NCT00001420

Brief Summary

This study will examine the genetic and immune factors involved in the cause and development of psoriatic arthritis-a disease of both the skin and joints. It will describe the medical features and natural course of the disease and determine participants' eligibility for experimental treatment protocols. Patients with known or suspected psoriatic arthritis 5 years of age and older and their relatives may enroll in this study. Patients will be evaluated with a medical history and physical examination, electrocardiogram, blood tests and X-rays. Additional procedures may include:

  1. 1.Leukapheresis-Collection of white blood cells for genetic analysis. Whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The plasma is removed and the cells are returned to the body through a second needle placed in the other arm.
  2. 2.Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin is numbed with an anesthetic and one to three small circular portions (about 1/4 inch in diameter) are cut and removed.
  3. 3.Joint aspiration-Removal of a small sample of synovial fluid (lubricating joint fluid). An area of skin around the biopsy site is numbed with an anesthetic, and a needle is inserted into the joint to pull out a small fluid sample.
  4. 4.Synovial needle biopsy-Removal of a small sample of synovial tissue (tissue lining the joint). An area of skin around the biopsy site is numbed with an anesthetic and a large needle is inserted into the joint. A smaller needle attached to a syringe is then placed inside the larger needle and small pieces of synovial tissue are removed.
  5. 5.Genetic studies-Saliva and blood samples will be collected for gene testing. Saliva is collected by rinsing the mouth with a tablespoon of salt water and spitting into a test tube.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1995

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1995

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2006

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

PsoriasisPsoriatic Arthritis

Keywords

LymphocytesCytokinesApoptosisPsoriasisGeneticsPsoriatic Arthritis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Psoriatic arthritis (proven or suspected) or;
  • Family history of psoriasis or psoriatic arthritis (i.e. family members of patients with psoriasis or psoriatic arthritis); and
  • Willingness and ability of the subject or guardian to give informed consent.

You may not qualify if:

  • Concomitant medical problems which would confound the interpretation of immunological studies.
  • Concomitant medical, surgical or other conditions for which inadequate facilities or funds are available to support their care at the NIH.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Barker JN. The pathophysiology of psoriasis. Lancet. 1991 Jul 27;338(8761):227-30. doi: 10.1016/0140-6736(91)90357-u. No abstract available.

    PMID: 1676787BACKGROUND

  • Espinoza LR, Cuellar ML, Silveira LH. Psoriatic arthritis. Curr Opin Rheumatol. 1992 Aug;4(4):470-8.

    PMID: 1503870BACKGROUND

  • Moll JM, Wright V. Psoriatic arthritis. Semin Arthritis Rheum. 1973;3(1):55-78. doi: 10.1016/0049-0172(73)90035-8. No abstract available.

    PMID: 4581554BACKGROUND

MeSH Terms

Conditions

PsoriasisArthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

March 1, 1995

Study Completion

January 1, 2006

Last Updated

March 4, 2008

Record last verified: 2006-01

Locations

US(1)