## Protocol Section
### Identification Module
**NCT ID:** NCT03284879

**Brief Title:** Post-Marketing Surveillance Study of OTEZLA

**Official Title:** OTEZLA® Tablets Drug Use-Results Survey

#### Organization Study ID Info
**ID:** CC-10004-PSOR-018
#### Organization
**Class:** INDUSTRY
**Full Name:** Amgen
### Status Module
#### Completion Date
**Date:** 2022-03-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-04-29

**Type:** ACTUAL

**Last Update Submit Date:** 2022-04-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-10-31

**Type:** ACTUAL

#### Start Date
**Date:** 2017-09-05

**Type:** ACTUAL

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2017-09-15
**Type:** ACTUAL
**Study First Submit Date:** 2017-08-31
**Study First Submit QC Date:** 2017-09-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Amgen

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients with Psoriasis vulgaris that is with an inadequate response to topical therapies and Psoriasis arthropathica

1. Planned registration period 2 years
2. Planned surveillance period for 4 years from 6 months after launch

### Conditions Module

**Conditions:**

- Psoriasis

**Keywords:**

- Psoriasis vulgaris

- Psoriasis arthropathica

- Serious infections

- Gastrointestinal Disorders

- Serious Hypersensitivity

- Weight Decrease

- Vasculitis

- Malignancies

- Depression and Suicidal Ideation

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1086

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets

**Label:** Patients with PsV and PsA treated with OTEZLA Tablets

### Outcomes Module

#### Primary Outcomes

**Description:** Number of participants with adverse events

**Measure:** Adverse Events (AEs)

**Time Frame:** Up to approximately 12 months

**Description:** General Improvement Rating will be assessed by physician's observation

**Measure:** General Improvement Rating

**Time Frame:** Approximately 1 year from administration

**Description:** Visual Analog Scale (VAS) pain will be used for psoriatic arthritis patients' assessment.

**Measure:** General health assessment on VAS

**Time Frame:** Approximately 1 year from administration

**Description:** PGA: assessment for psoriatic vulgaris by physician to classify disease activity in a consistent manner

**Measure:** Changes in physician general assessment

**Time Frame:** Approximately 1 year from administration

**Description:** The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire

**Measure:** Percentage of patients with Dermatology Life Quality Index (DLQI)

**Time Frame:** Approximately 1 year from administration

**Description:** Activity for arthritis Baseline is calculated by Disease Activity Score-DAS28 method

**Measure:** Change from baseline activity for arthritis

**Time Frame:** Approximately 1 year from administration

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

- Patients who have received a diagnosis of either of the following diseases and have received OTEZLA for the first time will be included in this survey.

* Psoriasis vulgaris that is with an inadequate response to topical therapies
* Psoriasis arthropathica

Exclusion Criteria:

* N/A

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients who have received a diagnosis of either of the following diseases and have received OTEZLA for the first time will be included in this survey.

* Psoriasis vulgaris that is with an inadequate response to topical therapies
* Psoriasis arthropathica

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kitakyushu

**Country:** Japan

**Facility:** Tugi dermatology clinic

**State:** Fukuoka

**Zip:** 804-0081

#### Overall Officials

**Official 1:**

**Affiliation:** Amgen

**Name:** MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

**Description:** De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

**URL:** http://www.amgen.com/datasharing

### References Module

#### See Also Links

**Label:** AmgenTrials clinical trials website

**URL:** http://www.amgentrials.com

**Label:** Expanded Access for CC-10004

**URL:** https://clinicaltrials.gov/ct2/show/NCT03284879?term=CC-10004-PSOR-018&rank=1

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017444

- Term: Skin Diseases, Papulosquamous

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M18102

- Name: Weight Loss

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M14422

- Name: Psoriasis

- Relevance: HIGH

- As Found: Psoriasis

- ID: M29364

- Name: Suicidal Ideation

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17405

- Name: Vasculitis

- Relevance: LOW

- As Found: Unknown

- ID: M18178

- Name: Arthritis, Psoriatic

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19713

- Name: Skin Diseases, Papulosquamous

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011565

- Term: Psoriasis

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M341074

- Name: Apremilast

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
