Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants

Psoriatic Arthritis (PsA) Clinical Trial

— ALTEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419143
• Other study ID #: IM101-675
• Status: Completed
• Start date: March 2, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis (PsA)

Locations

Country	Name	City	State
Germany	Local Institution - 0001	Nurnberg

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity index for PSoriatic Arthritis (DAPSA)		12 months
Secondary	Participant retention rate		12 Months
Secondary	Proportion of concomitant treatment given		12 Months
Secondary	Initial dosage of Abatacept given		At Treatment Initiation
Secondary	Frequency of Abatacept administration		12 months
Secondary	Descriptive Analysis: Reasons for Abatacept initiation		up to 2 years prior to treatment
Secondary	Proportion of patients previously receiving by type of Disease modifying anti-rheumatic drug (DMARD)		up to 2 years prior to treatment
Secondary	Descriptive Analysis: Socio-Demographics at Treatment Initiation		At Treatment Initiation
Secondary	Descriptive Analysis: Disease history at Treatment initiation		Prior to treatment
Secondary	Incidence of Risk factors and Comorbidities		At Treatment Initiation
Secondary	Descriptive Analysis: Baseline Characteristics		up to 2 years prior to treatment
Secondary	Descriptive Analysis: Change in participant characteristics and symptoms		12 months
Secondary	Proportion of Rheumatologist: Geography		up to 2 months prior to treatment to 12 months post treatment
Secondary	Proportion of Rheumatologist: Type of Institution		up to 2 months prior to treatment to 12 months post treatment
Secondary	Proportion and type of treatment after abatacept discontinuation		12 months
Secondary	Proportion of reasons for abatacept discontinuation and initiation of new therapy		12 Months

External Links

•   BMS Clinical Trial Information