Extended Release Tacrolimus (Advagraf®) in Severe Adult A... | NCT01789619

Studies
Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients

NCT01789619

Sponsor

UMC Utrecht

Status

Completed

Last Update Posted

May 29, 2015Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Atopic Dermatitis

Interventions

Extended release tacrolimus (Advagraf®)

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Feb 6, 2013

First Submission Date that Met QC Criteria

Feb 8, 2013

First Posted Date

Feb 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2015

Last Update Posted Date

May 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Extended release tacrolimus (Advagraf®)			Drug: Extended release tacrolimus (Advagraf®)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extended release tacrolimus (Advagraf®)	Drug		Extended release tacrolimus (Advagraf®)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Scoring Atopic Dermatitis (SCORAD)	Clinical eczema scores	Every 4 weeks up to one year

Secondary Outcomes

Measure	Description	Time Frame
Change in Patient-Oriented Eczema Measure (POEM)	Self administered eczema score	Every 4 weeks up to one year
Change in Thymus and Activation-Regulated Chemokine in serum (TARC)	Biomarker atopic dermatitis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with severe atopic dermatitis, who can not be treated adequately with Cycloporin A because of side effects and/or non-responsiveness.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
C AFM Bruijnzeel-Koomen, MD, PhD	UMC Utrecht	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Utrecht		Utrecht	Utrecht	3584CX	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided