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| Tracking Information | |||||||||
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| First Received Date † | February 26, 2002 | ||||||||
| Last Updated Date | November 18, 2008 | ||||||||
| Start Date † | February 2002 | ||||||||
| Current Primary Outcome Measures † | |||||||||
| Original Primary Outcome Measures † | |||||||||
| Change History | Complete list of historical versions of study NCT00031174 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Blood Component Collection From Patients With Rheumatic Disease and Healthy Volunteers | ||||||||
| Official Title † | Collection Of Blood Components Using Apheresis From Patients With Rheumatic Diseases And Healthy Volunteers | ||||||||
| Brief Summary | This study will collect white blood cells or plasma (the liquid part of the blood), or both, from healthy volunteers and from patients with rheumatic disorders for research purposes. Rheumatic disorders involve abnormalities of the immune system, the body's defense against disease. The immune system consists of white blood cells such as lymphocytes and monocytes, which produce substances such as antibodies and cytokines. White cells and plasma will be collected through a procedure called apheresis (described below). Healthy volunteers and patients with confirmed or suspected rheumatic disease who are 18 years of age or older may be eligible for this study. Patients must be participating in a current protocol of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. All candidates will be screened with a history, physical examination, and blood tests for hepatitis B and C and HIV infection. Women of childbearing age will be tested for pregnancy. Routine blood tests will be done in all volunteers, and in patients where needed. Pregnant women and people who test positive for hepatitis or HIV may not participate. Participants will undergo apheresis to collect lymphocytes, monocytes, or plasma from the blood. For this procedure, a needle is placed in a vein in the arm. Blood flows from the vein through a tube (catheter) into a machine that spins the blood, separating it into its components. The required cells or plasma are extracted, and the rest of the blood, including the red cells and platelets, is returned to the body through the same needle or through a second needle placed in the other arm. Cells collected from volunteers will be used in studies comparing the number and function of similar cells from patients with rheumatic diseases, focusing on the differences in number and function of the cells in health and disease. Components collected from patients will be used only for studies described in the protocol in which they are currently enrolled. |
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| Detailed Description | Blood components will be collected using apheresis from normal volunteers and patients with rheumatic diseases. Mononuclear cells and plasma will be used by various investigators for research studies. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | |||||||||
| Condition † |
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| Intervention † | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † |
Patients with a diagnosed or suspected rheumatic disease, who are actively involved in a NIAMS protocol (have a current, signed consent form) Ability to give informed consent Age greater than or equal to 18 years EXCLUSION CRITERIA - Subjects with Rheumatic Diseases: History of allergy to acid-citrate-dextrose (ACD) anticoagulant History of bleeding diatheses Hemoglobin less than 9.0 g/dL Platelet count less than 50,000/mm(3) Pregnancy Inadequate peripheral venous access Active hepatitis B, C and/or HIV infection Symptomatic coronary artery or valvular heart disease Any concomitant illness that in the opinion of the investigators will substantially increase risk of apheresis. INCLUSION CRITERIA - Healthy Volunteers: Subjects shall meet all donor eligibility criteria for autologous blood donation recommended or required by the Standards of the American Association of Blood Banks (1) and the Code of Federal Regulations of the Food and Drug Administration (2), with the exception of the travel exclusions related to malaria exposure and hypothetical exposure to the agent of variant Creutzfeldt-Jacob disease. Ability to give informed consent Age greater than or equal to 18 years EXCLUSION CRITERIA - Healthy Volunteers: History of autoimmune or chronic rheumatic disease within the last 5 years, with the exception of osteoarthritis Active hepatitis B, C, and/or HIV infection History of allergy to acid-citrate (ACD) anticoagulant History of coagulopathies and bleeding diatheses Symptomatic coronary artery disease or valvular heart disease Hemoglobin less than 12.0 g/dL Platelet count less than 100,000/cubic mm Pregnancy Inadequate peripheral venous access Any concomitant illness that in the opinion of the investigators will substantially increase the risk of apheresis or make the volunteer ineligible for study controls are needed for (eg: active infection, allergies, etc.) |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00031174 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | 02-AR-0131 | ||||||||
| Study Sponsor † | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Collaborators †† | |||||||||
| Investigators † | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | October 2008 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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