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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00010400
Date of registration: 02/02/2001
Prospective Registration: No
Primary sponsor: Johns Hopkins University
Public title: Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome
Scientific title:
Date of first enrolment: April 1997
Target sample size: 35
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
United States
Name:     Robert A. Brodsky
Affiliation:  Johns Hopkins University
Key inclusion & exclusion criteria


--Disease Characteristics--

Diagnosis of life-threatening systemic lupus erythematosus (SLE); must show at least 4
American College of Rheumatology criteria for SLE; must have severe organ damage in 1 or
more organs; must have 1 or more of the following indications of ongoing disease activity:
disease activity score (SLEDAI) at least 4, hospitalization for disease activity within 12
months, life-threatening disease not captured on SLEDAI


Diagnosis of antiphospholipid antibody syndrome by the Hughes criteria; must show severity
by ongoing symptoms or signs of hypercoagulability in spite of warfarin therapy

--Patient Characteristics--

Hepatic: Bilirubin no greater than 2.0 mg/dL; transaminases no greater than 2.0 times

Renal: Creatinine no greater than 3.0 mg/dL

Cardiovascular: Ejection fraction at least 45%

Pulmonary: FVC, FEV1, or DLCO at least 50% predicted

Other: Not preterminal or moribund; not pregnant or nursing; fertile patients must use
effective contraception

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Antiphospholipid Antibody Syndrome
Systemic Lupus Erythematosus
Drug: Cyclophosphamide
Drug: filgrastim
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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