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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Enthesitis Related Arthritis (ERA)

Intervention: adalimumab - blinded (Biological); placebo for adalimumab - blinded (Biological); Adalimumab - open label (Biological)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Aileen L Pangan, MD, Study Director, Affiliation: AbbVie


The study will evaluate how well adalimumab works and how safe it is in the treatment of children with Enthesitis Related Arthritis.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Percent change in the number of active joints with arthritis

Adverse Events

Secondary outcome:


Tender Joint Count

Swollen Joint Count

American College of Rheumatology (ACR) Pediatric 30, 50 and 70


Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.


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-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

Locations and Contacts

Site Reference ID/Investigator# 36382, Toronto M5G 1X8, Canada

Site Reference ID/Investigator# 36363, Bordeaux 33000, France

Site Reference ID/Investigator# 36362, Paris 75015, France

Site Reference ID/Investigator# 36365, Berlin 13353, Germany

Site Reference ID/Investigator# 36366, Hamburg 22081, Germany

Site Reference ID/Investigator# 36364, Sankt Augustin 53757, Germany

Site Reference ID/Investigator# 37245, Milan 20112, Italy

Site Reference ID/Investigator# 36386, Mexico D.F. C.P. 06720, Mexico

Site Reference ID/Investigator# 36383, Monterrey, N.L. C.P. 64460, Mexico

Site Reference ID/Investigator# 36784, Krakow 31-503, Poland

Site Reference ID/Investigator# 36368, Lodz 91-738, Poland

Site Reference ID/Investigator# 36369, Madrid 28034, Spain

Site Reference ID/Investigator# 38443, Madrid 28009, Spain

Site Reference ID/Investigator# 36371, Valencia 46026, Spain

Site Reference ID/Investigator# 36786, Stockholm SE-171 76, Sweden

Site Reference ID/Investigator# 36373, Lausanne 1011, Switzerland

Site Reference ID/Investigator# 36372, Zurich 8032, Switzerland

Additional Information

Starting date: September 2010
Last updated: July 13, 2015

Page last updated: August 23, 2015

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