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

Novo Nordisk A/S1 site in 1 country16 target enrollmentFebruary 2010

ConditionsInflammation Rheumatoid Arthritis

Interventionsanti-IL-20 placebo

Drugsanti-IL-20 placebo

Overview

Phase: Phase 1
Intervention: anti-IL-20
Conditions: Inflammation
Sponsor: Novo Nordisk A/S
Enrollment: 16
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

December 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility 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