Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372177
Status:
COMPLETED
Last Update Posted:
2008-05-28
First Post:
2006-09-05
Brief Title:
The Use of Anti-CD4 Monoclonal Antibody mAb-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis
Sponsor:
Biotectid GmbH
Organization:
Biotectid GmbH
Study Overview
Official Title:
The Use of Anti-CD4 mAb-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis an Open Proof of Concept Study
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rheumatoid arthritis RA is a disease with a large economic impact due to the long lasting disabling nature of the disease Furthermore diagnosis of the disease is difficult and only a scheme with different symptoms is used to diagnose rheumatoid arthritis often only by probability
Due to the fact that effective disease modifying pharmacological treatment is available and should be started early in established cases of RA in combination with the adverse effect potential of these substances eg methotrexate a fast reliable diagnostic tool to diagnose rheumatoid arthritis would be highly appreciated by the medical community and the patients Furthermore for invasive treatments surgery puncture an imaging method to display the activity pattern in different joints would be a major advantage
For the evaluation of the effectiveness of pharmacological therapy in rheumatoid arthritis up to now radiological measurements of the destruction process of the joints are used This method has the disadvantage that it is time consuming insofar as changes in the radiological images must occur It allows only an evaluation if the joints are destructed which should be excluded by the new therapy regimen Again a quantifiable method for the determination of the effects of new therapeutic approaches would be highly appreciated
Due to the fact that effective disease modifying pharmacological treatment is available and should be started early in established cases of RA in combination with the adverse effect potential of these substances eg methotrexate a fast reliable diagnostic tool to diagnose rheumatoid arthritis would be highly appreciated by the medical community and the patients Furthermore for invasive treatments surgery puncture an imaging method to display the activity pattern in different joints would be a major advantage
For the evaluation of the effectiveness of pharmacological therapy in rheumatoid arthritis up to now radiological measurements of the destruction process of the joints are used This method has the disadvantage that it is time consuming insofar as changes in the radiological images must occur It allows only an evaluation if the joints are destructed which should be excluded by the new therapy regimen Again a quantifiable method for the determination of the effects of new therapeutic approaches would be highly appreciated
Detailed Description:
The substance will be used as iv injection due to the protein nature of the antibody and to ensure a fast distribution within the body The study will be performed as an open clinical trial due to the fact that the applied radiation has to be documented the use of placebo radiation would be unethical
It is expected that the new antibody fragment with its radioactive linkage will display an image of the activity distribution of the disease Due to the fact that only patients with active disease have to be imaged and to allow for comparison of the activity and the clinical distribution of the disease this proof of concept study phase I study will be performed in patients with active disease Healthy volunteers could not display an activity pattern of the disease Furthermore it seems to be unethical to use volunteers for studies with radioactivity with such a riskbenefit ratio radiation risks vs missing chance of display of tissue distribution in a proof of concept study
It is expected that the new antibody fragment with its radioactive linkage will display an image of the activity distribution of the disease Due to the fact that only patients with active disease have to be imaged and to allow for comparison of the activity and the clinical distribution of the disease this proof of concept study phase I study will be performed in patients with active disease Healthy volunteers could not display an activity pattern of the disease Furthermore it seems to be unethical to use volunteers for studies with radioactivity with such a riskbenefit ratio radiation risks vs missing chance of display of tissue distribution in a proof of concept study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EP 1645 | None | None | None |