Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis

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
• 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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

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

External Links

•   Clinical Trials at Novo Nordisk