Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02626793
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2015-07-29
Brief Title:
A Study of Otezla in Patients With Plaque Psoriasis Under Routine Conditions
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Long-term Documentation of the Utilization of Otezla in Patients With Plaque Psoriasis Under Routine Conditions LAPIS-Pso
Status:
COMPLETED
Status Verified Date:
2022-02
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 objective of this NIS is the collection of data on the utilization of Apremilast under routine conditions in Germany Patients quality-of-life and treatment satisfaction on treatment with Apremilast in daily practice will be documented Moreover physicians and patients assessments of the effectiveness and safety of Apremilast will be recorded FPI was 3rd August 2015 LPO was 14th of June 2018 A total of 391 patients have been enrolled
Detailed Description:
The objective of this NIS according to section 423 of the German Medicinal Products Act is the documentation of data on the effectiveness and tolerability of an Apremilast treatment under routine clinical conditions in German patients with plaque psoriasis
This NIS is intended to reflect the apremilast treatment of patients with plaque psoriasis who have received at least one prior conventional systemic therapy or if a contraindication is present did not receive a systemic therapy so far and who were diagnosed by their treating physicians to be eligible for an apremilast treatment The treatment of Apremilast will be documented for a period of approximately 52 weeks
This NIS is intended to reflect the apremilast treatment of patients with plaque psoriasis who have received at least one prior conventional systemic therapy or if a contraindication is present did not receive a systemic therapy so far and who were diagnosed by their treating physicians to be eligible for an apremilast treatment The treatment of Apremilast will be documented for a period of approximately 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None