Juvenile Idiopathic ArthritisPhase 4ABC-STOPNCT01287715
Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis
A Phase 4 study testing etanercept in people with Juvenile Idiopathic Arthritis, run by Erasmus Medical Center at 10 sites in Netherlands.
Trial summary
The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached. Goals: 1. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- etanercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesNetherlands
- Study dates
- Jan 2011to Sep 2013
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Juvenile Idiopathic Arthritis (all subtypes) by the International League of Associations of Rheumatology (ILAR) criteria
- On etanercept therapy
- No MTX or low dose MTX (maximum 10 mg/m2)
- 3 or more months in remission according to the criteria of Wallace (i.e. 9 or more months of inactive disease)
- Age ≥4 and <18 years at start of study
- Written informed consent from parents and patients 12 years and over
Who cannot join
- Systemic corticosteroids (up to 9 months prior to inclusion)
- Intra-articular corticosteroids (up to 6 months prior to inclusion)
- Synthetic DMARDs besides low dose MTX (up to 9 months prior to inclusion)
- Biologic DMARDs besides etanercept (up to 9 months prior to inclusion)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites, 9 recruiting
- Not yet recruiting
Academic Medical Centre Emma Children's Hospital
Amsterdam
MAJ van Rossum, MD, PhD, m.a.vanrossum@amc.uva.nl
MAJ van Rossum, MD, PhD
- Not yet recruiting
Reade Institute Amsterdam
Amsterdam
MAJ van Rossum, MD, PhD, m.a.vanrossum@amc.uva.nl
MAJ van Rossum, MD, PhD
- Active, not recruiting
Sint-Lucas Andreas Hospital
Amsterdam
- Not yet recruiting
University Medical Centre Groningen
Groningen
W Armbrust, MD, PhD, w.armbrust@bkk.umcg.nl
W Armbrust, MD, PhD
- Not yet recruiting
Leiden University Medical Center
Leiden
R ten Cate, MD, PhD, r.tencate@lumc.nl
R ten Cate, MD, PhD
- Not yet recruiting
Maastricht University Medical Centre
Maastricht
SL Gorter, MD, PhD, sgo@sint.azm.nl
SL Gorter, MD, PhD
- Not yet recruiting
St Maartenskliniek
Nijmegen
EPAH Hoppenreijs, MD, PhD, e.hoppenreijs@cukz.umcn.nl
EPAH Hoppenreijs, MD, PhD
- Recruiting
Erasmus MC Sophia Children's Hospital
Rotterdam
LWA van Suijlekom-Smit, MD,PhD,MSCE, l.vansuijlekom@erasmusmc.nl
LWA van Suijlekom-Smit, MD,PhD,MSCE
- Not yet recruiting
Haga Hospital, Juliana Children's Hospital
The Hague
Y Koopman, MD, y.koopman@hagaziekenhuis.nl
Y Koopman, MD
- Not yet recruiting
Utrecht Medical Centre Wilhelmina Children's Hospital
Utrecht
R van Royen, MD, PhD, a.vanroyen@umcutrecht.nl
A van Royen, MD, PhD
About this study
Official title: When and in Whom to Stop Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis
The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.
Goals:
Read more
- to investigate in a randomized controlled trial:
- which proportion of JIA patients in remission can successfully discontinue etanercept compared to JIA patients in remission who continue etanercept;
- if time in remission on etanercept is an important factor in retaining remission after discontinuation of etanercept.
- to investigate in alle JIA patients who discontinue etanercept (including the control group):
- predicting factors (patient or disease characteristics, including time in remission, and MRP8/MRP14) for successfully discontinuation of etanercept;
- the disease course after discontinuation of etanercept (time to flare) and the effect of restarting etanercept after flaring.
Read the detailed description
Juvenile Idiopathic Arthritis (JIA) is the most common cause of chronic arthritis in children. Etanercept has proven to be an effective treatment for JIA. Considering the risk of occurrence of long-term side-effects and to prevent the burden of the weekly injections and costs, it is a logical step to discontinue etanercept after reaching remission (no disease activity for at least six months). Especially since there are concerns about the long-term effect of suppressing the immune system with etanercept. However, little is known about if successful discontinuation is possible or when to stop. Risk is that the disease might flare (reactivate) again.
For this study, JIA patients in remission will be selected from the ABC-register (an observational study including all Dutch JIA patients who use etanercept). Eligible patients will be randomized to stop etanercept or continue it for another 9 months. Patients are followed with standard visits evaluating disease activity until 12 months after discontinuation of etanercept. In case of a disease flare etanercept therapy will be reintroduced immediately and the patient will be treated according to the insight of their treating physician. Expected is that JIA patients who were in remission for more than 12 months before discontinuation have a better chance to retain remission.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- etanercept
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
Also called enbrel
Discontinuation of etanercept (half of the dosis for 3 months and discontinuation thereafter)
etanerceptDrug
Also called enbrel
Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter.
| Study group | Role | What they receive |
|---|---|---|
| STOP-arm | Experimental | Discontinuation of etanercept Receives: Drug: etanercept |
| CONTROL-arm | No intervention | Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter. Receives: Drug: etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flare-rate
To evaluate if the flare-rate is different between the 2 arms (continuation and discontinuation of etanercept).
