A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA).

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Detailed Description

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Conditions

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Enthesitis Related Arthritis (ERA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Double-blind Placebo EOW

Placebo for adalimumab every other week (eow) for 12 weeks.

Group Type PLACEBO_COMPARATOR

placebo for adalimumab

Intervention Type BIOLOGICAL

Placebo for adalimumab solution for subcutaneous injection.

Double-blind Adalimumab EOW

Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.

Group Type EXPERIMENTAL

adalimumab

Intervention Type BIOLOGICAL

Adalimumab solution for subcutaneous injection.

Open-label Adalimumab EOW

Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.

Group Type EXPERIMENTAL

adalimumab

Intervention Type BIOLOGICAL

Adalimumab solution for subcutaneous injection.

Interventions

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adalimumab

Adalimumab solution for subcutaneous injection.

Intervention Type BIOLOGICAL

placebo for adalimumab

Placebo for adalimumab solution for subcutaneous injection.

Intervention Type BIOLOGICAL

Other Intervention Names

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ABT-D2E7 Humira

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Enthesitis Related Arthritis (ERA) as defined by International League of Associations for Rheumatology (ILAR);
* Disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location;
* Inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate.

Exclusion Criteria

* Any ILAR Juvenile Idiopathic Arthritis (JIA) subtype other than ERA;
* Psoriasis or a history of psoriasis in the patient or first-degree relative;
* Presence of Immunoglobulin M (IgM) rheumatoid factor;
* Presence of systemic JIA;
* History of inflammatory bowel disease;
* previous biologic therapy including anti-tumor necrosis factor (anti-TNF) therapy with a potential impact on pediatric ERA;
* Infection(s) requiring treatment with IV anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No