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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01166282
First received: July 19, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Enthesitis Related Arthritis (ERA)
Biological: adalimumab - blinded
Biological: placebo for adalimumab - blinded
Biological: Adalimumab - open label
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percent change in the number of active joints with arthritis [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    Assessment of joints with swelling not due to deformity or joints with loss of motion plus pain and/or tenderness

  • Adverse Events [ Time Frame: At every visit from Baseline (Week 0) to final Visit (Week 156) ] [ Designated as safety issue: Yes ]
    Any untoward medical occurrence


Secondary Outcome Measures:
  • Entheses [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The presence or absence of enthesitis at 35 different anatomical locations

  • Tender Joint Count [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The presence or absence of joint tenderness at 72 joints

  • Swollen Joint Count [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The presence or absence of joint swelling at 68 joints.

  • American College of Rheumatology (ACR) Pediatric 30, 50 and 70 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    30, 50 and 70% improvement, respectively, in at least three of the six Juvenile Rheumatoid Arthritis (JRA) core set criteria, with 30% worsening in no more than one of the six JRA core set criteria.


Estimated Enrollment: 45
Study Start Date: September 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab - Blinded Biological: adalimumab - blinded
blinded adalimumab BSA dosing 24mg/m^2, max 40 mg
Other Name: ABT-D2E7 Humira
Placebo Comparator: Placebo - Blinded Biological: placebo for adalimumab - blinded
blinded matching placebo for adalimumab, matching BSA dosing
Other Name: placebo
Experimental: Adalimumab - Open Label Biological: Adalimumab - open label
open-label adalimumab BSA dosing 24mg/m^2, max 40 mg
Other Name: ABT-D2E7 Humira

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166282

Locations
Canada
Site Reference ID/Investigator# 36382
Toronto, Canada, M5G 1X8
France
Site Reference ID/Investigator# 36363
Bordeaux, France, 33000
Site Reference ID/Investigator# 36362
Paris, France, 75015
Germany
Site Reference ID/Investigator# 36365
Berlin, Germany, 13353
Site Reference ID/Investigator# 36366
Hamburg, Germany, 22081
Site Reference ID/Investigator# 36364
Sankt Augustin, Germany, 53757
Italy
Site Reference ID/Investigator# 37245
Milan, Italy, 20112
Mexico
Site Reference ID/Investigator# 36386
Mexico D.F., Mexico, C.P. 06720
Site Reference ID/Investigator# 36383
Monterrey, N.L., Mexico, C.P. 64460
Poland
Site Reference ID/Investigator# 36784
Krakow, Poland, 31-503
Site Reference ID/Investigator# 36368
Lodz, Poland, 91-738
Spain
Site Reference ID/Investigator# 38443
Madrid, Spain, 28009
Site Reference ID/Investigator# 36369
Madrid, Spain, 28034
Site Reference ID/Investigator# 36371
Valencia, Spain, 46026
Sweden
Site Reference ID/Investigator# 36786
Stockholm, Sweden, SE-171 76
Switzerland
Site Reference ID/Investigator# 36373
Lausanne, Switzerland, 1011
Site Reference ID/Investigator# 36372
Zurich, Switzerland, 8032
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jaclyn Anderson, DO AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01166282     History of Changes
Other Study ID Numbers: M11-328, 2009-017938-46
Study First Received: July 19, 2010
Last Updated: July 21, 2014
Health Authority: Canada: Health Canada
Mexico: Ministry of Health
Ireland: Irish Medicines Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency
Switzerland: Swissmedic
Poland: The Central Register of Clinical Trials
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency

Keywords provided by AbbVie:
enthesitis
Juvenile Idiopathic Arthritis
ankylosing spondylitis
inflammatory back pain
sacroiliitis

Additional relevant MeSH terms:
Arthritis
Tendinopathy
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014