Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis

Sponsor
AstraZeneca
Study ID
NCT01569074
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fostamatinib — DRUG
    Fostamatinib 100mg twice daily for 12 weeks
  • Fostamatinib — DRUG
    Fostamatinib 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12
  • Fostamatinib — DRUG
    Fostamatinib 75mg twice daily for 12 weeks
  • Fostamatinib — DRUG
    Fostamatinib 50mg twice daily for 12 weeks
  • Placebo — DRUG
    Placebo twice daily for 12 weeks

Study Details

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.

Key Dates

Start date
Apr 30, 2012
Status verified
Feb 2014
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
163 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dosing A regimen
    Oral treatment
  • Experimental: Dosing B regimen
    Oral treatment
  • Experimental: Dosing C regimen
    Oral treatment
  • Experimental: Dosign D regimen
    Oral treatment
  • Placebo Comparator: Dosing E regimen
    Oral treatment

Primary Outcome Measure

Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo [ Time Frame: 12 weeks ]

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