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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammation Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anti-IL-20

Group Type EXPERIMENTAL

anti-IL-20

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No