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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03104400




Registration number
NCT03104400
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017

Titles & IDs
Public title
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
Scientific title
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1
Secondary ID [1] 0 0
2016-004130-24
Secondary ID [2] 0 0
M15-572
Universal Trial Number (UTN)
Trial acronym
SELECT - PsA 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Adalimumab
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo to Upadacitinib
Treatment: Drugs - Placebo to Adalimumab

Experimental: Upadacitinib 15 mg - Period 1: Participants receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks.

Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Experimental: Upadacitinib 30 mg - Period 1: Participants receive upadacitinib 30 mg orally once a day and matching placebo to adalimumab by subcutaneous injection every other week for 56 weeks.

Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Active comparator: Adalimumab - Period 1: Participants receive adalimumab 40 mg by subcutaneous injection every other week and matching placebo to upadacitinib orally QD for 56 weeks.

Period 2: Participants continue to receive adalimumab 40 mg every other week.

Placebo comparator: Placebo / Upadacitinib 15 mg - Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 15 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks.

Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Placebo comparator: Placebo / Upadacitinib 30 mg - Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 30 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks.

Period 2: Participants will continue to receive upadacitinib 30 mg once daily.


Treatment: Drugs: Adalimumab
Administered by subcutaneous injection

Treatment: Drugs: Upadacitinib
Oral tablet

Treatment: Drugs: Placebo to Upadacitinib
Oral tablet

Treatment: Drugs: Placebo to Adalimumab
Administered by subcutaneous injection
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 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
Timepoint [3] 0 0
Baseline and Week 16
Secondary outcome [4] 0 0
Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Percentage of Participants With Resolution of Enthesitis at Week 24
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab
Timepoint [7] 0 0
Baseline and Week 12
Secondary outcome [8] 0 0
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Timepoint [9] 0 0
Baseline and Week 12
Secondary outcome [10] 0 0
Percentage of Participants With an ACR20 Response at Week 12 - Superiority Versus Adalimumab
Timepoint [10] 0 0
Baseline and Week 12
Secondary outcome [11] 0 0
Percentage of Participants With Resolution of Dactylitis at Week 24
Timepoint [11] 0 0
Week 24
Secondary outcome [12] 0 0
Change From Baseline in Patient's Assessment of Pain - Superiority Versus Adalimumab
Timepoint [12] 0 0
Baseline and Week 12
Secondary outcome [13] 0 0
Change From Baseline in HAQ-DI - Superiority Versus Adalimumab
Timepoint [13] 0 0
Baseline and Week 12
Secondary outcome [14] 0 0
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire at Week 16
Timepoint [14] 0 0
Baseline and Week 16
Secondary outcome [15] 0 0
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Timepoint [15] 0 0
Baseline and Week 12
Secondary outcome [16] 0 0
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Timepoint [16] 0 0
Baseline and Week 12
Secondary outcome [17] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
Timepoint [17] 0 0
Baseline and Week 2

Eligibility
Key inclusion criteria
* Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria.
* Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits.
* Presence of either at Screening:

1. >= 1 erosion on x-ray as determined by central imaging review or;
2. high-sensitivity C-reactive protein (hs-CRP) > laboratory defined upper limit of normal (ULN).
* Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
* Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), cyclosporine, apremilast, bucillamin or iguratimod), or participant has an intolerance to or contraindication for DMARDs as defined by the investigator.
* Participant who is on current treatment with concomitant non-biologic DMARDs at study entry must be on <= 2 non-biologic DMARDs (except the combination of MTX and leflunomide). The following non-biologic DMARDs are allowed: MTX, sulfasalazine, leflunomide, apremilast, hydroxychloroquine (HCQ) , bucillamine or iguratimod, and have been ongoing for >= 12 weeks and at stable dose for >= 4 weeks prior to the Baseline Visit. No other DMARDs are permitted during the study.

i. Participants who need to discontinue DMARDs prior to the Baseline Visit to comply with this inclusion criterion must follow the procedure specified below or at least five times the mean terminal elimination half-life of a drug:
1. >= 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal or as per local label);
2. >= 4 weeks for all others.
Minimum age
18 Years
Maximum age
No limit
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 ruxolitinib, tofacitinib, baricitinib, and filgotinib).
* Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than methotrexate, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine, or iguratimod; or use of methotrexate in combination with leflunomide.
* History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

