The Immunological Basis for Treatment Resistance to Anti-TNF Treatments

NCT01971346 | Completed Phase 4 Results

• 1 other identifier: Derm 652
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Keywords

Psoriasis; ENBREL; etanercept; anti-TNF

Outcome Measures

Primary Outcomes (1)

• Change in Psoriasis Area and Severity Index (PASI) Score

  A cumulative change in PASI score from baseline to week 12 will be calculated for each patient. The PASI is the industry standard to decrease/eliminate subjectivity in determining psoriasis severity. It is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The severity of plaque characteristics (erythema, thickness and scaling) for body regions (head, upper limbs, trunk and lower limbs) is combined with the degree of plaque involvement in each body region to determine a single PASI score in the range of 0 (no disease) and 72 (maximal disease).

  Baseline, 12 weeks

Secondary Outcomes (3)

• Tumor Necrosis Factor (TNF)-Alpha Signal Strength

  Baseline, Week 6, Week 12

• Interferon (IFN)-Alpha Signal Strength

  Baseline, Week 6, Week 12

• Psoriasis Area and Severity Index (PASI) Response Profile

  12 Weeks

Study Arms (1)

Etanercept

OTHER

100 mg Etanercept injections per week for 3 months.

Drug: etanercept

Interventions

etanercept DRUG

100 mg Etanercept injections per week (2 separate single-use pre-filled 50 mg subcutaneous injections taken on two separate days) for 3 months

Also known as: ENBREL

Etanercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age at screening.
• Clinically stable moderate to severe plaque psoriasis at screening and baseline.
• Subject must be:
• A man or
• A woman who is surgically sterile or at least 3 years postmenopausal or
• A woman of childbearing potential who has had a negative pregnancy test within 7 days before the first dose of study drug.
• If the subject is sexually active, (s)he must agree to use a medically acceptable form of contraception during screening and throughout the study.

You may not qualify if:

• Grade 3 or 4 adverse events or infections within 28 days before screening, or between the screening visit and drug initiation.
• Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits.
• Evidence of skin conditions other than psoriasis that would interfere with the evaluations of the effect of study medication on psoriasis.
• Use of oral psoralen with ultraviolet A (PUVA), oral retinoids, cyclosporine, alefacept, or any other systemic anti-psoriasis therapy within 28 days study drug initiation.
• Use of ulltraviolet B (UVB) therapy, topical steroids at no higher than moderate strength, topical vitamin A or D analog preparations, or anthralin with 14 days of study initiation.
• Prior or concurrent use of cyclophosphamide therapy
• Concurrent sulfasalazine therapy.
• Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
• Current enrollment in any other investigational device or investigational drug trial(s), or receipt of any other investigational agent(s) within 28 days before baseline visit.
• Use of any biologic drugs within 28 days of study drug initiation.
• Concurrent use of Anakinra.
• Severe comorbidities (diabetes mellitus requiring insulin; congestive heart failure (CHF) of any severity or myocardial infarction or cerebrovascular accident or transient ischemic attack within 3 months of screening visit; unstable angina pectoris, uncontrolled hypertension (sitting systolic blood pressure (BP) \<80 mm Hg or \> 160 or diastolic BP \> 100 mm Hg), oxygen-dependent severe pulmonary disease, history of cancer within 5 years (other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer)
• Known history of tuberculosis (TB), or previous positive purified protein derivative (PPD) test. Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis medication.
• Known HIV-positive status or known history of any other immuno-suppressing disease.
• Concurrent or history of psychiatric disease that would interfere with ability to comply with study protocol or give informed consent.

Sponsors & Collaborators

• University of Michigan: lead
• Amgen: collaborator

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Heather Chubb
• Organization: University of Michigan

hdchubb@med.umich.edu

734-936-6394

Study Officials

• Johann Gudjonsson, MD PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology, Medical School

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: March 13, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 4, 2020
• Results First Posted: January 9, 2019

Record last verified: 2020-03

Locations

US (1)