Dermatitis Atopic Clinical Trial
— PEDISTADOfficial title:
Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable
Primary Objectives: - To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable. - To evaluate the time-course of AD and selected atopic comorbidities. Secondary Objectives: - To characterize disease burden and unmet need. - To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching). - To document the real-world effectiveness and safety of treatments.
| Status | Recruiting |
| Enrollment | 1856 |
| Est. completion date | April 21, 2036 |
| Est. primary completion date | April 21, 2036 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 0 Years to 11 Years |
| Eligibility | Inclusion criteria: - Patients with moderate to severe AD, according to the Investigator's assessment; - Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment. Exclusion criteria: - Concurrent participation in an interventional clinical trial which modifies patient care. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Investigational Site Number : 0320003 | Buenos Aires | |
| Argentina | Investigational Site Number : 0320001 | Ciudad Autonoma Bs As | |
| Argentina | Investigational Site Number : 0320005 | Ciudad Autonoma Buenos Aires | |
| Argentina | Investigational Site Number : 0320006 | Ciudad Autonoma de Buenos Aire | Buenos Aires |
| Argentina | Investigational Site Number : 0320002 | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Investigational Site Number : 0320004 | Rosario | Santa Fe |
| Argentina | Investigational Site Number : 0320007 | San Miguel de Tucuman | |
| Australia | Investigational Site Number : 0360010 | Box Hill | Victoria |
| Australia | Investigational Site Number : 0360009 | Campbelltown | New South Wales |
| Australia | Investigational Site Number : 0360004 | Fremantle | Western Australia |
| Australia | Investigational Site Number : 0360008 | Kogarah | New South Wales |
| Australia | Investigational Site Number : 0360003 | Parkville | Victoria |
| Australia | Investigational Site Number : 0360007 | Richmond | Victoria |
| Australia | Investigational Site Number : 0360001 | Westmead | New South Wales |
| Brazil | HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004 | Curitiba | Paraná |
| Brazil | HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005 | Curitiba | Paraná |
| Brazil | Universidade Federal do Paraná Site Number : 0760003 | Curitiba | Paraná |
| Brazil | Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002 | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital Sao Paulo Site Number : 0760006 | São Paulo | São Paulo |
| Brazil | Clínica de Alergia Martti Antila Site Number : 0760001 | Sorocaba | |
| Canada | Investigational Site Number : 1240004 | Calgary | Alberta |
| Canada | Investigational Site Number : 1240007 | Calgary | Alberta |
| Canada | Investigational Site Number : 1240001 | Markham | Ontario |
| Canada | Investigational Site Number : 1240006 | Montreal | Quebec |
| Canada | Investigational Site Number : 1240009 | Regina | Saskatchewan |
| Canada | Investigational Site Number : 1240008 | Toronto | Ontario |
| Canada | Investigational Site Number : 1240005 | Winnipeg | Manitoba |
| China | Investigational Site Number : 1560004 | Beijing | |
| China | Investigational Site Number : 1560006 | Changsha | |
| China | Investigational Site Number : 1560001 | Chongqing | |
| China | Investigational Site Number : 1560012 | Guangzhou | |
| China | Investigational Site Number : 1560007 | Harbin | |
| China | Investigational Site Number : 1560003 | Kunming | |
| China | Investigational Site Number : 1560011 | Shenzhen | |
| China | Investigational Site Number : 1560002 | Suzhou | |
| China | Investigational Site Number : 1560008 | Xuzhou | |
| Colombia | Investigational Site Number : 1700006 | Barranquilla | |
| Colombia | Investigational Site Number : 1700001 | Bogota | |
| Colombia | Investigational Site Number : 1700004 | Bogota | |
| Colombia | Investigational Site Number : 1700007 | Bogota | |
| Denmark | Investigational Site Number : 2080002 | Kobenhavn Nv | |
| France | Investigational Site Number : 2500008 | Argenteuil Cedex | |
| France | Investigational Site Number : 2500001 | Bordeaux | |
| France | Investigational Site Number : 2500010 | Lille cedex | |
