NCT02134613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

8.5 years

First QC Date

April 28, 2014

Last Update Submit

May 25, 2016

Conditions

Psoriatic ArthritisArthritis

Keywords

99mTc-anti-TNFInflammationPsoriatic arthritisRheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake

    1 week

Secondary Outcomes (1)

  • Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up

    5 months

Study Arms (1)

anti-TNF-alpha scintigraphy

EXPERIMENTAL

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

Interventions

99mTc-anti-TNF-alpha ScintigraphyOTHER

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

anti-TNF-alpha scintigraphy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid Arthritis (RA) patients must have 1 joint with edema.
  • Inflammatory lumbalgia
  • ankylosing spondylitis
  • Psoriatic arthritis with active disease and skin lesion

You may not qualify if:

  • Patients that do not return to scintigraphy
  • Pregnancy, Lactation, active infection, severe concomitant disease and medication allergy history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33306625DERIVED

MeSH Terms

Conditions

Arthritis, PsoriaticArthritisInflammationArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsRheumatic DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bianca Gutfilen, PhD

    UFRJ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bianca Gutfilen, PhD

CONTACT

55 21 999755614bianca.gutfilen@gmail.com

Sergio A Souza, PhD

CONTACT

55 21 994541440sergioalsouza@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 9, 2014

Study Start

January 1, 2009

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

May 27, 2016

Record last verified: 2016-05

Locations

BR(1)