Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Randomised, Double-blind, Placebo-controlled Trial for Establishing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of Multiple Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy

Trial Profile

A Randomised, Double-blind, Placebo-controlled Trial for Establishing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of Multiple Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 25 Mar 2024

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs BI 655064 (Primary)
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions; Pharmacokinetics; Proof of concept; Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 22 Mar 2019 Primary endpoint (ACR20 (American College of Rheumatology) response rate at week 12 (day 85) from the initiation of study treatment (Part 2)) has not been met as per results published in the Annals of the Rheumatic Diseases
    • 22 Mar 2019 Results published in the Annals of the Rheumatic Diseases
    • 16 Aug 2018 Results (n=40) published in the Journal of Clinical Pharmacology.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top