Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants

NCT ID: NCT03419143

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-02

Study Completion Date

2022-03-31

Brief Summary

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

Detailed Description

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Conditions

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Psoriatic Arthritis (PsA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

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

No interventions assigned to this group

Cohort 2

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

No interventions assigned to this group

Cohort 3

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

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Nuremberg, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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IM101-675

Identifier Type: -

Identifier Source: org_study_id

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