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

Universidade Federal do Rio de Janeiro

Status and phase: Unknown; Phase 2

Conditions: Arthritis; Psoriatic Arthritis

Treatments: Other: 99mTc-anti-TNF-alpha Scintigraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT02134613

CONEP-711/2008

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

anti-TNF-alpha scintigraphy

Experimental group

Description:

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

Treatment:

Other: 99mTc-anti-TNF-alpha Scintigraphy