| France | Investigational Site Number : 2500006 | Marseille cedex 5 | |
| France | Investigational Site Number : 2500005 | Martigues | |
| France | Investigational Site Number : 2500002 | Nantes Cedex 1 | |
| France | Investigational Site Number : 2500003 | Paris Cedex 15 | |
| France | Investigational Site Number : 2500004 | Saint-Etienne Cedex 2 | |
| Greece | Investigational Site Number : 3000001 | Athens | |
| Greece | Investigational Site Number : 3000004 | Larissa | |
| Greece | Investigational Site Number : 3000002 | Thessaloniki | |
| Greece | Investigational Site Number : 3000003 | Thessaloniki | |
| Israel | Investigational Site Number : 3760003 | Beer Sheva | |
| Israel | Investigational Site Number : 3760004 | Haifa | |
| Israel | Investigational Site Number : 3760005 | Kfar-Saba | |
| Israel | Investigational Site Number : 3760001 | Ramat Gan | |
| Israel | Investigational Site Number : 3760002 | Rehovot | |
| Italy | Investigational Site Number : 3800012 | Bari | |
| Italy | Investigational Site Number : 3800003 | Bologna | |
| Italy | Investigational Site Number : 3800010 | Catania | |
| Italy | Investigational Site Number : 3800001 | Milano | |
| Italy | Investigational Site Number : 3800008 | Naples | Napoli |
| Italy | Investigational Site Number : 3800005 | Napoli | |
| Italy | Investigational Site Number : 3800011 | Padova | |
| Italy | Investigational Site Number : 3800006 | Padua | Veneto |
| Italy | Investigational Site Number : 3800009 | Perugia | |
| Italy | Investigational Site Number : 3800004 | Terracina | Latina |
| Italy | Investigational Site Number : 3800007 | Trieste | |
| Japan | Investigational Site Number : 3920011 | Fuchu-shi | Tokyo |
| Japan | Investigational Site Number : 3920018 | Fukuoka-shi | |
| Japan | Investigational Site Number : 3920017 | Fukuyama-shi | |
| Japan | Investigational Site Number : 3920003 | Habikino-shi | Osaka-Fu |
| Japan | Investigational Site Number : 3920002 | Hiroshima-shi | Hiroshima |
| Japan | Investigational Site Number : 3920015 | Kumagaya-shi | |
| Japan | Investigational Site Number : 3920004 | Kyoto-shi | |
| Japan | Investigational Site Number : 3920012 | Nagasaki-shi | Nagasaki |
| Japan | Investigational Site Number : 3920020 | Nagoya-shi | |
| Japan | Investigational Site Number : 3920008 | Obu-shi | |
| Japan | Investigational Site Number : 3920005 | Osakasayama-shi | |
| Japan | Investigational Site Number : 3920009 | Sagamihara-shi | Kanagawa |
| Japan | Investigational Site Number : 3920014 | Sendai-shi | |
| Japan | Investigational Site Number : 3920019 | Sendai-shi | |
| Japan | Investigational Site Number : 3920001 | Setagaya-ku | Tokyo |
| Japan | Investigational Site Number : 3920010 | Tsu-shi | |
| Japan | Investigational Site Number : 3920016 | Yokohama-Shi | Kanagawa |
| Korea, Republic of | Investigational Site Number : 4100008 | Ansan-si | Gyeonggi-do |
| Korea, Republic of | Investigational Site Number : 4100001 | Gumi-city | Gyeongsangbuk-do |
| Korea, Republic of | Investigational Site Number : 4100007 | Incheon | Gyeonggi-do |
| Korea, Republic of | Investigational Site Number : 4100003 | Seoul | |
| Korea, Republic of | Investigational Site Number : 4100004 | Seoul | |
| Korea, Republic of | Investigational Site Number : 4100005 | Seoul | |
| Korea, Republic of | Investigational Site Number : 4100002 | Suwon | Gyeonggi-do |
| Mexico | Investigational Site Number : 4840001 | Mexico | |
| Mexico | Investigational Site Number : 4840006 | Mexico | |
| Mexico | Investigational Site Number : 4840003 | Monterrey | Nuevo León |
| Mexico | Investigational Site Number : 4840004 | Puebla | |
| Mexico | Investigational Site Number : 4840005 | Tlalnepantla | |
| Netherlands | Investigational Site Number : 5280001 | Amsterdam | |
| Netherlands | Investigational Site Number : 5280006 | Den Haag | |
| Netherlands | Investigational Site Number : 5280005 | Groningen | |
| Netherlands | Investigational Site Number : 5280002 | Rotterdam | |
| Netherlands | Investigational Site Number : 5280003 | Utrecht | |
| Norway | Investigational Site Number : 5780001 | Bergen | |
| Norway | Investigational Site Number : 5780002 | Oslo | |
| Portugal | Investigational Site Number : 6200003 | Braga | |
| Portugal | Investigational Site Number : 6200001 | Lisboa | |
| Portugal | Investigational Site Number : 6200005 | Lisboa | |
