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A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)

NCT00779012 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-05-11

No results posted yet for this study

Summary

The objective of this study is to prove reasonability of registration in Russian federation this new indication (ankylosing spondylitis \[AS\]) through evaluation of safety and efficacy rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).

Conditions

  • Spondylitis, Ankylosing

Interventions

BIOLOGICAL

Infliximab

Remicade 5 mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).

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
2007-06-01
Completion
2007-06-01

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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 NCT00779012 on ClinicalTrials.gov