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

NCT01718951 | Completed Phase 4

• 1 other identifier: CREC/769/09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy

Conditions

Spondyloarthropathy

Keywords

spondyloarthropathy; ankylosing spondylitis

Outcome Measures

Primary Outcomes (1)

• Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response

  Proportion of patients who achieve the Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response

  week 48

Secondary Outcomes (1)

• Changes in MRI spinal inflammation scores

  week 24 and 48

Study Arms (2)

golimumab

ACTIVE COMPARATOR

golimumab 50mg subcutaneous every 4 weeks

Drug: golimumab

pamidronate

ACTIVE COMPARATOR

Pamidronate (60mg) intravenously every 4 weeks

Drug: Pamidronate

Interventions

golimumab DRUG

golimumab

Also known as: Simponi

golimumab

Pamidronate DRUG

pamidronate

Also known as: Aridia

pamidronate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects greater than 18 years of age
• Fulfilling the latest classification criteria for axial spondyloarthropathy
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tuen Mun Hospital: lead

Study Sites (1)

Tuen Mun Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Spondylarthropathies; Spondylitis, Ankylosing

Interventions

golimumab; Pamidronate

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Ankylosis

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 1, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

HK (1)