Wegener's Granulomatosis Clinical Trial
Official title:
A Multi-Center, Open-label Pilot Study of Abatacept (CTLA4-Ig) in the Treatment of Mild Relapsing Wegener's Granulomatosis
Verified date | December 2015 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
Wegener's granulomatosis (WG) is a rare disease that causes inflammation of blood vessels, or vasculitis. It may involve many different parts of the body, but typically affects the upper and lower respiratory tract and kidneys. The purpose of this study is to determine the safety and effectiveness of the medication abatacept in treating adults with mild relapsing WG.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of WG, meeting at least 2 of the 5 modified American College of Rheumatology (ACR) criteria. More information about this criterion can be found in the protocol. - Relapse of WG within the past 28 days where disease activity is confined to one or more of the following sites and where the symptoms/signs are of such a nature that the usual treatment would consist of the reinstitution or increase in GC to no more than prednisone 30mg daily and/or an increase or addition of a second immunosuppressive agent other than CYC (more specific information about this criterion can be found in the protocol): 1. Sinonasal disease 2. Oral mucosa ulceration 3. Skin disease 4. Musculoskeletal disease 5. Pulmonary parenchymal disease 6. Mild ocular disease 7. Subglottic inflammation without significant stenosis 8. Otic disease 9. Breast involvement 10. Urogenital involvement 11. Other mild disease - Age of 15 years or older - Willing and able to undergo treatment and attend follow-up visits - Willing to use effective forms of contraception throughout the study Exclusion Criteria: - Disease involvement that does not meet the criteria for mild disease. More information about this criterion can be found in the protocol. - Disease activity that would usually be treated first with cyclophosphamide - Presence of disease activity for which the investigator would normally treat the participant with more than prednisone 30 mg daily. - Receiving cyclophosphamide at study entry - Treatment with prednisone at a dose of more than 15 mg daily at the time of relapse. Subjects will be eligible if prednisone was initiated or dose increased in the period between relapse and study enrollment provided that the prednisone dose was 15 mg daily or less at the time when the relapse occurred, the prednisone dosage was increased no higher than 30 mg daily following the recognition of relapse, and that the dosage increase was made no more than 28 days prior to enrollment. - Active infection - HIV infected, hepatitis C virus infected, or positive for hepatitis B - Unable to follow through with study participation - Cytopenia, defined as platelet count less than 80,000/mm3, absolute neutrophil count less than 1500/mm3, OR hematocrit less than 20% - Kidney insufficiency - Use of illegal drugs - Any other uncontrolled disease that would prevent participation - History of cancer. More information about this criterion can be found in the protocol. - Received an investigational medication or procedure within 30 days of study entry - Received a live vaccine within 4 weeks of study entry - Positive tuberculin skin test. More information about this criterion can be found in the protocol. - Tuberculosis as indicated by radiographic evidence - Past treatment with rituximab within the past 12 months, or past treatment with rituximab more than 12 months ago where the B lymphocyte count has not returned to normal - Certain other diseases. More information about this criterion can be found in the protocol. - Pregnant or breastfeeding |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Johns Hopkins Vasculitis Center | Baltimore | Maryland |
United States | Boston University School of Medicine | Boston | Massachusetts |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Mayo Clinic College of Medicine | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Rare Diseases (ORD), Rare Diseases Clinical Research Network |
United States,
Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, Birbara C, Box J, Natarajan K, Nuamah I, Li T, Aranda R, Hagerty DT, Dougados M. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med. 2005 Sep 15;353(11):1114-23. Erratum in: N Engl J Med. 2005 Nov 24;353(21):2311. — View Citation
Langford CA, Monach PA, Specks U, Seo P, Cuthbertson D, McAlear CA, Ytterberg SR, Hoffman GS, Krischer JP, Merkel PA; Vasculitis Clinical Research Consortium. An open-label trial of abatacept (CTLA4-IG) in non-severe relapsing granulomatosis with polyangi — View Citation
Langford CA, Talar-Williams C, Barron KS, Sneller MC. Use of a cyclophosphamide-induction methotrexate-maintenance regimen for the treatment of Wegener's granulomatosis: extended follow-up and rate of relapse. Am J Med. 2003 Apr 15;114(6):463-9. — View Citation
Wegener's Granulomatosis Etanercept Trial (WGET) Research Group. Etanercept plus standard therapy for Wegener's granulomatosis. N Engl J Med. 2005 Jan 27;352(4):351-61. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of Abatacept - Number of Participants With Adverse Events | This study examined the safety profile of this agent when used in Wegener's granulomatosis. Information was gathered on all adverse events with specific events being identified in the protocol for analysis that included the following: Infection Infusion reactions Cytopenias Transaminase elevation Skin reactions GI side effects Malignancy All adverse events were reportable for this study. |
Measured continuously from the screening visit through to the 6 month post-treatment study visit, up to 3 years and 4 months. | Yes |
Secondary | Disease Remission | Disease remission was measured by a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63. |
Measured monthly until common closing or early termination,up to 3 years and 4 months. | No |
Secondary | Disease Improvement | Disease improvement was measured by a reduction in the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG). The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63. |
Measured monthly until common closing or early termination, up to 3 years and 4 months. | No |
Secondary | Meeting Common Closing | The number of subjects that reached the common closing date. | Number assessed at the time of common closing, up to 3 years and 4 months. | No |
Secondary | Disease Relapse | Disease relapse was measured by a rise in the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of greater than or equal to 1 after achieving remission. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63. |
Measured monthly until common closing or early termination, up to 3 years and 4 months. | No |
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