee, United States
      • Research Site
    • Knoxville, Tennessee, United States
      • Research Site
    • Memphis, Tennessee, United States
      • Research Site
    • Nashville, Tennessee, United States
      • Research Site
  • Texas
    • Amarillo, Texas, United States
      • Research Site
    • Austin, Texas, United States
      • Research Site
    • Dallas, Texas, United States
      • Research Site
    • Houston, Texas, United States
      • Research Site
    • Katy, Texas, United States
      • Research Site
    • Lubbock, Texas, United States
      • Research Site
    • Mesquite, Texas, United States
      • Research Site
    • Nassau Bay, Texas, United States
      • Research Site
    • San Antonio, Texas, United States
      • Research Site
  • Virginia
    • Chesapeake, Virginia, United States
      • Research Site
  • Washington
    • Tacoma, Washington, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Oral treatment	Drug: Fostamatinib; Fostamatinib 100mg twice daily; Drug: Fostamatinib; Fostamatinib 150mg once daily; Drug: Fostamatinib; Fostamatinib 100mg once daily
EXPERIMENTAL: B; Oral treatment	Drug: Fostamatinib; Fostamatinib 100mg twice daily; Drug: Fostamatinib; Fostamatinib 150mg once daily; Drug: Fostamatinib; Fostamatinib 100mg once daily
EXPERIMENTAL: C; Oral treatment	Drug: Fostamatinib; Fostamatinib 100mg twice daily; Drug: Fostamatinib; Fostamatinib 150mg once daily; Drug: Fostamatinib; Fostamatinib 100mg once daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean DAS28-CRP Score	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	Weeks 0, 12, 24, 36 and 52
Mean mTSS Score	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	Weeks 0 and 52
Mean HAQ-DI Score	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	Weeks 0, 12, 24, 36 and 52

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): January 1, 2015
• Study Completion (ANTICIPATED): January 1, 2015

Study Registration Dates

• First Submitted: November 10, 2010
• First Submitted That Met QC Criteria: November 16, 2010
• First Posted (ESTIMATE): November 17, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 4, 2014
• Last Update Submitted That Met QC Criteria: February 25, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; OSKIRA; Fostamatinib
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: D4300C00005; 2010-020892-22 (EUDRACT_NUMBER)