Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis
A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis
3 other identifiers
interventional
16
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2009
CompletedFirst Posted
Study publicly available on registry
December 24, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 9, 2017
February 1, 2017
10 months
December 22, 2009
February 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
0 - 21 weeks after dosing
Secondary Outcomes (3)
Terminal serum half-life
0 - 21 weeks after dosing
Maximum observed serum concentration (Cmax)
6 - 10 weeks after dosing
Change in ACR20, ACR50 and ACR70
0-21 hours after dosing
Study Arms (2)
Anti-IL-20
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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 injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (2)
Novo Nordisk Investigational Site
Brussels, 1070, Belgium
Novo Nordisk Investigational Site
Warsaw, PL-02-274, Poland
Related Publications (1)
Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.
PMID: 25749867RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2009
First Posted
December 24, 2009
Study Start
February 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 9, 2017
Record last verified: 2017-02