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

NCT02739828 | Completed Results

• 1 other identifier: P15-692
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Hidradenitis Suppurativa

Keywords

Quality of life

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in DLQI at Week 12

  DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.

  Baseline, Week 12

Secondary Outcomes (30)

• Change From Baseline in DLQI at Week 4

  Baseline, Week 4

• Change From Baseline in DLQI at Week 24

  Baseline, Week 24

• Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 4

  Baseline, Week 4

• Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 12

  Baseline, Week 12

• Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 24

  Baseline, Week 24

Study Arms (1)

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.

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

Adalimumab

Also known as: Humira

Patients with Hidradenitis Suppurativa

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with moderate or severe Hidradenitis Suppurativa

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (11)

Universitetssjukhuset Linköping

Linkoping, Västra Götaland County, 581 85, Sweden

Location

Hallands Hospital Halmstad

Halmstad, 301 85, Sweden

Location

Blekinge Hospital

Karlskrona, SE-37185, Sweden

Location

Skaraborgs Hospital

Skövde, 541 85, Sweden

Location

Karolinska Univ Sjukhuset

Solna, 17176, Sweden

Location

Kungsholmens Hudklinik

Stockholm, 112 51, Sweden

Location

Sodersjukhuset

Stockholm, 11883, Sweden

Location

Danderyd Hospital

Stockholm, 182 88, Sweden

Location

Trelleborg Hospital

Trelleborg, 231 85, Sweden

Location

Norrlands Universitetssjukhus

Umeå, 90185, Sweden

Location

Akademiska sjukhuset

Uppsala, 751 85, Sweden

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 15, 2016
• Study Start: April 7, 2016
• Primary Completion: March 28, 2018
• Study Completion: March 28, 2018
• Last Updated: August 9, 2019
• Results First Posted: August 9, 2019

Record last verified: 2018-05

Locations

SE (11)