SPONDYLOARTHRITISPhase 4SPARTANCT00726804
Discontinuation of TNF-alpha Inhibitors in Patients With Spondyloarthritis
A Phase 4 study testing Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab) in people with SPONDYLOARTHRITIS, run by Glostrup University Hospital, Copenhagen at 6 sites in Denmark.
Trial summary
Spondylarthropathy (SpA) comprises a group of rheumatic diseases mainly affecting the spine and sacroiliac joints. In most of the patients disease activity alternates, and some patients have symptom free periods. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SPONDYLOARTHRITIS
- What is being tested?
- Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 6 sitesDenmark
- Study dates
- Mar 2008to May 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 12 months of treatment with infliximab, etanercept and adalimumab.
- Diagnosis of spondylarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria or modified New York Criteria
- No clinical active disease, defined as a BASDAI score < 4.
- Among other issues: Age >18 years; written informed consent, adequate birth control; no contraindications for anti-TNF-alpha-therapy
Who cannot join
- Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening
- Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening
- Pregnancy or lactation
- HIV, hepatitis B or C, tuberculosis, other infections
- Malignancies
- Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)
- Contraindications to anti-TNF-alpha-therapy
- Contraindications to MRI
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Glostrup Hospital
Copenhagen, 2600
Glostrup Hospital
Copenhagen, 2650
Gentofte Hospital
Copenhagen, 2730
Gentofte Hospital
Copenhagen, 2900
Gråsten Gigthospital
Gråsten
Vejle Sygehus
Vejle
About this study
Official title: Discontinuation of TNF-alpha Inhibitors in Spondylarthritis Patients With Low Disease Activity, and Re-initiation of Therapy if Disease Flares
Spondylarthropathy (SpA) comprises a group of rheumatic diseases mainly affecting the spine and sacroiliac joints. In most of the patients disease activity alternates, and some patients have symptom free periods. Tumor-Necrosis-Factor-alpha (TNF-alpha) antagonists have significantly improved the treatment options for patients with spondyloarthritis. TNF-alpha antagonist therapy is costly, implies an increased risk of infections, including reactivation of tuberculosis, and the risk of long-term adverse events, as cancer, is fully clarified. It is highly relevant to explore to which extent anti-TNF-alpha therapy can be discontinued in SpA patients without immediate relapse of disease activity. Two studies have investigated discontinuation of a TNF-alpha antagonist (infliximab and etanercept) in ankylosing spondylitis, reporting flares in the majority of patients within the 1-year follow-up period, with the longest times to relapse in patients with the lowest disease activity. The effect of adalimumab discontinuation has never been studied, and, furthermore, the effect of TNF-alpha-antagonist discontinuation has never been studied in patients with early spondyloarthritis not fulfilling the New York criteria.
- Conditions
- SPONDYLOARTHRITIS
- Being tested
- Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab)
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab)Drug
Discontinuation of infusion infliximab (Remicade) 3-5mg/kg every 6-8 week, injection of etanercept (Enbrel) 25 mg x 2/week or injection of adalimumab (Humira) 40 mg eow.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Other | Not described Receives: Drug: Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors
Measured: 40 weeks
Secondary outcomes (1)
Bath ankylosing spondylitis disaease activity score, Bath ankylosing spondylitis functional index, Bath ankylosing spondylitis metrology index, C-Reactive protein, MRI, biomarkers of inflammation, cartilage and bone turnover
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: It was not possible to recruit patients
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOstergaard, Glostrup University Hospital, Copenhagen
- Investigators
- Mikkel Østergaard, Professor, Study chair, Department of rheumatology, Glostrup Hospital, CopenhagenSusanne J Pedersen, MD, Study chair, Department of rheumatology, Glostrup Hospital, CopenhagenInge J Sørensen, MD, PhD, Study chair, Department of rheumatology, Glostrup Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726804
- Sponsor's protocol ID
- SPARTA
- Acronym
- SPARTA
- Status last verified
- Aug 2015
- First submitted
- 30 Jul 2008
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of TNF-alpha Inhibitors in Spondylarthritis Patients With Low Disease Activity, and Re-initiation of Therapy if Disease Flares
- ClinicalTrials.gov ID
- NCT00726804
- Acronym / sponsor ID
- SPARTA / SPARTA
- Conditions
- SPONDYLOARTHRITIS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was not possible to recruit patients
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Aug 2008 (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.
Spondylarthropathy (SpA) comprises a group of rheumatic diseases mainly affecting the spine and sacroiliac joints. In most of the patients disease activity alternates, and some patients have symptom free periods. Tumor-Necrosis-Factor-alpha (TNF-alpha) antagonists have significantly improved the treatment options for patients with spondyloarthritis. TNF-alpha antagonist therapy is costly, implies an increased risk of infections, including reactivation of tuberculosis, and the risk of long-term adverse events, as cancer, is fully clarified. It is highly relevant to explore to which extent anti-TNF-alpha therapy can be discontinued in SpA patients without immediate relapse of disease activity. Two studies have investigated discontinuation of a TNF-alpha antagonist (infliximab and etanercept) in ankylosing spondylitis, reporting flares in the majority of patients within the 1-year follow-up period, with the longest times to relapse in patients with the lowest disease activity. The effect of adalimumab discontinuation has never been studied, and, furthermore, the effect of TNF-alpha-antagonist discontinuation has never been studied in patients with early spondyloarthritis not fulfilling the New York criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Other | Drug: Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 12 months of treatment with infliximab, etanercept and adalimumab.
- Diagnosis of spondylarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria or modified New York Criteria
- No clinical active disease, defined as a BASDAI score < 4.
- Among other issues: Age >18 years; written informed consent, adequate birth control; no contraindications for anti-TNF-alpha-therapy
Key exclusion criteria (8 listed)
- Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening
- Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening
- Pregnancy or lactation
- HIV, hepatitis B or C, tuberculosis, other infections
- Malignancies
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 |
|---|---|---|
| Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab)Discontinuation of infusion infliximab (Remicade) 3-5mg/kg every 6-8 week, injection of etanercept (Enbrel) 25 mg x 2/week or injection of adalimumab (Humira) 40 mg eow. | Drug | 2 |
Primary outcome
Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors
Time frame: 40 weeks
1 secondary outcome
Bath ankylosing spondylitis disaease activity score, Bath ankylosing spondylitis functional index, Bath ankylosing spondylitis metrology index, C-Reactive protein, MRI, biomarkers of inflammation, cartilage and bone turnover
Time frame: 40 weeks
Results and safety
The study was stopped early (reason given: It was not possible to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 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.
Mikkel Østergaard, Professor study chair
Department of rheumatology, Glostrup Hospital, Copenhagen
Susanne J Pedersen, MD study chair
Department of rheumatology, Glostrup Hospital, Copenhagen
Inge J Sørensen, MD, PhD study chair
Department of rheumatology, Glostrup Hospital, Copenhagen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab) in people with SPONDYLOARTHRITIS, run by Glostrup University Hospital, Copenhagen at 6 sites in Denmark.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. 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 was stopped early (reason given: It was not possible to recruit patients). Results are not available in the source record.
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?
Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors (time frame: 40 weeks). 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 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.