Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01282255
First received: January 21, 2011
Last updated: May 10, 2012
Last verified: May 2012
  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
Rheumatoid Arthritis
Inflammation
Drug: NNC109-0012
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Terminal serum half-life (t½) [ Time Frame: end of treatment period ] [ Designated as safety issue: No ]
  • Serum levels of NNC109-0012 [ Time Frame: end of treatment period ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Brno, Czech Republic, 602 00
Poland
Bytom, Poland, 41-902
Romania
Cluj-Napoca, Cluj, Romania, 400006
Spain
Barcelona, Spain, 08036
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mitzi Eshof Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, 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: May 10, 2012
Health Authority: Poland: Ministry of Health
Romania: National Medicines Agency
Italy: Ministry of Health
Czech Republic: State Institute for Drug Control
Spain: Spanish Agency of Medicines and Health Care Products
Portugal: INFARMED
Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)

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

ClinicalTrials.gov processed this record on August 21, 2014