Professor Gerd Horneff - Clipper study overview

Overview

Professor Gerd Horneff giving an overview of the Clipper study, an open-label clinical trial with etanercept in three different JIA catagories. Filmed at the American College of Rheumatology 2017 annual meeting.

 

About the speaker

Gerd Horneff is Head of Department at Asklepios Klinic Sankt Angustin,Germany.

 

Transcript

Can you briefly explain what was studied?

CLIPPER study is an ongoing open-label clinical trial with etanercept in three different JIA categories. So initially etanercept was approved and studied in polyarticular JIA, and there were some further patients with sometimes very severe JIA categories without any approved treatment, and these were the psoriatic arthritis, the enthesitis-related arthritis and the extended oligoarthritis, which is a subcategory of JIA of the worst course.

And in these patients etanercept has been tried in an initial trial, and it was very successful in all three categories and efficacy was compared to historical controls and it was a statistically significant improvement in all these three categories, so it became approved. But what's of real importance, especially in childhood, is safety. And for safety and for sustainability of efficacy, there has to be done a long-term study like this. An open-label, long-term study for eight years and now we have passed six years so we are nearly finished with our studies. And it's important to see the six-year results.

What is the main result of the study?

First, 127 patients is still a large cohort, so assurance is nice. Then efficacy is sustained, so the patients have high rates of ACR response. And about a quarter to 30%, so far as I remember the data correctly, are in remission state. This is also good. And for safety, there are no new safety problems. A few patients with serious infections and few other safety reports.

How will these data impact clinical practice?

For clinical practice it's important that you can treat your child, your patient, for the mother, the child, with such drugs, and that you can do it for prolonged time. We know that if you discontinue drugs you have to expect a recurrence of the disease in up to three quarter. So it is of much importance to know that continuous treatment for several years is safe and efficacious.

 

PP-ENB-GBR-0763 | March 2018