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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01647451
First received: July 19, 2012
Last updated: February 6, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Inflammation Rheumatoid Arthritis Drug: NNC0114-0006 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, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis

Resource links provided by NLM:


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

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

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

Enrollment: 62
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: NNC0114-0006
Two i.v. (intravenous) doses administered 6 weeks apart.
Placebo Comparator: Placebo Drug: placebo
Two i.v. (intravenous) doses administered 6 weeks apart.

  Eligibility

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

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
  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: NCT01647451

Locations
Bulgaria
Novo Nordisk Investigational Site
Plovdiv, Bulgaria, 4002
Novo Nordisk Investigational Site
Sevlievo, Bulgaria, 5400
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1233
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1606
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1612
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1036
Novo Nordisk Investigational Site
Debrecen, Hungary, 4032
Novo Nordisk Investigational Site
Debrecen, Hungary, 4043
Novo Nordisk Investigational Site
Szikszó, Hungary, 3800
Novo Nordisk Investigational Site
Veszprém, Hungary, 8200
Latvia
Novo Nordisk Investigational Site
Riga, Latvia, 1038
Poland
Novo Nordisk Investigational Site
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
Russian Federation
Novo Nordisk Investigational Site
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
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site
Belgrade, Serbia, 11080
Novo Nordisk Investigational Site
Niska Banja, Serbia, 18205
Spain
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01647451     History of Changes
Other Study ID Numbers: NN8828-3842
2011-005376-42 ( EudraCT Number )
U1111-1125-6552 ( Other Identifier: WHO )
Study First Received: July 19, 2012
Last Updated: February 6, 2017

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 June 23, 2017