Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants
ALTEA
Abatacept - Long-Term Real-Life Experience in Psoriatic Arthritis (PsA) in Germany: an Observational Study (ALTEA)
1 other identifier
observational
190
1 country
1
Brief Summary
The purpose of this study is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2018
CompletedFirst Posted
Study publicly available on registry
February 1, 2018
CompletedStudy Start
First participant enrolled
March 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedMay 31, 2022
May 1, 2022
4.1 years
January 24, 2018
May 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Disease Activity index for PSoriatic Arthritis (DAPSA)
12 months
Secondary Outcomes (15)
Participant retention rate
12 Months
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
- +10 more secondary outcomes
Study Arms (3)
Cohort 1
naïve of abatacept, other biologic agents and Targeted synthetic disease modifying anti-rheumatic drugs (tsDMARDs)
Cohort 2
"naïve of abatacept, who previously failed one tumor necrosis factor inhibitor (TNFi), but are naïve of any other biologic agent and tsDMARDs"
Cohort 3
naïve of abatacept, who previously failed treatment with tsDMARDs and/or biologic agents\*\* other than a single TNFi
Eligibility Criteria
The patient population targeted by the study consists of patients with PsA that initiate treatment with abatacept
You may qualify if:
- 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
You may not qualify if:
- Participants who are currently included in any interventional clinical trial in PsA/Rheumatoid Arthritis (RA)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Nuremberg, 90429, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2018
First Posted
February 1, 2018
Study Start
March 2, 2018
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
May 31, 2022
Record last verified: 2022-05