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: April 8, 2014
Last verified: April 2014

July 19, 2010
April 8, 2014
September 2010
November 2012   (final data collection date for primary outcome measure)
  • 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
  • Percent change in the number of active joints with arthritis [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Assessment of tender and swollen joints and joints with limitation of motion
  • 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
Complete list of historical versions of study NCT01166282 on ClinicalTrials.gov Archive Site
  • 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.
  • Entheses [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The presence or absence of enthesitis at 27 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.
  • ACR 30, 50 and 70 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    30, 50 and 70% improvement respectively, with no more than 30% worsening in a core set of variables.
Not Provided
Not Provided
 
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
A Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Enthesitis Related Arthritis (ERA)
  • Biological: adalimumab - blinded
    blinded adalimumab BSA dosing 24mg/m^2, max 40 mg
    Other Name: ABT-D2E7 Humira
  • Biological: placebo for adalimumab - blinded
    blinded matching placebo for adalimumab, matching BSA dosing
    Other Name: placebo
  • Biological: Adalimumab - open label
    open-label adalimumab BSA dosing 24mg/m^2, max 40 mg
    Other Name: ABT-D2E7 Humira
  • Experimental: Adalimumab - Blinded
    Intervention: Biological: adalimumab - blinded
  • Placebo Comparator: Placebo - Blinded
    Intervention: Biological: placebo for adalimumab - blinded
  • Experimental: Adalimumab - Open Label
    Intervention: Biological: Adalimumab - open label
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
December 2015
November 2012   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   Italy,   Mexico,   Poland,   Spain,   Sweden,   Switzerland
 
NCT01166282
M11-328, 2009-017938-46
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Jaclyn Anderson, DO AbbVie
AbbVie
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP