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Trial record 2 of 560 for:    Cachectin OR Tumor Necrosis Factor-alpha

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

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ClinicalTrials.gov Identifier: NCT02134613
Recruitment Status : Unknown
Verified May 2016 by Bianca Gutfilen, Universidade Federal do Rio de Janeiro.
Recruitment status was:  Recruiting
First Posted : May 9, 2014
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Bianca Gutfilen, 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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Arthritis Other: 99mTc-anti-TNF-alpha Scintigraphy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity
Study Start Date : January 2009
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: 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.
Other: 99mTc-anti-TNF-alpha Scintigraphy
99mTc-anti-TNF-alpha Scintigraphy will be analysed and discussed by physicians who are in charge of the patients.




Primary Outcome Measures :
  1. Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up [ Time Frame: 5 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134613


Contacts
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Contact: Bianca Gutfilen, PhD 55 21 999755614 bianca.gutfilen@gmail.com
Contact: Sergio A Souza, PhD 55 21 994541440 sergioalsouza@gmail.com

Locations
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Brazil
Hospital Universitário Clementino Fraga Filho Recruiting
Rio de Janeiro, RJ, Brazil, 21941-913
Principal Investigator: Bianca Gutfilen, PhD         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
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Principal Investigator: Bianca Gutfilen, PhD UFRJ

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Responsible Party: Bianca Gutfilen, Associate Professor, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02134613     History of Changes
Other Study ID Numbers: CONEP-711/2008
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016

Keywords provided by Bianca Gutfilen, Universidade Federal do Rio de Janeiro:
99mTc-anti-TNF
Inflammation
Psoriatic arthritis
Rheumatoid arthritis

Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases