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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00936143
First received: July 7, 2009
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Spondylitis
Drug: infliximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Proportion of patients achieving ASAS20 improvement. [ Time Frame: 6th week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients achieving ASAS50 and ASAS70 [ Time Frame: 6th week and 24 week. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: infliximab
    100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
    Other Name: remicade
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936143

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

No publications provided

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
Study First Received: July 7, 2009
Last Updated: January 18, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by 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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014