Rheumatoid Arthritis
Conditions
Brief summary
This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA * Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics)
Exclusion criteria
* Participants who are currently included in any interventional clinical trial in RA Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients continuing with abatacept treatment | Up to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Up to 12 months | — |
| Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2 | Up to 12 months | — |
| Number of patients who achieve the first remission state, DAS28 < 2.6 | Up to 12 months | — |
| Number of Adverse Events (AE) | Up to 12 months | — |
| Anti-citrullinated protein antibody (ACPA) titer | At baseline | — |
| Concomitant treatment given with abatacept as determined by the investigator | Up to 12 months | — |
| Dosage of abatacept as determined by the investigator | Up to 12 months | — |
| Frequency of administration of abatacept | Up to 12 months | — |
| Reason for abatacept treatment initiation as determined by the investigator | At baseline | — |
| Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD) | Up to 12 months | — |
| Socio-demographics of participants as determined by the investigator | At baseline | — |
| Number of Serious Adverse Events (SAE) | Up to 12 months | — |
| Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia) | Up to 12 months | — |
| Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency) | Up to 12 months | — |
| Simplified Disease Activity Score (based on 28 joints) (DAS28) | Up to 12 months | DAS28: Swollen joint count \[SJC\], tender joint count \[TJC\], C-reactive protein \[CRP\], erythrocyte sedimentation rate \[ESR\] |
| Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria | Up to 12 months | — |
| Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2) | Up to 12 months | — |
| Existence or the absence of radiographic erosions as determined by the investigator by imaging technique | At baseline | — |
| Rheumatoid factor (RF) | Up to 12 months | — |
| Patient global assessment (PGA) | Up to 12 months | — |
| Evaluator global assessment (EGA) | Up to 12 months | — |
| Clinical disease activity index (CDAI) | Up to 12 months | — |
| Simple disease activity index (SDAI) | Up to 12 months | — |
| Disease history of participants as determined by the investigator | At baseline | — |
Countries
Germany
Outcome results
None listed