Inflammation, Rheumatoid Arthritis
Conditions
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).
Interventions
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
DRUGplacebo
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events (AEs) | at all scheduled visits (week 1 - week 11) |
Secondary
| Measure | Time frame |
|---|---|
| Serum concentrations of NNC 151-0000-0000 | at 48 hours after all dose administrations |
Countries
Czechia, Denmark, Hungary, Poland, Romania, United Kingdom
Outcome results
None listed