Status:
COMPLETED
The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis
Lead Sponsor:
Biotectid GmbH
Collaborating Sponsors:
Technische Universität Dresden
University of Leipzig
Conditions:
Rheumatoid Arthritis
Polyarthritis
Eligibility:
All Genders
50-80 years
Phase:
PHASE1
PHASE2
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 d...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00372177
Start Date
July 1 2007
End Date
May 1 2008
Last Update
May 28 2008
Active Locations (1)
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1
Clinic and Policlinic for Nuclear Medicine, Medical faculty, University of Leipzig
Leipzig, Saxony, Germany, 04103