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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01636843
First received: July 6, 2012
Last updated: November 19, 2014
Last verified: November 2014

July 6, 2012
November 19, 2014
October 2012
November 2014   (final data collection date for primary outcome measure)
ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) [ Time Frame: At week 12 (responder or non-responder) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01636843 on ClinicalTrials.gov Archive Site
  • ACR20, ACR50 and ACR70 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 Short Form Health Survey (SF-36v2) [ 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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate
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 Methotrexate

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 repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Inflammation
  • Rheumatoid Arthritis
  • Drug: NNC0109-0012
    Administered subcutaneously (s.c., under the skin), once weekly.
  • Drug: placebo
    Administered subcutaneously (s.c., under the skin), once weekly.
  • Experimental: 60 mg
    Intervention: Drug: NNC0109-0012
  • Experimental: 120 mg
    Intervention: Drug: NNC0109-0012
  • Experimental: 240 mg
    Intervention: Drug: NNC0109-0012
  • Experimental: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
298
November 2014
November 2014   (final data collection date for primary outcome measure)

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. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. C-reactive protein (CRP) above or equal to 1.0 mg/dL (10 mg/L)
  • Patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. Methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. Patient can be on MTX as low as 10 mg/week only if due to MTX intolerance b. Hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Mexico,   Poland,   Russian Federation,   Spain,   Ukraine
 
NCT01636843
NN8226-3613, 2012-000610-11, U1111-1127-9324
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2014

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