NCT00010400

Brief Summary

OBJECTIVES: I. Determine the induction of durable remission in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide. II. Determine the toxicity of this drug in these patients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

February 2, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2004

First QC Date

February 2, 2001

Last Update Submit

June 23, 2005

Conditions

Systemic Lupus ErythematosusAntiphospholipid Antibody Syndrome

Keywords

antiphospholipid antibody syndromearthritis & connective tissue diseasesimmunologic disorders and infectious disordersrare diseasesystemic lupus erythematosus

Interventions

CyclophosphamideDRUG
filgrastimDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

Location

Related Publications (1)

  • Petri M, Brodsky RA, Jones RJ, Gladstone D, Fillius M, Magder LS. High-dose cyclophosphamide versus monthly intravenous cyclophosphamide for systemic lupus erythematosus: a prospective randomized trial. Arthritis Rheum. 2010 May;62(5):1487-93. doi: 10.1002/art.27371.

    PMID: 20131296DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicAntiphospholipid SyndromeArthritisConnective Tissue DiseasesImmune System DiseasesCommunicable DiseasesRare Diseases

Interventions

CyclophosphamideFilgrastim

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesAutoimmune DiseasesJoint DiseasesMusculoskeletal DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Robert A. Brodsky

    Johns Hopkins University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 2, 2001

Study Start

April 1, 1997

Last Updated

June 24, 2005

Record last verified: 2004-07

Locations

US(2)