Study of Psoriatic Arthritis

Psoriasis Clinical Trial

Official title:

Studies of the Pathogenesis and Natural History of Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001420
• Other study ID #: 950082
• Secondary ID: 95-AR-0082
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: March 1995
• Est. completion date: January 2006

Study information

• Verified date: January 2006
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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. 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. 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. 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. 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. 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.

Patients will be followed once or twice a year and may be evaluated for participation in an experimental treatment study.

Participating relatives of patients will fill out a brief medical history questionnaire and provide a DNA sample (blood sample or tissue swab from the inside of the cheek).

Description:

Patients with known or suspected psoriatic arthritis will be evaluated at the Clinical Center. Studies will include characterization of the clinical and laboratory features of the disease, research studies of the natural history and pathogenesis, genetic studies, and determination of the patient's eligibility to enter experimental therapeutic protocols. Patients may be asked to contribute blood, skin or synovial membrane samples for immunologic and genetic research studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 999
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Study Design

N/A

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriatic Arthritis

Locations

Country	Name	City	State
United States	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barker JN. The pathophysiology of psoriasis. Lancet. 1991 Jul 27;338(8761):227-30. Review. — View Citation

Espinoza LR, Cuéllar ML, Silveira LH. Psoriatic arthritis. Curr Opin Rheumatol. 1992 Aug;4(4):470-8. Review. — View Citation

Moll JM, Wright V. Psoriatic arthritis. Semin Arthritis Rheum. 1973;3(1):55-78. Review. — View Citation