SpondyloarthritisSPACINGNCT01610947
Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity
A study testing Adalimumab, Etanercept, Golimumab or infliximab in people with Spondyloarthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Adalimumab, Etanercept, Golimumab or infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2012to 18 Oct 2018
- Phase
- Interventional
- 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
- Adult patients with spondyloarthritis according to ASAS criteria
- Stable low disease activity for at least 6 months
- Already treated by TNF blocking drug (adalimumab, etanercept or infliximab)
Who cannot join
- Raised acute phase reactants
- participation in another clinical trial
- Structural progression of peripheral joint damage
- Scheduled surgery within 12 months
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial
Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.
- Conditions
- Spondyloarthritis
- Being tested
- Adalimumab, Etanercept, Golimumab or infliximab
- Keywords
- Spondyloarthritis, Anti-TNF, Adalimumab, Etanercept, Infliximab
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab, Etanercept, Golimumab or infliximabDrug
Continuation of usual treatment with fixed intervals according to standard recommendations
Adalimumab, Etanercept, Golimumab or infliximabDrug
Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol
| Study group | Role | What they receive |
|---|---|---|
| Maintain | Active comparator | Continuation of usual treatment with fixed intervals according to standard recommendations Receives: Drug: Adalimumab, Etanercept, Golimumab or infliximab |
| Spacing | Active comparator | Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol. Receives: Drug: Adalimumab, Etanercept, Golimumab or infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients remaining in low disease activity
Measured: 12 months
Secondary outcomes (1)
Medico-economic comparison of arms
The cost-efficacy ratio will be compared between the 2 arms (maintain and spacing). The objective is to see if the spacing of the treatments will allow a better tolerance and reduce the cost due to the treatments.To assess this cost-efficacy ratio, questionnaires will be used (quality of life SF36, medico-economic Euroqol).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study start14 May 2012
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610947
- Sponsor's protocol ID
- 8785
- Acronym
- SPACING
- Status last verified
- Oct 2021
- First submitted
- 24 May 2012
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01610947
- Acronym / sponsor ID
- SPACING / 8785
- Conditions
- Spondyloarthritis
- Keywords
- Spondyloarthritis, Anti-TNF, Adalimumab, Etanercept, Infliximab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 14 May 2012 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 4 Jun 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.
Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintain | Active comparator | Drug: Adalimumab, Etanercept, Golimumab or infliximabContinuation of usual treatment with fixed intervals according to standard recommendations |
| Spacing | Active comparator | Drug: Adalimumab, Etanercept, Golimumab or infliximabProgressive spacing of injections according to disease activity observed during follow-up and predefined protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with spondyloarthritis according to ASAS criteria
- Stable low disease activity for at least 6 months
- Already treated by TNF blocking drug (adalimumab, etanercept or infliximab)
Key exclusion criteria (5 listed)
- Raised acute phase reactants
- participation in another clinical trial
- Structural progression of peripheral joint damage
- Scheduled surgery within 12 months
- pregnancy
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 |
|---|---|---|
| Adalimumab, Etanercept, Golimumab or infliximabContinuation of usual treatment with fixed intervals according to standard recommendations | Drug | Maintain |
| Adalimumab, Etanercept, Golimumab or infliximabProgressive spacing of injections according to disease activity observed during follow-up and predefined protocol | Drug | Spacing |
Primary outcome
Proportion of patients remaining in low disease activity
Time frame: 12 months
1 secondary outcome
Medico-economic comparison of arms
Time frame: 12 months
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 19 Oct 2021.
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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 study testing Adalimumab, Etanercept, Golimumab or infliximab in people with Spondyloarthritis, run by University Hospital, Montpellier at 1 site in France.
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 5 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 19 Oct 2021. 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 France. 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.
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?
Proportion of patients remaining in low disease activity (time frame: 12 months). 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 19 Oct 2021.