NCT00001761

Brief Summary

The purpose of this study is to assess the safety, tolerance, and immunologic effects of interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of Wegener's granulomatosis to warrant further study in a larger trial. In this study, IL-10 will be given either alone or in combination with standard therapeutic agents, usually consisting of cyclophosphamide, methotrexate, and/or prednisone. Patients will be eligible to receive IL-10 when there is evidence of active disease. IL-10 will be administered by subcutaneous injection at a dose of 4 µ (Micro)g/kg/day for 28 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 1998

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

February 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

VasculitisWegener's Granulomatosis

Keywords

AutoimmunityCytokineInflammationInterleukinVasculitisWegener's Granulomatosis

Interventions

Interleukin-10DRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Diagnosis of Wegener's granulomatosis based on clinical characteristics and histopathological and/or angiographic evidence of vasculitis or the presence of glomerulonephritis and a positive assay for anti-neutrophil cytoplasmic autoantibodies (ANCA). Age between 18 to 65 years. No change in immunosuppressive drug therapy during the prior 4 weeks and one of the following: Persistent disease activity ("Vasculitis Activity Index" score of greater than or equal to 3) despite optimal therapy; Persistent or recurrent disease activity in a patient who cannot tolerate optimal therapy; Patients not on maximal immunosuppressive therapy but with persistent or recurrent disease activity that is not, in the judgment of investigators, immediately threatening the function of a major organ system; No evidence of active infection. Patients may not be pregnant or nursing infants. Fertile women must have a negative pregnancy test within one week prior to study entry and all participants must be using effective means of birth control. Serum creatinine is less than 3.5 mg/dL. Hemocytopenia (platelet count is greater than 100,000/mm(3), leukocyte count is greater than 3,500/mm(s), hemoglobin is greater than 9 mg/dL). Liver function test abnormalities is less than 3x upper limits of normal (either serum GOT, GPT, alkaline phosphatase, and/or bilirubin). Patients cannot be anti-HIV, anti-HCV, or anti-Hepatitis B surface antigen (HBsAG) positive. Weight greater less than 104 Kg (because of SCH 52000 concentration and volume limitations for subcutaneous injection). No treatment with any investigational drug within 30 days. No pre-existing malignancy. No known allergy to E. coli protein or IL-10. No history of psychiatric illness that in the opinion of the principal investigator would preclude entrance into the study.

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

Sponsors & Collaborators

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Hoffman GS, Kerr GS, Leavitt RY, Hallahan CW, Lebovics RS, Travis WD, Rottem M, Fauci AS. Wegener granulomatosis: an analysis of 158 patients. Ann Intern Med. 1992 Mar 15;116(6):488-98. doi: 10.7326/0003-4819-116-6-488.

    PMID: 1739240BACKGROUND

  • Ludviksson BR, Sneller MC, Chua KS, Talar-Williams C, Langford CA, Ehrhardt RO, Fauci AS, Strober W. Active Wegener's granulomatosis is associated with HLA-DR+ CD4+ T cells exhibiting an unbalanced Th1-type T cell cytokine pattern: reversal with IL-10. J Immunol. 1998 Apr 1;160(7):3602-9.

    PMID: 9531324BACKGROUND

MeSH Terms

Conditions

VasculitisGranulomatosis with PolyangiitisAutoimmune DiseasesInflammation

Interventions

Interleukin-10

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic VasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

February 1, 1998

Study Completion

April 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-01

Locations

US(1)