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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03104374




Registration number
NCT03104374
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017
Date last updated
13/01/2020

Titles & IDs
Public title
A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
Scientific title
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)
Secondary ID [1] 0 0
2016-004152-30
Secondary ID [2] 0 0
M15-554
Universal Trial Number (UTN)
Trial acronym
SELECT - PsA 2
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 - Placebo
Treatment: Drugs - ABT-494

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

Placebo Comparator: Placebo followed by ABT-494 Dose B - It is administered once daily.

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

Placebo Comparator: Placebo followed by ABT-494 Dose A - It is administered once daily.


Treatment: Drugs: Placebo
Oral tablet

Treatment: Drugs: ABT-494
Oral tablet

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

Outcomes
Primary outcome [1] 0 0
Proportion 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
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 [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion 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% 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 16. 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
Proportion 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 [4] 0 0
Week 24
Secondary outcome [5] 0 0
Change from baseline 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 [5] 0 0
Week 12
Secondary outcome [6] 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 [6] 0 0
Week 12
Secondary outcome [7] 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 [7] 0 0
Week 2
Secondary outcome [8] 0 0
Change from baseline in Short-Form (SF)-36 Physical Component Summary (PCS) - 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
Week 12
Secondary outcome [9] 0 0
Change from baseline in 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
Week 12
Secondary outcome [10] 0 0
Change from baseline 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 [10] 0 0
Week 16

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

- 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) or intolerance to treatment with at least 1 bDMARD.
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 (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast,
Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with
LEF at Baseline.

- 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
non-radiographic 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# 166751 - Kogarah
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital /ID# 200840 - Woodville
Recruitment hospital [3] 0 0
Heidelberg Repatriation Hospital /ID# 167441 - Heidelberg West
Recruitment hospital [4] 0 0
Box Hill Hospital /ID# 166752 - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [4] 0 0
3128 - Melbourne
Recruitment outside Australia
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Alabama
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Arizona
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Illinois
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Glasgow
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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 in participants with moderately to severely active Psoriatic Arthritis
(PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug
(bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and
Dose B QD in subjects with PsA who have completed Period 1.
Trial website
https://clinicaltrials.gov/show/NCT03104374
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