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

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ClinicalTrials.gov Identifier: NCT00936143
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Spondylitis Drug: infliximab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis
Study Start Date : January 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: infliximab
200mg infliximab inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
Drug: infliximab
100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
Other Name: remicade



Primary Outcome Measures :
  1. Proportion of patients achieving ASAS20 improvement. [ Time Frame: 6th week ]

Secondary Outcome Measures :
  1. Proportion of patients achieving ASAS50 and ASAS70 [ Time Frame: 6th week and 24 week. ]


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936143


Locations
China, Guangdong
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Gu Jieruo

Responsible Party: Gu Jieruo, Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00936143     History of Changes
Other Study ID Numbers: REM-CHN-IIS-01
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Gu Jieruo, Sun Yat-sen University:
Spondylitis, Ankylosing
infliximab
Antibodies, Monoclonal

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents