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

This study is currently recruiting participants.
Verified October 2012 by Tuen Mun Hospital
Sponsor:
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT01718951
First received: October 29, 2012
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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

Further study details as provided by Tuen Mun Hospital:

Primary Outcome Measures:
  • Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in MRI spinal inflammation scores


Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718951

Locations
Hong Kong
Tuen Mun Hospital Recruiting
Hong Kong, Hong Kong
Contact: CC Mok, MD, FRCP     (852) 2468 5111     ccmok2006@gmail.com    
Contact: Becky Fong     (8520 2486 8342        
Principal Investigator: CC Mok, MD, FRCP            
Sponsors and Collaborators
Tuen Mun Hospital
  More Information

No publications provided

Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital
ClinicalTrials.gov Identifier: NCT01718951     History of Changes
Other Study ID Numbers: CREC/769/09
Study First Received: October 29, 2012
Last Updated: October 31, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Tuen Mun Hospital:
spondyloarthropathy
ankylosing spondylitis

Additional relevant MeSH terms:
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
 Arthritis
Joint Diseases
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013