The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata

NCT04239521

Last updated date
Study Location
Momentum Data Ltd
London, , WC1X 8QT, United Kingdom
Contact
+44 7531 221970

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

+44 7531 221970

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alopecia Areata, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorders, Atopic Dermatitis, Allergic Rhinitis, Asthma, Crohn Disease, Ulcerative Colitis, Pernicious Anemia, Type 1 Diabetes, Hashimoto Thyroiditis, Graves
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients contributing to Royal College of General Practitioners Research and Surveillance Centre(RCGP RCS) primary care database between January 1, 2009 and December 31, 2018, will be eligible for inclusion.

- Only patients aged ≥18 will be eligible for studies 2 and 3.

- Only patients aged ≥ 18 and ≤ 65 will be included in the unemployment and sick day analysis (study 2)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- People with the alternative non-AA diagnoses.


- People with AA diagnosis within 6 months of registration.


- People with less than 1 year of follow up available

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Alopecia Areata, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorders, Atopic Dermatitis, Allergic Rhinitis, Asthma, Crohn Disease, Ulcerative Colitis, Pernicious Anemia, Type 1 Diabetes, Hashimoto Thyroiditis, GravesThe Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata
NCT04239521
  1. London,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata
Official Title The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata
Brief Summary This study series consists of three related studies and aims to explore and describe many important elements of Alopecia areata over three key areas: (i) the current epidemiology of Alopecia areata, (ii) the prevalence and incidence of psychiatric co-morbidities in people with Alopecia areata and (iii) the prevalence and incidence of autoimmune and atopic conditions in people with Alopecia areata.
Detailed Description

The overall purpose of the first study (Study 1) is to describe the epidemiology of Alopecia areata (AA) and to assess the current level of primary care service utilisation and management patterns associated with patients diagnosed with AA.

The overall purpose of the second study (study 2) is to assess the prevalence and incidence of mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with AA relative to a control population of patients without a diagnosis of AA. In addition, the study will determine both the treatment, 'sick day' and unemployment burden. Treatment burden comprises that of medications and psychological interventions used to treat mental health conditions in adult patients diagnosed with Alopecia areata.

The overall purpose of the third study (Study 3) is to assess the prevalence and incidence of atopic and autoimmune conditions in adult patients diagnosed with AA relative to a control population of patients without AA.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population These studies will use routinely collected and collated data from the Royal College of General Practitioners Research and Surveillance Centre database to provide a broadly representative sample of the population of England.
Condition
  • Alopecia Areata
  • Depressive Episode
  • Recurrent Depressive Disorder
  • Anxiety Disorders
  • Atopic Dermatitis
  • Allergic Rhinitis
  • Asthma
  • Crohn Disease
  • Ulcerative Colitis
  • Pernicious Anemia
  • Type 1 Diabetes
  • Hashimoto Thyroiditis
  • Graves Disease
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Ankylosing Spondylitis
  • Systemic Lupus Erythematosus
  • Polymyalgia Rheumatica
  • Sjogren's Syndrome
  • Psoriasis
  • Vitiligo
  • Multiple Sclerosis
  • Celiac Disease
Intervention Other: Exposure of interest (studies 2 & 3).
Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder Atopic conditions consist of Atopic dermatitis, allergic rhinitis, asthma Autoimmune conditions consist of Crohn's disease, ulcerative colitis, Coeliac disease, Pernicious anaemia, Type 1 diabetes, Hashimoto's thyroiditis, Grave's disease, Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Systemic lupus erythematosus, polymyalgia rheumatica, Sjögren's syndrome, Psoriasis, vitiligo, Multiple sclerosis
Study Groups/Cohorts
  • Cases
    Patients with a confirmed diagnosis of Alopecia areata within the study period will be included as cases for analysis.
    Intervention: Other: Exposure of interest (studies 2 & 3).
  • Controls
    The control cohorts will be defined by matching cases with patients who have never been diagnosed with Alopecia areata either prior to or during the study period, by age and sex, at General Practice practice level.
    Intervention: Other: Exposure of interest (studies 2 & 3).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 20, 2020)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients contributing to Royal College of General Practitioners Research and Surveillance Centre(RCGP RCS) primary care database between January 1, 2009 and December 31, 2018, will be eligible for inclusion.
  • Only patients aged ?18 will be eligible for studies 2 and 3.
  • Only patients aged ? 18 and ? 65 will be included in the unemployment and sick day analysis (study 2)

Exclusion Criteria:

  • People with the alternative non-AA diagnoses.
  • People with AA diagnosis within 6 months of registration.
  • People with less than 1 year of follow up available
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Andrew McGovern, MD+44 7531 221970[email protected]
Contact: John Dennis, PhD+44 7734 940921[email protected]
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04239521
Other Study ID Numbers P005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:Yes
Plan Description:Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
Supporting Materials:Study Protocol
Responsible Party Momentum Data
Study Sponsor Momentum Data
Collaborators
  • Pfizer
  • University of Surrey
Investigators
Study Director:Andrew McGovern, MDMomentum Data
PRS Account Momentum Data
Verification Date January 2020