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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept for Rheumatoid Arthritis (RA) | Participants diagnosed with moderate to severe active RA within the last 24 months and initiated treatment with Abatacept |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients continuing with abatacept treatment | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-citrullinated protein antibody (ACPA) titer | At baseline | |
| Concomitant treatment given with abatacept as determined by the investigator | Up to 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Freiburg im Breisgau | 79095 | Germany |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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 |
| Disease history of participants as determined by the investigator | At baseline |
| 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) | DAS28: Swollen joint count [SJC], tender joint count [TJC], C-reactive protein [CRP], erythrocyte sedimentation rate [ESR] | Up to 12 months |
| 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 |
| 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 |
| Number of Serious Adverse Events (SAE) | Up to 12 months |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Up to 12 months |
| Existence or the absence of radiographic erosions as determined by the investigator by imaging technique | At baseline |
| Existence or the absence of radiographic erosions as determined by the investigator by imaging technique | Up to 12 months |
| 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 |
| BMS Clinical Trial Patient Recruiting | View source |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |