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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Inflammation

Rheumatoid Arthritis

Treatments

Drug: anti-IL-20

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01038674

2009-013132-20 (EudraCT Number)

U1111-1112-6382 (Other Identifier)

NN8226-3704

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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