Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis
This study has been completed.
Information provided by:
First received: December 22, 2009
Last updated: May 22, 2012
Last verified: May 2012
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Adverse events [ Time Frame: 0 - 21 weeks after dosing ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Terminal serum half-life [ Time Frame: 0 - 21 weeks after dosing ] [ Designated as safety issue: No ]
- Maximum observed serum concentration (Cmax) [ Time Frame: 6 - 10 weeks after dosing ] [ Designated as safety issue: No ]
- Change in ACR20, ACR50 and ACR70 [ Time Frame: 0-21 hours after dosing ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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||
Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
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