A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223911
• Other study ID #: NN8209-3607
• Secondary ID: U1111-1116-24302
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2010
• Last updated: February 8, 2017
• Start date: January 2011
• Est. completion date: February 2013

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 clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• CZ: Age between 18 and 65 years (both inclusive)

• A diagnosis of rheumatoid arthritis of at least three months before entry in trial

• Active rheumatoid arthritis (RA)

• Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration

Exclusion Criteria:

• Known or suspected allergy to trial product or related products

• Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Drug:
• NNC 0151-0000-0000
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
• placebo
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period

Locations

Country	Name	City	State
Czech Republic	Novo Nordisk Investigational Site	Praha 2
Denmark	Novo Nordisk Investigational Site	Frederiksberg
Denmark	Novo Nordisk Investigational Site	Silkeborg
Hungary	Novo Nordisk Investigational Site	Budapest
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Elblag
Poland	Novo Nordisk Investigational Site	Krakow
Poland	Novo Nordisk Investigational Site	Poznan
Romania	Novo Nordisk Investigational Site	Bacau
Romania	Novo Nordisk Investigational Site	Bucharest
Romania	Novo Nordisk Investigational Site	Bucharest
Romania	Novo Nordisk Investigational Site	Cluj-Napoca	Cluj
Romania	Novo Nordisk Investigational Site	Sfantu Gheorghe	Covasna
United Kingdom	Novo Nordisk Investigational Site	Burslem
United Kingdom	Novo Nordisk Investigational Site	Newcastle Upon Tyne
United Kingdom	Novo Nordisk Investigational Site	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Czech Republic,  Denmark,  Hungary,  Poland,  Romania,  United Kingdom, 

References & Publications (1)

Daniluk S, Skrumsager BK, Leszczynski P. Safety and tolerability of the anti-C5aR humanised monoclonal antibody NNC0151-0000 in patients with rheumatoid arthritis: A phase 2, randomised, double-blind, placebocontrolled, multiple-dose trial. EULAR (Europea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events (AEs)		at all scheduled visits (week 1 - week 11)
Secondary	Serum concentrations of NNC 151-0000-0000		at 48 hours after all dose administrations

External Links

•   Clinical Trials at Novo Nordisk