The Value of Orencia in Rapidly Progressing Rheumatoid Ar... | NCT03331393

Studies
The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis

NCT03331393

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jul 6, 2022Actual

Enrollment

265Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Non-interventional

Countries

United States

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

Jul 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 16, 2017Actual

Primary Completion Date

Jan 17, 2019Actual

Completion Date

Jan 17, 2019Actual

First Submitted Date

Oct 17, 2017

First Submission Date that Met QC Criteria

Nov 1, 2017

First Posted Date

Nov 6, 2017Actual

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

Jul 1, 2022

Last Update Posted Date

Jul 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

265Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RA patients treated with Abatacept		Treated with Abatacept as a first-line biologic	Other: Non-interventional
RA patients treated with TNFi		Treated with Tumor necrosis factor inhibitor (TNFi) as a first-line biologic	Other: Non-interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-interventional	Other	Non-interventional	RA patients treated with Abatacept RA patients treated with TNFi

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients discontinuing treatment before completing 12 months of therapy		approximately 1 year
time from treatment initiation to discontinuation		approximately 1 year

Secondary Outcomes

Measure	Description	Time Frame
Distribution of Healthcare Resource Utilization (HCRU)		approximately 1 year
Disease Activity Score	Disease Activity Score (DAS)	approximately 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age at enrollment
Confirmed diagnosed with RA
Initiated first-line treatment with abatacept, adalimumab, etanercept, or infliximab with a record of the start date at the practice site

Exclusion Criteria:

Does not have at least 1 or more poor RA prognostic factor: Evidence of joint erosions, Positive anti-CCP autoantibodies, Positive RF autoantibodies, Increased CRP levels, Increased ESR levels
Was followed at the site for less than 1 year since biologic treatment initiation
Patients with autoimmune diseases: Crohn's, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, anal fistula

Other protocol defined inclusion/exclusion criteria could apply

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

Rapidly-progressing RA patients initiating treatment with abatacept or TNFi at approximately 10 rheumatology practices across the US.

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		Beverly Hills	California	90212	United States
Local Institution - 0005

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases