Text Size

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

This study is currently recruiting participants.
Verified March 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01264770
First received: December 17, 2010
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The study will last for approximately six months


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Fostamatinib and placebo injections
Drug: Adalimumab and placebo of fostamatinib
Drug: Placebo of fostamatinib, fostamatinib, and placebo injections
 Phase 2

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
Official Title: (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • DAS28 score change from baseline to week 6 compared to placebo (DAS28 = Disease Activity Score based on a 28 joint count) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • DAS28 score change from baseline to week 24 compared to adalimumab [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Review of efficacy based on the following criteria: DAS28, DAS28 response criteria, ACR20, ACR50, ACR70, ACR-N [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    (ACR20 = American College of Rheumatology 20% response criteria) ACR50 = American College of Rheumatology 50% response criteria, ACR70 = American College of Rheumatology 70% response criteria, ACR N = numeric index of the ACR response)

  • Health Assessment Questionnaire - Disability Index (HAQ-DI). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 36-item Short Form Health Survey (SF-36) questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: January 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing Group A
Oral treatment and subcutaneous injection
 Drug: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Experimental: Dosing Group B
Oral treatment and subcutaneous injection
 Drug: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Experimental: Dosing Group C
Oral treatment and subcutaneous injection
 Drug: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Active Comparator: Dosing Group D
Oral treatment and subcutaneous injection
 Drug: Adalimumab and placebo of fostamatinib
Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
Other Name: Humira®
Placebo Comparator: Dosing Group E
Oral treatment and subcutaneous injection
 Drug: Placebo of fostamatinib, fostamatinib, and placebo injections
Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily / fostamatinib 150mg once daily. Placebo injection once every two weeks.

Detailed Description:

Sub-study:

Full title: Optional Genetic Research

Date: 10 September 2010

Version: 1

Objectives: To collect and store, with appropriate consent , DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or adalimumab; and/or susceptibility to, progression of and prognosis of RA

The main study recruitment is complete, and sub study recruitment will continue until the target is reached, estimated to be June 2013

Sub-study:

Full title: (Sub-study to OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study

Date: 21 March 2011

Version: 1

Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by:

  • Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.
  Eligibility

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

Inclusion Criteria:

  • Male or female aged 18 and over
  • Active rheumatoid arthritis (RA) diagnosed after the age of 16 and diagnosis within 5 years prior to study visit 1 and inadequate response to treatment with a maximum 2 Disease-Modifying anti-rheumatic drug (DMARD) therapies, or diagnosis within 5 years prior to study visit 1 and intolerance to DMARD therapy, or diagnosis within 2 years prior to study visit 1 and no previous use of DMARDs
  • 4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
  • At least 2 of the following: documented history or current presence of positive rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)

Exclusion Criteria:

  • Females who are pregnant or breast feeding
  • Poorly controlled hypertension
  • Liver disease or significant liver function test abnormalities
  • Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
  • Recent or significant cardiovascular disease
  • Significant active or recent infection including tuberculosis
  • Previously received treatment with a TNF alpha antagonist (including etanercept, certolizumab, adalimumab, infliximab, golimumab) or anakinra or previous treatment with other biological agent including rituximab, abatacept and tocilizumab
  • Use of any DMARDs within 6 weeks before first study visit
  • Severe renal impairment
  • Neutropenia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264770

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 ext 001-800236993 information.center@astrazeneca.com

