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Completed

NCT Number: NCT01282255

Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active 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, Brno, 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

  • Czech Republic: Age between 18 - 65 years (both inclusive)
  • A diagnosis of RA made at least 3 months prior to trial start
  • Active RA
  • Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start
  • Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication
  • Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode

Exclusion criteria

  • Known or suspected allergy to trial product or related products
  • Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m^2
  • Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)

Treatment and study plan

NNC109-0012

Drug

The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)

Placebo

Drug

The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)

Primary outcomes

  1. Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)

    Time frame: week 0, week 12

Secondary outcomes

  1. Terminal serum half-life (t½)

    Time frame: end of treatment period

  2. Serum levels of NNC109-0012

    Time frame: end of treatment period

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 Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 24, 2011
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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