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

Gu Jieruo

Status and phase: Completed; Phase 4

Conditions: Spondylitis

Treatments: Drug: infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00936143

REM-CHN-IIS-01

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

infliximab

Experimental group

Description:

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

Treatment:

Drug: infliximab