Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis
NCT ID: NCT01282255
Last Updated: 2017-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2011-02-28
2012-01-31
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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A
NNC109-0012
The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)
B
placebo
The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)
Interventions
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NNC109-0012
The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)
placebo
The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of RA made at least 3 months prior to trial start
* Active RA
* Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start
* Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication
* Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode
Exclusion Criteria
* Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m\^2
* Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)
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
Brno, , Czechia
Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Uherské Hradiště, , Czechia
Novo Nordisk Investigational Site
Zlín, , Czechia
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Mainz, , Germany
Novo Nordisk Investigational Site
Würzburg, , Germany
Novo Nordisk Investigational Site
Pavia, , Italy
Novo Nordisk Investigational Site
Bialystok, , Poland
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
Gmina Końskie, , Poland
Novo Nordisk Investigational Site
Poznan, , Poland
Novo Nordisk Investigational Site
Żyrardów, , Poland
Novo Nordisk Investigational Site
Lisbon, , Portugal
Novo Nordisk Investigational Site
Cluj-Napoca, Cluj, Romania
Novo Nordisk Investigational Site
Târgovişte, Dâmbovița County, Romania
Novo Nordisk Investigational Site
Ploieşti, Prahova, Romania
Novo Nordisk Investigational Site
Brăila, , Romania
Novo Nordisk Investigational Site
A Coruña, , Spain
Novo Nordisk Investigational Site
Barcelona, , Spain
Novo Nordisk Investigational Site
Santiago de Compostela, , Spain
Novo Nordisk Investigational Site
Seville, , Spain
Novo Nordisk Investigational Site
Cambridge, , United Kingdom
Novo Nordisk Investigational Site
Leeds, , United Kingdom
Novo Nordisk Investigational Site
Norwich, , United Kingdom
Countries
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References
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Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.
Senolt L, Leszczynski P, Dokoupilova E, Gothberg M, Valencia X, Hansen BB, Canete JD. Efficacy and Safety of Anti-Interleukin-20 Monoclonal Antibody in Patients With Rheumatoid Arthritis: A Randomized Phase IIa Trial. Arthritis Rheumatol. 2015 Jun;67(6):1438-48. doi: 10.1002/art.39083.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1117-1136
Identifier Type: OTHER
Identifier Source: secondary_id
2010-021283-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN8226-3875
Identifier Type: -
Identifier Source: org_study_id
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