Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001420
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Study of Psoriatic Arthritis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies of the Pathogenesis and Natural History of Psoriatic Arthritis
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 14 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
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 14 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
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 patients eligibility to enter experimental therapeutic protocols Patients may be asked to contribute blood skin or synovial membrane samples for immunologic and genetic research studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-AR-0082 | None | None | None |