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

May 25, 2016 updated by: Bianca Gutfilen, Universidade Federal do Rio de Janeiro
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-913
        • Recruiting
        • Hospital Universitario Clementino Fraga Filho
        • Principal Investigator:
          • Bianca Gutfilen, PhD

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anti-TNF-alpha scintigraphy
99mTc-anti-TNF-alpha Scintigraphy will be compared with MRI results, analysed and discussed by physicians who are in charge of the patients.
Other: 99mTc-anti-TNF-alpha Scintigraphy
99mTc-anti-TNF-alpha Scintigraphy will be analysed and discussed by physicians who are in charge of the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up
Time Frame: 5 months
5 months

Collaborators and Investigators

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

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Principal Investigator: Bianca Gutfilen, PhD, UFRJ

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.

General Publications

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

January 1, 2009

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONEP-711/2008

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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