Optimising Outpatient Care in Mild to Moderate Psoriasis (PSO-TOP)
Overview[ - collapse ][ - ]
| Purpose | A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems. |
|---|---|
| Condition | Mild to Moderate Psoriasis |
| Intervention | Other: TTOP Other: non-TTOP |
| Phase | Phase 4 |
| Sponsor | Kristian Reich, MD |
| Responsible Party | Reich, Kristian, M.D. |
| ClinicalTrials.gov Identifier | NCT01587755 |
| First Received | April 25, 2012 |
| Last Updated | April 10, 2013 |
| Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 25, 2012 |
|---|---|
| Last Updated Date | April 10, 2013 |
| Start Date | March 2012 |
| Estimated Primary Completion Date | June 2014 |
| Current Primary Outcome Measures | Physician Global Assessment (PGA) [Time Frame: Up to 64 weeks; primary outcome assessed at week 8 after treatment start] [Designated as safety issue: No]PGA (Physician Global Assessment) will be assessed at all study visits. For week 8, the rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 will be calculated. This is the primary study parameter. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Optimising Outpatient Care in Mild to Moderate Psoriasis (PSO-TOP) |
|---|---|
| Official Title | Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel |
| Brief Summary | A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems. |
| Detailed Description | A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board. This tool is created to address patients' non-adherence in topical therapy and the resulting underperformance of such treatments in controlling psoriatic disease. The study addresses the effect of the relationship between the patient and the health care professional, one of the important factors that can affect treatment adherence and therapeutic efficacy. The TTOP will be compared to standardised regular care (called 'non-TTOP'). It is intended to clinically show the importance of an optimised contact between the patient and health care professional. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label |
| Condition | Mild to Moderate Psoriasis |
| Intervention | Other: TTOP Patient is taken care of in an intensified, optimised manner Other: non-TTOP Standard medical care |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 1956 |
| Estimated Completion Date | June 2014 |
| Estimated Primary Completion Date | December 2013 |
| Eligibility Criteria | Inclusion Criteria: - Male and female patients aged at least 18 years - Mild to moderate active plaque psoriasis with PGA ≥ 2 on the 7-point scale by Langley and Ellis and a Body Surface Area (BSA) of ≤ 10% - Topical psoriasis treatment with coal or tar preparations, tazarotene, steroids, or vitamin D analogues, or combinations of steroids and vitamin D analogues (except gel combination products containing 50 micrograms calcipotriol/0.5mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to Visit 1 (week 0) - Written informed consent to participate in the study has been given prior to any study related procedures Exclusion Criteria: - Severe renal insufficiency - Severe hepatic disorders - Known hyper calcaemia - Erythrodermic, exfoliative, pustular or guttate psoriasis - Facial or genital psoriasis - Fulfilment of at least one contraindication according to the Summary of Product Characteristics of Daivobet®/Dovobet® Gel - Pregnant and/or breast-feeding women - Hypersensitivity to the active substances or to any of the excipients - Suspected non-compliance with the clinical study procedures - Current participation in another clinical study - Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1 (week 0): - etanercept - within 4 weeks prior to Visit 1 (week 0) - adalimumab, alefacept, infliximab - within 2 months prior to Visit 1 (week 0) - ustekinumab - within 4 months prior to Visit 1 (week 0) - experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1 (week 0) - Phototherapy within the following time periods prior to Visit 1 (week 0): - PUVA - within 4 weeks prior to Visit 1 (week 0) - UV-B - within 2 weeks prior to Visit 1 (week 0) |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01587755 |
