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

Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936143
• Other study ID #: REM-CHN-IIS-01
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2009
• Last updated: January 24, 2016
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

Intervention

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

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Gu Jieruo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving ASAS20 improvement.		6th week	Yes
Secondary	Proportion of patients achieving ASAS50 and ASAS70		6th week and 24 week.	Yes