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.
Study Type
OBSERVATIONAL
Enrollment
158
Local Institution
Freiburg im Breisgau, Germany
Number of patients continuing with abatacept treatment
Time frame: Up to 12 months
Anti-citrullinated protein antibody (ACPA) titer
Time frame: At baseline
Concomitant treatment given with abatacept as determined by the investigator
Time frame: Up to 12 months
Dosage of abatacept as determined by the investigator
Time frame: Up to 12 months
Frequency of administration of abatacept
Time frame: Up to 12 months
Reason for abatacept treatment initiation as determined by the investigator
Time frame: At baseline
Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD)
Time frame: Up to 12 months
Socio-demographics of participants as determined by the investigator
Time frame: At baseline
Disease history of participants as determined by the investigator
Time frame: At baseline
Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia)
Time frame: Up to 12 months
Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency)
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Time frame: Up to 12 months
Simplified Disease Activity Score (based on 28 joints) (DAS28)
DAS28: Swollen joint count \[SJC\], tender joint count \[TJC\], C-reactive protein \[CRP\], erythrocyte sedimentation rate \[ESR\]
Time frame: Up to 12 months
Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria
Time frame: Up to 12 months
Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2)
Time frame: Up to 12 months
Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2
Time frame: Up to 12 months
Number of patients who achieve the first remission state, DAS28 < 2.6
Time frame: Up to 12 months
Number of Adverse Events (AE)
Time frame: Up to 12 months
Number of Serious Adverse Events (SAE)
Time frame: Up to 12 months
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Up to 12 months
Existence or the absence of radiographic erosions as determined by the investigator by imaging technique
Time frame: At baseline
Existence or the absence of radiographic erosions as determined by the investigator by imaging technique
Time frame: Up to 12 months
Rheumatoid factor (RF)
Time frame: Up to 12 months
Patient global assessment (PGA)
Time frame: Up to 12 months
Evaluator global assessment (EGA)
Time frame: Up to 12 months
Clinical disease activity index (CDAI)
Time frame: Up to 12 months
Simple disease activity index (SDAI)
Time frame: Up to 12 months