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Trial record 1 of 90 for:    hidradenitis suppurativa
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Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting (HARMONY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786576
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study will assess the effects of adalimumab treatment in moderate to severe Hidradenitis Suppurativa (HS) patients in the real world setting. The objectives of this study are to estimate the effectiveness of adalimumab treatment on disease severity, to estimate the impact of adalimumab treatment on patients' quality of life, psychological effect, work productivity and healthcare resource utilization and to describe treatment practices over the study period.

Condition or disease
Hidradenitis Suppurativa

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Study Type : Observational
Actual Enrollment : 236 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting - HARMONY Study
Actual Study Start Date : July 5, 2016
Actual Primary Completion Date : January 7, 2019
Actual Study Completion Date : January 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort
Participants receiving adalimumab
Hidradenitis Suppurativa (HS) participants receiving adalimumab



Primary Outcome Measures :
  1. Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response [ Time Frame: At Week 12 ]
    Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)


Secondary Outcome Measures :
  1. Proportion of participants with moderate to severe HS who achieve a clinical response [ Time Frame: Up to week 52 ]
    Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)

  2. Changes from baseline in Dermatology Quality of Life Index (DLQI) [ Time Frame: From Week 0 to Week 52 ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hidradenitis Suppurativa (HS) participants receiving adalimumab
Criteria

Inclusion Criteria:

  • Clinical diagnosis of moderate to severe Hidradenitis Suppurativa
  • The decision to treat with adalimumab (Humira) is made by the physician in accordance with the local label (Summary of Product Characteristics; product label) prior to any decision to approach the participant to participate in this study
  • Participants willing to be involved in the study and to sign patient authorization form to use and disclose personal health information (or informed consent, where applicable)

Exclusion Criteria:

  • Participants in a clinical interventional study
  • Participants treated with adalimumab prior to baseline visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786576


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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02786576     History of Changes
Other Study ID Numbers: P15-769
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Moderate to Severe Hidradenitis Suppurativa
Adalimumab
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents