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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01647451
Recruitment Status : Completed
First Posted : July 23, 2012
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE July 19, 2012
First Posted Date  ICMJE July 23, 2012
Last Update Posted Date February 7, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP) [ Time Frame: Week 0, week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammation
  • Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: NNC0114-0006
    Two i.v. (intravenous) doses administered 6 weeks apart.
  • Drug: placebo
    Two i.v. (intravenous) doses administered 6 weeks apart.
Study Arms  ICMJE
  • Experimental: Active
    Intervention: Drug: NNC0114-0006
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2013)
62
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2012)
60
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Hungary,   Latvia,   Poland,   Russian Federation,   Serbia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01647451
Other Study ID Numbers  ICMJE NN8828-3842
2011-005376-42 ( EudraCT Number )
U1111-1125-6552 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Public Access to Clinical Trials, Novo Nordisk A/S
Current Study Sponsor  ICMJE Novo Nordisk A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP