Status:
COMPLETED
Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Adverse Drug Reactions, Advice and Consulting ADR-AC
University of Bern
Conditions:
Chronic Urticaria
Chronic Idiopathic Urticaria
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this study is to investigate the pathophysiological mechanism of omalizumab in patients with documented chronic urticaria who have complaints under standard antihistamine treatment. With th...
Detailed Description
Background Chronic urticaria (CU) is a frequent disease with a lifetime incidence of up to 25-30% of the population. Currently, CU treatment relies mainly on second generation antihistamines and is p...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 1\. Diagnosis of chronic urticaria made by clinical symptoms and clinical investigations
- 2\. Patients with chronic urticaria were defined as having symptoms for at least 6 weeks, with hives present at least twice weekly, refractory to H1 antihistaminics at time of randomization
- 3\. Signed informed consent documenting understanding of the study procedures and the investigational nature of the study
- Exclusion Criteria
- Age \<18 or \>70 year
- Patients with pure physical or cold urticaria, delayed pressure or cholinergic urticaria
- Patients with a clearly defined allergic urticaria (food, drugs etc.)
- Previous treatment with omalizumab within one year prior to randomization
- Known hypersensitivity to omalizumab or any of its components
- History of cancer in the previous 5 years
- Patients with parasitic infections
- Patients with documented active tuberculosis or undergoing anti-TB therapy
- Patients currently or recently (in the preceding 4 weeks) treated with systemic immunosuppressive agents according to medical history
- Pregnant or nursing women
- Known intolerance to any protocol intervention
- Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly
Exclusion
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01803763
Start Date
September 1 2012
End Date
March 1 2014
Last Update
April 15 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Rheumatology, Clinical Immunology and Allergology, Bern University Hospital
Bern, Canton of Bern, Switzerland, 3010