Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain. A Multi-center, Randomized Double-blind Controlled Study Prediction of Response to Certolizumab-Pegol in RA (PreCePRA)

NCT01864265 Phase 3 COMPLETED

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.

Details

Lead sponsor	University of Erlangen-Nürnberg Medical School
Phase	Phase 3
Status	COMPLETED
Enrolment	156
Start date	2013-07
Completion	2020-01-10

Conditions

• Rheumatoid Arthritis

Interventions

• Certolizumab Pegol
• Placebo

Primary outcomes

• Reaching low disease activity — 6 months
  Proportion of patients who reach low disease activity according to the DAS28 (DAS28 \< 3.2) during the first 12 weeks of study participation according their screening CNS activity measured by functional MRI.

Countries

Germany, Portugal, Serbia