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

NCT ID: NCT02134613

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2017-12-31

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.

Detailed Description

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Conditions

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Psoriatic Arthritis Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

99mTc-anti-TNF-alpha Scintigraphy

Intervention Type OTHER

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

Interventions

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99mTc-anti-TNF-alpha Scintigraphy

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Bianca Gutfilen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bianca Gutfilen, PhD

Role: PRINCIPAL_INVESTIGATOR

UFRJ

Locations

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Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Bianca Gutfilen, PhD

Role: CONTACT

55 21 999755614

Sergio A Souza, PhD

Role: CONTACT

55 21 994541440

References

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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.

Reference Type DERIVED
PMID: 33306625 (View on PubMed)

Other Identifiers

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CONEP-711/2008

Identifier Type: -

Identifier Source: org_study_id

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