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Study of Psoriatic Arthritis

Primary Purpose

Psoriasis, Psoriatic Arthritis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Psoriasis focused on measuring Lymphocytes, Cytokines, Apoptosis, Psoriasis, Genetics, Psoriatic Arthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001420
Brief Title
Study of Psoriatic Arthritis
Official Title
Studies of the Pathogenesis and Natural History of Psoriatic Arthritis
Study Type
Observational

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
March 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

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: 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. 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. 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. 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. 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Psoriatic Arthritis
Keywords
Lymphocytes, Cytokines, Apoptosis, Psoriasis, Genetics, Psoriatic Arthritis

7. Study Design

Enrollment
999 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1676787
Citation
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.
Results Reference
background
PubMed Identifier
1503870
Citation
Espinoza LR, Cuellar ML, Silveira LH. Psoriatic arthritis. Curr Opin Rheumatol. 1992 Aug;4(4):470-8.
Results Reference
background
PubMed Identifier
4581554
Citation
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.
Results Reference
background

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Study of Psoriatic Arthritis

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