|- candidate number||14961|
|- NTR Number||NTR4025|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jun-2013|
|- Secondary IDs||IM101348ST Ascore|
|- Public Title||LONG-TERM EXPERIENCE WITH ABATACEPT SC IN ROUTINE CLINICAL
PRACTICE STUDY ASCORE
|- Scientific Title||Observational Study Protocol IM101348ST
LONG-TERM EXPERIENCE WITH ABATACEPT SC IN ROUTINE CLINICAL
PRACTICE STUDY ASCORE
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis|
|- Inclusion criteria||*Patients ≥18 years old at treatment initiation;|
*Patients informed and accepting to participate;
*Patients diagnosed with established moderate to severe active RA as per the 1987 ACR criteria/2010 ACR/EULAR
Rheumatoid Arthritis Classification Criteria;
*Patients naÔve of abatacept IV and who at their physicianís discretion are initiated with
abatacept SC. In countries were required (e.g. Germany), patients naÔve of abatacept IV and who at their physicianís discretion have been initiated with abatacept SC at least 1
month prior to enrollment visit up to 3 months if baseline and disease characteristics data
*For Cohort 1: Patients naÔve of biologic prior to abatacept SC initiation;
*For Cohort 2: Patients who previously failed one or more biologic agent.
|- Exclusion criteria||*Patients who are currently included in any interventional clinical trial in RA.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||13-jun-2013|
|- planned closingdate||31-dec-2017|
|- Target number of participants||200|
|- Interventions||*Non-interventional study|
|- Primary outcome||*To estimate the retention rate of abatacept SC over 24 months in routine clinical
practice, in each participating country and overall, in 2 distinct populations of RA
patients: RA patients naive of biologic agents and RA patients who previously failed one or more biologic agents.|
*To describe how abatacept SC is prescribed in participating countries for each cohort (concomitant treatments, dosage and adherence to treatment).
*To describe the major characteristics of population of patients (joint population
depending on previous prescriptions) in real life conditions at abatacept SC initiation
(socio-demographic data, medical history, disease history, co-morbidities and clinical
*To assess the impact of the abatacept SC treatment on health status of each population of patients as assessed by morbi-mortality criteria (clinical measures, Patient Reported Outcomes (PRO), incidence of local site injection reaction, incidence of long-term adverse events (AE), withdrawal from study due to AE and Serious
Adverse Events (SAE).
|- Secondary outcome||*To identify the major determinants of abatacept SC retention rate in each population of patients; Determinants include : socio-demographic characteristics at treatment initiation, previous biologic treatments, clinical measurements (i.e. DAS28, CDAI, SDAI and their derived criteria) and PROs such as HAQ-DI and according to local clinical practices and/or according to local requirements WPAI:RA, RADAI or PROCLARA at treatment initiation and/or at studied drug discontinuation.|
*To estimate over the 24-month follow-up period the distribution of time-todiscontinuation of abatacept SC therapy for each major determinant of treatment
discontinuation, in each participating country and overall, in each cohort of patients.
*To estimate the retention rate of abatacept (whatever the formulation, SC or IV) over 24 months in routine clinical practice, in each participating country and overall, in 2 distinct populations of RA patients: RA patients naive of biologic agents and RA patients who previously failed one or more biologic agents.
2.3 Other Objectives
*To summarize the treatment experience and outcomes after switching abatacept
(whatever the formulation, SC or IV) to a biologic agent or conventional DMARD for
patients who discontinue abatacept (SC or IV) therapy during the follow-up period.
|- Timepoints||*First patient in (FPI) is foreseen in March 2013|
*The enrolment period will be 2 years per country and FU period will be 2 years/patient
*The Last Patient In (LPI) will be in March 2015
*Last Patient Out (LPO) will be in November 2017
*Data Base lock and Final Report are foreseen end of 2017 /beginning of 2018
*3 interim analyses are foreseen
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. M.T. Nurmohamed|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. M.T. Nurmohamed|
|- Sponsor/Initiator ||Bristol-Myers Squibb B.V.|
(Source(s) of Monetary or Material Support)
|Bristol-Myers Squibb B.V.|
|- Brief summary||Study Design: This is a non-interventional, multicenter, study consisting of 2 prospective cohorts of patients
diagnosed with moderate to severe active RA and initiated/treated with abatacept SC. In some countries, patients can
only be included in an observational study if already under treatment, so that inclusion in the study is clearly
distinguished from therapeutic decision.
Study Population: The patient populations targeted by the study consist in 2 cohorts will be defined as follows:|
Cohort 1 will focus on patients naÔve of biologics agents and Cohort 2 will focus on patients naÔve of abatacept and
who previously failed one or more biologic treatment.
|- Main changes (audit trail)|
|- RECORD||6-jun-2013 - 26-jun-2013|