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

Phase 2

• Conditions: Arthritis; Psoriatic Arthritis

• Registration Number: NCT02134613
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-27
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake	1 week

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up	5 months

Trial Locations

Locations (1)

Hospital Universitário Clementino Fraga Filho; 🇧🇷 Rio de Janeiro, RJ, Brazil