  Hide Study Locations
Locations
United States, Alabama
Research Site Recruiting
Birmingham, Alabama, United States
United States, Arizona
Research Site Recruiting
Glendale, Arizona, United States
Research Site Recruiting
Mesa, Arizona, United States
Research Site Recruiting
Phoenix, Arizona, United States
Research Site Recruiting
Scottsdale, Arizona, United States
United States, California
Research Site Recruiting
Huntington Beach, California, United States
Research Site Recruiting
Long Beach, California, United States
United States, Colorado
Research Site Recruiting
Colorado Springs, Colorado, United States
United States, Connecticut
Research Site Recruiting
Bridgeport, Connecticut, United States
United States, Florida
Research Site Recruiting
Daytona Beach, Florida, United States
Research Site Recruiting
Jacksonville, Florida, United States
Research Site Not yet recruiting
Miami, Florida, United States
Research Site Recruiting
Ocala, Florida, United States
Research Site Recruiting
Palm Harbor, Florida, United States
Research Site Recruiting
Pinellas Park, Florida, United States
Research Site Recruiting
Venice, Florida, United States
United States, Indiana
Research Site Recruiting
South Bend, Indiana, United States
United States, Kentucky
Research Site Recruiting
Bowling Green, Kentucky, United States
Research Site Recruiting
Elizabethtown, Kentucky, United States
United States, Maryland
Research Site Recruiting
Oxon Hill, Maryland, United States
United States, Michigan
Research Site Recruiting
Kalamazoo, Michigan, United States
United States, Missouri
Research Site Recruiting
Richmond Heights, Missouri, United States
United States, Montana
Research Site Recruiting
Kalispell, Montana, United States
United States, New Hampshire
Research Site Recruiting
Nashua, New Hampshire, United States
United States, New Mexico
Research Site Recruiting
Albuquerque, New Mexico, United States
Research Site Recruiting
Las Cruces, New Mexico, United States
United States, New York
Research Site Recruiting
Brooklyn, New York, United States
United States, North Carolina
Research Site Recruiting
Charlotte, North Carolina, United States
United States, Ohio
Research Site Recruiting
Perrysburg, Ohio, United States
United States, Pennsylvania
Research Site Recruiting
Duncansville, Pennsylvania, United States
United States, South Carolina
Research Site Recruiting
Greenville, South Carolina, United States
United States, Tennessee
Research Site Recruiting
Jackson, Tennessee, United States
Research Site Recruiting
Knoxville, Tennessee, United States
Research Site Recruiting
Memphis, Tennessee, United States
United States, Texas
Research Site Recruiting
Austin, Texas, United States
Research Site Recruiting
Mesquite, Texas, United States
Research Site Not yet recruiting
Plano, Texas, United States
Research Site Recruiting
San Antonio, Texas, United States
Bulgaria
Research Site Recruiting
Pleven, Bulgaria
Research Site Active, not recruiting
Plovdiv, Bulgaria
Research Site Active, not recruiting
Ruse, Bulgaria
Research Site Active, not recruiting
Sevlievo, Bulgaria
Research Site Active, not recruiting
Sofia, Bulgaria
Research Site Active, not recruiting
Veliko Tarnovo, Bulgaria
Canada, Ontario
Research Site Recruiting
Mississauga, Ontario, Canada
Czech Republic
Research Site Active, not recruiting
Brno, Czech Republic
Research Site Active, not recruiting
Bruntal, Czech Republic
Research Site Active, not recruiting
Hlucin, Czech Republic
Research Site Active, not recruiting
Liberec, Czech Republic
Research Site Active, not recruiting
Ostrava, Czech Republic
Research Site Active, not recruiting
Ostrava - Trebovice, Czech Republic
Research Site Recruiting
Praha, Czech Republic
Research Site Active, not recruiting
Praha 11, Czech Republic
Research Site Recruiting
Praha 2, Czech Republic
Research Site Active, not recruiting
Praha 4, Czech Republic
Research Site Active, not recruiting
Zlin, Czech Republic
Germany
Research Site Recruiting
Dresden, Germany
Research Site Recruiting
Hamburg, Germany
Research Site Recruiting
Muenchen, Germany
Hungary
Research Site Recruiting
Balatonfured, Hungary
Research Site Recruiting
Budapest, Hungary
Research Site Active, not recruiting
Debrecen, Hungary
Research Site Recruiting
Zalaegerszeg, Hungary
Netherlands
Research Site Recruiting
Amsterdam, Netherlands
Poland
Research Site Active, not recruiting
Bytom, Poland
Research Site Active, not recruiting
Chelm Slaski, Poland
Research Site Active, not recruiting
Grodzisk Mazowiecki, Poland
Research Site Active, not recruiting
Warszawa, Poland
Research Site Active, not recruiting
Wroclaw, Poland
Research Site Active, not recruiting
Zyrardow, Poland
Russian Federation
Research Site Active, not recruiting
Moscow, Russian Federation
Research Site Active, not recruiting
Nizhny Novgorod, Russian Federation
Research Site Active, not recruiting
Petrozavodsk, Russian Federation
Research Site Active, not recruiting
Ryazan, Russian Federation
Research Site Active, not recruiting
St. Petersburg, Russian Federation
Research Site Active, not recruiting
Voronezh, Russian Federation
Research Site Recruiting
Yaroslavl, Russian Federation
Slovakia
Research Site Completed
Trebisov, Slovakia
Research Site Completed
Trnava, Slovakia
South Africa
Research Site Recruiting
Pretoria, Gauteng, South Africa
Research Site Recruiting
Durban, Kwazulu Natal, South Africa
Research Site Recruiting
Cape Town, Western Cape, South Africa
Research Site Recruiting
Stellenbosch, South Africa
Ukraine
Research Site Completed
Donetsk, Ukraine
Research Site Completed
Ivano-frankivsk, Ukraine
Research Site Completed
Kharkiv, Ukraine
Research Site Completed
Kyiv, Ukraine
Research Site Completed
Lutsk, Ukraine
Research Site Completed
Lviv, Ukraine
Research Site Completed
Odessa, Ukraine
Research Site Completed
Simferopol, Ukraine
Research Site Completed
Zaporyzhzhya, Ukraine
United Kingdom
Research Site Recruiting
Reading, Berkshire, United Kingdom
Research Site Recruiting
London, Greater London, United Kingdom
Research Site Active, not recruiting
Eastbourne, Sussex, United Kingdom
Research Site Not yet recruiting
Basingstoke, United Kingdom
Research Site Recruiting
Manchester, United Kingdom
Research Site Recruiting
Wolverhampton, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Chris O'Brien, MD PhD AstraZeneca
  More Information

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
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Bulgaria: Bulgarian Drug Agency Ministry of Health (BDA)
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Hungary: National Institute of Pharmacy (Medicines Agency)
Netherlands: Medicines Evaluation Board
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocides
Russia: Public Health Institute
Ukraine: Ministry of Public Health of Ukraine (MPHU)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Africa: Medicines Control Council (MCC)

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
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 17, 2013