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
27/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/09/2024
Sample size
Target
Accrual to date
Final
1705
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Emeritus Research Sydney /ID# 166780 - Botany
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital /ID# 169333 - Woodville
Recruitment hospital [3] 0 0
Barwon Rheumatology /ID# 166782 - Geelong
Recruitment hospital [4] 0 0
Heidelberg Repatriation Hospital /ID# 167450 - Heidelberg West
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg West
Recruitment outside Australia
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United States of America
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Alabama
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State/province [171] 0 0
San Juan
Country [172] 0 0
Russian Federation
State/province [172] 0 0
Moskva
Country [173] 0 0
Russian Federation
State/province [173] 0 0
Novosibirskaya Oblast
Country [174] 0 0
Russian Federation
State/province [174] 0 0
Tatarstan, Respublika
Country [175] 0 0
Russian Federation
State/province [175] 0 0
Moscow
Country [176] 0 0
Russian Federation
State/province [176] 0 0
St. Petersburg
Country [177] 0 0
Serbia
State/province [177] 0 0
Beograd
Country [178] 0 0
Singapore
State/province [178] 0 0
Central Singapore
Country [179] 0 0
Singapore
State/province [179] 0 0
Singapore
Country [180] 0 0
Slovakia
State/province [180] 0 0
Martin
Country [181] 0 0
Slovakia
State/province [181] 0 0
Nové Mesto Nad Váhom
Country [182] 0 0
Slovakia
State/province [182] 0 0
Pieštany
Country [183] 0 0
Slovenia
State/province [183] 0 0
Ljubljana
Country [184] 0 0
Slovenia
State/province [184] 0 0
Maribor
Country [185] 0 0
Slovenia
State/province [185] 0 0
Murska Sobota
Country [186] 0 0
South Africa
State/province [186] 0 0
Eastern Cape
Country [187] 0 0
South Africa
State/province [187] 0 0
Gauteng
Country [188] 0 0
South Africa
State/province [188] 0 0
Western Cape
Country [189] 0 0
Spain
State/province [189] 0 0
A Coruna
Country [190] 0 0
Spain
State/province [190] 0 0
Granada
Country [191] 0 0
Spain
State/province [191] 0 0
Madrid
Country [192] 0 0
Switzerland
State/province [192] 0 0
Sankt Gallen
Country [193] 0 0
Switzerland
State/province [193] 0 0
Fribourg
Country [194] 0 0
Taiwan
State/province [194] 0 0
Taichung
Country [195] 0 0
Taiwan
State/province [195] 0 0
Taipei City
Country [196] 0 0
Taiwan
State/province [196] 0 0
Taoyuan City
Country [197] 0 0
Turkey
State/province [197] 0 0
Adana
Country [198] 0 0
Turkey
State/province [198] 0 0
Ankara
Country [199] 0 0
Turkey
State/province [199] 0 0
Istanbul
Country [200] 0 0
Turkey
State/province [200] 0 0
Meram Konya
Country [201] 0 0
Turkey
State/province [201] 0 0
Sakarya
Country [202] 0 0
Ukraine
State/province [202] 0 0
Kharkivska Oblast
Country [203] 0 0
Ukraine
State/province [203] 0 0
Lvivska Oblast
Country [204] 0 0
Ukraine
State/province [204] 0 0
Kharkiv
Country [205] 0 0
Ukraine
State/province [205] 0 0
Kiev
Country [206] 0 0
Ukraine
State/province [206] 0 0
Kyiv
Country [207] 0 0
Ukraine
State/province [207] 0 0
Odesa
Country [208] 0 0
Ukraine
State/province [208] 0 0
Vinnytsia
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United Kingdom
State/province [209] 0 0
London, City Of
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Christchurch
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United Kingdom
State/province [211] 0 0
Coventry
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United Kingdom
State/province [212] 0 0
Glasgow
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Luton

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 and 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)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


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/NCT03104400