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Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain

NCT01864265 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2020-03-10

No results posted yet for this study

Summary

By using functional MRI the investigators have recently shown that TNFi elicit rapid changes in brain function linked to the perception of RA \[5\]. Functional MRI represents a method allowing detecting tiny changes in neuronal activity by measuring alterations of blood flow in the context of neuronal activation. TNFi rapidly reversed the widespread activation of brain centers involved in pain such as the thalamus and the somatosensoric cortex, as well as those involved in the control, of mood and emotions such as the limbic system. Moreover, as small phase I study with 10 patients with RA showed that high brain activity detected in the functional MRI predicts clinical response to Certolizumab Pegol after 1 month, suggesting the central nervous system activity may be used as a tool to predict response to TNFi \[8\]. The rationale of this study is to test whether response to TNFi can be predicted by using functional MRI.

Conditions

Interventions

DRUG

Certolizumab Pegol

Certolizumab Pegol (Cimzia®) is an engineered, humanized antibody-Fab'-fragment with specificity for human TNF-α, that is conjugated to polyethylene glycol (PEG). Certolizumab Pegol (Cimzia®) is a humanized antibody-Fab'-fragment that is produced in Escherichia coli and subsequently PEGylated to prolong its circulating half-time to be similar to that of an intact mAB. Certolizumab Pegol has a high affinity for TNF α with a Kd90pM and is an effective TNF α inhibitor. Certolizumab pegol does not neutralize TNFß (lymphotoxin), a related cytokine, and does not activate complement or kill cells via antibody-dependent cellular toxicity.

DRUG

Placebo

Placebo will be administered according to the label of the biological

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Juergen Rech, MD · University of Erlangen-Nuremberg, Department of Internal Medicine 3, Rheumatology & Immunology

  • Georg Schett, MD, Prof. · University of Erlangen-Nuremberg, Department of Internal Medicine 3, Rheumatology & Immunology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2019-06-30
Completion
2020-01-10

Countries

  • Germany
  • Portugal
  • Serbia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01864265 on ClinicalTrials.gov