The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372177
• Other study ID #: Biotectid POC EP 1645
• Secondary ID: EP 1645
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 5, 2006
• Last updated: May 26, 2008
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Biotectid GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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 (e.g. 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.

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 risk/benefit ratio (radiation risks vs. missing chance of display of tissue distribution) in a proof of concept study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female subjects above 50 years of age

• Suffering from joint pain which is due to active rheumatoid arthritis

• Obvious signs of inflammation in at least one joint (e.g. swelling, erythema, or local elevated temperature)

• Otherwise healthy

• Informed consent

Exclusion Criteria:

• Patients 80 years and older

• Clinically significant disease of the cardiovascular system, respiratory system, hepato-biliary system or central nervous system (CNS)

• Excretory hepatic or renal insufficiency

• Regular intake of any drug, except for hormone replacement therapy in females

• Previous administration of xenogenous proteins

• History of anaphylactic reaction to any drug administered by a parenteral pathway

• Previous participation in a radiopharmaceutical drug trial (unless the effective dose acquired by participation in the current trial will remain below 10 mSv)

• Participation in any clinical drug trial within 3 months prior to enrolment

• Women of child-bearing potential (child-bearing potential to be ruled out by one of the following: at least 2 years past menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)

• Long term medication with strong antiphlogistic agents/pain killers such as methotrexate, corticoids, or immunosuppressants prior to enrolment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Disease
• Autoimmune Diseases
• Inflammation
• Polyarthritis
• Rheumatism
• Rheumatoid Arthritis

Intervention

Radiation:
• Fab-fragment of Anti-human CD4
Sterile lyophilized Powder for Preparation of a Solution and sterile labelling Buffer labelling with Tc99m-Pertechnetat Intravenous injection

Locations

Country	Name	City	State
Germany	Clinic and Policlinic for Nuclear Medicine, Medical faculty, University of Leipzig	Leipzig	Saxony

Sponsors (3)

Lead Sponsor	Collaborator
Biotectid GmbH	Technische Universität Dresden, University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability of this diagnostic agent		duration of study	Yes
Secondary	endpoint for the proof of concept will be the number of patients needed to obtain a series of equal results		duration of study	Yes

External Links

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