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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

Page last updated: August 23, 2015

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