ID
Bron
Verkorte titel
Aandoening
Rheumatoid Arthritis
Ondersteuning
Vijzelmolenlaan 9
3447 GX Woerden
Telefoon: 0348-574222
Telefax: 0348-423084
Vijzelmolenlaan 9
3447 GX Woerden
Telefoon: 0348-574222
Telefax: 0348-423084
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
*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.<br>
Co-primary objectives:<br>
*To describe how abatacept SC is prescribed in participating countries for each cohort (concomitant treatments, dosage and adherence to treatment).<br>
*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
measures).<br>
*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).
Achtergrond van het onderzoek
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 naïve of biologics agents and Cohort 2 will focus on patients naïve of abatacept and
who previously failed one or more biologic treatment.
Onderzoeksopzet
*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
Onderzoeksproduct en/of interventie
*Non-interventional study
Algemeen / deelnemers
Postbus 58271
M.T. Nurmohamed
Dr. Jan van Breemenstraat 2
Amsterdam 1040 HG
The Netherlands
+31 020 242 1000
Wetenschappers
Postbus 58271
M.T. Nurmohamed
Dr. Jan van Breemenstraat 2
Amsterdam 1040 HG
The Netherlands
+31 020 242 1000
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
*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 naïve of abatacept IV and who at their physician’s discretion are initiated with
abatacept SC. In countries were required (e.g. Germany), patients naïve of abatacept IV and who at their physician’s 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
are available;
*For Cohort 1: Patients naïve of biologic prior to abatacept SC initiation;
*For Cohort 2: Patients who previously failed one or more biologic agent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
*Patients who are currently included in any interventional clinical trial in RA.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3865 |
| NTR-old | NTR4025 |
| Ander register | Ascore : IM101348ST |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |