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

NCT01166282 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-07-12

Study results available
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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).

Conditions

  • Enthesitis Related Arthritis (ERA)

Interventions

BIOLOGICAL

adalimumab

Adalimumab solution for subcutaneous injection.

BIOLOGICAL

placebo for adalimumab

Placebo for adalimumab solution for subcutaneous injection.

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Jaclyn Anderson, DO, MS · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-11-30
Completion
2015-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166282 on ClinicalTrials.gov