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Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718951
First Posted: November 1, 2012
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital
  Purpose
To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy

Condition Intervention Phase
Spondyloarthropathy Drug: golimumab Drug: Pamidronate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chi Chiu Mok, Tuen Mun Hospital:

Primary Outcome Measures:
  • Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response [ Time Frame: week 48 ]
    Proportion of patients who achieve the Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response


Secondary Outcome Measures:
  • Changes in MRI spinal inflammation scores [ Time Frame: week 24 and 48 ]
    Changes in MRI spinal inflammation scores


Enrollment: 30
Study Start Date: August 2012
Study Completion Date: October 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: golimumab
golimumab 50mg subcutaneous every 4 weeks
Drug: golimumab
golimumab
Other Name: Simponi
Active Comparator: pamidronate
Pamidronate (60mg) intravenously every 4 weeks
Drug: Pamidronate
pamidronate
Other Name: Aridia

Detailed Description:
To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological axial spondyloarthropathy
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects greater than 18 years of age
  2. Fulfilling the latest classification criteria for axial spondyloarthropathy
  3. Active spondylitis as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of more than 4 despite treatment with non-steroid anti-inflammatory drugs for more than 3 months

Exclusion Criteria:

  1. Major surgery (including joint surgery) within 8 weeks prior to study entry
  2. History of treatment with anti-tumor necrosis factor agents or any investigational therapies within 12 months of study entry
  3. Immunization with a live/attenuated vaccine within 4 weeks prior to study entry
  4. Active current bacterial, viral, fungal, mycobacterial or other infections at study entry
  5. Chronic hepatitis B or hepatitis C carriers
  6. History of malignancies, including solid tumors and hemic malignancies
  7. History of congestive heart failure
  8. History of demyelinating disorders
  9. History of peripheral neuropathy
  10. Pregnant women or lactating mothers
  11. Baseline liver parenchymal enzymes elevated to more than 2 times normal
  12. Absolute lymphocyte count less than 500/mm3
  13. Serum creatinine level of more than 200umol/L
  Contacts and Locations
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): NCT01718951


Locations
Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Tuen Mun Hospital
  More Information

Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital
ClinicalTrials.gov Identifier: NCT01718951     History of Changes
Other Study ID Numbers: CREC/769/09
First Submitted: October 29, 2012
First Posted: November 1, 2012
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Chi Chiu Mok, Tuen Mun Hospital:
spondyloarthropathy
ankylosing spondylitis

Additional relevant MeSH terms:
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs