Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

• Register: EUCTR
• Last refreshed on: 19 May 2014
• Main ID: EUCTR2009-012520-84-CZ
• Date of registration: 31/07/2009
• Prospective Registration: Yes
• Primary sponsor: Wyeth Pharmaceuticals Inc, (a Pfizer Company) 500 Arcola Road, Collegeville, PA 19426 USA
• Public title: Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
• Scientific title: A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis - CLIPPER
• Date of first enrolment: 08/02/2010
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012520-84
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Russian Federation, Slovenia, Spain, Sweden

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:
1. Male and female subjects must have met ILAR criteria for diagnosis of 1 of the
following JIA subtypes (see Attachment 1 for ILAR criteria) before the screening
visit and must be within the specified age range at the time of the screening visit:

- extended oligoarticular JIA between the ages of 2 and 17 years.
- ERA between the ages of 12 and 17 years.
- PsA between the ages of 12 and 17 years.

2. At both the screening and baseline visits, the following criteria must be met for
the relevant JIA subtype:
- Extended oligoarticular JIA:
- >= 2 active peripheral joints (swollen or, in the absence of swelling, limited
range of motion accompanied by either pain or tenderness)
- A history of intolerance or an unsatisfactory response to at least a 3 month
course of at least 1 DMARD at an adequate dose.
- PsA:
- >= 2 active peripheral joints (swollen or, in the absence of swelling, limited
range of motion accompanied by either pain or tenderness)
- A history of intolerance or an unsatisfactory response to at least a 3 month
course of at least 1 DMARD at an adequate dose.
- ERA:
- >= 2 active peripheral joints (swollen or, in the absence of swelling, limited
range of motion accompanied by either pain or tenderness)
- A history of intolerance or an unsatisfactory response to at least 1 of the following:
- at least a 1 month course of at least 1 NSAID at an adequate dose
OR
- at least a 3 month course of at least 1 DMARD at an adequate dose.

3. Subjects taking hydroxychloroquine, chloroquine, sulphasalazine, or MTX must
have been receiving these for at least 3 months before the baseline visit. Only 1
of these DMARDs is to be taken throughout the study and the dose must be held
stable for at least 8 weeks before the baseline visit.

4. All male and female subjects who, in the opinion of the investigator, are
bologically capable of having children and are sexually active, must agree and
commit to the use of a reliable method of birth control for the duration of the
study and for 30 days after the last dose of investigational product.

- Female subjects who, in the opinion of the investigator, are biologically capable
of having children must have a negative urine pregnancy test at screening and
baseline (day 1) before administration of investigational product.

5. Either the subject or an available adult must be capable (according to the
investigator’s judgment) of reconstituting and administering injections of SC
etanercept.

6. The parent or legally authorized representative/guardian of the subject must be
able to read and complete the protocol-specified efficacy assessments.

7. The subject and the parent or legally authorized representative/guardian of the
subject must be willing and able to participate in all applicable aspects of the
study

Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subjects with systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or
undifferentiated arthritis per ILAR criteria.
2. Arthritis in an HLA-B27 positive male beginning after the 6th birthday (for PsA
and extended oligoarticular JIA subtypes only as defined per ILAR criteria).
3. The presence of immunoglobulin M (IgM) rheumatoid factor (RF) on at least 2
occasions at least 3 months apart.
4. Subjects with active uveitis within 6 months of the baseline visit.
5. Subjects with other rheumatic diseases including but not limited to Lyme disease,
systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious or
reactive arthritis, overlap syndrome (eg, Sharp’s syndrome), or Reiter’s syndrome.
6. Subjects with pustular, or erythrodermic psoriasis.
7. Prior treatment with any biologic drugs, including TNF inhibitors, abatacept,
rituximab, and tocilizumab.
8. Receipt within 6 months before the baseline visit:
- Immunosuppressive drugs (excluding corticosteroids) (eg, cyclophosphamide,
cyclosporine, azathioprine).
- Leflunomide.
9. Receipt within 3 months before the baseline visit:
- Any investigational nonbiologic drugs or devices.
10. Receipt within 2 month before the baseline visit:
- Any live (attenuated) vaccines
11. Receipt within 4 weeks before the baseline visit:
- A combination of nonbiologic DMARDs (eg, hydroxychloroquine, chloroquine,
sulphasalazine, MTX).
- Nonbiologic DMARDs other than that which will be continued during the study
(ie, hydroxychloroquine, chloroquine, sulphasalazine, or MTX), or those not
listed under other exclusion criteria.
- Ultraviolet A (UVA), ultraviolet B (UVB), or psoralen + UVA (PUVA) therapy for
psoriatic lesions.
12. Receipt within 2 weeks before the baseline visit:
- More than 1 NSAID, or a change in the dose or type of the NSAID, or an NSAID
dose greater than the maximum recommended dose.
- More than 0.2 mg/kg/day or > 10 mg/day, whichever is less, of oral prednisone
or equivalent, or a change in the dose of prednisone or its equivalent. Receipt
of intra-articular or soft tissue corticosteroid injection or bolus intramuscular
(IM) or corticosteroids.

