Phase 3
N=46
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
Enthesitis Related Arthritis (ERA)
Bottom Line
View on ClinicalTrials.gov: NCT01166282 ↗Enrolled (actual)
46
Serious AEs
12.0%
Results posted
Jun 2016
Primary outcome: Primary: Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12 — -11.6; -62.6 percent change — p==0.039
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (Biological); placebo for adalimumab (Biological)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12 |
-11.6; -62.6 | =0.039 sig |
| SECONDARY Number of Sites of Enthesitis: Change From Baseline to Week 12 |
7.8; 8.3; 5.1; 3.9; -2.7; -4.4 | =0.382 |
| SECONDARY Tender Joint Count (TJC72): Change From Baseline to Week 12 |
11.9; 13.4; 7.5; 5.5; -4.5; -7.9 | =0.209 |
| SECONDARY Swollen Joint Count (SJC68): Change From Baseline to Week 12 |
5.2; 6.7; 2.8; 3.2; -2.4; -3.5 | =0.509 |
| SECONDARY Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30) |
60.0; 71.0 | =0.514 |
| SECONDARY Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50) |
40.0; 67.7 | =0.111 |
| SECONDARY Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70) |
20.0; 54.8 | =0.031 sig |
| SECONDARY Number of Participants With Adverse Events (AEs) |
8; 21; 46; 4; 9; 29 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01166282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.