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Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01197755
First received: September 8, 2010
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: fostamatinib
Drug: placebo
 Phase 3

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-3): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With Inadequate Response to a TNF-alpha Antagonist

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: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with ACR20, ACR50, ACR70, ACR-N compared to placebo (ACR50 = American College of Rheumatology 50% response criteria, ACR70 = American College of Rheumatology 70% response criteria, [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with DAS28 and DAS28 EULAR response criteria compared to baseline (DAS28 = Disease Activity Score based on a 28 joint count; EULAR = European League Against Rheumatism) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire - Disability Index (HAQ-DI). [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment: 322
Study Start Date: September 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing Regimen A
Oral Treatment
 Drug: fostamatinib
fostamatinib 100 mg twice daily
Experimental: Dosing Regimen B
Oral Treatment
 Drug: fostamatinib
fostamatinib 100 mg twice daily/150 mg once daily
Placebo Comparator: Dosing Regimen C
Oral Treatment
 Drug: placebo
Placebo twice daily

Detailed Description:

Sub-study:

Full title: Optional Genetic Research

Date: 18 June 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 methotrexate; and/or susceptibility to, progression of and prognosis of RA

  Eligibility

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

Inclusion Criteria:

  • Active rheumatoid arthritis (RA) diagnosed after the age of 16
  • Currently taking methotrexate
  • 6 or more swollen joints and 6 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 one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12months 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
  • Previous failure to respond to anakinra or previous treatment with biological agent (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)
  • Severe renal impairment
  • Neutropenia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197755

  Show 136 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Chris O'Brien, MD PhD AstraZeneca
  More Information

Additional Information:
Aimed at US participants  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01197755     History of Changes
Other Study ID Numbers: D4300C00003, 2010-020745-27
Study First Received: September 8, 2010
Last Updated: March 5, 2013
Health Authority: United States: 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 21, 2013