Post Marketing Observational Study (PMOS) to Assess Quality of Life in Swedish Hidradenitis Suppurativa (HS) Patients

NCT ID: NCT02739828

Last Updated: 2019-08-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-07

Study Completion Date

2018-03-28

Brief Summary

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The objective of this study is to assess quality of life (QoL), skin pain, work productivity/activity and health related problems in Swedish patients with moderate to severe HS before and after 6 months treatment with Adalimumab. Participants will be treated in accordance with normal routine clinical care.

Detailed Description

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Conditions

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Hidradenitis Suppurativa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Hidradenitis Suppurativa

Patients with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.

Adalimumab

Intervention Type BIOLOGICAL

Adalimumab

Interventions

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Adalimumab

Adalimumab

Intervention Type BIOLOGICAL

Other Intervention Names

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Humira

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Hidradenitis Suppurativa
* Prescribed Adalimumab according to the Summary of Product Characteristics (SmPC)
* Willingness to sign and date a Patient Information/Informed Consent Form

Exclusion Criteria

* Prior biologic treatment discontinued \<6 months before the baseline visit
* Patient not able to understand the language of the provided patient questionnaires
* History of non-compliance with medication or a medical history that could enhance non-compliance with medication, as determined by the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Universitetssjukhuset Linköping

Linkoping, Västra Götaland County, Sweden

Site Status

Hallands Hospital Halmstad

Halmstad, , Sweden

Site Status

Blekinge Hospital

Karlskrona, , Sweden

Site Status

Skaraborgs Hospital

Skövde, , Sweden

Site Status

Karolinska Univ Sjukhuset

Solna, , Sweden

Site Status

Kungsholmens Hudklinik

Stockholm, , Sweden

Site Status

Sodersjukhuset

Stockholm, , Sweden

Site Status

Danderyd Hospital

Stockholm, , Sweden

Site Status

Trelleborg Hospital

Trelleborg, , Sweden

Site Status

Norrlands Universitetssjukhus

Umeå, , Sweden

Site Status

Akademiska sjukhuset

Uppsala, , Sweden

Site Status

Countries

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Sweden

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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P15-692

Identifier Type: -

Identifier Source: org_study_id

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