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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02706847




Registration number
NCT02706847
Ethics application status
Date submitted
18/02/2016
Date registered
11/03/2016
Date last updated
18/02/2019

Titles & IDs
Public title
A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
Scientific title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
Secondary ID [1] 0 0
2015-003335-35
Secondary ID [2] 0 0
M13-542
Universal Trial Number (UTN)
Trial acronym
SELECT-BEYOND
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 - ABT-494
Treatment: Drugs - Placebo

Experimental: ABT-494 Dose A - ABT-494 Dose A once daily for 240 weeks

Experimental: ABT-494 Dose B - ABT-494 Dose B once daily for 240 weeks

Placebo Comparator: Placebo followed by ABT-494 Dose B - Placebo once daily for 12 weeks followed by ABT-494 Dose B for 228 weeks

Placebo Comparator: Placebo followed by ABT-494 Dose A - Placebo once daily for 12 weeks followed by ABT-494 Dose A for 228 weeks


Treatment: Drugs: ABT-494
ABT-494 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
Proportion of participants achieving American College Rheumatology (ACR) 20 response rate - ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
Timepoint [1] 0 0
At week 12
Secondary outcome [1] 0 0
Proportion of participants achieving low disease activity (LDA) - Proportion of participants achieving low disease activity as defined by a clinical response DAS28[CRP] less than or equal to 3.2. The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than or equal to 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Timepoint [1] 0 0
At week 12
Secondary outcome [2] 0 0
Change in Short-Form 36 (SF-36) Physical Component Score (PCS) - SF-36 is a 36 item participant questionnaire with questions regarding participant health and daily activities.
Timepoint [2] 0 0
At week 12
Secondary outcome [3] 0 0
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) - HAQ-DI is a participant questionnaire with questions regarding the participant's illness and how it affect their daily life activities.
Timepoint [3] 0 0
At week 12
Secondary outcome [4] 0 0
Change in Disease Activity Score (DAS)28 C-Reactive Protein (CRP) - The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.
Timepoint [4] 0 0
At week 12

Eligibility
Key inclusion criteria
- Diagnosis of rheumatoid arthritis (RA) for >= 3 months.

- Subjects have been treated for >= 3 months with >= 1 bDMARD therapy, but continue to
exhibit active RA or had to discontinue due to intolerability or toxicity,
irrespective of treatment duration prior to the first dose of study drug.

- Subjects have been receiving csDMARD therapy >= 3 months and on a stable dose for >= 4
weeks prior to the first dose of study drug. The following csDMARDs are allowed:
methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A
combination of up to two background csDMARDs is allowed except the combination of MTX
and leflunomide.

- Meets the following criteria: >= 6 swollen joints (based on 66 joint counts) and >= 6
tender joints (based on 68 joint counts) at Screening and Baseline Visits.
Minimum age
18 Years
Maximum age
99 Years
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
tofacitinib, baricitinib, and filgotinib).

- Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of
secondary Sjogren's Syndrome is permitted.

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)
SA,VIC
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital /ID# 142419 - Woodville
Recruitment hospital [2] 0 0
Emeritus Research /ID# 142416 - Camberwell
Recruitment postcode(s) [1] 0 0
5011 - Woodville
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment outside Australia
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Alabama
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Wirral

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

Ethics approval
Ethics application status

Summary
Brief summary
The comparison of safety and efficacy of two doses of Upadacitinib (ABT-494) versus placebo
in participants with rheumatoid arthritis on a stable background conventional synthetic
Disease Modifying Anti-Rheumatic Drug (csDMARD).
Trial website
https://clinicaltrials.gov/show/NCT02706847
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