Treatment of chronic refractory urticaria with the medicine adalimumab
Treatment of chronic refractory urticaria with adalimumab
Senior doctor Claus Zachariae
10 participants
Aug 1, 2011
Interventional
Conditions
Summary
The purpose of the study is to examine, whether patients with longlasting urticaria, where other treatments have been ineffective, will benefit from treatment with the drug adalimumab. The cytokine tumour necrosis factor alfa is upregulated in the skin and serum in patients with urticaria. Adalimumab is a drug, that blocks tumour necrosis factor alfa.
Eligibility
Inclusion Criteria1
- Patients with chronic urticaria. Duration of chronic urticaria more than 6 months with maximum 2 days between urticaria outbreaks. Unsatisfactory treatment with high dose antihistamines, prednisolone and at least one other immunosuppressive drug for at least 3 months. Unsatisfactory treatment is defined as symptoms several times at week despite treatment.
Exclusion Criteria6
- Pregnancy and lactation
- Diabetes Mellitus
- Severe heart disease, kidney disease or liver disease
- Chronic infections
- Former malignancies except non-melanoma skin cancer
- Former treatment with tumour necrosis factor alpha-inhibitors
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Interventions
Treatment with adalimumab Dose: 80 mg at first administration week 0, thereafter 40 mg at week 1+3+5+7+9+11+13+15. Total duration af treatment is 16 weeks. The mode of administration is subcutaneous.
Locations(1)
View Full Details on ANZCTR
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ACTRN12611001095954