Rheumatoid Arthritis
Conditions
Interventions
*Non-interventional study
Sponsors
Bristol-Myers Squibb B.V.
Vijzelmolenlaan 9
3447 GX Woerden
Telefoon: 0348-574222
Telefax: 0348-423084
Eligibility
Inclusion criteria
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 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.
Exclusion criteria
Exclusion criteria: *Patients who are currently included in any interventional clinical trial in RA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *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. Co-primary objectives: *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 measures). *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
| Measure | Time frame |
|---|---|
| *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. | — |
Contacts
Public ContactM.T. Nurmohamed
Jan van Breemen Research Institute | Reade Postbus 58271
Outcome results
None listed