A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
NCT ID: NCT01647451
Last Updated: 2017-02-07
Study Results
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Basic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2012-09-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active
NNC0114-0006
Two i.v. (intravenous) doses administered 6 weeks apart.
Placebo
placebo
Two i.v. (intravenous) doses administered 6 weeks apart.
Interventions
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NNC0114-0006
Two i.v. (intravenous) doses administered 6 weeks apart.
placebo
Two i.v. (intravenous) doses administered 6 weeks apart.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Plovdiv, , Bulgaria
Novo Nordisk Investigational Site
Sevlievo, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Debrecen, , Hungary
Novo Nordisk Investigational Site
Debrecen, , Hungary
Novo Nordisk Investigational Site
Szikszó, , Hungary
Novo Nordisk Investigational Site
Veszprém, , Hungary
Novo Nordisk Investigational Site
Riga, , Latvia
Novo Nordisk Investigational Site
Bialystok, , Poland
Novo Nordisk Investigational Site
Bydgoszcz, , Poland
Novo Nordisk Investigational Site
Bytom, , Poland
Novo Nordisk Investigational Site
Elblag, , Poland
Novo Nordisk Investigational Site
Katowice, , Poland
Novo Nordisk Investigational Site
Poznan, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Kazan', , Russia
Novo Nordisk Investigational Site
Kursk, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Skt Petersburg, , Russia
Novo Nordisk Investigational Site
Skt Petersburg, , Russia
Novo Nordisk Investigational Site
Skt. Petersburg, , Russia
Novo Nordisk Investigational Site
Skt. Petersburg, , Russia
Novo Nordisk Investigational Site
Yaroslavl, , Russia
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Niška Banja, , Serbia
Novo Nordisk Investigational Site
A Coruña, , Spain
Novo Nordisk Investigational Site
Barcelona, , Spain
Novo Nordisk Investigational Site
Elche, , Spain
Novo Nordisk Investigational Site
Seville, , Spain
Countries
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References
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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
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2011-005376-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1125-6552
Identifier Type: OTHER
Identifier Source: secondary_id
NN8828-3842
Identifier Type: -
Identifier Source: org_study_id
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