SpondyloarthropathyPhase 4NCT01718951
Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial
A Phase 4 study testing golimumab and Pamidronate in people with Spondyloarthropathy, run by Tuen Mun Hospital at 1 site in Hong Kong.
Trial summary
To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthropathy
- What is being tested?
- golimumab and Pamidronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2012to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Randomized Controlled Trial
To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy
Read the detailed description
To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological axial spondyloarthropathy
- Conditions
- Spondyloarthropathy
- Being tested
- golimumab, Pamidronate
- Keywords
- spondyloarthropathy, ankylosing spondylitis
- Medical subject headings
- Spondylarthropathies, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
golimumabDrug
Also called Simponi
golimumab
PamidronateDrug
Also called Aridia
pamidronate
| Study group | Role | What they receive |
|---|---|---|
| golimumab | Active comparator | golimumab 50mg subcutaneous every 4 weeks Receives: Drug: golimumab |
| pamidronate | Active comparator | Pamidronate (60mg) intravenously every 4 weeks Receives: Drug: Pamidronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 48
Secondary outcomes (1)
Changes in MRI spinal inflammation scores
Changes in MRI spinal inflammation scores
Measured: week 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chi Chiu Mok, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718951
- Sponsor's protocol ID
- CREC/769/09
- Status last verified
- May 2015
- First submitted
- 29 Oct 2012
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01718951
- Acronym / sponsor ID
- CREC/769/09
- Conditions
- Spondyloarthropathy
- Keywords
- spondyloarthropathy, ankylosing spondylitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy
Detailed description
To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological axial spondyloarthropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| golimumab | Active comparator | Drug: golimumabgolimumab 50mg subcutaneous every 4 weeks |
| pamidronate | Active comparator | Drug: PamidronatePamidronate (60mg) intravenously every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| golimumabAlso: Simponigolimumab | Drug | golimumab |
| PamidronateAlso: Aridiapamidronate | Drug | pamidronate |
Primary outcome
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
1 secondary outcome
Changes in MRI spinal inflammation scores
Time frame: week 24 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing golimumab and Pamidronate in people with Spondyloarthropathy, run by Tuen Mun Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response (time frame: week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.