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Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis

NCT00665925 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2016-09-16

Study results available
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Summary

The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.

Conditions

Interventions

DRUG

Fostamatinib disodium (R935788)

100 mg tablet, orally, twice-a-day

DRUG

Fostamatinib disodium (R935788)

150 mg tablet, orally, once a day

DRUG

Placebo

Placebo, orally, either once a day, or twice a day

Sponsors & Collaborators

  • Rigel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Daniel B Magilavy, MD · Rigel Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States
  • Bulgaria
  • Colombia
  • Mexico
  • Poland
  • Romania

Study Locations

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Entities

Drugs
Diseases

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 NCT00665925 on ClinicalTrials.gov