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Completed

NCT Number: NCT01038674

Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.

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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 1

Primary location

Novo Nordisk Investigational Site, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent obtained before any trial-related activities
  • A diagnosis of rheumatoid arthritis made at least 3 months prior to screening
  • Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2
  • Methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
  • Male subjects and female subjects of non-child bearing potential

Exclusion criteria

  • Body mass index (BMI) less than 18.5 or above 35.0 kg/m2
  • Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
  • History of or current inflammatory joint disease other than rheumatoid arthritis
  • Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
  • Past or current malignancy (as judged by the investigator)
  • Clinically significant cardiac or cardiovascular disease
  • Positive for human immunodeficiency virus (HIV), hepatitis or tuberculosis
  • Blood donation or blood loss of more than 0.45L within 2 months prior to study start, or longer if required by local regulations
  • Breast-feeding women

Treatment and study plan

anti-IL-20

Drug

Anti-IL-20 injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.

Placebo

Drug

Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.

Primary outcomes

  1. Adverse events

    Time frame: 0 - 21 weeks after dosing

Secondary outcomes

  1. Terminal serum half-life

    Time frame: 0 - 21 weeks after dosing

  2. Maximum observed serum concentration (Cmax)

    Time frame: 6 - 10 weeks after dosing

  3. Change in ACR20, ACR50 and ACR70

    Time frame: 0-21 hours after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 24, 2009
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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