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Onderzoek naar het voorspellen van het effect van biologicals op de ziekteactiviteit van een individuele patiŽnt met reumatoÔde artritis (RA)


- candidate number18139
- NTR NumberNTR4647
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jun-2014
- Secondary IDsNL47946.091.14 CCMO 
- Public TitleOnderzoek naar het voorspellen van het effect van biologicals op de ziekteactiviteit van een individuele patiŽnt met reumatoÔde artritis (RA)
- Scientific TitlePrediction of individual treatment response to biologics by ex-vivo immunological testing in rheumatoid arthritis
- ACRONYMBIO-TOP (Biologic Individual Optimized Treatment Outcome Prediction)
- hypothesisThe objective of this study is to investigate ex-vivo cytokine profiling and several other determinants (e.g. proteomics, genomics) before the start of treatment with abatacept, adalimumab, etanercept, rituximab and tocilizumab as a predictor of individual treatment response after 3 months of treatment in RA patients.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Biological
- Inclusion criteria1. Rheumatoid arthritis (either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion)
2. Patients with RA who start with (or switch to) biological therapy (including abatacept, adalimumab, etanercept, rituximab and tocilizumab)
3. Concomitant treatment with conventional DMARDs and/or NSAIDs is permitted
4. Age > 18 years
5. Informed consent
6. Ability to measure the study outcome in the patient (e.g. life expectancy >6 months, no planned relocation far away)
7. Ability to read and communicate well in Dutch
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 12-jun-2014
- planned closingdate30-nov-2017
- Target number of participants400
- InterventionsThe day of the first biologic administration is appointed as baseline.
At baseline (before start biologic), blood samples will be obtained from every patient. During follow-up, all patients will receive usual care and tight control.
In usual care, trained nurses assess the disease activity (DAS28CRP) during the outpatient clinic visits every 3 months (+/- 1 month). With these data, individual treatment response (EULAR good response criteria) can be calculated after 3 and 6 months (+/- 1 month) of treatment with the biologic.
- Primary outcomeIndividual treatment response prediction based on the European League against Rheumatism (EULAR) good response criteria after 3 months of treatment with the biologic.
- Secondary outcome1. Response prediction based on the European League against Rheumatism (EULAR) response criteria after 6 months of treatment with the biologic.
2. Response prediction based on ∆DAS28CRP response criteria, after 3 and 6 months of treatment with the biologic.
3. Response prediction based on ACR/EULAR remission criteria, after 3 and 6 months of treatment with the biologic.
- TimepointsData will be recorded at baseline and after 3 and 6 months (+/- 1 month) of treatment with the biologic.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. L. Tweehuysen
- CONTACT for SCIENTIFIC QUERIESDr. A.A. Broeder, den
- Sponsor/Initiator Sint Maartenskliniek Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Sint Maartenskliniek Nijmegen
- PublicationsN/A
- Brief summaryBackground: Rheumatoid arthritis (RA) is characterized by heterogeneity in its clinical manifestations, pathological features and response to treatment. Clinical studies reveal that approximately 60% of RA a biologic as a predictor of individual treatment response after 3 months of treatment in RA patients. One of the determinants will be ex-vivo (un)stimulated and inhibited cytokine profiling, since this is in our view a promising candidate predictor and has not been investigated before.
Objective: To investigate ex-vivo cytokine profiling and several other determinants (e.g. proteomics, genomics) before the start of treatment with abatacept, adalimumab, etanercept, rituximab and tocilizumab as a predictor of individual treatment response after 3 months of treatment in RA patients.
Study design: This is a prospective longitudinal prediction cohort study.
Study population: RA patients > 18 years, treated in the Sint Maartenskliniek (Nijmegen, The Netherlands), who are going to start with (or switch to) a biologic (including abatacept, adalimumab, etanercept, rituximab and tocilizumab) will be included in this study.
Method: At baseline (before start biologic), blood samples will be obtained from every patient. Ex-vivo cytokine profiling will be performed with specific cytokine-inducing stimuli, in the presence or absence of several concentrations of respectively abatacept, adalimumab, etanercept, rituximab and tocilizumab. Also, several other determinants (e.g. proteomics, genomics) will be investigated in the peripheral blood.
Main study endpoint: Primary outcome is the European League against Rheumatism (EULAR) good response criteria (DAS28CRP <3.2, and ∆DAS28CRP > 1.2 compared to baseline), 3 months after the start of treatment with one of the above biologics.
- Main changes (audit trail)
- RECORD17-jun-2014 - 27-jul-2014


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