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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00588393 |
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Date of registration:
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22/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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FolateScan in Autoimmune Disease
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Scientific title:
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Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00588393 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Eric L Matteson, M.D., M.P.H. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Study will include 40 subjects with rheumatoid arthritis (active or inactive disease,
defined as no swollen joints) and 5 patients in each of the following diagnosis:
osteoarthritis, multiple sclerosis, Crohn's disease, systemic lupus erythematosus,
interstitial lung disease and no autoimmune disease (healthy).
- Subjects must have disease duration of at least 6 months and creatinine level may not
be greater than 1.5 mg/dL.
Exclusion Criteria:
- Subjects will be excluded if they are pregnant, have an active infection, received an
investigational therapy in the past month or previous malignancy within the past 5
years.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Crohn's Disease
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Rheumatoid Arthritis
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Systemic Lupus Erythematosus
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Multiple Sclerosis
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Intervention(s)
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Drug: FolateScan (Technetium Tc 99mEC20)
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Primary Outcome(s)
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detection of joint inflammation due to active rheumatoid arthritis
[Time Frame: 1 hour post injection of 0.1 mg of EC20]
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Secondary Outcome(s)
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detection of systemic organ inflammation due to rheumatoid arthritis
[Time Frame: 1 hour post injection of 0.1mg of EC20]
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Secondary ID(s)
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06-002680
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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