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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01038674
First Posted: December 24, 2009
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Inflammation Rheumatoid Arthritis Drug: anti-IL-20 Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 0 - 21 weeks after dosing ]

Secondary Outcome Measures:
  • Terminal serum half-life [ Time Frame: 0 - 21 weeks after dosing ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: 6 - 10 weeks after dosing ]
  • Change in ACR20, ACR50 and ACR70 [ Time Frame: 0-21 hours after dosing ]

Enrollment: 16
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti-IL-20 Drug: anti-IL-20
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 Comparator: Placebo Drug: placebo
Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038674


Locations
Belgium
Novo Nordisk Investigational Site
Brussels, Belgium, 1070
Poland
Novo Nordisk Investigational Site
Warszawa, Poland, PL-02-274
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01038674     History of Changes
Other Study ID Numbers: NN8226-3704
2009-013132-20 ( EudraCT Number )
U1111-1112-6382 ( Other Identifier: WHO )
First Submitted: December 22, 2009
First Posted: December 24, 2009
Last Update Posted: February 9, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes