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Trial registered on ANZCTR


Registration number
ACTRN12611001095954
Ethics application status
Approved
Date submitted
19/10/2011
Date registered
21/10/2011
Date last updated
21/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of chronic refractory urticaria with the medicine adalimumab
Scientific title
Treatment of chronic refractory urticaria with adalimumab
Secondary ID [1] 273231 0
Nil known
Universal Trial Number (UTN)
U1111-1125-3242
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urticaria 278991 0
Condition category
Condition code
Skin 279173 279173 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 269563 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279810 0
Urticaria Activity Score
Timepoint [1] 279810 0
Baseline and week 4, 9, 16, 18, 20 and 28
Secondary outcome [1] 294496 0
Itch assessed with Structured Itch Questionnaire
Timepoint [1] 294496 0
Baseline and week 4, 9, 16, 18, 20 and 28
Secondary outcome [2] 294497 0
Life quality and emotions assessed with Becks Depression Inventory, Brief Symptom Inventory and Dermatology Life Quality Index
Timepoint [2] 294497 0
Baseline and week 4, 9, 16, 18, 20 and 28
Secondary outcome [3] 294498 0
Sleep quality assessed with Pittsburg Sleep Quality Index
Timepoint [3] 294498 0
Baseline and week 4, 9, 16, 18, 20 and 28
Secondary outcome [4] 294499 0
Bodily sensations assessed with Somatosensory Amplification Scale
Timepoint [4] 294499 0
Baseline and week 4, 9, 16, 18, 20 and 28

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
67 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 3914 0
Denmark
State/province [1] 3914 0

Funding & Sponsors
Funding source category [1] 270060 0
Commercial sector/Industry
Name [1] 270060 0
Abbott Denmark
Country [1] 270060 0
Denmark
Funding source category [2] 270061 0
Charities/Societies/Foundations
Name [2] 270061 0
Aage Bang Foundation
Country [2] 270061 0
Denmark
Primary sponsor type
Individual
Name
Senior doctor Claus Zachariae
Address
Niels Andersens Vej 65
2900 Hellerup
Country
Denmark
Secondary sponsor category [1] 269024 0
None
Name [1] 269024 0
Address [1] 269024 0
Country [1] 269024 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272017 0
Ethics Committee of the Capital Region of Denmark
Ethics committee address [1] 272017 0
Kongens Vaenge 2
3400 Hilleroed
Ethics committee country [1] 272017 0
Denmark
Date submitted for ethics approval [1] 272017 0
Approval date [1] 272017 0
Ethics approval number [1] 272017 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33280 0
Address 33280 0
Country 33280 0
Phone 33280 0
Fax 33280 0
Email 33280 0
Contact person for public queries
Name 16527 0
Claus Zachariae
Address 16527 0
Niels Andersens Vej 65
2900 Hellerup
Country 16527 0
Denmark
Phone 16527 0
+45 3977 3203
Fax 16527 0
Email 16527 0
[email protected]
Contact person for scientific queries
Name 7455 0
Claus Zachariae
Address 7455 0
Niels Andersens Vej 65
2900 Hellerup
Country 7455 0
Denmark
Phone 7455 0
+45 3977 3203
Fax 7455 0
Email 7455 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.