Rheumatic DiseasesNCT00031174
Blood Component Collection From Patients With Rheumatic or Kidney Disease and Healthy Volunteers
An observational study of Rheumatic Diseases and Healthy Volunteers, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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 or kidney disorders for research purposes. Rheumatic disorders involve abnormalities of the immune system, the body s defense against disease. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Diseases, Healthy Volunteers
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2002to 17 Aug 2020
- 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 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Rheumatic or kidney diseases and healthy volunteers.
Who may be able to join
- Patients with a diagnosed or suspected rheumatic or kidney disease, who are actively involved in a NIAMS or NIDDK protocol (have a current, signed consent form)
- Ability to give informed consent
- Age greater than or equal to 18 years
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 the risk of apheresis.
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Collection Of Blood Components Using Apheresis From Patients With Rheumatic or Kidney Diseases and Healthy Volunteers
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 or kidney 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 or kidney 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 or the National Institute of Digestive, Diabetes and Kidney 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.
Read more
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.
...
Read the detailed description
Blood components will be collected using apheresis from normal volunteers and patients with rheumatic or kidney diseases. Mononuclear cells and plasma will be used by various investigators for research studies.
- Conditions
- Rheumatic Diseases, Healthy Volunteers
- Keywords
- Apheresis, Healthy Volunteer, Rheumatoid Disease, Rheumatic Disease, Lupus, Rheumatoid Arthritis, Myositis, HV, Normal Control
- Medical subject headings
- Rheumatic Diseases, Arthritis, Rheumatoid, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Blood components collected using apheresis from normal volunteers. | |
| 2 | Blood components collected using apheresis from patients with rheumatic or kidney diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PBMC and Mononuclear cell study
Blood components will be collected using apheresis from normal volunteers and patients with rheumatic or kidney diseases. Mononuclear cells and plasma will be used by various investigators for research studies.
Measured: 1/1/2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2002 (estimated)
- Study start13 Feb 2002
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Why it stopped: Due to technical and logistical constraints and a change in the study team's focus of research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sarfaraz A Hasni, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031174
- Sponsor's protocol ID
- 020131
- Other IDs
- 02-AR-0131
- Status last verified
- Aug 2020
- First submitted
- 26 Feb 2002
- Last updated
- 21 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection Of Blood Components Using Apheresis From Patients With Rheumatic or Kidney Diseases and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00031174
- Acronym / sponsor ID
- 020131
- Conditions
- Rheumatic Diseases, Healthy Volunteers
- Keywords
- Apheresis, Healthy Volunteer, Rheumatoid Disease, Rheumatic Disease, Lupus, Rheumatoid Arthritis, Myositis, HV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to technical and logistical constraints and a change in the study team's focus of research
- Enrolment
- 151 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 13 Feb 2002 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 27 Feb 2002 (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 collect white blood cells or plasma (the liquid part of the blood), or both, from healthy volunteers and from patients with rheumatic or kidney 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 or kidney 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 or the National Institute of Digestive, Diabetes and Kidney 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.
...
Detailed description
Blood components will be collected using apheresis from normal volunteers and patients with rheumatic or kidney diseases. Mononuclear cells and plasma will be used by various investigators for research studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Blood components collected using apheresis from normal volunteers. |
| 2 | – | –Blood components collected using apheresis from patients with rheumatic or kidney diseases. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Rheumatic or kidney diseases and healthy volunteers.
Key inclusion criteria (6 listed)
- Patients with a diagnosed or suspected rheumatic or kidney disease, who are actively involved in a NIAMS or NIDDK protocol (have a current, signed consent form)
- Ability to give informed consent
- Age greater than or equal to 18 years
- 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
Key exclusion criteria (19 listed)
- 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
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
PBMC and Mononuclear cell study
Time frame: 1/1/2030
Blood components will be collected using apheresis from normal volunteers and patients with rheumatic or kidney diseases. Mononuclear cells and plasma will be used by various investigators for research studies.
Results and safety
The study was stopped early (reason given: Due to technical and logistical constraints and a change in the study team's focus of research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Sarfaraz A Hasni, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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 Rheumatic Diseases and Healthy Volunteers, 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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 21 Aug 2020. 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 was stopped early (reason given: Due to technical and logistical constraints and a change in the study team's focus of research). Results are not available in the source record.
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.
What does the primary outcome measure?
PBMC and Mononuclear cell study (time frame: 1/1/2030). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2020.