The Immunological Basis for Treatment Resistance to Anti-TNF Treatments

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the relationship between two types of cell signals, type I interferon (IFN) and tumor necrosis factor (TNF), in psoriatic skin prior to and during treatment with etanercept and correlate that information with the degree of the improvement in the psoriasis.

Clinical Trial Description

Hypothesis: The balance between type I IFN and TNF determines the response to anti-TNF treatment. The goal of the proposed study is to address this hypothesis and demonstrate that the strength of the type I IFN signature in psoriatic skin is the major determinant of the clinical response to anti-TNF treatment.

Purpose: Determine the strength of the type I interferon and TNF signal in psoriatic skin prior to and during treatment with etanercept and correlate with degree of clinical improvement.

Study Population: up to 50 subjects, men or women over the age of 18 with clinically stable plaque psoriasis, who meet the wash out requirements and other exclusion criteria

Psoriatic patients will receive 100 mg etanercept per week (2 separate single-use pre-filled 50 mg subcutaneous injections taken on two separate days) for 3 months.

Procedures: Urine pregnancy test, TB test, photography, Physical Examinations, Skin Examinations, Study Drug, Peripheral blood and biopsies

Anticipated Results: We expect that patients with strong IFN-α signature in psoriatic skin along with weak TNF-α signature will have minimal response to anti-TNF treatment, while patients with the opposite pattern, weak IFN and strong TNF signature, will have significant clinical improvement. ;

Study Design

Related Conditions & MeSH terms

Psoriasis

Clinical Trial Details

NCT number	NCT01971346
Study type	Interventional
Source	University of Michigan
Contact
Status	Completed
Phase	Phase 4
Start date	March 13, 2014
Completion date	November 1, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03236870` - A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
Completed	`NCT00078819` - Etanercept (Enbrel®) in Psoriasis - Pediatrics	Phase 3
Completed	`NCT04841187` - Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
Active, not recruiting	`NCT03927352` - The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis	Phase 3
Completed	`NCT03284879` - Post-Marketing Surveillance Study of OTEZLA
Recruiting	`NCT06027034` - Effectiveness of a Digital Health Application for Psoriasis	N/A
Not yet recruiting	`NCT06050330` - CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study	N/A
Recruiting	`NCT05744466` - A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
Completed	`NCT04149587` - A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
Completed	`NCT01384630` - Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis	Phase 2
Completed	`NCT03998683` - A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis	Phase 3
Terminated	`NCT03556202` - A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)	Phase 3
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting	`NCT06077331` - A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis	Phase 2
Completed	`NCT04316585` - A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants	Phase 1
Completed	`NCT04894890` - A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Completed	`NCT00358384` - Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034	Phase 1
Completed	`NCT03757013` - A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
Completed	`NCT03265613` - Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis	Phase 1/Phase 2
Completed	`NCT05003531` - A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis	Phase 2