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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.
Register: ClinicalTrials.gov
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
URL:  http://clinicaltrials.gov/show/NCT00010400
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Robert A. Brodsky
Address: 
Telephone:
Email:
Affiliation:  Johns Hopkins University
Key inclusion & exclusion criteria

PROTOCOL ENTRY 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

OR

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
normal

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
Intervention(s)
Drug: Cyclophosphamide
Drug: filgrastim
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
199/15673
JHOC-97022128
JHOC-J9717
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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