Clinical trial NCT01166282: A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
Official title: A Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Enthesitis Related Arthritis (ERA)
Keywords: inflammatory back pain
ankylosing spondylitis
sacroiliitis
Juvenile Idiopathic Arthritis
enthesitis
arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 46
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is 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).


Eligibility 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-tumor necrosis factor (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.

Primary outcomes:
measure: Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Number of Sites of Enthesitis: Change From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Tender Joint Count (TJC72): Change From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Swollen Joint Count (SJC68): Change From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30)
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50)
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70)
timeFrame: Baseline and Week 12
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Jaclyn Anderson, DO, MS
role: STUDY_DIRECTOR
References:
citation: Burgos-Vargas R, Tse SM, Horneff G, Pangan AL, Kalabic J, Goss S, Unnebrink K, Anderson JK. A Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Adalimumab in Pediatric Patients With Enthesitis-Related Arthritis. Arthritis Care Res (Hoboken). 2015 Nov;67(11):1503-12. doi: 10.1002/acr.22657.
citation: Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.