Clinical trial NCT03419143: Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants
Official title: Abatacept - Long-Term Real-Life Experience in Psoriatic Arthritis (PsA) in Germany: an Observational Study (ALTEA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis (PsA)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-02-01
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population targeted by the study consists of patients with PsA that initiate treatment with abatacept

Brief summary: The purpose of this study is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder.


Eligibility criteria: 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)

Primary outcomes:
measure: Disease Activity index for PSoriatic Arthritis (DAPSA)
timeFrame: 12 months
Secondary outcomes:
measure: Participant retention rate
timeFrame: 12 Months
measure: Proportion of concomitant treatment given
timeFrame: 12 Months
measure: Initial dosage of Abatacept given
timeFrame: At Treatment Initiation
measure: Frequency of Abatacept administration
timeFrame: 12 months
measure: Descriptive Analysis: Reasons for Abatacept initiation
timeFrame: up to 2 years prior to treatment
measure: Proportion of patients previously receiving by type of Disease modifying anti-rheumatic drug (DMARD)
timeFrame: up to 2 years prior to treatment
measure: Descriptive Analysis: Socio-Demographics at Treatment Initiation
timeFrame: At Treatment Initiation
measure: Descriptive Analysis: Disease history at Treatment initiation
timeFrame: Prior to treatment
measure: Incidence of Risk factors and Comorbidities
timeFrame: At Treatment Initiation
measure: Descriptive Analysis: Baseline Characteristics
timeFrame: up to 2 years prior to treatment
measure: Descriptive Analysis: Change in participant characteristics and symptoms
timeFrame: 12 months
measure: Proportion of Rheumatologist: Geography
timeFrame: up to 2 months prior to treatment to 12 months post treatment
measure: Proportion of Rheumatologist: Type of Institution
timeFrame: up to 2 months prior to treatment to 12 months post treatment
measure: Proportion and type of treatment after abatacept discontinuation
timeFrame: 12 months
measure: Proportion of reasons for abatacept discontinuation and initiation of new therapy
timeFrame: 12 Months
Other outcomes:
Locations:
city: Nurnberg
country: Germany
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: