Status:

COMPLETED

Serologically Active, Clinically Stable Systemic Lupus Erythematosus

Lead Sponsor:

NYU Langone Health

Collaborating Sponsors:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Conditions:

Systemic Lupus Erythematosus

Eligibility:

FEMALE

13-65 years

Phase:

PHASE2

Brief Summary

The first part of this study will use the database of a large, ongoing NIH-sponsored lupus study, Safety of Estrogen in Lupus Erythematosus National Assessment. We will examine the levels of a blood p...

Detailed Description

In lupus, serial evaluation of dsDNA antibody titers and complement (C3 and C4) in blood samples have been useful in assessing disease activity in patients. High levels of C3a, a split product of C3, ...

Eligibility Criteria

Inclusion Criteria:

  • Meets ACR criteria for SLE
  • Inactive or stable in lupus activity
  • History of positive dsDNA
  • Current prednisone dose no more than 15 mg daily

Exclusion Criteria:

  • Active infections
  • Poorly controlled diabetes mellitus
  • Pregnancy
  • Uncontrolled hypertension

Key Trial Info

Start Date :

September 1 1997

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2003

Estimated Enrollment :

154 Patients enrolled

Trial Details

Trial ID

NCT00000421

Start Date

September 1 1997

End Date

August 1 2003

Last Update

March 4 2016

Active Locations (3)

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Page 1 of 1 (3 locations)

1

North Shore-Long Island Jewish Health System

New Hyde Park, New York, United States, 11040

2

Lenox Hill Hospital

New York, New York, United States, 10002

3

Office of Betty Diamond, M.D.

The Bronx, New York, United States, 10461