99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity
Primary Purpose
Psoriatic Arthritis, Arthritis
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
99mTc-anti-TNF-alpha Scintigraphy
Sponsored by
About this trial
This is an interventional diagnostic trial for Psoriatic Arthritis focused on measuring 99mTc-anti-TNF, Inflammation, Psoriatic arthritis, Rheumatoid arthritis
Eligibility Criteria
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
Sites / Locations
- Hospital Universitário Clementino Fraga FilhoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anti-TNF-alpha scintigraphy
Arm Description
99mTc-anti-TNF-alpha Scintigraphy will be compared with MRI results, analysed and discussed by physicians who are in charge of the patients.
Outcomes
Primary Outcome Measures
Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake
Secondary Outcome Measures
Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up
Full Information
NCT ID
NCT02134613
First Posted
April 28, 2014
Last Updated
May 25, 2016
Sponsor
Universidade Federal do Rio de Janeiro
1. Study Identification
Unique Protocol Identification Number
NCT02134613
Brief Title
99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity
Official Title
99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis, Arthritis
Keywords
99mTc-anti-TNF, Inflammation, Psoriatic arthritis, Rheumatoid arthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anti-TNF-alpha scintigraphy
Arm Type
Experimental
Arm Description
99mTc-anti-TNF-alpha Scintigraphy will be compared with MRI results, analysed and discussed by physicians who are in charge of the patients.
Intervention Type
Other
Intervention Name(s)
99mTc-anti-TNF-alpha Scintigraphy
Intervention Description
99mTc-anti-TNF-alpha Scintigraphy will be analysed and discussed by physicians who are in charge of the patients.
Primary Outcome Measure Information:
Title
Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bianca Gutfilen, PhD
Phone
55 21 999755614
Email
bianca.gutfilen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio A Souza, PhD
Phone
55 21 994541440
Email
sergioalsouza@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bianca Gutfilen, PhD
Organizational Affiliation
UFRJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bianca Gutfilen, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
33306625
Citation
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.
Results Reference
derived
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99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity
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