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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03104374




Registration number
NCT03104374
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017
Date last updated
13/11/2023

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 (bDMARD)
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) - SELECT - PsA 2
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 - Upadacitinib
Treatment: Drugs - Placebo

Experimental: Upadacitinib 15 mg - Period 1: Participants receive upadacitinib 15 mg once daily 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 once daily for 56 weeks.
Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Placebo Comparator: Placebo then Upadacitinib 15 mg - Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 15 mg once daily for 32 weeks.
Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Placebo Comparator: Placebo then Upadacitinib 30 mg - Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 30 mg once daily for 32 weeks.
Period 2: Participants will continue to receive upadacitinib 30 mg once daily.


Treatment: Drugs: Upadacitinib
Oral tablet

Treatment: Drugs: Placebo
Oral tablet
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 Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16
Timepoint [7] 0 0
Baseline and Week 16
Secondary outcome [8] 0 0
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Timepoint [9] 0 0
Baseline and Week 12
Secondary outcome [10] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
Timepoint [10] 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

- 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
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 (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
1/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
Accrual to date
Final
642
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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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
The study objectives of Period 1 are to compare the efficacy, safety, and tolerability of
upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo for the treatment of signs and
symptoms in adults with moderately to severely active psoriatic arthritis (PsA) who have had
an inadequate response or intolerance to biologic disease-modifying anti-rheumatic drug
(bDMARD).

The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of
upadacitinib 15 mg QD and 30 mg QD in participants who have completed Period 1.
Trial website
https://clinicaltrials.gov/ct2/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