Safety and Effectiveness of Abatacept in Psoriatic Arthri... | NCT03419143

Studies
Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants

NCT03419143

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

May 31, 2022Actual

Enrollment

190Actual

Phase

Not provided

Conditions

Psoriatic Arthritis (PsA)

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2018Actual

Primary Completion Date

Mar 31, 2022Actual

Completion Date

Mar 31, 2022Actual

First Submitted Date

Jan 24, 2018

First Submission Date that Met QC Criteria

Jan 31, 2018

First Posted Date

Feb 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2022

Last Update Posted Date

May 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

190Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Participant retention rate		12 Months
Proportion of concomitant treatment given		12 Months
Initial dosage of Abatacept given

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0001		Nuremberg		90429	Germany

Label	URL
BMS Clinical Trial Information	View source

Condition Browse Module

MeSH Terms

ID	Term
D015535	Arthritis, Psoriatic

Ancestor Terms

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided