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Completed

NCT Number: NCT01223911

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

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).

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Key information

Conditions

Inflammation Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NNC 0151-0000-0000

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of adverse events (AEs)

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

Secondary outcomes

  1. Serum concentrations of NNC 151-0000-0000

    Time frame: at 48 hours after all dose administrations

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 19, 2010
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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