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Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus

NCT00752999 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-04-30

No results posted yet for this study

Summary

Approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to R788 or placebo. Patients will be followed for efficacy and safety parameters for 6 months. The investigator should taper corticosteroids if clinically warranted.

Conditions

Interventions

DRUG

Fostamatinib Disodium (R935788)

150 mg tablet, oral, twice-a-day

DRUG

Placebo

Placebo tablet, oral, twice-a-day

Sponsors & Collaborators

  • Rigel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Daniel B. Magilavy, MD · Rigel Pharmaceuticals,Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-11-30
Completion
2010-03-31

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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 NCT00752999 on ClinicalTrials.gov