Treatment of chronic refractory urticaria with the medicine adalimumab

Treatment of chronic refractory urticaria with adalimumab

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001095954

Enrollment

Registered

2011-10-21

Start date

2011-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 67 Years

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results