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

NCT00936143 | Completed Phase 4 DMC

• 1 other identifier: REM-CHN-IIS-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Spondylitis, Ankylosing; infliximab; Antibodies, Monoclonal

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving ASAS20 improvement.

  6th week

Secondary Outcomes (1)

• Proportion of patients achieving ASAS50 and ASAS70

  6th week and 24 week.

Study Arms (1)

infliximab

EXPERIMENTAL

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

Drug: infliximab

Interventions

infliximab DRUG

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

Also known as: remicade

infliximab

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old, having signed the informed consent;
• fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
• have inflammatory back pain defined by Calin criteria;
• disease duration range from 6 months to 2 years;
• BASDAI score more than 4;
• MRI score of sacroiliac joint more than 4;
• 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.

You may not qualify if:

• History of psoriasis or inflammatory bowel disease.
• Intra-articular injection of cortisone within 3 months.
• Patients were taking cortisone, SASP or MTX, unless the dose has been stable for at least 3 months.
• Active iritis.
• History of heart failure, multiple sclerosis, COPD, lymphoma or other tumor, tuberculosis.
• Female of pregnancy or breast feeding.
• History of mental disease and poor compliance.
• History of drug abuse or alcoholism.

Sponsors & Collaborators

• Gu Jieruo: lead

Study Sites (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Spondylitis; Spondylitis, Ankylosing

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 9, 2009
• Study Start: January 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

CN (1)