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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03915964




Registration number
NCT03915964
Ethics application status
Date submitted
12/04/2019
Date registered
16/04/2019

Titles & IDs
Public title
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis
Scientific title
A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
Secondary ID [1] 0 0
I4V-MC-JAJA
Secondary ID [2] 0 0
17172
Universal Trial Number (UTN)
Trial acronym
RA-BRIDGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baricitinib
Treatment: Drugs - TNF Inhibitor

Experimental: Baricitinib Low Dose - Baricitinib administered orally.

Experimental: Baricitinib High Dose - Baricitinib administered orally.

Active comparator: TNF Inhibitor - Adalimumab or etanercept administered subcutaneously (SC) per standard of care.


Treatment: Drugs: Baricitinib
Administered orally.

Treatment: Drugs: TNF Inhibitor
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
Timepoint [1] 0 0
Baseline through Study Completion (Approximately 5.5 Years)
Secondary outcome [1] 0 0
Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE)
Timepoint [1] 0 0
Baseline through Study Completion (Approximately 5.5 Years)
Secondary outcome [2] 0 0
Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE)
Timepoint [2] 0 0
Baseline through Study Completion (Approximately 5.5 Years)
Secondary outcome [3] 0 0
Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC])
Timepoint [3] 0 0
Baseline through Study Completion (Approximately 5.5 Years)
Secondary outcome [4] 0 0
Time from First Dose of Study Treatment to First Opportunistic Infection
Timepoint [4] 0 0
Baseline through Study Completion (Approximately 5.5 Years)
Secondary outcome [5] 0 0
Time from First Dose of Study Treatment to First Serious Infection
Timepoint [5] 0 0
Baseline through Study Completion (Approximately 5.5 Years)

Eligibility
Key inclusion criteria
* Participants must have at least one of the following characteristics:

* Documented evidence of a VTE prior to this study
* At least 60 years of age
* A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
* Age 50 to less than 60 years and BMI 25 to less than 30 kg/m².
* Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant should have no reason to not take a TNF inhibitor.
* Participants must not be pregnant or breastfeeding.
* Participants must not have had more than one VTE.
* Participants must not have cancer.
* Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness.
* Participants must not have had a live vaccine within four weeks of study start.
* Participants must not have participated in any other clinical trial within four weeks of study start.
* Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
2600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Optimus Clinical Research - Botany
Recruitment hospital [2] 0 0
Genesis Research Services - Newcastle
Recruitment hospital [3] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [4] 0 0
Southern Clinical Research - Hobart
Recruitment hospital [5] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2292 - Newcastle
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment outside Australia
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Córdoba
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Madrid
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Sevilla
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Switzerland
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Fribourg
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Eskisehir
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Istanbul
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Edirne
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Izmir
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Konya
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Bournemouth
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Devon
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England
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Essex
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United Kingdom
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Hampshire
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United Kingdom
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Kingston Upon Hull
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United Kingdom
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North Tyneside
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United Kingdom
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Nottinghamshire
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United Kingdom
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Waltham Forest
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Liverpool
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Incyte Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03915964