- Topical steroids, oral retinoids, topical vitamin A or D analog preparations or
anthralin for psoriatic lesions (exception – topical therapies are permitted on
the scalp, axillae, and groin at low to moderate strength; the dose and type
must be held stable for at least 2 weeks before the baseline visit).

13. Any major illness/condition or evidence of unstable clinical condition (eg,
cardiovascular [including congestive heart failure], cerebrovascular, neurologic,
metabolic, immunologic, infectious, hepatic, renal condition, uncontrolled
diabetes mellitus or hypertension), or any serious disorder (eg, current or history
of alcohol or drug abuse, current or history of psychiatric disease) that, in the
investigator’s judgment, will substantially increase the risk associated with the
subject’s participation in and completion of the study, or could preclude
the evaluation of the subject’s response, or interfere with the subject’s ability to
give informed consent.
14. Pregnant or breastfeeding female subjects.

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

Health Condition(s) or Problem(s) studied

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

Extended oligoarticular juvenile idiopathic arthritis (JIA) Enthesitis-related arthritis (ERA) Psoriatic arthritis (PsA)
MedDRA version: 14.0 Level: PT Classification code 10003246 Term: Arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Trade Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Primary end point(s): The main endpoint for the combined population is the proportion of subjects meeting the ACR Pedi 30 criteria at week 12, defined as = 30% improvement from baseline in at least 3 of 6 of the following variables, with worsening > 30% in no more than 1 of these variables:
1. PGA of Disease Activity on a 21-circle VAS
2. Parent/Patient Global Assessment on a 21-circle VAS
3. CHAQ
4. Number of active joints, defined as joints with swelling or, in the absence of swelling, joints with limitation of motion with pain and/or tenderness
5. Number of joints with limited range of motion (see attachment 2)
6. Laboratory measure of inflammation (CRP, see laboratory determination section of the protocol)

Secondary Objective: Part 1: To assess the effect of etanercept on safety and physical functioning in subjects with extended oligoarticular JIA, ERA, or PsA.
Part 2: To assess the effect of etanercept on clinical benefit and physical functioning in subjects with extended oligoarticular JIA, ERA, or PsA.

Main Objective: Part 1: To assess the clinical benefit of etanercept in subjects with extended oligoarticular JIA, ERA, or PsA.
Part 2: To assess the long-term safety of etnaercept in subjects with extended oligoarticular JIA, ERA, or PsA.

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96, or upon early withdrawal

Secondary end point(s): ACR Pedi 30 at all other timepoints, ACR Pedi 50, 70, 90, and 100; PGA of Disease Activity; Patient/Parent Global Assessment; CHAQ; Number of Active Joints; Number of Joints with Limitation of Motion; CRP; Pain Assessment; Duration of Morning Stiffness; Disease Status; Tender Entheseal Assessment (for ERA subjects only); PGA of Psoriasis and BSA (for PsA subjects only)

Secondary ID(s)

2009-012520-84-HU

0881A1-3338

NCT00962741

Source(s) of Monetary Support

Pfizer Inc