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Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease

NCT02015793 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-05-30

Study results available
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Summary

The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese subjects with Crohn's disease.

Conditions

Interventions

BIOLOGICAL

Adalimumab

Adalimumab pre-filled syringe, administered by subcutaneous injection.

BIOLOGICAL

Placebo for adalimumab

Placebo for adalimumab pre-filled syringe, administered by subcutaneous injection to maintain double-blind.

Sponsors & Collaborators

Principal Investigators

  • Anne Robinson · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-02-28
Completion
2015-02-28

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Entities

Drugs
Diseases
Companies

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 NCT02015793 on ClinicalTrials.gov