Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial
NCT ID: NCT01718951
Last Updated: 2015-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2012-08-31
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Golimumab in Participants With Active Psoriatic Arthritis
NCT02181673
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
NCT02186873
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)
NCT01453725
Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
NCT01248793
Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
NCT05881785
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
golimumab
golimumab 50mg subcutaneous every 4 weeks
golimumab
golimumab
pamidronate
Pamidronate (60mg) intravenously every 4 weeks
Pamidronate
pamidronate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
golimumab
golimumab
Pamidronate
pamidronate
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tuen Mun Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chi Chiu Mok
Consultant
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tuen Mun Hospital
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CREC/769/09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.