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

• Register: EUCTR
• Last refreshed on: 19 April 2022
• Main ID: EUCTR2010-023802-10-ES
• Date of registration: 12/07/2011
• Prospective Registration: Yes
• Primary sponsor: PFIZER, S.L.U.
• 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: 15/09/2011
• Target sample size: 123
• Recruitment status: Not Recruiting
• 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: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
Subject eligibility should be reviewed and documented by an
appropriately qualified member of the investigator's study team before
subjects are included in the study. Subjects must meet all of the
following inclusion criteria to be eligible for enrollment into the study:
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.
4.1.1. Additional Inclusion Criteria for Subjects Planning to Continue
Investigational Product - Subjects must meet the following additional
inclusion criteria to be eligible to continue investigational product in
study B1801023:
5. Have completed approximately 96 weeks of investigational product in
study 0881A1 3338 and, in the investigator's judgment, is appropriate to
continue treatment with etanercept.
6. Either the subject or an available adult must be capable (according to
the investigator's judgment) of reconstituting and administering
injections of subcutaneous (SC) etanercept.
7. The subject, parent, or legally authorized representative/guardian of
the subject must be able to read and complete the protocol specified
efficacy assessments.
8. The first dose of etanercept in study B1801023 must be administered
within 6 weeks of receiving the last dose of etanercept in the study
0881A1 3338.
Those subjects who do not meet entry criteria for continuing
investigational product after completion of 96 weeks of investigational
product in study 0881A1 3338 will be asked to participate in the
observational period in study B1801023.
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:
Exclusion Criteria for All Subjects - Subjects presenting with any of the
following will not be included in the study:
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.
6. Receipt of any of the following between the week 96 visit in study
0881A1 3338 and the baseline visit in study B1801023:
Any biologic drugs, including but not limited to TNF inhibitors (other
than etanercept), abatacept, rituximab, anakinra and tocilizumab;
Immunosuppressive drugs (excluding corticosteroids) (eg,
cyclophosphamide, cyclosporine, azathioprine);
Leflunomide;
Use of more than 1 of the non biologic DMARDs permitted in study
0881A1-3338 (ie, methotrexate, hydroxychloroquine, chloroquine,
sulfasalazine) in subject's <18 years of age;
Use of more than 2 of the non biologic DMARDs permitted in study
0881A1 3338 (ie, methotrexate, hydroxychloroquine, chloroquine,
sulfasalazine) or hydroxychloroquine and chloroquine taken at the same
time in subjects 18 years of age;
Non biologic DMARDs other than those permitted in study 0881A1
3338 (ie, methotrexate, hydroxychloroquine, chloroquine, sulfasalazine),
or those not listed under other exclusion criteria;
Any live (attenuated) vaccines.
7. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study
participation or investigational product administration or may interfere
with the interpretation of study results and, in the judgment of the
investigator, would make the subject inappropriate for entry into this
study.
8. Signs and symptoms or suspicion of active tuberculosis.


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

Health Condition(s) or Problem(s) studied

Oligoarticular juvenile idiopathic arthritis, enthesistis related arthritis, or psoriatic arthritis
MedDRA version: 14.0 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 25 mg/ml polvo y disolvente para solución inyectable para uso pediátrico
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Current Sponsor code: B1801023
Other descriptive name: ETANERCEPT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: ENBREL 50 mg solución inyectable en jeringas precargadas
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Current Sponsor code: B1801023
Other descriptive name: ETANERCEPT
Concentration unit: mg milligram(s)
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.

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

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

Secondary Outcome(s)

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).
Additional Key Secondary Endpoints for Subjects in the Active Treatment
Period
-Occurrence of all adverse events, including infections, infections
considered preventable by vaccination, and injection site reactions;
-Occurrence of withdrawals from investigational product due to adverse
events;
-Laboratory evaluations;
-Growth parameters;
-Tanner Stage Assessment for selected subjects.
- Other Secondary Endpoints for Subjects in the Active Treatment Period
-Physician's Global Assessment (PGA) of Disease Activity on a 21 circle
visual analogue scale (VAS);
-Patient/Parent Global Assessment on a 21 circle VAS;
-C reactive protein (CRP).

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

Secondary ID(s)

2010-023802-10-HU

B1801023

Source(s) of Monetary Support

Pfizer Inc.

Ethics review

Status: Approved
Approval date: 04/08/2011
Contact:

Results

• Results available: Yes
• Date Posted: 15/08/2021
• Date Completed: 04/02/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-023802-10/results