E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS |
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E.1.1.1 | Medical condition in easily understood language |
3 Sub-types of Childhood Arthritis (Extended Oligoarticular Arthritis, Enthesitis-Related Arthritis, and Psoriatic Arthritis) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059176 |
E.1.2 | Term | Juvenile idiopathic arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To monitor the occurrence of malignancy in pediatric subjects with extended
oligoarticular JIA, ERA, or PsA. |
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E.2.2 | Secondary objectives of the trial |
To assess the long term safety profile of etanercept.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of malignancy. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belgium |
Colombia |
Czech Republic |
France |
Germany |
Hungary |
Italy |
Latvia |
Lithuania |
Mexico |
Netherlands |
Norway |
Poland |
Russian Federation |
Serbia |
Slovakia |
Slovenia |
Spain |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 9 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 12 |
E.8.9.2 | In all countries concerned by the trial years | 9 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 12 |