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Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis (OSKIRA-Asia-1)

This study is currently recruiting participants.
Verified May 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01569074
First received: March 30, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of the study is to evaluate the effectiveness of four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 12 weeks.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Fostamatinib
Drug: Placebo
 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-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Proportion of patients with ACR20 compared to placebo (ACR20 = American College of Rheumatology 20% response criteria) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with ACR20, ACR50, ACR70, ACR-N response compared to placebo (ACR50 = American College of Rheumatology 50% response criteria, ACR70 = American College of Rheumatology 70% response criteria) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Disease Activity Score based on a 28 joint count (DAS28) and proportion of patients with DAS28 EULAR response criteria (EULAR = European League Against Rheumatism) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 36-item Short Form Health Survey (SF-36) questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability of fostamatinib as measured by: Adverse Events, Serious Adverse Events, Serious Infective Events, vital signs, electrocardiogram (ECG), clinical chemistry, urinalysis and physical examination. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • UGT1A1 genotype [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 175
Study Start Date: April 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing A regimen
Oral treatment
 Drug: Fostamatinib
Fostamatinib 100mg twice daily for 12 weeks
Experimental: Dosing B regimen
Oral treatment
 Drug: Fostamatinib
Fostamatinib 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12
Experimental: Dosing C regimen
Oral treatment
 Drug: Fostamatinib
Fostamatinib 75mg twice daily for 12 weeks
Experimental: Dosign D regimen
Oral treatment
 Drug: Fostamatinib
Fostamatinib 50mg twice daily for 12 weeks
Placebo Comparator: Dosing E regimen
Oral treatment
 Drug: Placebo
Placebo twice daily for 12 weeks

Detailed Description:

(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients with Active Rheumatoid Arthritis who are Inadequate Responders to Methotrexate Therapy

  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
  • 6 or more swollen joints and 6 or more tender/painful joints from certain joints in the hands, wrists, arms and knees
  • At least one of: positive result for rheumatoid factor test, either in the past or currently (blood test); x-ray showing bone erosion within the last 12 months; presence of certain antibodies in the blood (blood test)
  • Currently taking methotrexate for at least 4 months (and on a stable dose for at least 6 weeks)

Exclusion Criteria:

  • Females who are pregnant or breast feeding
  • Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders.
  • Previously taken, but not responded to, certain biological treatments for rheumatoid arthritis
  • High blood pressure that is not controlled by medication
  • Low levels of neutrophils in the blood (blood test).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569074

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

Locations
Hong Kong
Research Site Recruiting
New Territories, HK, Hong Kong
Research Site Recruiting
Hong Kong, Hong Kong
Japan
Research Site Recruiting
Matsuyama, Ehime, Japan
Research Site Recruiting
Fukuoka-shi, Fukuoka, Japan
Research Site Recruiting
Kitakyushu-shi, Fukuoka, Japan
Research Site Recruiting
Kurume, Fukuoka, Japan
Research Site Recruiting
Sapporo, Hokkaido, Japan
Research Site Recruiting
Kato-shi, Hyogo, Japan
Research Site Recruiting
Kasama-shi, Ibaraki, Japan
Research Site Not yet recruiting
Kanazawa, Ishikawa, Japan
Research Site Recruiting
Sendai, Miyagi, Japan
Research Site Recruiting
Isahaya, Nagasaki, Japan
Research Site Recruiting
Omura-shi, Nagasaki, Japan
Research Site Recruiting
Sasebo-shi, Nagasaki, Japan
Research Site Recruiting
Shibata, Niigata, Japan
Research Site Recruiting
Okayama-shi, Okayama, Japan
Research Site Recruiting
Tomigusuku-shi, Okinawa, Japan
Research Site Recruiting
Hamamatsu-shi, Shizuoka, Japan
Research Site Recruiting
Itabashi, Tokyo, Japan
Research Site Recruiting
Shinjuku, Tokyo, Japan
Research Site Recruiting
Nagasaki, Japan
Korea, Republic of
Research Site Recruiting
Anyang-si, Gyeonggi-do, Korea, Republic of
Research Site Recruiting
Gwangju, Korea, Republic of
Research Site Recruiting
Incheon, Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of
Taiwan
Research Site Recruiting
Chiayi, Taiwan
Research Site Not yet recruiting
Hualien City, Taiwan
Research Site Recruiting
Kaohsiung, Taiwan
Research Site Recruiting
Taichung, Taiwan
Research Site Recruiting
Taipei, Taiwan
Research Site Not yet recruiting
Taoyuan, Taiwan
Thailand
Research Site Recruiting
Bangkok, Thailand
Research Site Recruiting
Singapore, Thailand
Vietnam
Research Site Recruiting
Hanoi, Vietnam
Research Site Recruiting
Ho Chi Minh, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Chris - O'Brien, MD PhD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01569074     History of Changes
Other Study ID Numbers: D4300C00008
Study First Received: March 30, 2012
Last Updated: May 13, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Hong Kong: Department of Health
Taiwan: Department of Health
Vietnam: Ministry of Health
Thailand: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by AstraZeneca:
Rheumatoid Arthritis

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 May 23, 2013