RecruitingPhase 4ACTRN12611001095954

Treatment of chronic refractory urticaria with the medicine adalimumab

Treatment of chronic refractory urticaria with adalimumab


Sponsor

Senior doctor Claus Zachariae

Enrollment

10 participants

Start Date

Aug 1, 2011

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 67 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called adalimumab (which blocks an inflammatory chemical in the body) can help people with chronic hives (urticaria) that have not responded to other treatments. People with this condition can experience severe, disabling itching and hive outbreaks for months or years. Adalimumab targets the specific inflammation pathway involved. You may be eligible if: - You are between 18 and 67 years old - You have had chronic hives for more than 6 months with outbreaks nearly every other day - You have already tried high-dose antihistamines, prednisolone, and at least one other immunosuppressive drug for at least 3 months without enough relief You may NOT be eligible if: - You are pregnant or breastfeeding - You have diabetes, severe heart, kidney, or liver disease - You have a chronic infection - You have had a previous cancer (except non-melanoma skin cancer) - You have previously been treated with TNF-alpha inhibitors Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 subcutaneo

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)

Denmark

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ACTRN12611001095954