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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 But Not Responding.

NCT01197521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 923

Last updated 2014-04-07

Study results available
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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.

Conditions

Interventions

DRUG

fostamatinib

fostamatinib 100 mg twice daily

DRUG

fostamatinib

fostamatinib 100 mg twice daily/150 mg once daily

DRUG

placebo, fostamatinib

Placebo for 24 weeks followed by fostamatinib 100 mg twice daily

Sponsors & Collaborators

Principal Investigators

  • Neil MacKillop, MD PhD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Chile
  • Estonia
  • France
  • Hungary
  • India
  • Mexico
  • Peru
  • Poland
  • Slovakia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197521 on ClinicalTrials.gov