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

May 26, 2008 updated by: Biotectid GmbH

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Clinic and Policlinic for Nuclear Medicine, Medical faculty, University of Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EP1645
Single-Dose
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability of this diagnostic agent
Time Frame: duration of study
duration of study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotectid GmbH

Collaborators

University of Leipzig
Technische Universität Dresden

Investigators

  • Principal Investigator: Osama Sabri, Prof. Dr., Clinic and Policlinic for Nuclear Medicine, Medical Faculty, University of Leipzig, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 5, 2006

First Submitted That Met QC Criteria

September 5, 2006

First Posted (Estimate)

September 6, 2006

Study Record Updates

Last Update Posted (Estimate)

May 28, 2008

Last Update Submitted That Met QC Criteria

May 26, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biotectid POC EP 1645
  • EP 1645

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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