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

May 26, 2022 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Nurnberg, Germany, 90429
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patient population targeted by the study consists of patients with PsA that initiate treatment with abatacept

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease Activity index for PSoriatic Arthritis (DAPSA)
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2018

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-675

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriatic Arthritis (PsA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe