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

Novo Nordisk A/S34 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Inflammation Rheumatoid Arthritis

Interventions

NNC 0151-0000-0000DRUG

Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period

placeboDRUG

Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (16)

Novo Nordisk Investigational Site

Prague, Czechia

Novo Nordisk Investigational Site

Frederiksberg, Denmark

Outcomes

Primary Outcomes

Number of adverse events (AEs)

Time frame: at all scheduled visits (week 1 - week 11)

Secondary Outcomes

Serum concentrations of NNC 151-0000-0000

Time frame: at 48 hours after all dose administrations

Data from ClinicalTrials.gov

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