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

Primary Purpose

Rheumatoid Arthritis, Polyarthritis, Rheumatism

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Fab-fragment of Anti-human CD4
Sponsored by
Biotectid GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rheumatoid Arthritis focused on measuring monoclonal antibody, diagnostics, RA, Immunoglobulins, molecular target, Tc99m-pertechnetate, Fab-fragment of Anti-human CD4, Radiopharmaceutical, chronic inflammatory diseases, active Rheumatoid Arthritis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinic and Policlinic for Nuclear Medicine, Medical faculty, University of Leipzig

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

EP1645

Arm Description

Single-Dose

Outcomes

Primary Outcome Measures

safety and tolerability of this diagnostic agent

Secondary Outcome Measures

endpoint for the proof of concept will be the number of patients needed to obtain a series of equal results

Full Information

First Posted
September 5, 2006
Last Updated
May 26, 2008
Sponsor
Biotectid GmbH
Collaborators
Technische Universität Dresden, University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT00372177
Brief Title
The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biotectid GmbH
Collaborators
Technische Universität Dresden, University of Leipzig

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Polyarthritis, Rheumatism, Autoimmune Disease, Inflammation
Keywords
monoclonal antibody, diagnostics, RA, Immunoglobulins, molecular target, Tc99m-pertechnetate, Fab-fragment of Anti-human CD4, Radiopharmaceutical, chronic inflammatory diseases, active Rheumatoid Arthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EP1645
Arm Type
Active Comparator
Arm Description
Single-Dose
Intervention Type
Radiation
Intervention Name(s)
Fab-fragment of Anti-human CD4
Intervention Description
Sterile lyophilized Powder for Preparation of a Solution and sterile labelling Buffer labelling with Tc99m-Pertechnetat Intravenous injection
Primary Outcome Measure Information:
Title
safety and tolerability of this diagnostic agent
Time Frame
duration of study
Secondary Outcome Measure Information:
Title
endpoint for the proof of concept will be the number of patients needed to obtain a series of equal results
Time Frame
duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Sabri, Prof. Dr.
Organizational Affiliation
Clinic and Policlinic for Nuclear Medicine, Medical Faculty, University of Leipzig, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic and Policlinic for Nuclear Medicine, Medical faculty, University of Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://nuklmed.uniklinikum-leipzig.de/
Description
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The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis

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