NCT00315406

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
2 countries

9 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

13.7 years

First QC Date

April 14, 2006

Last Update Submit

July 11, 2022

Conditions

Polyarteritis Nodosa

Keywords

PANPeriarteritis Nodosa

Outcome Measures

Primary Outcomes (1)

  • Discover biomarkers in PAN capable of measuring disease activity and response to treatment.

    Study completion

Secondary Outcomes (1)

  • Measure the predictive value of biomarkers for clinical outcome in PAN.

    Study completion.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • Arteriographic abnormality
  • Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy
  • Mononeuropathy or polyneuropathy
  • MINOR CRITERIA
  • Weight loss of more than 4 kg (8.8 lbs)
  • Livedo reticularis, cutaneous ulcerations, or skin nodules
  • Testicular pain or tenderness
  • Myalgias
  • Diastolic blood pressure greater than 90 mm Hg
  • Elevated blood urea nitrogen (BUN) or serum creatinine levels
  • Ischemic abdominal pain

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Mayo Clinic College of Medicine

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (2)

  • Bonsib SM. Polyarteritis nodosa. Semin Diagn Pathol. 2001 Feb;18(1):14-23.

    PMID: 11296989BACKGROUND

  • Said G, Lacroix C. Primary and secondary vasculitic neuropathy. J Neurol. 2005 Jun;252(6):633-41. doi: 10.1007/s00415-005-0833-9. Epub 2005 Apr 5.

    PMID: 15806339BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood (serum and plasma), urine, and DNA

MeSH Terms

Conditions

Polyarteritis Nodosa

Condition Hierarchy (Ancestors)

ArteritisVasculitisVascular DiseasesCardiovascular DiseasesSystemic VasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Peter A. Merkel, MD, MPH

    University of Pennsylvania

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 12, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(7)CA(2)