Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195676
Status:
COMPLETED
Last Update Posted:
2011-04-13
First Post:
2005-09-13
Brief Title:
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Multicenter Open-Label Continuation Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Who Completed a Preceding Psoriasis Clinical Study With Adalimumab
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment
Detailed Description:
Study M03-658 was a continuation study for participants with moderate to severe psoriasis who had participated in a prior psoriasis adalimumab study Study M03-658 consisted of three sequential treatment periods The first period was Period O in which participants received open-label treatment with adalimumab 40 mg every other week or 40 mg every week for a minimum of 104 weeks and a maximum of 252 weeks Period O was the only period of the study until May 2008 when the subsequent periods were added via amendment to the protocol At that time participants who had achieved satisfactory therapeutic response a Physicians Global Assessment PGA of 0 1 or 2 clear minimal or mild were given the opportunity to discontinue from the study or to continue and participate in the subsequent two periods The second period was Period W a maximum of 52 weeks in which participants with a PGA of 2 mild or less were withdrawn from adalimumab treatment ie participants received no treatment until relapse of their psoriasis occurred defined as a PGA of 3 moderate or worse The third period was Period R a 16-week period in which participants were retreated with open-label adalimumab 80 mg initial dose followed by 40 mg every other week Period O was designed to evaluate the first objective regarding long-term efficacy and safety of adalimumab treatment and Period R was designed to evaluate the effectiveness of adalimumab retreatment following relapse Specific subsets of the study population that were identified as the populations of interest were the modified intent-to-treat populations for Period W and Period R and these are described further in the outcome measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-000095-41 | EUDRACT_NUMBER | None | None |