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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01038674
First received: December 22, 2009
Last updated: May 22, 2012
Last verified: May 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Terminal serum half-life [ Time Frame: 0 - 21 weeks after dosing ] [ Designated as safety issue: No ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: 6 - 10 weeks after dosing ] [ Designated as safety issue: No ]
  • Change in ACR20, ACR50 and ACR70 [ Time Frame: 0-21 hours after dosing ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038674

Locations
Belgium
Brussels, Belgium, 1070
Poland
Warszawa, Poland, PL-02-274
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mitzi Eshof Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01038674     History of Changes
Other Study ID Numbers: NN8226-3704, 2009-013132-20, U1111-1112-6382
Study First Received: December 22, 2009
Last Updated: May 22, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Poland: National Medicines Institute

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

ClinicalTrials.gov processed this record on April 17, 2014