Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants (ALTEA)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Psoriatic Arthritis (PsA)

Study type: Observational

Funder types: Industry

Identifiers

NCT03419143

IM101-675

Details and patient eligibility

About

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

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

190 participants in 3 patient groups

Cohort 1

Description:

naïve of abatacept, other biologic agents and Targeted synthetic disease modifying anti-rheumatic drugs (tsDMARDs)

Cohort 2

Description:

"naïve of abatacept, who previously failed one tumor necrosis factor inhibitor (TNFi), but are naïve of any other biologic agent and tsDMARDs"

Cohort 3

Description:

naïve of abatacept, who previously failed treatment with tsDMARDs and/or biologic agents\*\* other than a single TNFi