A study of the efficacy and safety of adalimumab in pediatric subjects with enthesitis related arthritis

Conditions: Enthesitis Related Arthritis (ERA)
MedDRA version: 14.1Level: PTClassification code 10003246Term: ArthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2009-017938-46-Outside-EU/EEA

Lead Sponsor: Abbott GmbH & Co. KG (Abbott)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 45

Inclusion Criteria

1. Age 6 through 17 years
2. Diagnosis of ERA as defined by ILAR
3. Disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location
4. Inadequate response or intolerance to at least one nonsteroidal anti-nflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate.
Are the trial subjects under 18? yes
Number of subjects for this age range: 45
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. Any ILAR JIA subtype other than ERA
2. Psoriasis or a history of psoriasis in the patient or first-degree relative
3. Presence of IgM rheumatoid factor
4. Presence of systemic JIA, history of inflammatory bowel disease, previous biologic therpay including anti-TNF therapy with a potential impact on pediatric ERA
5. Infection(s) requiring treatment with IV anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objectives of this study are 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), and to examine the pharmacokinetics and immunogenicity of adalimumab following SC administration in this subject population.;Secondary Objective: ;Primary end point(s): Percent change in the number of active joints with arthritis;Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. The presence or absence of enthesitis at 35 different anatomical locations<br>2. The presence or absence of joint tenderness at 72 joints<br>3. The presence or absence of joint swelling at 68 joints<br>4. 30, 50 and 70% improvement, respectively, in at least three of the six JRA core set criteria, with 30% worsening in no more than one of the six JRA core set criteria.;Timepoint(s) of evaluation of this end point: Week 12