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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02706873




Registration number
NCT02706873
Ethics application status
Date submitted
18/02/2016
Date registered
11/03/2016

Titles & IDs
Public title
A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
Scientific title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis
Secondary ID [1] 0 0
2015-003334-27
Secondary ID [2] 0 0
M13-545
Universal Trial Number (UTN)
Trial acronym
SELECT-EARLY
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 - Placebo to Upadacitinib
Treatment: Drugs - Methotrexate
Treatment: Drugs - Placebo to Methotrexate
Treatment: Drugs - Upadacitinib

Active comparator: Methotrexate - Period 1: Participants will receive placebo to upadacitinib once daily and methotrexate once weekly for 48 weeks.

Period 2: Participants will continue on placebo to upadacitinib once daily and methotrexate once weekly until the study is unblinded, after which participants will receive open-label methotrexate up to Week 260.

Experimental: Upadacitinib 7.5 mg (Japan-only) - Period 1: Participants will receive upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly for 48 weeks.

Period 2: Participants will continue on upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 7.5 mg up to Week 260.

Experimental: Upadacitinib 15 mg - Period 1: Participants will receive upadacitinib 15 mg once daily and placebo to methotrexate once weekly for 48 weeks.

Period 2: Participants will continue on upadacitinib 15 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 15 mg up to Week 260.

Experimental: Upadacitinib 30 mg - Period 1: Participants will receive upadacitinib 30 mg once daily and placebo to methotrexate once weekly for 48 weeks.

Period 2: Participants will continue on upadacitinib 30 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 30 mg once daily. After implementation of Protocol Amendment 6 participants will receive upadacitinib 15 mg once daily up to Week 260.


Treatment: Drugs: Placebo to Upadacitinib
Tablet; Oral

Treatment: Drugs: Methotrexate
Capsule or Tablet; Oral

Treatment: Drugs: Placebo to Methotrexate
Capsule or Tablet; Oral

Treatment: Drugs: Upadacitinib
Tablet; 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 50% (ACR50) Response at Week 12 - Global Analysis
Timepoint [1] 0 0
Baseline and Week 12
Primary outcome [2] 0 0
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Global Analysis
Timepoint [2] 0 0
Week 24
Primary outcome [3] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 - Global Analysis
Timepoint [3] 0 0
Baseline and Week 12
Primary outcome [4] 0 0
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Global Analysis
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Change From Baseline in DAS28 (CRP) at Week 12 - Global Analysis
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Global Analysis
Timepoint [2] 0 0
Baseline to week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Global Analysis
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Global Analysis
Timepoint [4] 0 0
Baseline to week 12
Secondary outcome [5] 0 0
Change From Baseline in DAS28 (CRP) at Week 24 - Global Analysis
Timepoint [5] 0 0
Baseline to Week 24
Secondary outcome [6] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 - Global Analysis
Timepoint [6] 0 0
Baseline to Week 24
Secondary outcome [7] 0 0
Percentage of Participants With an ACR50 Response at Week 24 - Global Analysis
Timepoint [7] 0 0
Baseline and Week 24
Secondary outcome [8] 0 0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 24 - Global Analysis
Timepoint [8] 0 0
Week 24
Secondary outcome [9] 0 0
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 24 - Global Analysis
Timepoint [9] 0 0
Baseline to Week 24
Secondary outcome [10] 0 0
Percentage of Participants With No Radiographic Progression at Week 24 - Global Analysis
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 - Global Analysis
Timepoint [11] 0 0
Baseline and Week 12
Secondary outcome [12] 0 0
Percentage of Participants With an ACR20 Response at Week 24 - Global Analysis
Timepoint [12] 0 0
Baseline and Week 24
Secondary outcome [13] 0 0
Percentage of Participants With an ACR70 Response at Week 24 - Global Analysis
Timepoint [13] 0 0
Baseline and Week 24
Secondary outcome [14] 0 0
Percentage of Participants With an ACR20 Response at Week 12 - Japan Sub-study
Timepoint [14] 0 0
Baseline and Week 12
Secondary outcome [15] 0 0
Percentage of Participants With an ACR50 Response at Week 12 - Japan Sub-study
Timepoint [15] 0 0
Baseline and Week 12
Secondary outcome [16] 0 0
Percentage of Participants With an ACR70 Response at Week 12 - Japan Sub-study
Timepoint [16] 0 0
Baseline and Week 12
Secondary outcome [17] 0 0
Change From Baseline in DAS28 (CRP) at Week 12 - Japan Sub-study
Timepoint [17] 0 0
Baseline to Week 12
Secondary outcome [18] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Japan Sub-study
Timepoint [18] 0 0
Baseline to week 12
Secondary outcome [19] 0 0
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Japan Sub-study
Timepoint [19] 0 0
Baseline to Week 12
Secondary outcome [20] 0 0
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Japan Sub-study
Timepoint [20] 0 0
Week 12
Secondary outcome [21] 0 0
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Japan Sub-study
Timepoint [21] 0 0
Week 24
Secondary outcome [22] 0 0
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Japan Sub-study
Timepoint [22] 0 0
Baseline to Week 24
Secondary outcome [23] 0 0
Percentage of Participants With No Radiographic Progression at Week 24 - Japan Sub-study
Timepoint [23] 0 0
Week 24

