Skip to main content
OpenTrials
Completed

NCT Number: NCT00936143

Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis

This is a prospective open-label study to evaluated the efficacy and safety of infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS). Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not necessary. The adverse events at any time were recorded.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Bone Diseases, Infectious Infections Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis, Ankylosing

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 16 to 65 years old, having signed the informed consent;
  • fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
  • have inflammatory back pain defined by Calin criteria;
  • disease duration range from 6 months to 2 years;
  • BASDAI score more than 4;
  • MRI score of sacroiliac joint more than 4;
  • lab examination: hemoglobin more than 90 gram/liter. Aspartate aminotransferase and Alanine aminotransferase less than 2 fold of upper level of normal range. Creatine less than upper level of normal range.

Exclusion criteria

  • History of psoriasis or inflammatory bowel disease.
  • Intra-articular injection of cortisone within 3 months.
  • Patients were taking cortisone, SASP or MTX, unless the dose has been stable for at least 3 months.
  • Active iritis.
  • History of heart failure, multiple sclerosis, COPD, lymphoma or other tumor, tuberculosis.
  • Female of pregnancy or breast feeding.
  • History of mental disease and poor compliance.
  • History of drug abuse or alcoholism.

Treatment and study plan

Infliximab

Drug

100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week

Other names: remicade

Primary outcomes

  1. Proportion of patients achieving ASAS20 improvement.

    Time frame: 6th week

Secondary outcomes

  1. Proportion of patients achieving ASAS50 and ASAS70

    Time frame: 6th week and 24 week.

Sponsors and collaborators

Lead sponsor

Gu Jieruo

Other

Registry information

Official study title

An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 9, 2009
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.