Psoriatic ArthritisPhase 2NCT02134613
99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity
A Phase 2 study testing 99mTc-anti-TNF-alpha Scintigraphy in people with Psoriatic Arthritis and Arthritis, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
Rheumatoid and psoriatic arthritis patients benefit from anti-TNF-α therapy, once it is effective in reducing joint and skin manifestations in 60-70% of patients with inflammatory articular joint and skin diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis, Arthritis
- What is being tested?
- 99mTc-anti-TNF-alpha Scintigraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Dec 2017
- Phase
- Phase 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Rheumatoid Arthritis (RA) patients must have 1 joint with edema.
- Inflammatory lumbalgia
- ankylosing spondylitis
- Psoriatic arthritis with active disease and skin lesion
Who cannot join
- Patients that do not return to scintigraphy
- Pregnancy, Lactation, active infection, severe concomitant disease and medication allergy history
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, 21941-913
Bianca Gutfilen, PhD
About this study
Rheumatoid and psoriatic arthritis patients benefit from anti-TNF-α therapy, once it is effective in reducing joint and skin manifestations in 60-70% of patients with inflammatory articular joint and skin diseases. Thus, identifying the presence and amount of TNF-α in the joint or skin in these patients may help in guiding the course of treatment more efficiently. The investigators research group has developed a novel approach to label anti-TNF-α with technetium-99m. Here the investigators compare the results obtained with scintigraphy and MRI in rheumatoid and psoriatic arthritis. The 99mTc-anti-TNF-α scintigraphy might recognize the molecule involved in the inflammatory process and provide crucial information to help physicians taking decisions about the drugs to be used based on biological evidence and which are cost-effective and appropriate for the treatment of choice. It allows direct identification of the monoclonal antibody anti-TNF-α in the articular joints and skin while it also ensures that the drug has reached its therapeutic target. It also allows correlation between the presence of the drug and clinical responses.
- Conditions
- Psoriatic Arthritis, Arthritis
- Being tested
- 99mTc-anti-TNF-alpha Scintigraphy
- Keywords
- 99mTc-anti-TNF, Inflammation, Psoriatic arthritis, Rheumatoid arthritis
- Medical subject headings
- Arthritis, Psoriatic, Arthritis, Inflammation, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-anti-TNF-alpha ScintigraphyOther
99mTc-anti-TNF-alpha Scintigraphy will be analysed and discussed by physicians who are in charge of the patients.
| Study group | Role | What they receive |
|---|---|---|
| anti-TNF-alpha scintigraphy | Experimental | 99mTc-anti-TNF-alpha Scintigraphy will be compared with MRI results, analysed and discussed by physicians who are in charge of the patients. Receives: Other: 99mTc-anti-TNF-alpha Scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake
Measured: 1 week
Secondary outcomes (1)
Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJan 2009
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bianca Gutfilen, Universidade Federal do Rio de Janeiro
- Investigators
- Bianca Gutfilen, PhD, Principal investigator, UFRJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134613
- Sponsor's protocol ID
- CONEP-711/2008
- Status last verified
- May 2016
- First submitted
- 28 Apr 2014
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alexandre DJA, Carmo CCM, Romeiro LD, Gutfilen-Schlesinger G, Amarante JLM Jr, de Souza SAL, Gutfilen B. 99mTc-antitumor necrosis factor-alpha scintigraphy for the detection of inflammatory activity in rheumatoid arthritis. Nucl Med Commun. 2021 Apr 1;42(4):389-395. doi: 10.1097/MNM.0000000000001333.
PubMed 33306625
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity
- ClinicalTrials.gov ID
- NCT02134613
- Acronym / sponsor ID
- CONEP-711/2008
- Conditions
- Psoriatic Arthritis, Arthritis
- Keywords
- 99mTc-anti-TNF, Inflammation, Psoriatic arthritis, Rheumatoid arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 May 2014 (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 and psoriatic arthritis patients benefit from anti-TNF-α therapy, once it is effective in reducing joint and skin manifestations in 60-70% of patients with inflammatory articular joint and skin diseases. Thus, identifying the presence and amount of TNF-α in the joint or skin in these patients may help in guiding the course of treatment more efficiently. The investigators research group has developed a novel approach to label anti-TNF-α with technetium-99m. Here the investigators compare the results obtained with scintigraphy and MRI in rheumatoid and psoriatic arthritis. The 99mTc-anti-TNF-α scintigraphy might recognize the molecule involved in the inflammatory process and provide crucial information to help physicians taking decisions about the drugs to be used based on biological evidence and which are cost-effective and appropriate for the treatment of choice. It allows direct identification of the monoclonal antibody anti-TNF-α in the articular joints and skin while it also ensures that the drug has reached its therapeutic target. It also allows correlation between the presence of the drug and clinical responses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-TNF-alpha scintigraphy | Experimental | Other: 99mTc-anti-TNF-alpha Scintigraphy99mTc-anti-TNF-alpha Scintigraphy will be compared with MRI results, analysed and discussed by physicians who are in charge of the patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rheumatoid Arthritis (RA) patients must have 1 joint with edema.
- Inflammatory lumbalgia
- ankylosing spondylitis
- Psoriatic arthritis with active disease and skin lesion
Key exclusion criteria (2 listed)
- Patients that do not return to scintigraphy
- Pregnancy, Lactation, active infection, severe concomitant disease and medication allergy history
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 |
|---|---|---|
| 99mTc-anti-TNF-alpha Scintigraphy99mTc-anti-TNF-alpha Scintigraphy will be analysed and discussed by physicians who are in charge of the patients. | Other | anti-TNF-alpha scintigraphy |
Primary outcome
Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake
Time frame: 1 week
1 secondary outcome
Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Derived from this study: PubMed 33306625Alexandre DJA, Carmo CCM, Romeiro LD, Gutfilen-Schlesinger G, Amarante JLM Jr, de Souza SAL, Gutfilen B. 99mTc-antitumor necrosis factor-alpha scintigraphy for the detection of inflammatory activity in rheumatoid arthritis. Nucl Med Commun. 2021 Apr 1;42(4):389-395. doi: 10.1097/MNM.0000000000001333.
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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.
Bianca Gutfilen, PhD principal investigator
UFRJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 99mTc-anti-TNF-alpha Scintigraphy in people with Psoriatic Arthritis and Arthritis, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 May 2016. 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 Brazil. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bianca Gutfilen, PhD (55 21 999755614, bianca.gutfilen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02134613, which also lists 1 linked publication.
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 27 May 2016.