Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients
observational
9
1 country
1
Brief Summary
To evaluate the clinical efficacy of the extended release formulation of tacrolimus (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with cyclosporine A because of side effects and/or non-responsiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 6, 2013
CompletedFirst Posted
Study publicly available on registry
February 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMay 29, 2015
May 1, 2015
1.3 years
February 6, 2013
May 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Scoring Atopic Dermatitis (SCORAD)
Clinical eczema scores
Every 4 weeks up to one year
Secondary Outcomes (2)
Change in Patient-Oriented Eczema Measure (POEM)
Every 4 weeks up to one year
Change in Thymus and Activation-Regulated Chemokine in serum (TARC)
Every 4 weeks up to one year
Study Arms (1)
Extended release tacrolimus (Advagraf®)
Interventions
Eligibility Criteria
Patients with severe atopic dermatitis, who can not be treated adequately with Cycloporin A because of side effects and/or non-responsiveness.
You may qualify if:
- Adult patients with severe atopic dermatitis, uncontrolled by topical treatment (indication for oral immunosuppressive drugs), who are unresponsive to Cyclosporin A, or in which treatment was discontinued because of side effects.
You may not qualify if:
- Concomitant use of other oral immunosuppressive drugs and/or UV light therapy
- Preexisting abnormalities in liver function, kidney function or haematological abnormalities
- History of malignancy within the last 5 years
- Uncontrolled hypertension
- Pregnancy or lactation; wish for pregnancy during the treatment period
- Infections requiring continued therapy
- Known positivity for HIV
- Evidence of drug and/or alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (1)
University Medical Center Utrecht
Utrecht, Utrecht, 3584CX, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C AFM Bruijnzeel-Koomen, MD, PhD
UMC Utrecht
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 6, 2013
First Posted
February 12, 2013
Study Start
October 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
May 29, 2015
Record last verified: 2015-05