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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00936143

Enrollment

Registered

2009-07-09

Start date

2008-01-31

Completion date

2009-12-31

Last updated

2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylitis

Keywords

Spondylitis, Ankylosing, infliximab, Antibodies, Monoclonal

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.

Interventions

DRUGinfliximab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving ASAS20 improvement.	6th week

Secondary

Measure	Time frame
Proportion of patients achieving ASAS50 and ASAS70	6th week and 24 week.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026