The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata
NCT04239521
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Adult Trials: 18+ Years
- 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)
- 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
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| Descriptive Information | |||||||||
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| 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 |
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| 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 |
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| 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 | 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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | United Kingdom | ||||||||
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| Administrative Information | |||||||||
| NCT Number | NCT04239521 | ||||||||
| Other Study ID Numbers | P005 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Momentum Data | ||||||||
| Study Sponsor | Momentum Data | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Momentum Data | ||||||||
| Verification Date | January 2020 | ||||||||