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
Summary
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 arthritisAdverse Events
Secondary outcome: EnthesesTender Joint Count Swollen Joint Count American College of Rheumatology (ACR) Pediatric 30, 50 and 70
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
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