Measured: 9 months
Secondary outcomes (3)
Duration of remission before withdrawal of etanercept
To evaluate between the 2 arms (continuation and discontinuation of etanercept) if time in remission on etanercept is an important factor in retaining remission after discontinuation of etanercept.
Measured: 9 months
Predictors for successful discontinuation of etanercept
Evaluation of predictors (patient or disease characteristics, including time in remission, and MRP8/MRP14) for successful discontinuation of etanercept in all JIA patient who discontinue etanercept.
Measured: 12 months after discontinuation of etanercept
Disease course after flaring
After a flare (exacerbation) occurs: evaluation of time to flare and the effect of restarting etanercept after flaring.
Measured: 6 months after flare
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Arthritis Association
- Investigators
- LWA van Suijlekom-Smit, MD,PhD,MSCE, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287715
- Sponsor's protocol ID
- NR 10-1-203
- Acronym
- ABC-STOP
- Status last verified
- Jan 2011
- First submitted
- 31 Jan 2011
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When and in Whom to Stop Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT01287715
- Acronym / sponsor ID
- ABC-STOP / NR 10-1-203
- Conditions
- Juvenile Idiopathic Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Arthritis Association
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 1 Feb 2011 (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.
The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.
Goals:
- to investigate in a randomized controlled trial:
- which proportion of JIA patients in remission can successfully discontinue etanercept compared to JIA patients in remission who continue etanercept;
- if time in remission on etanercept is an important factor in retaining remission after discontinuation of etanercept.
- to investigate in alle JIA patients who discontinue etanercept (including the control group):
- predicting factors (patient or disease characteristics, including time in remission, and MRP8/MRP14) for successfully discontinuation of etanercept;
- the disease course after discontinuation of etanercept (time to flare) and the effect of restarting etanercept after flaring.
Detailed description
Juvenile Idiopathic Arthritis (JIA) is the most common cause of chronic arthritis in children. Etanercept has proven to be an effective treatment for JIA. Considering the risk of occurrence of long-term side-effects and to prevent the burden of the weekly injections and costs, it is a logical step to discontinue etanercept after reaching remission (no disease activity for at least six months). Especially since there are concerns about the long-term effect of suppressing the immune system with etanercept. However, little is known about if successful discontinuation is possible or when to stop. Risk is that the disease might flare (reactivate) again.
For this study, JIA patients in remission will be selected from the ABC-register (an observational study including all Dutch JIA patients who use etanercept). Eligible patients will be randomized to stop etanercept or continue it for another 9 months. Patients are followed with standard visits evaluating disease activity until 12 months after discontinuation of etanercept. In case of a disease flare etanercept therapy will be reintroduced immediately and the patient will be treated according to the insight of their treating physician. Expected is that JIA patients who were in remission for more than 12 months before discontinuation have a better chance to retain remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STOP-arm | Experimental | Drug: etanerceptDiscontinuation of etanercept |
| CONTROL-arm | No intervention | Drug: etanerceptContinuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of Juvenile Idiopathic Arthritis (all subtypes) by the International League of Associations of Rheumatology (ILAR) criteria
- On etanercept therapy
- No MTX or low dose MTX (maximum 10 mg/m2)
- 3 or more months in remission according to the criteria of Wallace (i.e. 9 or more months of inactive disease)
- Age ≥4 and <18 years at start of study
Key exclusion criteria (4 listed)
- Systemic corticosteroids (up to 9 months prior to inclusion)
- Intra-articular corticosteroids (up to 6 months prior to inclusion)
- Synthetic DMARDs besides low dose MTX (up to 9 months prior to inclusion)
- Biologic DMARDs besides etanercept (up to 9 months prior to inclusion)
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 |
|---|---|---|
| etanerceptAlso: enbrelDiscontinuation of etanercept (half of the dosis for 3 months and discontinuation thereafter) | Drug | STOP-arm |
| etanerceptAlso: enbrelContinuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter. | Drug | CONTROL-arm |
Primary outcome
Flare-rate
Time frame: 9 months
To evaluate if the flare-rate is different between the 2 arms (continuation and discontinuation of etanercept).
3 secondary outcomes
Duration of remission before withdrawal of etanercept
Time frame: 9 months
Predictors for successful discontinuation of etanercept
Time frame: 12 months after discontinuation of etanercept
Disease course after flaring
Time frame: 6 months after flare
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
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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.
LWA van Suijlekom-Smit, MD,PhD,MSCE principal investigator
Erasmus Medical Center
10 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 etanercept in people with Juvenile Idiopathic Arthritis, run by Erasmus Medical Center at 10 sites in Netherlands.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LWA van Suijlekom-Smit, MD,PhD,MSCE (+31-10-7036146, l.vansuijlekom@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flare-rate (time frame: 9 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 1 Feb 2011.