Treatment of chronic refractory urticaria with the medicine adalimumab

Phase 4

Recruiting

• Conditions: rticaria; Urticaria; Skin - Dermatological conditions

• Registration Number: ACTRN12611001095954
• Lead Sponsor: Senior doctor Claus Zachariae

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rticaria Activity Score[Baseline and week 4, 9, 16, 18, 20 and 28]

Secondary Outcome Measures

Name	Time	Method
Itch assessed with Structured Itch Questionnaire[Baseline and week 4, 9, 16, 18, 20 and 28];Life quality and emotions assessed with Becks Depression Inventory, Brief Symptom Inventory and Dermatology Life Quality Index[Baseline and week 4, 9, 16, 18, 20 and 28];Sleep quality assessed with Pittsburg Sleep Quality Index[Baseline and week 4, 9, 16, 18, 20 and 28];Bodily sensations assessed with Somatosensory Amplification Scale[Baseline and week 4, 9, 16, 18, 20 and 28]