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The expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.The investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The investigators will focus on the modification of the cytokine "signature" in these skin lesions and of some markers of keratinocyte inflammation. The modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response Psoriasis Area and Severity Index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Experimental | Adalimumab was administered subcutaneously at a dose of 80 mg at Week 0 and 40 mg every other week starting from Week 1 to Week 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab Every Week | Drug | Adalimumab was administered subcutaneously at a dose of 80 mg at Week 0 and 40 mg every other week starting from Week 1 to Week 16. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area and Severity Index (PASI) | Number of patients with a reduction in PASI score at 4 weeks | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatology Life Quality Index (DLQI) Scores | Number of patients with a reduction in DLGI score at 4 weeks | 4 weeks |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Poitiers | Poitiers | 86021 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37315881 | Result | Croquette M, Faugeroux A, Fonlupt C, Godet J, Frouin E, Garcia M, Bernard FX, Cordier-Dirikoc S, Pedretti N, Larid G, Favot L, Roblot P, Boutin D, Hainaut-Wierzbicka E, Heymann D, Lecron JC, Morel F, Jegou JF. IL-34 Exerts Anti-Inflammatory Activities on Keratinocytes and Is Downregulated in Psoriatic-Inflamed Skin. J Invest Dermatol. 2023 Dec;143(12):2521-2524.e5. doi: 10.1016/j.jid.2023.05.023. Epub 2023 Jun 12. No abstract available. | |
| 29171393 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Adalimumab was administered subcutaneously at a dose of 80 mg at Week 0 and 40 mg every other week starting from Week 1 to Week 16. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Adalimumab was administered subcutaneously at a dose of 80 mg at Week 0 and 40 mg every other week starting from Week 1 to Week 16. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area and Severity Index (PASI) | Number of patients with a reduction in PASI score at 4 weeks | Posted | Count of Participants | Participants | 4 weeks |
|
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adalimumab | Adalimumab was administered subcutaneously at a dose of 80 mg at Week 0 and 40 mg every other week starting from Week 1 to Week 16. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank MOREL | Université de Poitiers | franck.morel@univ-poitiers.fr |
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| Result |
| Buffiere-Morgado A, Couderc E, Delwail A, Favot L, Jegou JF, Solau E, Guillet G, Lecron JC, Morel F. Characterization of skin Th17 transcriptional profiles in psoriatic patients under adalimumab biotherapy. Eur J Dermatol. 2017 Dec 1;27(6):579-589. doi: 10.1684/ejd.2017.3127. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Dermatology Life Quality Index (DLQI) Scores | Number of patients with a reduction in DLGI score at 4 weeks | Posted | Count of Participants | Participants | 4 weeks |
|
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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