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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01038674

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Rheumatoid Arthritis	Drug: anti-IL-20 Drug: placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Adverse events [0 - 21 weeks after dosing]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Brussels		Belgium	1070
2	Novo Nordisk Investigational Site	Warszawa		Poland	PL-02-274

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical Trials at Novo Nordisk

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01038674

Other Study ID Numbers:

NN8226-3704
2009-013132-20
U1111-1112-6382

First Posted:

Dec 24, 2009

Last Update Posted:

Feb 9, 2017

Last Verified:

Feb 1, 2017

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Inflammation

Study Results

No Results Posted as of Feb 9, 2017