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Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01282255
First received: January 21, 2011
Last updated: February 8, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention Phase
Inflammation
Rheumatoid Arthritis
Drug: NNC109-0012
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • Terminal serum half-life (t½) [ Time Frame: end of treatment period ]
  • Serum levels of NNC109-0012 [ Time Frame: end of treatment period ]

Enrollment: 67
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282255

Locations
Czech Republic
Novo Nordisk Investigational Site
Brno, Czech Republic, 602 00
Novo Nordisk Investigational Site
Praha 2, Czech Republic, 128 50
Novo Nordisk Investigational Site
Praha, Czech Republic, 140 00
Novo Nordisk Investigational Site
Uherske Hradiste, Czech Republic, 686 01
Novo Nordisk Investigational Site
Zlin, Czech Republic, 760 01
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 14059
Novo Nordisk Investigational Site
Mainz, Germany, 55131
Novo Nordisk Investigational Site
Würzburg, Germany, 97080
Italy
Novo Nordisk Investigational Site
Pavia, Italy, 27100
Poland
Novo Nordisk Investigational Site
Bialystok, Poland, 15-296
Novo Nordisk Investigational Site
Bialystok, Poland, 15-351
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
Portugal
Novo Nordisk Investigational Site
Lisboa, Portugal, 1649-035
Romania
Novo Nordisk Investigational Site
Cluj-Napoca, Cluj, Romania, 400006
Novo Nordisk Investigational Site
Targoviste, Dambovita, Romania, 130095
Novo Nordisk Investigational Site
Ploiesti, Prahova, Romania, 100550
Novo Nordisk Investigational Site
Braila, Romania, 810019
Spain
Novo Nordisk Investigational Site
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
United Kingdom
Novo Nordisk Investigational Site
Cambridge, United Kingdom, CB2 0QQ
Novo Nordisk Investigational Site
Leeds, United Kingdom, LS7 4SA
Novo Nordisk Investigational Site
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01282255     History of Changes
Other Study ID Numbers: NN8226-3875  U1111-1117-1136  2010-021283-14 
Study First Received: January 21, 2011
Last Updated: February 8, 2017

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 17, 2017