PsoriasisNCT00001420
Study of Psoriatic Arthritis
An observational study of Psoriasis and Psoriatic Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis
- How many people
- 999 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1995to Jan 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, 20892
About this study
Official title: Studies of the Pathogenesis and Natural History of Psoriatic Arthritis
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:
Read more
- 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).
Read the 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.
- Conditions
- Psoriasis, Psoriatic Arthritis
- Keywords
- Lymphocytes, Cytokines, Apoptosis, Psoriasis, Genetics, Psoriatic Arthritis
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startMar 1995
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 999 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001420
- Sponsor's protocol ID
- 950082
- Other IDs
- 95-AR-0082
- Status last verified
- Jan 2006
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 1676787Espinoza LR, Cuellar ML, Silveira LH. Psoriatic arthritis. Curr Opin Rheumatol. 1992 Aug;4(4):470-8.
PubMed 1503870Moll JM, Wright V. Psoriatic arthritis. Semin Arthritis Rheum. 1973;3(1):55-78. doi: 10.1016/0049-0172(73)90035-8. No abstract available.
PubMed 4581554
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of the Pathogenesis and Natural History of Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT00001420
- Acronym / sponsor ID
- 950082
- Conditions
- Psoriasis, Psoriatic Arthritis
- Keywords
- Lymphocytes, Cytokines, Apoptosis, Psoriasis, Genetics, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 999 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Mar 1995
- Study completion
- Jan 2006
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 1676787Barker JN. The pathophysiology of psoriasis. Lancet. 1991 Jul 27;338(8761):227-30. doi: 10.1016/0140-6736(91)90357-u. No abstract available.
- Background: PubMed 1503870Espinoza LR, Cuellar ML, Silveira LH. Psoriatic arthritis. Curr Opin Rheumatol. 1992 Aug;4(4):470-8.
- Background: PubMed 4581554Moll JM, Wright V. Psoriatic arthritis. Semin Arthritis Rheum. 1973;3(1):55-78. doi: 10.1016/0049-0172(73)90035-8. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Psoriatic Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001420, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.