Rheumatoid ArthritisPhase 1/2NCT00372177
The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis
A Phase 1/2 study testing Fab-fragment of Anti-human CD4 in people with Rheumatoid Arthritis and Polyarthritis, run by Biotectid GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis, Polyarthritis, Rheumatism
- What is being tested?
- Fab-fragment of Anti-human CD4
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to May 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic and Policlinic for Nuclear Medicine, Medical faculty, University of Leipzig
Leipzig, Saxony, 04103
About this study
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)
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.
Read the 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.
- Being tested
- Fab-fragment of Anti-human CD4
- Keywords
- monoclonal antibody, diagnostics, RA, Immunoglobulins, molecular target, Tc99m-pertechnetate, Fab-fragment of Anti-human CD4, Radiopharmaceutical, chronic inflammatory diseases, active Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Rheumatic Diseases, Autoimmune Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fab-fragment of Anti-human CD4Radiation
Sterile lyophilized Powder for Preparation of a Solution and sterile labelling Buffer labelling with Tc99m-Pertechnetat Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| EP1645 | Active comparator | Single-Dose Receives: Radiation: Fab-fragment of Anti-human CD4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability of this diagnostic agent
Measured: duration of study
Secondary outcomes (1)
endpoint for the proof of concept will be the number of patients needed to obtain a series of equal results
Measured: duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotectid GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Technische Universität Dresden, University of Leipzig
- Investigators
- Osama Sabri, Prof. Dr., Principal investigator, Clinic and Policlinic for Nuclear Medicine, Medical Faculty, University of Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372177
- Sponsor's protocol ID
- Biotectid POC EP 1645
- Other IDs
- EP 1645
- Status last verified
- May 2008
- First submitted
- 5 Sep 2006
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00372177
- Acronym / sponsor ID
- Biotectid POC EP 1645
- Keywords
- monoclonal antibody, diagnostics, RA, Immunoglobulins, molecular target, Tc99m-pertechnetate, Fab-fragment of Anti-human CD4, Radiopharmaceutical
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Biotectid GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Technische Universität Dresden, University of Leipzig
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 6 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EP1645 | Active comparator | Radiation: Fab-fragment of Anti-human CD4Single-Dose |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fab-fragment of Anti-human CD4Sterile lyophilized Powder for Preparation of a Solution and sterile labelling Buffer labelling with Tc99m-Pertechnetat Intravenous injection | Radiation | EP1645 |
Primary outcome
safety and tolerability of this diagnostic agent
Time frame: duration of study
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Sabri, Prof. Dr. principal investigator
Clinic and Policlinic for Nuclear Medicine, Medical Faculty, University of Leipzig, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fab-fragment of Anti-human CD4 in people with Rheumatoid Arthritis and Polyarthritis, run by Biotectid GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability of this diagnostic agent (time frame: duration of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2008.