Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

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

A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active Rheumatoid Arthritis (RA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

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
      • Brno, Czech Republic, 602 00
        • Novo Nordisk Investigational Site
      • Praha, Czech Republic, 140 00
        • Novo Nordisk Investigational Site
      • Praha 2, Czech Republic, 128 50
        • Novo Nordisk Investigational Site
      • Uherske Hradiste, Czech Republic, 686 01
        • Novo Nordisk Investigational Site
      • Zlin, Czech Republic, 760 01
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 14059
        • Novo Nordisk Investigational Site
      • Mainz, Germany, 55131
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, 97080
        • Novo Nordisk Investigational Site
  • Italy
      • Pavia, Italy, 27100
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-351
        • Novo Nordisk Investigational Site
      • Bialystok, Poland, 15-296
        • Novo Nordisk Investigational Site
      • Bydgoszcz, Poland, 85-021
        • Novo Nordisk Investigational Site
      • Bytom, Poland, 41-902
        • Novo Nordisk Investigational Site
      • Elblag, Poland, 82-300
        • Novo Nordisk Investigational Site
      • Konskie, Poland, 26-200
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-218
        • Novo Nordisk Investigational Site
      • Zyrardow, Poland, 96-300
        • Novo Nordisk Investigational Site
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Novo Nordisk Investigational Site
  • Romania
      • Braila, Romania, 810019
        • Novo Nordisk Investigational Site
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Novo Nordisk Investigational Site
    • Dambovita
      • Targoviste, Dambovita, Romania, 130095
        • Novo Nordisk Investigational Site
    • Prahova
      • Ploiesti, Prahova, Romania, 100550
        • Novo Nordisk Investigational Site
  • Spain
      • A Coruña, Spain, 15006
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08036
        • Novo Nordisk Investigational Site
      • Santiago de Compostela, Spain, 15706
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41009
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Novo Nordisk Investigational Site
      • Leeds, United Kingdom, LS7 4SA
        • Novo Nordisk Investigational Site
      • Norwich, United Kingdom, NR4 7UY
        • 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:

  • Czech Republic: Age between 18 - 65 years (both inclusive)
  • A diagnosis of RA made at least 3 months prior to trial start
  • Active RA
  • Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start
  • Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication
  • Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m^2
  • Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)

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: NNC109-0012
The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)
Placebo Comparator: B
Drug: placebo
The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)
Time Frame: week 0, week 12
week 0, week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Terminal serum half-life (t½)
Time Frame: end of treatment period
end of treatment period
Serum levels of NNC109-0012
Time Frame: end of treatment period
end of treatment period

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

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

February 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

January 21, 2011

First Posted (Estimate)

January 24, 2011

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

  • NN8226-3875
  • U1111-1117-1136 (Other Identifier: WHO)
  • 2010-021283-14 (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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