Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis
Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spondylitis
Intervention: infliximab (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Gu Jieruo
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 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.
Clinical Details
Official title: An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of patients achieving ASAS20 improvement.
Secondary outcome: Proportion of patients achieving ASAS50 and ASAS70
Eligibility
Minimum age: 16 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China
Additional Information
Starting date: January 2008
Last updated: January 18, 2012
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