Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000295640
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
5/09/2005
Date last updated
5/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Open-Label, Multicentre Study to Evaluate the Duration of Clinical Remission of Two Courses of Weekly Intramuscular administration of AMEVIVE (alefacept) by evaluating the time to retreatment with AMEVIVE or an alternative systemic therapy in patients with chronic plaque psoriasis in the context of standard dermatological practice
Scientific title
An Open-Label, Multicentre Study to Evaluate the Duration of Clinical Remission of Two Courses of Weekly Intramuscular administration of AMEVIVE (alefacept) by evaluating the time to retreatment with AMEVIVE or an alternative systemic therapy in patients with chronic plaque psoriasis in the context of standard dermatological practice
Secondary ID [1] 137 0
AUS-7001
Universal Trial Number (UTN)
Trial acronym
MEDRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic plaque psoriasis 383 0
Condition category
Condition code
Skin 454 454 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One or two courses of Amevive (alefacept) 15mg im weekly for 12 weeks.
Intervention code [1] 285 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 515 0
Time to retreatment with AMEVIVE or an alternative systemic therapy
Timepoint [1] 515 0
Patients are followed up at monthly intervals after completion of the 12-week dosing phase until they are deemed to require retreatment by the investigator
Secondary outcome [1] 1105 0
To determine the safety and tolerability of two courses of alefacept given alone patients with chronic plaque psoriasis.
Timepoint [1] 1105 0
atients are followed-up at monthly intervals after completion of the 12-week dosing phase until they are deemed to require retreatment by the investigator.
Secondary outcome [2] 1106 0
To determine the effect of AMEVIVE on patients' Quality of Life (QOL).
Timepoint [2] 1106 0
At baseline, day 92, day 162 and then monthly after completion of a second course until the patient is deemed to require retreatment by the investigator.

Eligibility
Key inclusion criteria
1. Must give written informed consent. 2. Must have been diagnosed with chronic plaque psoriasis and require systemic therapy. 3. Must have CD4+ lymphocyte counts at or above the lower limit of normal.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current erythrodermic, generalized pustular, or guttate psoriasis. 2. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months prior to the first dose of alefacept. 3. History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that would be contraindicated for this study as determined by the investigator. 4. Prior history of systemic malignancy, untreated localised skin cancer or a >10 squamous cell carcinoma that have been previously treated. 5. Current enrollment in any other investigational drug study within 30 days prior to study drug administration. 6. Current treatment with any therapy for active tuberculosis or tuberculosis prophylaxis. 9. Female patients who are currently pregnant or breast-feeding.

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 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/07/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 503 0
Commercial sector/Industry
Name [1] 503 0
Biogen Idec
Country [1] 503 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Biogen Idec
Address
Country
United States of America
Secondary sponsor category [1] 412 0
None
Name [1] 412 0
n/a
Address [1] 412 0
Country [1] 412 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35493 0
Address 35493 0
Country 35493 0
Phone 35493 0
Fax 35493 0
Email 35493 0
Contact person for public queries
Name 9474 0
Dr James Garner
Address 9474 0
Biogen Idec Australia
PO Box 380
North Ryde BC NSW 1670
Country 9474 0
Australia
Phone 9474 0
+61 2 88753900
Fax 9474 0
Email 9474 0
James.Garner@biogenidec.com
Contact person for scientific queries
Name 402 0
Dr James Garner
Address 402 0
Biogen Idec Australia
PO Box 380
North Ryde BC NSW 1670
Country 402 0
Australia
Phone 402 0
+61 2 88753900
Fax 402 0
Email 402 0
James.Garner@biogenidec.com

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.