Etanercept for the Treatment of Chronic Urticaria

• Status: Withdrawn
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of etanercept for patients with chronic idiopathic urticaria unresponsive to antihistamines.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Treatments: Etanercept

Criteria

Inclusion Criteria:

1. History of CIU occurring at least biweekly for greater than 6 week

2. Adult subjects between the ages of 18-70 years

3. Failure to respond to systemic antihistaminic therapy

4. Negative TB skin testing at baseline

5. Subjects willing to comply with study requirements

6. Negative urine pregnancy test at enrollment

7. Voluntarily sign and date informed consent form

Exclusion Criteria:

1. 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.

2. Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.

3. Latex sensitivity

4. Prior or concurrent use of cyclophosphamide therapy

5. Concurrent sulfasalazine therapy.

6. Known HIV-positive status or known history of any other immuno-suppressing disease.

7. 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

8. Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits.

9. Severe comorbidities (diabetes mellitus requiring insulin; 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 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])

10. Exposure to hepatitis B or hepatitis C or to high risk factors for hepatitis B or C, such as intravenous drug use in patient.

11. Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder.

12. Use of a live vaccine 90 days prior to screening visit, or concurrent use of a live vaccine..

13. Any condition or circumstances judged by the patient's investigator to render this clinical trial detrimental or otherwise unsuitable for the patient's participation.

14. History of non-compliance with other therapies.

15. Concurrent use of anakinra.

16. Use of systemic immunosuppressive medication within 2 weeks of enrollment

17. Use of dapsone, sulfapyridine, sulfasalazine, or colchicine within 2 weeks of enrollment

18. Use of systemic corticosteroid within 2 weeks of enrollment

19. For females of childbearing potential, a refusal to use an acceptable form of contraceptive including oral or patch birth control, injectable birth control, intrauterine device, surgical sterilization, condom, barrier, or spermicide, post-menopausal, or complete abstinence from sexual activity.

20. For females, pregnancy, breast-feeding, or lactation

21. Active or recent (within the previous month) infection by staphylococcus aureus