An observational study in Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by Bristol-Myers Squibb · Observational
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.
The participant population targeted in this study consists of participants with early-stage RA (i.e. diagnosis of RA not longer than 24 months) that initiate treatment with Abatacept.
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Participants diagnosed with moderate to severe active RA within the last 24 months and initiated treatment with Abatacept
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)
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
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb