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

Primary Purpose

Spondylitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
infliximab
Sponsored by
Gu Jieruo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylitis focused on measuring Spondylitis, Ankylosing, infliximab, Antibodies, Monoclonal

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Third Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

infliximab

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of patients achieving ASAS20 improvement.

Secondary Outcome Measures

Proportion of patients achieving ASAS50 and ASAS70

Full Information

First Posted
July 7, 2009
Last Updated
January 24, 2016
Sponsor
Gu Jieruo
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1. Study Identification

Unique Protocol Identification Number
NCT00936143
Brief Title
Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis
Official Title
An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gu Jieruo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylitis
Keywords
Spondylitis, Ankylosing, infliximab, Antibodies, Monoclonal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
infliximab
Arm Type
Experimental
Arm Description
200mg infliximab inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
Intervention Type
Drug
Intervention Name(s)
infliximab
Other Intervention Name(s)
remicade
Intervention Description
100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
Primary Outcome Measure Information:
Title
Proportion of patients achieving ASAS20 improvement.
Time Frame
6th week
Secondary Outcome Measure Information:
Title
Proportion of patients achieving ASAS50 and ASAS70
Time Frame
6th week and 24 week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 16 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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