Trial record 1 of 14 for:    "Polyarteritis nodosa"
Previous Study | Return to List | Next Study

Determining Disease Activity Biomarkers in Individuals With Polyarteritis Nodosa

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Pennsylvania
Sponsor:
Collaborators:
Rare Diseases Clinical Research Network
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00315406
First received: April 14, 2006
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition
Polyarteritis Nodosa

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Protocol of Polyarteritis Nodosa

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Discover biomarkers in PAN capable of measuring disease activity and response to treatment. [ Time Frame: Study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure the predictive value of biomarkers for clinical outcome in PAN. [ Time Frame: Study completion. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood (serum and plasma), urine, and DNA


Estimated Enrollment: 150
Study Start Date: April 2006
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with polyarteritis nodosa. Enrollment will be sequential and participants will have disease in various stages and of different duration.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315406

Locations
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Naomi Amudala, NP    617-414-2512    namudala@bu.edu   
Principal Investigator: Paul A. Monach, MD, PhD         
United States, Minnesota
Mayo Clinic College of Medicine Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jane Jaquith       jaquith.jane@mayo.edu   
Principal Investigator: Steven R. Ytterberg, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Katie Gartner    216-445-1397    gartnek@ccf.org   
Principal Investigator: Carol A. Langford, MD, MHS         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brian Rice    215-614-4407    Brian.Rice@uphs.upenn.edu   
Principal Investigator: Peter Merkel, MD, MPH         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Dawn McBride, RN    412-586-3545    dlmc@pitt.edu   
Principal Investigator: Larry Moreland, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Julieanne Nielsen    801-585-0798    Julieanne.Nielsen@hsc.utah.edu   
Principal Investigator: Curry Koening, MD, MHS         
Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada
Contact: Sandra Messier    905-522-1155 ext 35873    smessier@stjoes.ca   
Principal Investigator: Nader A. Khalidi, MD         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5T 3L9
Contact: Julia Farquharson    416-586-8616    JFarquharson@mtsinai.on.ca   
Principal Investigator: Simon Carette, MD         
Sponsors and Collaborators
University of Pennsylvania
Rare Diseases Clinical Research Network
Investigators
Study Chair: Peter A. Merkel, MD, MPH University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: Peter Merkel, Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00315406     History of Changes
Other Study ID Numbers: RDCRN 5504, U54AR057319
Study First Received: April 14, 2006
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
PAN
Periarteritis Nodosa

Additional relevant MeSH terms:
Polyarteritis Nodosa
Arteritis
Cardiovascular Diseases
Skin Diseases
Skin Diseases, Vascular
Systemic Vasculitis
Vascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on October 21, 2014