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

Study Overview
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Brief Summary
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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.

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

Conditions
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Psoriatic Arthritis, Arthritis

Intervention / Treatment
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* Other: 99mTc-anti-TNF-alpha Scintigraphy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-TNF-alpha scintigraphy<br>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<br>* 99mTc-anti-TNF-alpha Scintigraphy will be analysed and discussed by physicians who are in charge of the patients.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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99mTc-anti-TNF, Inflammation, Psoriatic arthritis, Rheumatoid arthritis