Advanced Therapeutics in Rheumatoid Arthritis (RA) | NCT03976245

Studies
Advanced Therapeutics in Rheumatoid Arthritis (RA)

NCT03976245

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Recruiting

Last Update Posted

Nov 29, 2024Actual

Enrollment

144Estimated

Phase

Phase 4

Conditions

Rheumatoid Arthritis

Interventions

Etanercept
tofacitinib

Countries

Canada

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

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Jun 3, 2019

First Submission Date that Met QC Criteria

Jun 3, 2019

First Posted Date

Jun 5, 2019Actual

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

Nov 26, 2024

Last Update Posted Date

Nov 29, 2024Actual

Name	Class
Academic Medical Organization of Southwestern Ontario	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study will evaluate the retention rates of two advanced therapies, Tumour Necrosis Factor (TNF) and Janus kinase inhibitor (JAK) in the treatment of adults with Rheumatoid Arthritis (RA) over a two year period. It will also examine the ability to embed a clinical trial in a clinical situation using an electronic medical record (EMR).

Detailed Description

Conventional therapies for Rheumatoid Arthritis (RA) treatment include nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) selective inhibitors, corticosteroids and disease modifying anti-rheumatic drugs (DMARDs). These therapies are often partially effective.

For those patients, where conventional therapies have failed to alleviate their symptoms, Tumour Necrosis Factor (TNFis) is often prescribed to treat the pain and inflammation associated with RA. The main problem with TNFi and other advanced therapies in RA is retention. At least ¼ of patients stop treatment within a year and another ⅕ to ¼ in the second year, mostly due to secondary loss of efficacy.

Another advanced therapy, the Janus kinase inhibitor (JAK) has demonstrated similar efficacy to TNFi treatment in RA. This trial will determine if using a different class of treatment (small molecule, oral drug, JAK kinase inhibitor) will have a better retention than a TNFi (using the most commonly prescribed TNFi for RA in Canada).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

144Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
etanercept	Active Comparator	etanercept 50 mg subcutaneously injected per week	Drug: Etanercept
tofacitinib	Active Comparator	tofacitinib 5 mg orally daily	Drug: tofacitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etanercept	Drug	injection	etanercept	enbrel Brenzys

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retention Rates	Evaluation of the proportion of patients in each arm still on the randomized treatment	24 months

Secondary Outcomes

Measure	Description	Time Frame
Mean Change in Disease Activity	The mean change from baseline in the Clinical Disease Activity Index in each arm of the study. The Clinical Disease Activity Index measures the number of tender or swollen joints, patient global assessment of disease activity, and provider global assessment of disease activity. Total tender joint count=0-28, total swollen joint count=0-28, patient global score=0-10, provider global score=0-10. Total range score=0-76. Higher values for all subscales, tender and swollen joints, global assessments indicate higher disease activity. Scores for subscales are combined to calculate the total score.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with RA who meet criteria for obtaining an advanced therapeutic through usual care
active RA with 5 or more swollen joints
seropositive
presence of erosions
failure of methotrexate and hydroxychloroquine and sulfasalazine
failure of Leflunomide

-> or equal to 18 years
able to provide consent
able to attend usual follow up visits

Exclusion Criteria:

no contraindication to etanercept or tofacitinib
active serious infection
active Tuberculosis
multiple sclerosis
current cancer
lymphoma ever
previous use of an advanced therapeutic (biologic or JAK kinase inhibitor)
less than 18 years of age
unable to provide consent

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Janet E Pope, MD MPH	Contact	519 646-6000	66332	janet.pope@sjhc.london.on.ca

Overall Officials

Name	Affiliation	Role
Janet E Pope, MD MPH	Western University, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rheumatology Clinic, St. Joseph's Health Care	Recruiting	London	Ontario	N6A 4V2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068800	Etanercept
C479163	tofacitinib

Ancestor Terms

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided