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

• Register: EUCTR
• Last refreshed on: 5 April 2021
• Main ID: EUCTR2010-023802-10-HU
• Date of registration: 08/06/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc.235 East 42nd Street, New York, NY 10017
• 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: 29/07/2011
• 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, ENTHESITIS 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®
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Current Sponsor code: B1801023
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: B1801023
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

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

Primary end point(s): Occurrence of malignancy.

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

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

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).

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).

Secondary ID(s)

B1801023

Source(s) of Monetary Support

Pfizer Inc.

Ethics review

Status: Approved
Approval date: 13/07/2011
Contact: