Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.

Last updated: February 27, 2014
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT01197521
D4300C00001
2010-020743-12
  • Ages > 18
  • All Genders

Study Summary

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 but not responding. The study will last for 1 year.

Eligibility Criteria

Inclusion

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) andeither Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, orC-Reactive Protein (CRP) blood result of 10mg/L or more

  • At least one of the following: documented history of positive rheumatoid factor (bloodtest), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinatedpeptide antibodies (blood test)

Exclusion

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 tissuediseases or chronic pain disorders

  • Recent or significant cardiovascular disease

  • Significant active or recent infection including tuberculosis

  • Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatmentwith other biological agent

  • Severe renal impairment

  • Neutropenia

Study Design

Total Participants: 923
Study Start date:
September 01, 2010
Estimated Completion Date:
November 30, 2012

Study 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

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  • Research Site

    Reading, Berkshire
    Argentina

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    Ciudad Autonoma Bs As, CBA
    Argentina

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    Cordoba, CRD
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    Buenos Aires, Caba
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    Rosario, Santa Fe
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    San Miguel de Tucuman, TUC
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    Caba,
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    Capital Federal,
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    Ciudad Aut�noma Bs As,
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    Ciudad de Buenos Aires,
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    Quilmes,
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    San Juan,
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    Camperdown, New South Wales
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    Cairns, Queensland
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    Southport, Queensland
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    Footscray, Victoria
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    Antwerpen,
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    Brussels,
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    Porto Alegre, Brasil
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