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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01282255
Other study ID # NN8226-3875
Secondary ID U1111-1117-11362
Status Completed
Phase Phase 2
First received January 21, 2011
Last updated February 8, 2017
Start date February 2011
Est. completion date January 2012

Study information

Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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)

Study Design


Intervention

Drug:
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)

Locations

Country Name City State
Czech Republic Novo Nordisk Investigational Site Brno
Czech Republic Novo Nordisk Investigational Site Praha
Czech Republic Novo Nordisk Investigational Site Praha 2
Czech Republic Novo Nordisk Investigational Site Uherske Hradiste
Czech Republic Novo Nordisk Investigational Site Zlin
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Mainz
Germany Novo Nordisk Investigational Site Würzburg
Italy Novo Nordisk Investigational Site Pavia
Poland 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 Konskie
Poland Novo Nordisk Investigational Site Poznan
Poland Novo Nordisk Investigational Site Zyrardow
Portugal Novo Nordisk Investigational Site Lisboa
Romania Novo Nordisk Investigational Site Braila
Romania Novo Nordisk Investigational Site Cluj-Napoca Cluj
Romania Novo Nordisk Investigational Site Ploiesti Prahova
Romania Novo Nordisk Investigational Site Targoviste Dambovita
Spain 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 Sevilla
United Kingdom Novo Nordisk Investigational Site Cambridge
United Kingdom Novo Nordisk Investigational Site Leeds
United Kingdom Novo Nordisk Investigational Site Norwich

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Czech Republic,  Germany,  Italy,  Poland,  Portugal,  Romania,  Spain,  United Kingdom, 

References & Publications (2)

Šenolt L, Leszczynski P, Dokoupilová E, Göthberg M, Valencia X, Hansen BB, Cañete 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):1 — View Citation

Lundblad MS, Overgaard RV, Göthberg 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value) week 0, week 12
Secondary Terminal serum half-life (t½) end of treatment period
Secondary Serum levels of NNC109-0012 end of treatment period
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