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

Phase 1

Completed

• Conditions: Inflammation; Rheumatoid Arthritis
• Interventions: Drug: placebo; Drug: anti-IL-20

• Registration Number: NCT01038674
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-24
• Study Start: 2010-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Anti-IL-20	anti-IL-20	-

Primary Outcome Measures

Name	Time	Method
Adverse events	0 - 21 weeks after dosing

Secondary Outcome Measures

Name	Time	Method
Change in ACR20, ACR50 and ACR70	0-21 hours after dosing
Maximum observed serum concentration (Cmax)	6 - 10 weeks after dosing
Terminal serum half-life	0 - 21 weeks after dosing

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇱 Warszawa, Poland