Determining Disease Activity Biomarkers in Individuals With Polyarteritis Nodosa

Polyarteritis Nodosa Clinical Trial

Official title:

Longitudinal Protocol of Polyarteritis Nodosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315406
• Other study ID #: VCRC5504
• Secondary ID: U54AR057319
• Status: Completed
• Start date: April 2006
• Est. completion date: December 2019

Study information

• Verified date: July 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Polyarteritis nodosa (PAN) is a rare immune system disorder that causes swelling and damage to small- and medium-sized blood vessels in the body. In order to properly treat this disease, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of disease in people with PAN.

Description:

PAN, also known as systemic necrotic vasculitis, was the first recognized form of primary systemic vasculitis. PAN causes the inflammation of small- to medium-sized blood vessels, especially those supplying the nerves, skin, kidneys, gastrointestinal tract, heart, eye, and genitals. Unlike another form of vasculitis called microscopic polyangiitis, PAN does not usually cause glomerulonephritis, a type of kidney disease, or vasculitis in the very smallest blood vessels (arterioles, capillaries, and venules). There are no radiographic or serologic tests that can reliably measure disease activity in PAN. Currently, clinicians must rely on patients' symptoms, signs, laboratory tests, and imaging to guide treatment decisions, but such data are rarely consistently reliable in determining PAN disease activity. This study will use new scientific methods to discover new biomarkers that can be used to monitor disease activity in PAN patients. These biomarkers may be used to help direct clinical care for PAN patients and assist in future drug development. Study visits will occur monthly for the first year, then every 3 months thereafter for the remainder of the study. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will occur every 3 months; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use. Participants may have additional study visits if a disease flare or disease-related complications occur during the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parent or guardian willing to provide informed consent, if applicable
• Diagnosis of vasculitis
• Diagnosis of PAN, meeting at least 1 major criterion and 1 minor criterion OR 2 major criteria of the following adapted American College of Rheumatology (ACR) criteria that fall under the diagnosis of PAN and that are not explained by other causes: MAJOR CRITERIA

1. Arteriographic abnormality

2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy

3. Mononeuropathy or polyneuropathy MINOR CRITERIA

1. Weight loss of more than 4 kg (8.8 lbs)

2. Livedo reticularis, cutaneous ulcerations, or skin nodules

3. Testicular pain or tenderness

4. Myalgias

5. Diastolic blood pressure greater than 90 mm Hg

6. Elevated blood urea nitrogen (BUN) or serum creatinine levels

7. Ischemic abdominal pain

Exclusion Criteria:

• Microscopic polyangiitis
• Granulomatosis with polyangiitis(Wegener's)
• Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
• Takayasu's arteritis
• Giant cell arteritis
• Cogan's syndrome
• Behcet's disease
• Sarcoidosis
• Kawasaki disease
• Cryoglobulinemic vasculitis
• Systemic lupus erythematosus
• Rheumatoid arthritis
• Mixed connective tissue disease or any overlap autoimmune syndrome
• Presence of antiproteinase 3 or antimyeloperoxidase antineutrophil cytoplasmic antibodies (ANCA)
• Glomeronephritis
• Alveolar hemorrhage
• Hepatitis B, hepatitis C, or HIV infection
• Any other infectious form of medium vessel vasculitis
• Isolated cutaneous PAN

Related Conditions & MeSH terms

• Polyarteritis Nodosa

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic College of Medicine	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah

Sponsors (4)

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

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Bonsib SM. Polyarteritis nodosa. Semin Diagn Pathol. 2001 Feb;18(1):14-23. Review. — View Citation

Said G, Lacroix C. Primary and secondary vasculitic neuropathy. J Neurol. 2005 Jun;252(6):633-41. Epub 2005 Apr 5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discover biomarkers in PAN capable of measuring disease activity and response to treatment.		Study completion
Secondary	Measure the predictive value of biomarkers for clinical outcome in PAN.		Study completion.

External Links

•   Rare Diseases Clinical Research Network
•   Vasculitis Clinical Research Consortium