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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05814627




Registration number
NCT05814627
Ethics application status
Date submitted
4/04/2023
Date registered
18/04/2023

Titles & IDs
Public title
Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis
Scientific title
A Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)
Secondary ID [1] 0 0
2022-502578-18-00
Secondary ID [2] 0 0
M23-700
Universal Trial Number (UTN)
Trial acronym
SELECT- SWITCH
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 - Upadacitinib
Treatment: Drugs - Adalimumab
Treatment: Drugs - Upadacitinib Matching Placebo
Treatment: Drugs - Adalimumab Matching Placebo

Experimental: Upadacitinib+ Adalimumab matching Placebo - Participants will receive upadacitinib once a day along with matching placebo for adalimumab at eow (every other week) in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.

Experimental: Adalimumab + Upadacitinib matching Placebo - Participants will receive adalimumab at eow (every other week) along with matching placebo for upadacitinib once a day in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.


Treatment: Drugs: Upadacitinib
Oral Tablets

Treatment: Drugs: Adalimumab
Subcutaneous Injection

Treatment: Drugs: Upadacitinib Matching Placebo
Oral Tablets

Treatment: Drugs: Adalimumab Matching Placebo
Subcutaneous Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) < 2.6
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change from Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Change from Baseline in Participants Assessment of Pain
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Timepoint [5] 0 0
Week 12

Eligibility
Key inclusion criteria
* Diagnosis of Rheumatoid Arthritis (RA) for >= 3 months based on the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for RA.
* Treated for >= 3 consecutive months prior to screening with 1 tumor necrosis factor inhibitor (TNFi) (only 1 of originator or biosimilar certolizumab pegol, etanercept, golimumab or infliximab) for RA, but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. Up to 15% of participants who were intolerant to 1 TNFi will be allowed to enroll. Prior administration of different biosimilar versions for the same originator TNFi or switching between originator and biosimilar version of the same originator TNFi are acceptable. Cycling between biosimilars of different originator TNF inhibitors is not acceptable.
* On oral or parenteral methotrexate (MTX) therapy >= 3 consecutive months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. In addition, all participants should take a dietary supplement of folic acid or folinic acid throughout the study participation.

* For a Chinese, Japanese, Korean, or Taiwanese participant, a stable dose of MTX >= 7.5 mg/week is acceptable.
* Additional local requirements for MTX may apply.
* Meets both of the following disease activity criteria:

* >= 6 swollen joint (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at screening and baseline;
* High-sensitivity C-reactive protein (hsCRP) >= 3 mg/L (central lab, upper limit of normal [ULN] 2.87 mg/L) at screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than Rheumatoid Arthritis (RA).
* Prior exposure to any janus kinase (JAK) inhibitor.
* Prior exposure to adalimumab (original or biosimilar) or to any approved or investigational TNF inhibitor other than infliximab, etanercept, certolizumab pegol and golimumab.
* Prior exposure to an approved or investigational non-TNFi biologic disease modifying anti-rheumatic drug (bDMARD) or targeted synthetic disease modifying antirheumatic drug (tsDMARD).

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2026
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Texas
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Wisconsin
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Argentina
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Ciudad Autonoma De Buenos Aires
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Tucuman
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Belgium
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Limburg
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Belgium
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Belgium
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Liege
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Chile
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Chile
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Santander
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Grad Zagreb
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Istarska Zupanija
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Gwangju Gwang Yeogsi
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Korea, Republic of
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Seoul Teugbyeolsi
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Ciudad De Mexico
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Portugal
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Viana Do Castelo
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Portugal
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Lisboa
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Puerto Rico
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San Juan
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Romania
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Olt
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Romania
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Timis
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Romania
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Bacau
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Serbia
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Beograd
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Serbia
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Vojvodina
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South Africa
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Gauteng
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South Africa
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Kwazulu-Natal
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South Africa
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Western Cape
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Spain
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A Coruna
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Valencia
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United Kingdom
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London, City Of
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Norfolk
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London
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United Kingdom
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Portsmouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
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?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


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/NCT05814627