A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

February 8, 2017 updated by: Novo Nordisk A/S

A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Praha 2, Czech Republic, 128 50
        • Novo Nordisk Investigational Site
  • Denmark
      • Frederiksberg, Denmark, 2000
        • Novo Nordisk Investigational Site
      • Silkeborg, Denmark, 8600
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1027
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-879
        • Novo Nordisk Investigational Site
      • Elblag, Poland, 82-300
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-637
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 61-218
        • Novo Nordisk Investigational Site
  • Romania
      • Bacau, Romania, 600114
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 020475
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 011172
        • Novo Nordisk Investigational Site
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Novo Nordisk Investigational Site
    • Covasna
      • Sfantu Gheorghe, Covasna, Romania, 520064
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Burslem, United Kingdom, ST6 7AG
        • Novo Nordisk Investigational Site
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA6 6NL
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CZ: Age between 18 and 65 years (both inclusive)
  • A diagnosis of rheumatoid arthritis of at least three months before entry in trial
  • Active rheumatoid arthritis (RA)
  • Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: NNC 0151-0000-0000
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
Placebo Comparator: B
Drug: placebo
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events (AEs)
Time Frame: at all scheduled visits (week 1 - week 11)
at all scheduled visits (week 1 - week 11)

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum concentrations of NNC 151-0000-0000
Time Frame: at 48 hours after all dose administrations
at 48 hours after all dose administrations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Daniluk S, Skrumsager BK, Leszczynski P. Safety and tolerability of the anti-C5aR humanised monoclonal antibody NNC0151-0000 in patients with rheumatoid arthritis: A phase 2, randomised, double-blind, placebocontrolled, multiple-dose trial. EULAR (European League Against Rheumatism) 2014; Country: France City: Paris

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 18, 2010

First Posted (Estimate)

October 19, 2010

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8209-3607
  • U1111-1116-2430 (Other Identifier: WHO)
  • 2009-011791-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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