Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

NCT01114880 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2011-12-01

Study results available
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Summary

Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese participants with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

Conditions

Interventions

BIOLOGICAL

adalimumab

Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week

OTHER

placebo

Prefilled syringe, matching placebo administered subcutaneously every other week

Sponsors & Collaborators

Principal Investigators

  • Aileen Pangan · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-09-30
Completion
2011-02-28

Countries

  • China

Study Locations

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Entities

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 NCT01114880 on ClinicalTrials.gov