|---|---|
| Other Study ID Numbers | 055-006 |
| Has Data Monitoring Committee | No |
| Information Provided By | Reich, Kristian, M.D. |
| Study Sponsor | Kristian Reich, MD |
| Collaborators | LEO Pharma |
| Investigators | Principal Investigator: Kristian Reich, MD Prof. |
| Verification Date | April 2013 |
Locations[ + expand ][ + ]
| Denmark | Herning, Denmark |
|---|---|
| Denmark | Hobro, Denmark |
| Denmark | Roskilde, Denmark |
| Denmark | Vejle, Denmark |
| France | Angers Cedex 9, France |
| France | Auxerre, France |
| France | Brest, France |
| France | Lille Cedex, France |
| France | Limeil Brevannes, France |
| France | Marseille Cedex 08, France |
| France | Martigues, France |
| France | Paris Cedex 10, France |
| France | Poitiers Cedex, France |
| France | Saint Mande, France |
| France | Saint Priest en Jarez, France |
| France | Saint-Germain en Laye, France |
| France | Tours Cedex 1, France |
| France | Vienne, France |
| Germany | Bad Bentheim, Germany |
| Germany | Berlin, Germany |
| Germany | Biberach, Germany |
| Germany | Blaubeuren, Germany |
| Germany | Bochum, Germany |
| Germany | Buchholz, Germany |
| Germany | Dessau, Germany |
| Germany | Frankfurt, Germany |
| Germany | Friedrichshafen, Germany |
| Germany | Gilching, Germany |
| Germany | Hamburg, Germany |
| Germany | Hannover, Germany |
| Germany | Kiel, Germany |
| Germany | Köln, Germany |
| Germany | Mahlow, Germany |
| Germany | Osnabrück, Germany |
| Germany | Pinneberg, Germany |
| Germany | Selters, Germany |
| Germany | Weißenfels, Germany |
| Germany | Wolfenbüttel, Germany |
| Germany | Wuppertal, Germany |
| Italy | Brescia, Italy |
| Italy | Catania, Italy |
| Italy | Genova, Italy |
| Italy | L'Aquila, Italy |
| Italy | Lucca, Italy |
| Italy | Messina, Italy |
| Italy | Padova, Italy |
| Italy | Palermo, Italy |
| Italy | Parma, Italy |
| Italy | Pavia, Italy |
| Italy | Perugia, Italy |
| Italy | Rome, Italy |
| Italy | Trapani, Italy |
| Italy | Verona, Italy |
| Netherlands | Amsterdam, Netherlands |
| Netherlands | Geldrop, Netherlands |
| Netherlands | Maastricht, Netherlands |
| Netherlands | Nijmegen, Netherlands |
| Netherlands | Rotterdam, Netherlands |
| Spain | Alicante, Spain |
| Spain | Barcelona, Spain |
| Spain | Barcelona,, Spain |
| Spain | Fuenlabrada (Madrid), Spain |
| Spain | Getafe (Madrid), Spain |
| Spain | Madrid, Spain |
| Spain | Palma de Mallorca, Spain |
| Spain | Tarragona, Spain |
| Spain | Valencia, Spain |
| Spain | Zaragoza, Spain |
| Sweden | Eskilstuna, Sweden |
| Sweden | Göteborg, Sweden |
| Sweden | Kristianstad, Sweden |
| Sweden | Linköping, Sweden |
| Sweden | Uppsala, Sweden |
| Sweden | Örebrö, Sweden |
| United Kingdom | Bexhill, United Kingdom |
| United Kingdom | Bradford, United Kingdom |
| United Kingdom | Burbage, United Kingdom |
| United Kingdom | Canterbury, United Kingdom |
| United Kingdom | Cheshire, United Kingdom |
| United Kingdom | Chesterfield, United Kingdom |
| United Kingdom | Coventry, United Kingdom |
| United Kingdom | Darwen, United Kingdom |
| United Kingdom | East Sussex, United Kingdom |
| United Kingdom | Leamington Spa, United Kingdom |
| United Kingdom | London, United Kingdom |
| United Kingdom | Manchester, United Kingdom |
| United Kingdom | Merseyside, United Kingdom |
| United Kingdom | Middlesex, United Kingdom |
| United Kingdom | Nantwich, United Kingdom |
| United Kingdom | Nuneaton, United Kingdom |
| United Kingdom | Oldham, United Kingdom |
| United Kingdom | Tunbridge Wells, United Kingdom |
| United Kingdom | Warwickshire, United Kingdom |
| United Kingdom | West Sussex, United Kingdom |