Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus

Completed · Phase 1

Conditions studied: Lupus Erythematosus, Systemic

In brief

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).

Key facts

Study ID

NCT00714116

Run by

Pfizer

People needed

30

Starts

2009-03-01

Expected to finish

2012-09-01

Last updated by the study team

2018-12-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology [ACR] Revised Criteria) greater than 6 months before study day 1.
• History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent.

You may not qualify if…

• Treatment with more than 20 mg of prednisone per day.
• Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE.
• History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state.

Where it is running

• Arthritis & Rheumatology Care Center — South Miami, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• MRA Clinical Research — South Miami, Florida, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.