Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants
Completed
- Conditions
- Psoriatic Arthritis (PsA)
- Registration Number
- NCT03419143
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
Inclusion Criteria
- Participants 18 years or older
- Participants who signed an informed consent
- Participants diagnosed with PsA as per the criteria of the Classification of Psoriatic Arthritis (CASPAR) Study Group18
- Participants naïve of abatacept and who at their physician's discretion initiate abatacept
- Participants meeting criteria for abatacept treatment for PsA as specified in the German label
Exclusion Criteria
- Participants who are currently included in any interventional clinical trial in PsA/Rheumatoid Arthritis (RA)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Activity index for PSoriatic Arthritis (DAPSA) 12 months
- Secondary Outcome Measures
Name Time Method Initial dosage of Abatacept given At Treatment Initiation Participant retention rate 12 Months Descriptive Analysis: Baseline Characteristics up to 2 years prior to treatment Proportion of Rheumatologist: Geography up to 2 months prior to treatment to 12 months post treatment Frequency of Abatacept administration 12 months Descriptive Analysis: Change in participant characteristics and symptoms 12 months Descriptive Analysis: Reasons for Abatacept initiation up to 2 years prior to treatment Proportion of patients previously receiving by type of Disease modifying anti-rheumatic drug (DMARD) up to 2 years prior to treatment Descriptive Analysis: Disease history at Treatment initiation Prior to treatment Incidence of Risk factors and Comorbidities At Treatment Initiation Proportion of Rheumatologist: Type of Institution up to 2 months prior to treatment to 12 months post treatment Proportion of reasons for abatacept discontinuation and initiation of new therapy 12 Months Proportion of concomitant treatment given 12 Months Descriptive Analysis: Socio-Demographics at Treatment Initiation At Treatment Initiation Proportion and type of treatment after abatacept discontinuation 12 months
Trial Locations
- Locations (1)
Local Institution - 0001
🇩🇪Nurnberg, Germany
Local Institution - 0001🇩🇪Nurnberg, Germany