Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis (ABC-STOP)
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| ClinicalTrials.gov Identifier: NCT01287715 |
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Recruitment Status : Unknown
Verified January 2011 by Erasmus Medical Center.
Recruitment status was: Recruiting
First Posted : February 1, 2011
Last Update Posted : February 1, 2011
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The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.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:
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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.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Juvenile Idiopathic Arthritis | Drug: etanercept | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | When and in Whom to Stop Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis |
| Study Start Date : | January 2011 |
| Estimated Primary Completion Date : | September 2012 |
| Estimated Study Completion Date : | September 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: STOP-arm
Discontinuation of etanercept
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Drug: etanercept
Discontinuation of etanercept (half of the dosis for 3 months and discontinuation thereafter)
Other Name: enbrel |
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No Intervention: CONTROL-arm
Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter.
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Drug: etanercept
Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter.
Other Name: enbrel |
- Flare-rate [ Time Frame: 9 months ]To evaluate if the flare-rate is different between the 2 arms (continuation and discontinuation of etanercept).
- Duration of remission before withdrawal of etanercept [ Time Frame: 9 months ]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.
- Predictors for successful discontinuation of etanercept [ Time Frame: 12 months after 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.
- Disease course after flaring [ Time Frame: 6 months after flare ]After a flare (exacerbation) occurs: evaluation of time to flare and the effect of restarting etanercept after flaring.
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| Ages Eligible for Study: | 4 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287715
| Contact: LWA van Suijlekom-Smit, MD,PhD,MSCE | +31-10-7036146 | l.vansuijlekom@erasmusmc.nl | |
| Contact: MH Otten, MD | +31-10-7036778 | m.otten@erasmusmc.nl |
| Netherlands | |
| Academic Medical Centre Emma Children's Hospital | Not yet recruiting |
| Amsterdam, Netherlands | |
| Contact: MAJ van Rossum, MD, PhD m.a.vanrossum@amc.uva.nl | |
| Principal Investigator: MAJ van Rossum, MD, PhD | |
| Reade Institute Amsterdam | Not yet recruiting |
| Amsterdam, Netherlands | |
| Contact: MAJ van Rossum, MD, PhD m.a.vanrossum@amc.uva.nl | |
| Principal Investigator: MAJ van Rossum, MD, PhD | |
| Sint-Lucas Andreas Hospital | Active, not recruiting |
| Amsterdam, Netherlands | |
| University Medical Centre Groningen | Not yet recruiting |
| Groningen, Netherlands | |
| Contact: W Armbrust, MD, PhD w.armbrust@bkk.umcg.nl | |
| Principal Investigator: W Armbrust, MD, PhD | |
| Leiden University Medical Center | Not yet recruiting |
| Leiden, Netherlands | |
| Contact: R ten Cate, MD, PhD r.tencate@lumc.nl | |
| Principal Investigator: R ten Cate, MD, PhD | |
| Maastricht University Medical Centre | Not yet recruiting |
| Maastricht, Netherlands | |
| Contact: SL Gorter, MD, PhD sgo@sint.azm.nl | |
| Principal Investigator: SL Gorter, MD, PhD | |
| St Maartenskliniek | Not yet recruiting |
| Nijmegen, Netherlands | |
| Contact: EPAH Hoppenreijs, MD, PhD e.hoppenreijs@cukz.umcn.nl | |
| Principal Investigator: EPAH Hoppenreijs, MD, PhD | |
| Erasmus MC Sophia Children's Hospital | Recruiting |
| Rotterdam, Netherlands | |
| Contact: LWA van Suijlekom-Smit, MD,PhD,MSCE l.vansuijlekom@erasmusmc.nl | |
| Principal Investigator: LWA van Suijlekom-Smit, MD,PhD,MSCE | |
| Haga Hospital, Juliana Children's Hospital | Not yet recruiting |
| The Hague, Netherlands | |
| Contact: Y Koopman, MD y.koopman@hagaziekenhuis.nl | |
| Principal Investigator: Y Koopman, MD | |
| Utrecht Medical Centre Wilhelmina Children's Hospital | Not yet recruiting |
| Utrecht, Netherlands | |
| Contact: R van Royen, MD, PhD a.vanroyen@umcutrecht.nl | |
| Principal Investigator: A van Royen, MD, PhD | |
| Principal Investigator: | LWA van Suijlekom-Smit, MD,PhD,MSCE | Erasmus Medical Center |
| Responsible Party: | L.W.A. van Suijlekom-Smit, MD, PhD, MSCE, Erasmus Medical Center Sophia Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01287715 History of Changes |
| Other Study ID Numbers: |
NR 10-1-203 |
| First Posted: | February 1, 2011 Key Record Dates |
| Last Update Posted: | February 1, 2011 |
| Last Verified: | January 2011 |
Additional relevant MeSH terms:
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Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Etanercept Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors |