Clinical trial NCT01282255: Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis
Official title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammation
Rheumatoid Arthritis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active Rheumatoid Arthritis (RA).


Eligibility criteria: Inclusion Criteria:

* Czech Republic: Age between 18 - 65 years (both inclusive)
* 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:

* Known or suspected allergy to trial product or related products
* 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)

Primary outcomes:
measure: Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)
timeFrame: week 0, week 12
Secondary outcomes:
measure: Terminal serum half-life (t½)
timeFrame: end of treatment period
measure: Serum levels of NNC109-0012
timeFrame: end of treatment period
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Praha 2
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Praha
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Uherske Hradiste
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Zlin
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Würzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Pavia
country: Italy
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Bydgoszcz
country: Poland
facility: Novo Nordisk Investigational Site
city: Bytom
country: Poland
facility: Novo Nordisk Investigational Site
city: Elblag
country: Poland
facility: Novo Nordisk Investigational Site
city: Konskie
country: Poland
facility: Novo Nordisk Investigational Site
city: Poznan
country: Poland
facility: Novo Nordisk Investigational Site
city: Zyrardow
country: Poland
facility: Novo Nordisk Investigational Site
city: Lisboa
country: Portugal
facility: Novo Nordisk Investigational Site
city: Cluj-Napoca
country: Romania
facility: Novo Nordisk Investigational Site
state: Cluj
city: Targoviste
country: Romania
facility: Novo Nordisk Investigational Site
state: Dambovita
city: Ploiesti
country: Romania
facility: Novo Nordisk Investigational Site
state: Prahova
city: Braila
country: Romania
facility: Novo Nordisk Investigational Site
city: A Coruña
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Santiago de Compostela
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Cambridge
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leeds
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Norwich
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.