Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants

Abatacept - Long-Term Real-Life Experience in Psoriatic Arthritis (PsA) in Germany: an Observational Study (ALTEA)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03419143

Acronym

ALTEA

Enrollment

190

Registered

2018-02-01

Start date

2018-03-02

Completion date

2022-03-31

Last updated

2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis (PsA)

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Disease Activity index for PSoriatic Arthritis (DAPSA)	12 months

Secondary

Measure	Time frame
Proportion of concomitant treatment given	12 Months
Initial dosage of Abatacept given	At Treatment Initiation
Frequency of Abatacept administration	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: Socio-Demographics at Treatment Initiation	At Treatment Initiation
Descriptive Analysis: Disease history at Treatment initiation	Prior to treatment
Participant retention rate	12 Months
Descriptive Analysis: Baseline Characteristics	up to 2 years prior to treatment
Descriptive Analysis: Change in participant characteristics and symptoms	12 months
Proportion of Rheumatologist: Geography	up to 2 months prior to treatment to 12 months post treatment
Proportion of Rheumatologist: Type of Institution	up to 2 months prior to treatment to 12 months post treatment
Proportion and type of treatment after abatacept discontinuation	12 months
Proportion of reasons for abatacept discontinuation and initiation of new therapy	12 Months
Incidence of Risk factors and Comorbidities	At Treatment Initiation

Countries

Germany

Outcome results