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99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity

99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02134613
Enrollment
50
Registered
2014-05-09
Start date
2009-01-31
Completion date
2017-12-31
Last updated
2016-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Psoriatic Arthritis

Keywords

99mTc-anti-TNF, Inflammation, Psoriatic arthritis, Rheumatoid arthritis

Brief 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. 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.

Interventions

OTHER99mTc-anti-TNF-alpha Scintigraphy

99mTc-anti-TNF-alpha Scintigraphy will be analysed and discussed by physicians who are in charge of the patients.

Sponsors

Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Rheumatoid Arthritis (RA) patients must have 1 joint with edema. * Inflammatory lumbalgia * ankylosing spondylitis * Psoriatic arthritis with active disease and skin lesion

Exclusion criteria

* Patients that do not return to scintigraphy * Pregnancy, Lactation, active infection, severe concomitant disease and medication allergy history

Design outcomes

Primary

MeasureTime frame
Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake1 week

Secondary

MeasureTime frame
Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up5 months

Countries

Brazil

Contacts

Primary ContactBianca Gutfilen, PhD
bianca.gutfilen@gmail.com55 21 999755614
Backup ContactSergio A Souza, PhD
sergioalsouza@gmail.com55 21 994541440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026