A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01636817
First received: July 6, 2012
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.


Condition Intervention Phase
Inflammation
Rheumatoid Arthritis
Drug: NNC0109-0012
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

Resource links provided by NLM:


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

Primary Outcome Measures:
  • ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) [ Time Frame: At Week 12 (i.e., responder or non-responder) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 20%/50%/or 70% improvement of ACR score from baseline [ Time Frame: At Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline [ Time Frame: At Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below) [ Time Frame: At Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • European League Against Rheumatism (EULAR) criteria response [ Time Frame: At Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: At Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Change from baseline in the overall scores of Short Form Health Survey (SF-36v2) [ Time Frame: At Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Incidence and type of adverse events (AEs) [ Time Frame: At Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Change from baseline in van der Heijde modified sharp score [ Time Frame: At Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Incidence and type of adverse events (AEs) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 268
Study Start Date: August 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 60 mg Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin) once weekly.
Experimental: 120 mg Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin) once weekly.
Experimental: 240 mg Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin) once weekly.
Placebo Comparator: Placebo Drug: placebo
Administered subcutaneously (s.c., under the skin) once weekly.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  • A documented diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010
  • Active RA, characterised by: a. above 5 tender and above 5 swollen joints based on a 28 joint count b. CRP (C-reactive protein) above or equal to 1.0 mg/dL (10 mg/L)
  • Patients must be anti-TNF (anti-Tumour Necrosis Factor) inadequate responders to at least one but not more than two anti-TNF biologics with active disease documented in medical records at the time of discontinuation

Exclusion Criteria:

  • Patients with arthritis due to other autoimmune diseases than RA
  • Any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
  • History of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy
  • Patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
  • Females of childbearing potential who are pregnant or breast feeding or intend to become pregnant
  • Any other disease or clinically significant abnormality in laboratory parameters which, according to the Investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective
  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: NCT01636817

  Show 100 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01636817     History of Changes
Other Study ID Numbers: NN8226-3612, 2012-000609-58, U1111-1127-9273
Study First Received: July 6, 2012
Last Updated: August 20, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Belgium: Federal Agency for Medicines and Healthcare Products
Brazil: National Committee of Ethics in Research
France: French National Agency for Health
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Ministry of Health, Social and Family Affairs
Italy: The Italian Medicines Agency
Mexico: National Institute of Public Health, Health Secretariat
Poland: Ministry of Health and Social Security
Spain: Spanish Agency of Medicines and Health Care Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on October 29, 2014