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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02706951




Registration number
NCT02706951
Ethics application status
Date submitted
18/02/2016
Date registered
11/03/2016

Titles & IDs
Public title
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Scientific title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX
Secondary ID [1] 0 0
2015-003376-75
Secondary ID [2] 0 0
M15-555
Universal Trial Number (UTN)
Trial acronym
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 - Methotrexate
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo Upadacitinib
Treatment: Drugs - Placebo Methotrexate

Experimental: Upadacitinib 30 mg - Period 1: Participants receive upadacitnib 30 mg once daily and placebo to methotrexate once weekly for 14 weeks.

Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.

Experimental: Upadacitinib 15 mg - Period 1: Participants receive upadacitnib 15 mg once daily and placebo to methotrexate once weekly for 14 weeks.

Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.

Experimental: Methotrexate / Upadacitinib 30 mg - Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib once daily for 14 weeks.

Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.

Experimental: Methotrexate / Upadacitinib 15 mg - Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib for 14 weeks.

Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.


Treatment: Drugs: Methotrexate
Capsule; Oral

Treatment: Drugs: Upadacitinib
Tablet; Oral

Treatment: Drugs: Placebo Upadacitinib
Tablet; Oral

Treatment: Drugs: Placebo Methotrexate
Capsule; Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14
Timepoint [1] 0 0
Baseline and week 14
Primary outcome [2] 0 0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14
Timepoint [2] 0 0
Week 14
Secondary outcome [1] 0 0
Change From Baseline in in Disease Activity Score 28 (CRP) at Week 14
Timepoint [1] 0 0
Baseline to week 14
Secondary outcome [2] 0 0
Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14
Timepoint [2] 0 0
Baseline to week 14
Secondary outcome [3] 0 0
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14
Timepoint [3] 0 0
Baseline to week 14
Secondary outcome [4] 0 0
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 14
Timepoint [4] 0 0
Week 14
Secondary outcome [5] 0 0
Change From Baseline in Duration of Morning Stiffness at Week 14
Timepoint [5] 0 0
Baseline to week 14
Secondary outcome [6] 0 0
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 14
Timepoint [6] 0 0
Baseline and week 14
Secondary outcome [7] 0 0
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 14
Timepoint [7] 0 0
Baseline and week 14

Eligibility
Key inclusion criteria
* Diagnosis of RA for >= 3 months.
* Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable dose for >= 4 weeks prior to first dose of study drug.
* Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.
* Meets the following minimum disease activity criteria: >= 6 swollen joints (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
* Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
* Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/08/2022
Sample size
Target
Accrual to date
Final
648
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital /ID# 146028 - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
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Illinois
Country [9] 0 0
United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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Nebraska
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United States of America
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New Hampshire
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United States of America
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New Mexico
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North Carolina
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Ohio
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Oklahoma
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South Carolina
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Tennessee
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Texas
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United States of America
State/province [21] 0 0
Virginia
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United States of America
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Wisconsin
Country [23] 0 0
Argentina
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Buenos Aires
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Argentina
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Salta
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Argentina
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Santa Fe
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Austria
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Wien
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Belgium
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Oost-Vlaanderen
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Belgium
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Genk
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Bulgaria
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Sofia
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Chile
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Concepcion
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Chile
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Puerto Varas
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Chile
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Santiago
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Czechia
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Olomoucky Kraj
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Czechia
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Praha 4
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Czechia
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Breclav
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Czechia
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Uherské Hradište
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Estonia
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Tartumaa
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Estonia
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Tallinn
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Greece
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Athens
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Budapest
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Israel
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Ramat Gan
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Italy
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Calabria
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Italy
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Verona
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Fukuoka
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Hyuga
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Sanuki
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Sapporo
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Shunan
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Takaoka
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Tokyo
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Yotsukaido
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Nuevo LEON
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Mexico
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Mexico City
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Poland
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Dolnoslaskie
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Lubelskie
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Mazowieckie
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Podlaskie
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Pomorskie
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Warminsko-mazurskie
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Wielkopolskie
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Portugal
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Lisboa
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Porto
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Puerto Rico
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Carolina
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Puerto Rico
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Ponce
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Romania
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Ploiesti
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Russian Federation
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Moskva
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Russian Federation
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Novosibirskaya Oblast
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Russian Federation
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Permskiy Kray
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Russian Federation
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Tverskaya Oblast
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Russian Federation
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Ivanovo
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Russian Federation
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Moscow
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Russian Federation
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Nizhnij Novgorod
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Russian Federation
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Orenburg
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Russian Federation
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Petrozavodsk
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Russian Federation
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Samara
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Russian Federation
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UFA
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Russian Federation
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Yaroslavl
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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
State/province [92] 0 0
Gauteng
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South Africa
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Western Cape
Country [94] 0 0
Spain
State/province [94] 0 0
Barcelona
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Spain
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Sevilla
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Spain
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Valencia
Country [97] 0 0
Turkey
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Bursa
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Ukraine
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Lvivska Oblast
Country [99] 0 0
Ukraine
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Vinnytska Oblast
Country [100] 0 0
Ukraine
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Ivano-frankivsk
Country [101] 0 0
Ukraine
State/province [101] 0 0
Kiev
Country [102] 0 0
Ukraine
State/province [102] 0 0
Zaporizhia

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02706951