A Study of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions
Study Purpose
The objective of this Non-interventional study (NIS) is the collection of data on the utilization of Apremilast under routine conditions in Germany. Patients' quality-of-life and treatment satisfaction on treatment with Apremilast in daily practice will be documented. Moreover, physician's and patient's assessments of the effectiveness and safety of Apremilast will be recorded.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Inclusion Criteria:
- - The decision for a therapy with Apremilast was made before enrolment and independent of this study.
- - Patient ≥ 18 years of age - Diagnosis of moderate to severe plaque psoriasis - Inadequate response or intolerance to a previous systemic treatment, or contraindication for systemic therapies.
- - Written informed consent by the patient for data recording, statistical analysis,
filing and forwarding of the data
Exclusion Criteria:
- Pregnancy - Hypersensitivity to apremilast or any of the excipients of the film-coated tablet - Other criteria according to the Summary of product characteristics (SmPC).
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02626793 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Celgene |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Volker Koscielny, MD |
| Principal Investigator Affiliation | Celgene Sarl |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Germany |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriasis |
The objective of this NIS (according to section 67(6) of the German Medicinal Products Act) is the documentation of data on the effectiveness and tolerability of an Apremilast treatment under routine clinical conditions in German patients with plaque psoriasis. This NIS is intended to reflect the apremilast treatment of patients with plaque psoriasis who have received at least one prior conventional, systemic therapy or, if a contraindication is present, did not receive a systemic therapy so far, and who were diagnosed by their treating physicians to be eligible for an apremilast treatment. The treatment of Apremilast will be documented for a period of approximately 52 weeks.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Active, not recruiting
Address
Gertraud Krähn-Senftleben
Blaubeuren, Baden-Württemberg, 89143
Site Contact
Status
Active, not recruiting
Address
Ralf-Uwe Peter
Blaustein, Baden-Württemberg, 89134
Site Contact
Status
Recruiting
Address
Regina Renner
Esslingen am Neckar, Baden-Württemberg, 73728
Site Contact
Status
Recruiting
Address
Universitätsklinikum Heidelberg - Hautklinik
Heidelberg, Baden-Württemberg, 69120
Site Contact
Status
Recruiting
Address
Ina Reitenbach-Blindt
Karlsruhe, Baden-Württemberg, 76133
Site Contact
Status
Active, not recruiting
Address
Kaiserstraße 231-233
Karlsruhe, Baden-Württemberg, 76133
Site Contact
Status
Recruiting
Address
Naomi Gerhardus
Karlsruhe, Baden-Württemberg, 76133
Site Contact
Status
Active, not recruiting
Address
Johannes Glutsch
Karlsruhe, Baden-Württemberg, 76149
Site Contact
Status
Recruiting
Address
Beate Schwarz
Langenau, Baden-Württemberg, 89129
Site Contact
Status
Recruiting
Address
Astrid Schmieder
Mannheim, Baden-Württemberg, 68167
Site Contact
Status
Active, not recruiting
Address
Katharina Wroblewska
Spaichingen, Baden-Württemberg, 78549
Site Contact
Status
Recruiting
Address
Pia Freyschmidt-Paul
Schwalmstadt, Hessen, 34613
Site Contact
Status
Active, not recruiting
Address
Clarissa Allmacher
Hersbruck, Bayern, 91217
Site Contact
Status
Recruiting
Address
Technische Universität München - Kilian Eyerich
München, Bayern, 80802
Site Contact
Status
Recruiting
Address
Universitätsklinikum Regensburg
Regensburg, Bayern, 93053
Site Contact
Status
Recruiting
Address
Förster-Funke-Allee 104
Kleinmachnow, Brandenburg, 14532
Site Contact
Status
Recruiting
Address
Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt am Main, Hessen, 60590
Site Contact
Status
Recruiting
Address
Andreas Timmel
Bergen, Mecklenburg-Vorpommern, 18528
Site Contact
Status
Recruiting
Address
Raimund Paech
Neubrandenburg, Mecklenburg-Vorpommern, 17034
Site Contact
Status
Recruiting
Address
Jutta Ramaker-Brunke
Braunschweig, Niedersachsen, 38114
Site Contact
Status
Recruiting
Address
Andreas Kleinheinz
Buxtehude, Niedersachsen, 21614
Site Contact
Status
Active, not recruiting
Address
Marco Averbeck
