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Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED)

NCT00779935 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-05-11

No results posted yet for this study

Summary

This is a Phase 4, multi-center, open-label, one-arm, pilot study in patients with active ankylosing spondylitis refractory to conventional treatment. Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54. The number of patients showing ASAS-20 clinical response at Week 14 will be evaluated.

Conditions

  • Spondylitis, Ankylosing

Interventions

BIOLOGICAL

Remicade

Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-10-01
Primary Completion
2005-10-01
Completion
2007-02-01

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Entities

Drugs
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 NCT00779935 on ClinicalTrials.gov