search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Mesenchymal stromal cells for treatment of drug resistant pediatric juvenile idiopathic arthritis


- candidate number15358
- NTR NumberNTR4146
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-sep-2013
- Secondary IDsEUDRACT 2012-002067-10
- Public TitleMesenchymal stromal cells for treatment of drug resistant pediatric juvenile idiopathic arthritis
- Scientific TitleMesenchymal stromal cells for treatment of drug resistant pediatric juvenile idiopathic arthritis
- ACRONYMMSC-JIA
- hypothesisTo find out if intravenous MSC is a safe treatment for children with therapy-resistant JIA
- Healt Condition(s) or Problem(s) studiedJuvenile idiopathic arthritis (JIA)
- Inclusion criteriaInclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Patients (4-18 years of age) diagnosed with juvenile idiopathic arthritis according to the ILAR-criteria with active arthritis resistant to intra-articular steroids and systemic use of methotrexate and for whom no on-label indication exists for (not yet used) biologicals.
The patient is followed for adverse events via the Pharmachild database.
Informed consent signed.
- Exclusion criteriaConcurrent use of biological response modifiers.
Concurrent infection, febrile illness or malignancy.
Pregnancy.
No signed informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2014
- planned closingdate1-nov-2017
- Target number of participants6
- Interventions1 to maximal 3 iv MSC infusions.3 MRI scans, 4 extra visits to the hospital and 3 extra venapunctures when compared to standard treatment in the typical JIA patient
- Primary outcomeTotal number of adverse events in the 3 months prior to MSC infusion and the number of adverse events 3 months after MSC infusion.
To offer an effective alternative for that category of JIA patients that is therapy-resistant.
For this effectiveness the ACR Pediatric 70 criteria should be achieved.
The ACR Pedi 70 criteria are defined as improvement of >= 70% in at least 3 of 6 core response variables used to assess disease activity with no more than 1 variable worsening by >= 30%.
- Secondary outcome- The ACR Pediatric 30 criteria should be met.
The ACR Pedi 30 criteria are defined as improvement of ≥ 30% in at least 3 of 6 core response variables used to assess disease activity with no more than 1 variable worsening by ≥ 30%. Core response variables are:
1. Physician global assessment of overall disease activity
2. Parent or patient global assessment of overall well-being
3. Functional ability (CHAQ)
4. Number of joints with active arthritis
5. Number of joints with limited range of motion
6. Index of inflammation: ESR or CRP

- Radiological (MRI) improvement of most active large joint.
- Improvement in laboratory parameters or biomarkers.
- Timepoints52 weeks after the (first) MSC injection the primary outcome will be measured and the third MRI will be made.
Also all data and materials for the secondary outcomes are collected within this time frame. This will also be the end of the study for the individual.
- Trial web sitehttp://www.zonmw.nl/nl/projecten/project-detail/
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD Joost Swart
- CONTACT for SCIENTIFIC QUERIESMD Joost Swart
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryThe main objective is to offer a safe alternative for that category of JIA patients that is therapy-resistant. We hypothesize that intravenous administration of MSC in therapy refractory JIA patients is safe and has the potential to have clinical relevant effect as measured by the ACR Pedi 30.
Aims:
1. Total number of adverse events in the 3 months prior to MSC infusion and the number of adverse events 3 months after MSC infusion.
2. The ACR Pediatric 30 criteria should be met
3. Radiological (MRI) improvement of most active large joint.
4. Improvement in laboratory parameters or biomarkers.
- Main changes (audit trail)
- RECORD4-sep-2013 - 16-feb-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl