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

NCT01569074 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2014-04-07

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Fostamatinib

Fostamatinib 100mg twice daily for 12 weeks

DRUG

Fostamatinib

Fostamatinib 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12

DRUG

Fostamatinib

Fostamatinib 75mg twice daily for 12 weeks

DRUG

Fostamatinib

Fostamatinib 50mg twice daily for 12 weeks

DRUG

Placebo

Placebo twice daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Neil - Mackillop, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Hong Kong
  • Japan
  • South Korea
  • Taiwan
  • Thailand
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
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 NCT01569074 on ClinicalTrials.gov