| Russian Federation | Investigational Site Number : 6430001 | Moscow | |
| Russian Federation | Investigational Site Number : 6430002 | Moscow | |
| Russian Federation | Investigational Site Number : 6430003 | Moscow | |
| Russian Federation | Investigational Site Number : 6430004 | Moscow | |
| Russian Federation | Investigational Site Number : 6430005 | Moscow | |
| Spain | Investigational Site Number : 7240001 | Alicante | |
| Spain | Investigational Site Number : 7240002 | Barcelona | |
| Spain | Investigational Site Number : 7240005 | Barcelona | Catalunya [Cataluña] |
| Spain | Investigational Site Number : 7240008 | Comunidad Valenciana | Valencia |
| Spain | Investigational Site Number : 7240003 | Madrid | |
| Spain | Investigational Site Number : 7240009 | Santullano De Mieres | Asturias |
| United States | Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057 | Albany | Georgia |
| United States | Amarillo Center for Clinical Research Site Number : 8400055 | Amarillo | Texas |
| United States | Orange County Research Institute Site Number : 8400028 | Anaheim | California |
| United States | Allervie Clinical Research Site Number : 8400012 | Birmingham | Alabama |
| United States | C Squared Research Center Site Number : 8400068 | Birmingham | Alabama |
| United States | Cahaba Dermatology Site Number : 8400046 | Birmingham | Alabama |
| United States | Daxia Trials Site Number : 8400082 | Boca Raton | Florida |
| United States | Philip Fried, M.D., PLLC Site Number : 8400029 | Bronx | New York |
| United States | Tiga Pediatrics, PC Site Number : 8400037 | Bronx | New York |
| United States | Immunoe Research Centers Site Number : 8400026 | Centennial | Colorado |
| United States | UNC Hospitals Site Number : 8400016 | Chapel Hill | North Carolina |
| United States | MUSC Site Number : 8400013 | Charleston | South Carolina |
| United States | Northwestern University Feinberg School of Medicine Site Number : 8400001 | Chicago | Illinois |
| United States | Cincinnati Children's Hospital Medical Center Site Number : 8400017 | Cincinnati | Ohio |
| United States | Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056 | Columbus | Georgia |
| United States | Pediatric Center Of Excellence Site Number : 8400072 | Coral Gables | Florida |
| United States | Green Dermatology and Cosmetic Center. Site Number : 8400078 | Deerfield Beach | Florida |
| United States | 2G Clinical Research Services Site Number : 8400031 | Durham | North Carolina |
| United States | Clinical Research of Gastonia Site Number : 8400041 | Gastonia | North Carolina |
| United States | Pediatric Dermatology of North Texas Site Number : 8400003 | Grapevine | Texas |
| United States | Allergic Disease and Asthma Research Center, PA Site Number : 8400048 | Greenville | South Carolina |
| United States | Cyn3rgy Research & Development Site Number : 8400023 | Gresham | Oregon |
| United States | Amedica Research Institute, Inc. Site Number : 8400067 | Hialeah | Florida |
| United States | Eastern Research, Inc. Site Number : 8400032 | Hialeah | Florida |
| United States | Heights Dermatology and Aesthetic Center Site Number : 8400065 | Houston | Texas |
| United States | Tokunbo T. Dada, MD PA Site Number : 8400079 | Irvington | New Jersey |
| United States | Children's Mercy Hospital and Clinics Site Number : 8400020 | Kansas City | Missouri |
| United States | Viable Research Management Site Number : 8400027 | Las Vegas | Nevada |
| United States | Michael W. Simon, M.D., PSC Site Number : 8400073 | Lexington | Kentucky |
| United States | Axis Clinical Trials Site Number : 8400025 | Los Angeles | California |
| United States | Family Allergy and Asthma Research Site Number : 8400060 | Louisville | Kentucky |
| United States | Madera Family Medical Group Site Number : 8400054 | Madera | California |
| United States | Dermatology Associates of Mid-Ohio Site Number : 8400052 | Marion | Ohio |
| United States | The Dermatology Institute of South Texas Site Number : 8400076 | McAllen | Texas |
| United States | Ciocca, Giovanna Site Number : 8400018 | Miami | Florida |
| United States | Premier Dermatology Partners Site Number : 8400075 | Miami | Florida |
| United States | Vista Health Research, LLC Site Number : 8400034 | Miami | Florida |
