Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions (STRAUSS)
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|ClinicalTrials.gov Identifier: NCT03629379|
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases Psoriasis||Drug: Ustekinumab Drug: Vedolizumab||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||prospective, interventional study|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||July 1, 2021|
Active Comparator: ustekinumab arm
First 10 patients who are switched from anti-TNF to ustekinumab because of psoriasiform skin lesions refractory to 12 weeks of topical therapy.
Patients will receive standard dosing of ustekinumab with a single intravenous infusion of about 6mg/kg ustekinumab at week 0, followed by ustekinumab 90mg subcutaneously every 8 weeks.
Active Comparator: vedolizumab arm
First 10 patients who are switched from anti-TNF to vedolizumab because of psoriasiform skin lesions refractory to 12 weeks of topical therapy.
Patients will receive standard dosing of vedolizumab 300mg at weeks 0, 2, 6, and 14. Patients with Crohn's disease could receive an extra infusion at week 10.
- Transcriptomic features [ Time Frame: 3 years ]Transcriptomic profile will be established by analysis of the expression of the mRNAs by using Next Generation Sequencing.
- Proteomic features [ Time Frame: 3 years ]Proteomic profile will be established by using a proximity extension assay from OLINK
- Mechanistic changes in psoriasiform skin lesions [ Time Frame: 3 years ]Physiological changes that occur with respect to cell types and cytokines will be investigated using immunohistochemistry and cell sorting
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): NCT03629379
|Contact: Marc Ferrante, MDfirstname.lastname@example.org|
|Contact: Annick Moens, MDemail@example.com|