Full Text View
Tabular View
No Study Results Posted
Related Studies
FolateScan in Autoimmune Disease
This study has been completed.
First Received: December 22, 2007   Last Updated: May 20, 2008   History of Changes
Sponsors and Collaborators: Mayo Clinic
Endocyte
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588393
  Purpose

This study will gather information on the safety of FolateScan and the ability of FolateScan to detect inflammation in the joints and other organs in people with arthritis (rheumatoid arthritis and osteoarthritis), systemic lupus erythematosus, multiple sclerosis, interstitial pneumonitis, Crohn's disease as well as in healthy persons without these conditions.


Condition Intervention Phase
Rheumatoid Arthritis
Osteoarthritis
Multiple Sclerosis
Crohn's Disease
Systemic Lupus Erythematosus
Drug: FolateScan (Technetium Tc 99mEC20)
Phase II

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Autoimmune Diseases Crohn's Disease Lupus Multiple Sclerosis Osteoarthritis Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • detection of joint inflammation due to active rheumatoid arthritis [ Time Frame: 1 hour post injection of 0.1 mg of EC20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • detection of systemic organ inflammation due to rheumatoid arthritis [ Time Frame: 1 hour post injection of 0.1mg of EC20 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: FolateScan (Technetium Tc 99mEC20)
    0.1 mg. of EC20 labeled with 20-25 mCi of technetium-99m followed by FolateScan
Detailed Description:

The folate receptor is over-expressed on many types of cancer cells and in RA models, and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. As with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy.

EC20 concentrates in the extremities and liver and spleen of rats with adjuvant induced arthritis. The increased uptake is mediated by overexpressed folate receptor on macrophages, and the intensity of the uptake is greatly reduced by addition of excess folate, supporting the specificity of the uptake. Depletion of macrophages greatly reduced folate receptor and abolishes uptake of EC20. This suggests that EC20 may be useful in assessing macrophage involvement in the active inflammatory process of RA, and perhaps other systemic immune mediated disorders as well.

FolateScan may allow the clinician to get accurate real-time data on receptor binding, in a less invasive manner, at all actively inflamed sites throughout the treatment regimen. This kind of information may help the physician make better clinical decisions regarding therapy, including folate targeted therapies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588393

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Endocyte
Investigators
Principal Investigator: Eric L Matteson, M.D., M.P.H. Mayo Clinic
  More Information

Additional Information:
No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Mayo Clinic ( Eric L. Matteson, M.D., M.P. H. )
Study ID Numbers: 06-002680
Study First Received: December 22, 2007
Last Updated: May 20, 2008
ClinicalTrials.gov Identifier: NCT00588393     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Crohn's Disease
Osteoarthritis
Gastrointestinal Diseases
Lupus
Arthritis, Rheumatoid
Inflammatory Bowel Diseases
Ileal Diseases
Multiple Sclerosis
Musculoskeletal Diseases
Lupus Erythematosus, Systemic
Arthritis
Connective Tissue Diseases
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Demyelinating Diseases
Ileitis
Joint Diseases
Enteritis
Sclerosis
Rheumatic Diseases
Intestinal Diseases
Digestive System Diseases
Crohn Disease
Demyelinating Autoimmune Diseases, CNS
Gastroenteritis

Additional relevant MeSH terms:
Osteoarthritis
Gastrointestinal Diseases
Arthritis, Rheumatoid
Inflammatory Bowel Diseases
Ileal Diseases
Pathologic Processes
Multiple Sclerosis
Musculoskeletal Diseases
Lupus Erythematosus, Systemic
Arthritis
Connective Tissue Diseases
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Demyelinating Diseases
Ileitis
Joint Diseases
Enteritis
Nervous System Diseases
Sclerosis
Rheumatic Diseases
Intestinal Diseases
Digestive System Diseases
Crohn Disease
Demyelinating Autoimmune Diseases, CNS
Gastroenteritis

ClinicalTrials.gov processed this record on May 07, 2009