| United States | Medical College Of Wisconsin Site Number : 8400008 | Milwaukee | Wisconsin |
| United States | C2 Research Center, LLC Site Number : 8400071 | Montgomery | Alabama |
| United States | Family Pediatrics Iwuozo L Obilo Md Site Number : 8400077 | Newark | New Jersey |
| United States | Providence Medical Center Site Number : 8400081 | North Plainfield | New Jersey |
| United States | Pediatric & Adult Research Center Site Number : 8400040 | Orlando | Florida |
| United States | Phoenix Children's Hospital, Inc. Site Number : 8400015 | Phoenix | Arizona |
| United States | The Indiana Clinical Trials Center, PC Site Number : 8400007 | Plainfield | Indiana |
| United States | AIM Trials Site Number : 8400035 | Plano | Texas |
| United States | Dermatology Associates PC Site Number : 8400049 | Rockville | Maryland |
| United States | NorthShore University HealthSystem Site Number : 8400064 | Skokie | Illinois |
| United States | VAMA Medical Health Center Site Number : 8400083 | Union | New Jersey |
| United States | Carey Chronis, MD, FAAP Site Number : 8400033 | Ventura | California |
| United States | Michigan Dermatology Institute Site Number : 8400059 | Waterford | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States, Argentina, Australia, Brazil, Canada, China, Colombia, Denmark, France, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Portugal, Russian Federation, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Demographics | Age, sex, race, ethnicity, body weight and height | Baseline | |
| Primary | Age at AD onset | Age of study patients at time of AD onset | Baseline | |
| Primary | Time from AD onset to initiation of therapy | Duration from onset of AD to start of AD therapy | Baseline | |
| Primary | Type of current AD therapy | Type of therapy administered to treat AD (e.g., systemic, topical, other) | Baseline | |
| Primary | Presence of AD and selected comorbid conditions | Percentage of patients with AD and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study | Baseline to Month 60 | |
| Secondary | Percentage of patients using specific AD therapies and initiating new therapies | Percentage of patients using specific AD therapies and initiating new therapies | Baseline to Month 60 | |
| Secondary | Eczema Area and Severity Index (EASI) | EASI score as assessed by physician | Baseline to Month 60 | |
| Secondary | Body Surface Area (BSA) percentage affected by AD | BSA score as assessed by physician | Baseline to Month 60 | |
| Secondary | Patient Oriented Eczema Measure (POEM) questionnaire | POEM score as reported by the participant's caregiver | Baseline to Month 60 | |
| Secondary | Children's Dermatology Life Quality Index (CDLQI) | CDLQI score as reported by the participant | Baseline to Month 60 | |
| Secondary | Infant's Dermatitis Quality of Life (IDQOL) | IDQOL score as reported by the participant's caregiver | Baseline to Month 60 | |
| Secondary | Dermatitis Family Impact (DFI) questionnaires | DFI score as reported by the participant's caregiver | Baseline to Month 60 | |
| Secondary | Peak Pruritus Numerical Rating Scale (NRS) | Peak Pruritus NRS score as reported by the participant | Baseline to Month 60 | |
| Secondary | Worst scratching NRS questionnaires | Worst scratching NRS score as reported by the participant's caregiver | Baseline to Month 60 | |
| Secondary | Caregiver Global Assessment of Disease (CGAD) questionnaire | CGAD score as reported by the participant's caregiver | Baseline to Month 60 | |
| Secondary | Total Nasal Symptom Score (TNSS) questionnaire | TNSS score as reported by the participant's caregiver | Baseline to Month 60 | |
| Secondary | Days missed from school for the patient and days missed from work for the primary caregiver due to AD | Days missed from school for the patient and days missed from work for the primary caregiver due to AD | Baseline to Month 60 | |
| Secondary | Number of visits to healthcare professionals | Number of visits to healthcare professionals for evaluation of healthcare utilization | Baseline to Month 60 | |
| Secondary | Incidence of adverse events | Frequency of patients with at least one event, the number of events, and the incidence rate will be summarized by System Organ Class and Preferred Term | Baseline to Month 60 |
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