Cloppenburg, Niedersachsen, 49661
Site Contact
Status
Recruiting
Address
Florian Schenck
Hannover, Niedersachsen, 30159
Site Contact
Status
Active, not recruiting
Address
Ulrike Stein
Hannover, Niedersachsen, 30167
Site Contact
Status
Active, not recruiting
Address
Holger Petering
Hildesheim, Niedersachsen, 31134
Site Contact
Status
Active, not recruiting
Address
Silke Reinecke
Holzminden, Niedersachsen, 37603
Site Contact
Status
Active, not recruiting
Address
Gesundheitszentrum Winsen
Winsen, Niedersachsen, 21423
Site Contact
Status
Active, not recruiting
Address
Theaterplatz 9
Aachen, Nordrhein-Westfalen, 52062
Site Contact
Status
Recruiting
Address
Isaak Effendy
Bielefeld, Nordrhein-Westfalen, 33647
Site Contact
Status
Active, not recruiting
Address
Volker Riesopp
Duisburg, Nordrhein-Westfalen, 47249
Site Contact
Status
Recruiting
Address
Bernhard Korge
Düren, Nordrhein-Westfalen, 52349
Site Contact
Status
Active, not recruiting
Address
Herderstr.71 b
Düsseldorf, Nordrhein-Westfalen, 40237
Site Contact
Status
Recruiting
Address
Dechant-Deckers-Straße 5-7
Eschweiler, Nordrhein-Westfalen, 52249
Site Contact
Status
Active, not recruiting
Address
Universitätsklinikum Essen
Essen, Nordrhein-Westfalen, 45147
Site Contact
Status
Recruiting
Address
Christina Huerkamp
Euskirchen, Nordrhein-Westfalen, 53879
Site Contact
Status
Recruiting
Address
Sebastian Rotterdam
Gelsenkirchen-Feldmark, Nordrhein-Westfalen, 45883
Site Contact
Status
Recruiting
Address
Jörg Brinkmann
Gladbeck, Nordrhein-Westfalen, 45964
Site Contact
Status
Active, not recruiting
Address
Hautartzpraxis
Kleve, Nordrhein-Westfalen, 47533
Site Contact
Status
Recruiting
Address
Rudolf Stadler
Minden, Nordrhein-Westfalen, 32429
Site Contact
Status
Recruiting
Address
Rolf Ostendorf
Mönchengladbach, Nordrhein-Westfalen, 41061
Site Contact
Status
Active, not recruiting
Address
Athanasios Tsianakas
Münster, Nordrhein-Westfalen, 48149
Site Contact
Status
Recruiting
Address
Stefanie Montag
Rheinbach, Nordrhein-Westfalen, 53359
Site Contact
Status
Recruiting
Address
Hautarztpraxis, Steinfeldstr. 5
Stolberg (Rheinland), Nordrhein-Westfalen, 52222
Site Contact
Status
Active, not recruiting
Address
Oliver Mainusch
Velbert, Nordrhein-Westfalen, 42551
Site Contact
Status
Active, not recruiting
Address
Kurt-Kräcker-Str. 47
Wesel, Nordrhein-Westfalen, 46485
Site Contact
Status
Active, not recruiting
Address
Schloss Straße 17
Koblenz, Rheinland-Pfalz, 56068
Site Contact
Status
Recruiting
Address
Petra Staubach-Renz
Mainz, Rheinland-Pfalz, 55131
Site Contact
Status
Active, not recruiting
Address
Dirk Maaßen
Maxdorf, Rheinland-Pfalz, 67133
Site Contact
Status
Active, not recruiting
Address
Praxis für Haut- und Geschlechtskrankheiten - Allergologie - Am Johannisborn
Prüm, Rheinland-Pfalz, 54595
Site Contact
Status
Recruiting
Address
Ralph von Kiedrowski
Selters, Rheinland-Pfalz, 56242
Site Contact
Status
Recruiting
Address
Mohammad Asefi
Simmern, Rheinland-Pfalz, 55469
Site Contact
Status
Active, not recruiting
Address
Puschkinstr. 110
Eilenburg, Sachsen-Anhalt, 04838
Site Contact
Status
Recruiting
Address
Franckestr. 1
Magdeburg, Sachsen-Anhalt, 39104
Site Contact
Status
Recruiting
Address
Jens Ulrich
Quedlinburg, Sachsen-Anhalt, 06484
Site Contact
Status
Recruiting
Address
Gabriela Fiedler
Weißenfels, Sachsen-Anhalt, 06667
Site Contact
Status
Active, not recruiting
Address
Karolin Schneider
Chemnitz, Sachsen, 09116
Site Contact
Status
Active, not recruiting
Address
Stefan Beissert
Dresden, Sachsen, 01307
Site Contact
Status
Active, not recruiting
Address
Bernhard-Göring-Str. 162
Leipzig, Sachsen, 04277
Site Contact
Status
Active, not recruiting
Address
Riebeckstraße 65
Leipzig, Sachsen, 04317
Site Contact
Status
Active, not recruiting
Address
Schweizergartenstr. 2a
Wurzen, Sachsen, 04808
Site Contact
Status
Active, not recruiting
Address
Harald Brüning
Kiel, Schleswig-Holstein, 24148
Site Contact
Status
Active, not recruiting
Address
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23562
Site Contact
Status
Active, not recruiting
Address
Christian Meewes
Neumünster, Schleswig-Holstein, 24534
Site Contact
Status
Active, not recruiting
Address
Hautarztpraxis Zahn
Berlin, , 13187
Site Contact
Status
Active, not recruiting
Address
Matthias Augustin
Hamburg, , 20246
Site Contact
Status
Not yet recruiting
Address
Johannes-R.-Becher-Straße 24
Königs Wusterhausen, , 15711
Site Contact
