A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis

February 6, 2017 updated by: Novo Nordisk A/S
This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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

  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Novo Nordisk Investigational Site
      • Sevlievo, Bulgaria, 5400
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1606
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1233
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1612
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1036
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4043
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4032
        • Novo Nordisk Investigational Site
      • Szikszó, Hungary, 3800
        • Novo Nordisk Investigational Site
      • Veszprém, Hungary, 8200
        • Novo Nordisk Investigational Site
  • Latvia
      • Riga, Latvia, 1038
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-351
        • Novo Nordisk Investigational Site
      • Bydgoszcz, Poland, 85-168
        • Novo Nordisk Investigational Site
      • Bytom, Poland, 41-902
        • Novo Nordisk Investigational Site
      • Elblag, Poland, 82-300
        • Novo Nordisk Investigational Site
      • Katowice, Poland, 40-954
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-218
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-256
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Kazan, Russian Federation, 420103
        • Novo Nordisk Investigational Site
      • Kursk, Russian Federation, 305007
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 119991
        • Novo Nordisk Investigational Site
      • Skt Petersburg, Russian Federation, 194044
        • Novo Nordisk Investigational Site
      • Skt Petersburg, Russian Federation, 196084
        • Novo Nordisk Investigational Site
      • Skt. Petersburg, Russian Federation, 191025
        • Novo Nordisk Investigational Site
      • Skt. Petersburg, Russian Federation, 191186
        • Novo Nordisk Investigational Site
      • Yaroslavl, Russian Federation, 150051
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
      • Belgrade, Serbia, 11080
        • Novo Nordisk Investigational Site
      • Niska Banja, Serbia, 18205
        • Novo Nordisk Investigational Site
  • Spain
      • A Coruña, Spain, 15006
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08036
        • Novo Nordisk Investigational Site
      • Elche, Spain, 3203
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41013
        • 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:

  • A diagnosis of RA meeting the 2010 ACR (American College of Rheumatology) classification criteria, obtained at least 6 months prior to dosing with the trial product. (If the diagnosis was made prior to 2010, a diagnosis meeting the 1987 ACR classification criteria is acceptable)
  • Active RA characterised by DAS28-CRP (disease activity score based on 28 joints and c-reactive protein) equal to or above 4.5 and at least five tender and five swollen joints (can be the same joints) of the 28 joint count
  • Concomitant treatment with MTX above or equal to 15 mg/week for at least 4 months prior to screening, with stable dose of between or equal to 15 mg/week and 25 mg/week for at least 6 weeks prior to screening (MTX doses between 7.5 and 12.5 mg/week are allowed, if patient had intolerance to 15 mg/week)
  • Biologic naïve subjects or subjects having been treated with biologics for RA (biologic experienced) provided they meet one of the following criteria: a. Reason for discontinuation of biologic therapy was intolerance (e.g., unable to receive recommended doses or achieve adequate treatment duration because of drug related side effects), b. Discontinued biologic therapy for other reasons than lack of efficacy (primary or secondary failure) or intolerance (e.g., drug holiday)

Exclusion Criteria:

  • Body mass index (BMI) below or equal to 18.0 or above or equal to 38.0 kg/m^2
  • Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome). Subjects with secondary Sjögren's syndrome or stable hypothyroidism are eligible
  • Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy (e.g., simple urinary tract infection)
  • Any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
  • History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy

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
Placebo Comparator: Placebo
Drug: placebo
Two i.v. (intravenous) doses administered 6 weeks apart.
Experimental: Active
Drug: NNC0114-0006
Two i.v. (intravenous) doses administered 6 weeks apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP)
Time Frame: Week 0, week 12
Week 0, week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Time Frame: Week 12
Week 12
Incidence of adverse events (AEs)
Time Frame: Up to week 24
Up to week 24
Incidence of antibodies against NNC0114-0006
Time Frame: Up to Week 24
Up to Week 24
Terminal serum half-life (t½)
Time Frame: After second dose administration at week 6
After second dose administration at week 6
Change in serum levels of total interleukin-21 (IL-21)
Time Frame: Up to week 12
Up to week 12
Change in Health Assessment Questionnaire - Disability Index score (HAQ-DI)
Time Frame: Week 0, week 12
Week 0, week 12

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

  • Canete J, Leszczynski P, Riisbro R, Frederiksen K. Efficacy and safety of NNC0114-0006, an anti-IL-21 monoclonal antibody, in patients with active rheumatoid arthritis. Arthritis and Rheumatology; 66 (10 (Supplement)): Abstract 947

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

September 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 23, 2012

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8828-3842
  • 2011-005376-42 (EudraCT Number)
  • U1111-1125-6552 (Other Identifier: WHO)

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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