FolateScan in Autoimmune Disease
Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases
1 other identifier
interventional
75
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Sep 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 22, 2007
CompletedFirst Posted
Study publicly available on registry
January 8, 2008
CompletedApril 16, 2010
April 1, 2010
1.2 years
December 22, 2007
April 15, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
detection of joint inflammation due to active rheumatoid arthritis
1 hour post injection of 0.1 mg of EC20
Secondary Outcomes (1)
detection of systemic organ inflammation due to rheumatoid arthritis
1 hour post injection of 0.1mg of EC20
Interventions
0.1 mg. of EC20 labeled with 20-25 mCi of technetium-99m followed by FolateScan
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Endocytecollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Xia W, Hilgenbrink AR, Matteson EL, Lockwood MB, Cheng JX, Low PS. A functional folate receptor is induced during macrophage activation and can be used to target drugs to activated macrophages. Blood. 2009 Jan 8;113(2):438-46. doi: 10.1182/blood-2008-04-150789. Epub 2008 Oct 24.
PMID: 18952896DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric L Matteson, M.D., M.P.H.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 22, 2007
First Posted
January 8, 2008
Study Start
September 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
April 16, 2010
Record last verified: 2010-04