A Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects with Enthesitis Related Arthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017938-46-DE

Enrollment

Registered

2010-04-20

Start date

2010-08-24

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enthesitis Related Arthritis (ERA) MedDRA version: 14.1 Level: PT Classification code 10003246 Term: Arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Humira 40 mg solution for injection Product Name: Adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg/ml m

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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

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

Design outcomes

Primary

Measure	Time frame
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 from Baseline to Week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with limitation of motion plus pain and/or tenderness).	—

Measure

Time frame

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 from Baseline to Week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with limitation of motion plus pain and/or tenderness).

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Countries

France, Germany, Ireland, Italy, Spain, Sweden

Contacts

Public ContactClinical Trials Helpdesk

AbbVie Ltd.

euclinicaltrials@abbott.com+441628644330

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026