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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014