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

NCT ID: NCT00936143

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-12-31

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 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.

Conditions

Spondylitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

infliximab

200mg infliximab inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week

Group Type: EXPERIMENTAL

infliximab

Intervention Type: DRUG

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

Interventions

infliximab

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

Intervention Type: DRUG

Other Intervention Names

remicade

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gu Jieruo

OTHER

Sponsor Role: lead

Responsible Party

Gu Jieruo

Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

REM-CHN-IIS-01

Identifier Type: -

Identifier Source: org_study_id