Clinical trial NCT00560378: Long-term Safety of Protopic in Atopic Eczema
Official title: A Long-term, Open Label, Noncomparative Study to Evaluate the Safety of 0.1% Tacrolimus (FK506) Ointment for Treatment of Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis, Atopic
Eczema, Atopic
Keywords: Tacrolimus
Administration, topical
Drug safety
Adults
Children
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 789
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%

Detailed description: A long-term, multi-centre, open label, non-comparative phase III study in patients with atopic dermatitis. All centres in Europe which have participated or are still participating in the FG-506-06-12, FG-506-06-18 or FG-506-06-19, FG-506-06-22 or FG-506-06-23 studies will be offered a participation in the protocol. Only patients enrolled by those centres for the above mentioned studies, who have received at least one dose of study medication can be enrolled. Tacrolimus ointment 0.1% will be administered until clearance of the skin occurs. Treatment is restarted after signs and symptoms reoccur. Safety will be assessed from adverse events reported by the patient/parent/guardian or observed by the investigator at the site of application and elsewhere. The safety evaluation will include monitoring of routine hematology and serum chemistry parameters at Baseline/Day 1, Week 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and/or at the end of the study (End-of-Study Visit).

Eligibility criteria: Inclusion Criteria:

* Every patient who has participated in the FG-506-06-12, FG-506-06-18, FG-506-06-19, FG-506-06-22 or FG-506-06-23 study, and has received at least one dose of study medication
* Patient is likely to benefit from further treatment with Tacrolimus (FK506) ointment in the opinion of the investigator
* Patient has atopic dermatitis with Body surface involvement between 5% and 60% for patients with the age of 2 years to 15 years (not having reached their 16th birthday) and between 5% and 100% for patients with 16 years of age or older

Exclusion Criteria:

* Patient has an infection requiring treatment
* Patient is known to be HIV positive
* Patient has a systemic disease, including cancer or history of cancer or AIDS, which would contraindicate the use of Tacrolimus (FK506) ointment

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 4 Years
Secondary outcomes:
measure: Haematology and biochemistry parameters and vital signs
timeFrame: 4 Years
Other outcomes:
Locations:
city: Brussels
country: Belgium
city: Bruxelles
country: Belgium
city: Aarhus
country: Denmark
city: Helsinki
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Bordeaux
country: France
city: Brest
country: France
city: Gael
country: France
city: Lyon
country: France
city: Nantes
country: France
city: Paris
country: France
city: Pessac
country: France
city: Quimper
country: France
city: Saint Etienne
country: France
city: Tours
country: France
city: Bonn
country: Germany
city: Duesseldorf
country: Germany
city: Erlangen
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Muenchen
country: Germany
city: Muenster
country: Germany
city: Tuebingen
country: Germany
city: Szeged
country: Hungary
city: Cork
country: Ireland
city: Dublin
country: Ireland
city: Riga
country: Latvia
city: Amsterdam
country: Netherlands
city: Warszawa
country: Poland
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Cardiff
country: United Kingdom
city: Coventry
country: United Kingdom
city: Lancaster
country: United Kingdom
city: Leicester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Southhampton
country: United Kingdom
Study officials:
affiliation: Astellas Pharma GmbH
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: Reitamo S, Rustin M, Harper J, Kalimo K, Rubins A, Cambazard F, Brenninkmeijer EE, Smith C, Berth-Jones J, Ruzicka T, Sharpe G, Taieb A; 0.1% Tacrolimus Ointment Long-term Follow-up Study Group. A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol. 2008 Sep;159(4):942-51. doi: 10.1111/j.1365-2133.2008.08747.x. Epub 2008 Jul 15.