Status:
COMPLETED
Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis
Lead Sponsor:
Gu Jieruo
Conditions:
Spondylitis
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00936143
Start Date
January 1 2008
End Date
December 1 2009
Last Update
January 26 2016
Active Locations (1)
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1
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630