Clinical trial NCT01223911: A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
Official title: A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 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: 2010-10-19
Enrollment: 34
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 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Number of adverse events (AEs)
timeFrame: at all scheduled visits (week 1 - week 11)
Secondary outcomes:
measure: Serum concentrations of NNC 151-0000-0000
timeFrame: at 48 hours after all dose administrations
Other outcomes:
Locations:
city: Praha 2
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Frederiksberg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Silkeborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Elblag
country: Poland
facility: Novo Nordisk Investigational Site
city: Krakow
country: Poland
facility: Novo Nordisk Investigational Site
city: Poznan
country: Poland
facility: Novo Nordisk Investigational Site
city: Cluj-Napoca
country: Romania
facility: Novo Nordisk Investigational Site
state: Cluj
city: Sfantu Gheorghe
country: Romania
facility: Novo Nordisk Investigational Site
state: Covasna
city: Bacau
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Burslem
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Swansea
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: 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 (European League Against Rheumatism) 2014; Country: France City: Paris