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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Enthesitis Related Arthritis (ERA)

Treatments: Biological: adalimumab; Biological: placebo for adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01166282

M11-328

2009-017938-46 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 46 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 3 patient groups, including a placebo group

Double-blind Placebo EOW

Placebo Comparator group

Description:

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

Treatment:

Biological: placebo for adalimumab

Double-blind Adalimumab EOW

Experimental group

Description:

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

Treatment:

Biological: adalimumab

Open-label Adalimumab EOW

Experimental group

Description:

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.

Treatment:

Biological: adalimumab