Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types of Childhood Arthritis.

• Register: EUCTR
• Last refreshed on: 2 October 2012
• Main ID: EUCTR2010-023802-10-IT
• Date of registration: 02/04/2012
• Prospective Registration: No
• Primary sponsor: PFIZER INC.
• Public title: Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types of Childhood Arthritis.
• Scientific title: AN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014) - Clipper 2
• Date of first enrolment: 21/02/2012
• Target sample size: 123
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023802-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Australia, Belgium, Colombia, Czech Republic, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Russian Federation, Slovakia, Slovenia, Spain

Contacts

• Name: ClinicalTrials.gov Call Center
• Affiliation: Pfizer Inc.

• Name: ClinicalTrials.gov Call Center
• Affiliation: Pfizer Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Evidence of a personally signed and dated informed consent document (and assent document, as applicable) indicating that the subject (or a legally authorized representative/guardian) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with all applicable aspects of the study, including scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Receipt of at least 1 dose of investigational product and participation for approximately 96 weeks in study 0881A1 3338. 4. The subject and the parent or legally authorized representative/guardian of the subject must be able to provide contact information, including primary care physician or other treating physician.
Are the trial subjects under 18? yes
Number of subjects for this age range: 99
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. Additional Exclusion Criteria for Subjects Planning to Continue Investigational Product - Subjects who completed approximately 96 weeks of investigational product in study 0881A1 3338 and present with any of the following will not be allowed to continue investigational product in study B1801023: 2. Withdrawal from investigational product in study 0881A1 3338 for any reason (safety or non safety). 3. History of malignancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ. 4. Participation in other clinical studies of investigational drugs or investigational combinations of approved drugs between the week 96 visit in study 0881A1 3338 and the baseline visit in study B1801023 or during participation in the active treatment period of study B1801023. 5. Pregnant or breastfeeding female subjects.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS
MedDRA version: 14.1 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Current Sponsor code: B1801023
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: To monitor the occurrence of malignancy in pediatric subjects with extended oligoarticular JIA, ERA, or PsA.

Primary end point(s): Occurrence of malignancy.

Timepoint(s) of evaluation of this end point: at minimum every 2 years

Secondary Objective: To assess the long term safety profile of etanercept.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: at minimum every 2 years

Secondary end point(s): Key Secondary Endpoints for All Subjects -Occurrence of serious adverse events; -Occurrence of medically important infections (ie, an infection requiring hospitalization and /or parenteral [intravenous (IV), intra-muscular (IM)] anti infective agents).

Secondary ID(s)

B1801023

2010-023802-10-HU

Source(s) of Monetary Support

Pfizer Inc.