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Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies

NCT00591201 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2008-01-17

No results posted yet for this study

Summary

Tumor necrosis factor (TNF) alpha is a pro-inflammatory cytokine playing a significant role in the pathogenesis of the spondyloarthropathies (SpA). Infliximab is a TNF alpha blocking monoclonal antibody efficacious and safe as treatment of adult-onset SpA.

In this study we will try to demonstrate that infliximab administered at 5mg/kg to patients with juvenile onset SpA over a period of 12 weeks will have more efficacy than placebo and that it will be well tolerated. At the end of this phase, patients will go into a 52-week open extension to demonstrate sustained efficacy, safety, and tolerability of infliximab We will include 34 patients with juvenile onset SpA unresponsive to standard treatment. Efficacy will be assessed by counting the number of actively inflamed joints and a number of other parameters.

Conditions

  • Spondylarthropathies

Interventions

DRUG

infliximab

Infliximab 5mg/kg diluted in 250 ml of isotonic solution of sodium chloride will be administered by the intravenous route on weeks 0, 2, 6, 12, 18, 24, 30, 36, 42, and 48.

DRUG

Placebo

Placebo -powder diluted in 250 ml of isotonic solution of sodium chloride- will be administered on weeks 0, 2 and 6.

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Hospital General de Mexico

    lead OTHER_GOV

Principal Investigators

  • Rubén Burgos-Vargas, MD · Rheumatologist, Hospital General de México/Professor of Medicine, Universidad Nacional Autónoma de México

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2007-06-30
Completion
2007-09-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

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 NCT00591201 on ClinicalTrials.gov