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

This study has been completed.
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University Identifier:
First received: July 7, 2009
Last updated: January 24, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Drug: infliximab
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis

Resource links provided by NLM:

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Proportion of patients achieving ASAS20 improvement. [ Time Frame: 6th week ]

Secondary Outcome Measures:
  • Proportion of patients achieving ASAS50 and ASAS70 [ Time Frame: 6th week and 24 week. ]

Enrollment: 70
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: infliximab
200mg infliximab inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
Drug: infliximab
100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
Other Name: remicade


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 16 to 65 years old, having signed the informed consent;
  2. fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
  3. have inflammatory back pain defined by Calin criteria;
  4. disease duration range from 6 months to 2 years;
  5. BASDAI score more than 4;
  6. MRI score of sacroiliac joint more than 4;
  7. 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:

  1. History of psoriasis or inflammatory bowel disease.
  2. Intra-articular injection of cortisone within 3 months.
  3. Patients were taking cortisone, SASP or MTX, unless the dose has been stable for at least 3 months.
  4. Active iritis.
  5. History of heart failure, multiple sclerosis, COPD, lymphoma or other tumor, tuberculosis.
  6. Female of pregnancy or breast feeding.
  7. History of mental disease and poor compliance.
  8. History of drug abuse or alcoholism.
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Please refer to this study by its identifier: NCT00936143

China, Guangdong
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Gu Jieruo
  More Information

Responsible Party: Gu Jieruo, Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University Identifier: NCT00936143     History of Changes
Other Study ID Numbers: REM-CHN-IIS-01
Study First Received: July 7, 2009
Last Updated: January 24, 2016

Keywords provided by Sun Yat-sen University:
Spondylitis, Ankylosing
Antibodies, Monoclonal

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents processed this record on April 28, 2017