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Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

NCT00844805 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2017-04-12

Study results available
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Summary

The primary objective of this study was to assess the proportion of participants in the infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of participants with moderate-to-severe active axial spondyloarthritis and disease duration of ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission criteria.

Conditions

Interventions

DRUG

Infliximab

DRUG

Placebo

DRUG

Naproxen

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-04-30
Completion
2011-09-30

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Entities

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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 NCT00844805 on ClinicalTrials.gov