Long-term Safety of Protopic in Atopic Eczema

NCT ID: NCT00560378

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 789 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-06-30
• Study Completion Date: 2005-06-30

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).

Conditions

Dermatitis, Atopic; Eczema, Atopic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus Ointment 0.1%

Group Type: EXPERIMENTAL

Tacrolimus ointment 0.1%

Intervention Type: DRUG

Topical

Interventions

Tacrolimus ointment 0.1%

Topical

Intervention Type: DRUG

Other Intervention Names

Protopic

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma GmbH

Locations

Brussels, , Belgium

Aarhus, , Denmark

Helsinki, , Finland

Tampere, , Finland

Turku, , Finland

Bordeaux, , France

Brest, , France

Gaël, , France

Lyon, , France

Nantes, , France

Paris, , France

Pessac, , France

Quimper, , France

Saint-Etienne, , France

Tours, , France

Bonn, , Germany

Düsseldorf, , Germany

Erlangen, , Germany

Freiburg im Breisgau, , Germany

Hamburg, , Germany

Hanover, , Germany

München, , Germany

Münster, , Germany

Tübingen, , Germany

Szeged, , Hungary

Cork, , Ireland

Dublin, , Ireland

Riga, , Latvia

Amsterdam, , Netherlands

Warsaw, , Poland

Barcelona, , Spain

Madrid, , Spain

Seville, , Spain

Cardiff, , United Kingdom

Coventry, , United Kingdom

Lancaster, , United Kingdom

Leicester, , United Kingdom

Liverpool, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Southhampton, , United Kingdom

Countries

Belgium; Denmark; Finland; France; Germany; Hungary; Ireland; Latvia; Netherlands; Poland; Spain; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 18637898 (View on PubMed)

Other Identifiers

FG-506-06-21

Identifier Type: -

Identifier Source: org_study_id