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: November 7, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]
  • Incidence of antibodies against NNC0114-0006 [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
  • Terminal serum half-life (t½) [ Time Frame: After second dose administration at week 6 ] [ Designated as safety issue: No ]
  • Change in serum levels of total interleukin-21 (IL-21) [ Time Frame: Up to week 12 ] [ Designated as safety issue: No ]
  • Change in Health Assessment Questionnaire - Disability Index score (HAQ-DI) [ Time Frame: Week 0, week 12 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Sofia, Bulgaria, 1612
Hungary
Veszprém, Hungary, 8200
Latvia
Riga, Latvia, 1038
Poland
Katowice, Poland, 40-954
Russian Federation
Skt. Petersburg, Russian Federation, 191025
Serbia
Niska Banja, Serbia, 18205
Spain
Barcelona, Spain, 8036
La Coruña, Spain, 15006
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mitzi Kaarløv Eshof Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01647451     History of Changes
Other Study ID Numbers: NN8828-3842, 2011-005376-42, U1111-1125-6552
Study First Received: July 19, 2012
Last Updated: November 7, 2013
Health Authority: Bulgaria: Ministry of Health
Hungary: Ministry of Health, Social and Family Affairs
Latvia: Ministry of Health
Poland: Ministry of Health and Social Security
Russia: Federal Service for Control of Health Care and Social Development
Serbia: Medicines and Medical Devices Agency of Serbia
Spain: Spanish Agency of Medicines and Health Care Products

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 28, 2014