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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03104400
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017
Date last updated
16/06/2020

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
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 - ABT-494
Treatment: Drugs - Placebo for ABT-494
Treatment: Drugs - Placebo for Adalimumab

Experimental: ABT-494 Dose A + Placebo Adalimumab - It is administered once daily.

Experimental: ABT-494 Dose B + Placebo Adalimumab - It is administered once daily.

Active Comparator: Adalimumab + Placebo ABT-494 - It is administered subcutaneously once every two weeks.

Experimental: Placebo ABT-494 + Placebo Adalimumab Then ABT-494 Dose A - It is administered once daily.

Experimental: Placebo ABT-494 + Placebo Adalimumab Then ABT-494 Dose B - It is administered once daily.


Treatment: Drugs: Adalimumab
Adalimumab subcutaneous injection

Treatment: Drugs: ABT-494
Oral tablet

Treatment: Drugs: Placebo for ABT-494
Oral tablet

Treatment: Drugs: Placebo for Adalimumab
Subcutaneous injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response - Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change in HAQ-DI - The HAQ DI is a patient-reported questionnaire. It includes the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. It asks patients about the amount of difficulty they experience in these activities as well as the use of aids and/or devices.
Timepoint [1] 0 0
Baseline (Day 1) to 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 - The sIGA is a 5 point score ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the patient's previous disease states, whether at Baseline or at a previous visit.
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Psoriasis Area Severity Index (PASI) 75 Response (For Participants With >= 3% Body Surface Area (BSA) Psoriasis at Baseline) - The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Change in Modified PsA Sharp/van der Heijde Score (SHS) - This will be evaluated through centrally read xray images of bilateral hands and feet.
Timepoint [4] 0 0
Baseline (Day 1) to Week 24
Secondary outcome [5] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) - The proportion of subjects achieving MDA will be determined based on subjects fulfilling 5 of 7 outcome measures: TJC <= 1; SJC <= 1; PASI <= 1 or BSA-Ps <= 3%; Patient's Assessment of Pain NRS <= 1.5; PtGA-Disease Activity NRS <= 2.0; HAQ-DI score <= 0.5; and tender entheseal points <= 1.
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Percentage of Participants With Resolution of Enthesitis (Leeds Enthesitis Index (LEI)=0) - LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions.
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
ACR 20 Response Rate (Non-Inferiority of ABT-494 vs Adalimumab) - Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Change in Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2) - The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores are aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being).
Timepoint [8] 0 0
Baseline (Day 1) to Week 12
Secondary outcome [9] 0 0
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaire - The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.
Timepoint [9] 0 0
Baseline (Day 1) to Week 12
Secondary outcome [10] 0 0
ACR 20 Response Rate (Superiority of ABT-494 vs. Adalimumab) - Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Percentage of Participants With Resolution of Dactylitis (Leeds Dactylitis Index (LDI)=0) - LDI assesses the presence or absence of dactylitis in all 20 of the subject's digits.
Timepoint [11] 0 0
Week 24
Secondary outcome [12] 0 0
Change in Patient's Assessment of Pain Numerical Rating Scale (NRS) (Superiority of ABT-494 vs. Adalimumab) - Participant will complete the patient's assessment of pain on a numeric rating scale.
Timepoint [12] 0 0
Baseline (Day 1) to Week 12
Secondary outcome [13] 0 0
Change in HAQ-DI (Superiority of ABT-494 vs. Adalimumab) - The HAQ DI is a patient-reported questionnaire. It includes the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. It asks patients about the amount of difficulty they experience in these activities as well as the use of aids and/or devices.
Timepoint [13] 0 0
Baseline (Day 1) to Week 12
Secondary outcome [14] 0 0
Change in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire - The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain.
Timepoint [14] 0 0
Baseline (Day 1) to Week 16
Secondary outcome [15] 0 0
ACR 50 Response - Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Timepoint [15] 0 0
Week 12
Secondary outcome [16] 0 0
ACR 70 Response - Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Timepoint [16] 0 0
Week 12
Secondary outcome [17] 0 0
ACR 20 Response - Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Timepoint [17] 0 0
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. 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 (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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Optimus Clinical Research Pty. /ID# 166780 - Kogarah
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
2217 - Kogarah
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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Israel
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Korea, Republic of
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Luton

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to
compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B
QD versus placebo and versus adalimumab every other week (eow) in participants with
moderately to severely active Psoriatic Arthritis (PsA) and have an inadequate response to
non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of ABT-494
Dose A QD and Dose B QD versus placebo for the prevention of structural progression. Period 2
evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in
participants with PsA who have completed Period 1.
Trial website
https://clinicaltrials.gov/show/NCT03104400
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

Summary results
Other publications