Eligibility
Key inclusion criteria
* Duration of symptoms consistent with RA for = 6 weeks who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
* Naïve to Methotrexate (MTX) or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.
* Participants with prior exposure to conventional synthetic disease-modifying anti-rheumatic drugs(csDMARDs) other than MTX may be enrolled if completed the washout period.
* Participant meets both of 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.
* high sensitivity C reactive protein (hsCRP) = 5 mg/L (central lab, upper limit of normal [ULN] 2.87 mg/L at Screening Visit.
* Greater than or equal to 1 bone erosion on x-ray (by local reading) OR in the absence of documented bone erosion, both positive rheumatoid factor (RF) and positive anti-cyclic citrullinated peptide (anti CCP) autoantibodies are required at Screening.
* Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral corticosteroids (equivalent to prednisone = 10 mg/day), or inhaled corticosteroids for stable medical conditions are allowed but must have been at a stable dose = 1 week prior to the first dose of study drug.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Intolerant to Methotrexate (MTX).
* Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
* Prior exposure to any biologic disease-modifying anti-rheumatic drugs (bDMARDs).
* History of any arthritis with onset prior to age 17 years or current diagnosis, inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]. Current diagnosis of secondary Sjogren's Syndrome is permitted.
* Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug.

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
23/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/11/2022
Sample size
Target
Accrual to date
Final
1002
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital /ID# 143149 - Camperdown
Recruitment hospital [2] 0 0
Rheumatology Research Unit /ID# 143147 - Maroochydore
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital /ID# 143148 - Woodville
Recruitment hospital [4] 0 0
Southern Clinical Research Pty /ID# 143150 - Hobart
Recruitment hospital [5] 0 0
Emeritus Research /ID# 143146 - Camberwell
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment outside Australia
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United States of America
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Florida
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Nové Mesto Nad Váhom
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Slovakia
State/province [164] 0 0
Partizanske
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Slovakia
State/province [165] 0 0
Pieštany
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Slovakia
State/province [166] 0 0
Puchov
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Slovakia
State/province [167] 0 0
Stará Lubovna
Country [168] 0 0
Slovakia
State/province [168] 0 0
Topolcany
Country [169] 0 0
Slovakia
State/province [169] 0 0
Trencin
Country [170] 0 0
Slovakia
State/province [170] 0 0
Trnava
Country [171] 0 0
Slovakia
State/province [171] 0 0
Zvolen
Country [172] 0 0
Slovakia
State/province [172] 0 0
Žiar nad Hronom
Country [173] 0 0
Slovenia
State/province [173] 0 0
Ljubljana
Country [174] 0 0
South Africa
State/province [174] 0 0
Gauteng
Country [175] 0 0
South Africa
State/province [175] 0 0
Western Cape
Country [176] 0 0
Spain
State/province [176] 0 0
Cantabria
Country [177] 0 0
Spain
State/province [177] 0 0
A Coruna
Country [178] 0 0
Spain
State/province [178] 0 0
Barcelona
Country [179] 0 0
Spain
State/province [179] 0 0
Madrid
Country [180] 0 0
Spain
State/province [180] 0 0
Santiago de Compostela
Country [181] 0 0
Switzerland
State/province [181] 0 0
Fribourg
Country [182] 0 0
Taiwan
State/province [182] 0 0
Taichung
Country [183] 0 0
Taiwan
State/province [183] 0 0
Taipei
Country [184] 0 0
Taiwan
State/province [184] 0 0
Dalin
Country [185] 0 0
Tunisia
State/province [185] 0 0
La Marsa
Country [186] 0 0
Tunisia
State/province [186] 0 0
Manouba
Country [187] 0 0
Tunisia
State/province [187] 0 0
Sousse
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Tunisia
State/province [188] 0 0
Tunis
Country [189] 0 0
Turkey
State/province [189] 0 0
Bursa
Country [190] 0 0
Turkey
State/province [190] 0 0
Izmir
Country [191] 0 0
Ukraine
State/province [191] 0 0
Lvivska Oblast
Country [192] 0 0
Ukraine
State/province [192] 0 0
Vinnytska Oblast
Country [193] 0 0
Ukraine
State/province [193] 0 0
Ivano-frankivsk
Country [194] 0 0
Ukraine
State/province [194] 0 0
Kiev
Country [195] 0 0
Ukraine
State/province [195] 0 0
Kyiv
Country [196] 0 0
Ukraine
State/province [196] 0 0
Lviv
Country [197] 0 0
Ukraine
State/province [197] 0 0
Odesa
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Ukraine
State/province [198] 0 0
Zaporizhia
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United Kingdom
State/province [199] 0 0
England
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United Kingdom
State/province [200] 0 0
London, City Of
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United Kingdom
State/province [201] 0 0
Edinburgh
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United Kingdom
State/province [202] 0 0
Leeds
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United Kingdom
State/province [203] 0 0
Portsmouth
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Southampton

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
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 data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

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?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02706873