Efficacy of Novel Drug-combinations for Relief of Psoriasis (ENDURE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02394301|
Recruitment Status : Suspended (Poor enrollment)
First Posted : March 20, 2015
Last Update Posted : May 18, 2015
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||12 Weeks|
|Official Title:||Efficacy of Novel Drug-combinations for Relief of Psoriasis (ENDURE)|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
- Change in Psoriasis Area Severity Index (PASI) Score [ Time Frame: 12 Week Study [Baseline, 2, 4, 8, and 12 week evaluation] ]To evaluate the change in psoriasis plaque resolution, the PASI tool will be utilized. The psoriasis plaques will be evaluated by the overseeing study investigator as part of the normal evaluation of the area.
- Quality of Life [ Time Frame: 12 Weeks [Baseline, 2, 4, 8, and 12 week evaluation] ]To assess change in quality of life, the Skindex-16 assessment tool will be used at all study visits.
- Methotrexate absorption [ Time Frame: 12 Weeks [Baseline, 4, 12 week evaluation] ]To assess changes in serum methotrexate concentration, methotrexate serum levels and other associated laboratory values (complete blood count, serum creatinine, alanine transaminase, aspartate aminotransferase, C-reactive protein, erythrocyte sedimentation rate, glucose, and insulin levels) will be monitored in patients that agree to participate in the sub-study who are prescribed a methotrexate-containing compounded psoriasis formulation (maximum 25 patients). This outcome measure is a composite.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394301
|United States, Florida|
|The Medimix Specialty Pharmacy, LLC|
|Jacksonville, Florida, United States, 32216|
|Study Chair:||Benjamin J Epstein, PharmD||Medimix Specialty Pharmacy|