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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/NCT01960855
Registration number
NCT01960855
Ethics application status
Date submitted
9/10/2013
Date registered
11/10/2013
Date last updated
24/08/2021
Titles & IDs
Public title
A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 Given With Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy
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Secondary ID [1]
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2013-002358-57
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Secondary ID [2]
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M13-550
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABT-494
Treatment: Drugs - Placebo
Placebo Comparator: Placebo BID - Placebo twice daily (BID) for 12 weeks.
Experimental: ABT-494 3 mg BID - ABT-494 3 mg twice daily (BID) for 12 weeks.
Experimental: ABT-494 6 mg BID - ABT-494 6 mg twice daily (BID) for 12 weeks.
Experimental: ABT-494 12 mg BID - ABT-494 12 mg twice daily (BID) for 12 weeks.
Experimental: ABT-494 18 mg BID - ABT-494 18 mg twice daily (BID) for 12 weeks.
Treatment: Drugs: ABT-494
ABT-494 capsule administered orally twice daily (BID).
Treatment: Drugs: Placebo
Placebo for ABT-494 capsule administered orally twice daily (BID).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
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Assessment method [1]
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Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), 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 (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hs CRP). Last observation carried forward (LOCF) was used for missing data.
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Timepoint [1]
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Baseline (Week 0) and Week 12
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Secondary outcome [1]
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Number of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
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Assessment method [1]
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Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.
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Timepoint [1]
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Baseline (Week 0) and Week 12
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Secondary outcome [2]
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Number of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
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Assessment method [2]
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Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.
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Timepoint [2]
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Baseline (Week 0) and Week 12
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Secondary outcome [3]
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Number of Subjects Achieving Low Disease Activity (LDA) Based on Disease Activity Score (DAS28) or Clinical Remission (CR) Based on (DAS28) at Week 12
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Assessment method [3]
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LDA is defined as DAS28 from 2.6 to < 3.2 at Week 12. CR is defined as DAS28 (CRP) < 2.6 at Week 12. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. LOCF was used.
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Timepoint [3]
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Baseline (Week 0) and Week 12
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Secondary outcome [4]
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Number of Subjects Achieving CR Based on DAS28 at Week 12
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Assessment method [4]
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The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. LOCF was used.
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Timepoint [4]
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Baseline (Week 0) and Week 12
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Eligibility
Key inclusion criteria
- Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American
College of Rheumatology (ACR) classification criteria or the 2010 American College of
Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for = 3 months.
- Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy = 3
months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to
initiating the study drug. Subjects should also be on a stable dose of folic acid (or
equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should
continue with their stable doses of MTX and folic acid throughout the study
- Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics
(no maximum cap) for = 3 months but continue to exhibit active RA, or had to
discontinue due to intolerability or toxicity. In addition, subjects with prior
exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab,
anakinra, or tocilizumab) are allowed.
- Have active RA as defined by the following minimum disease activity criteria: = 6
swollen joints (based on 66 joint counts) at Screening and Baseline, = 6 tender joints
(based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive
protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor
and anti-cyclic citrullinated peptide (anti-CCP) antibody.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib,
baricitinib)
- Pregnant or breastfeeding female
- Ongoing or active infection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2015
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Sample size
Target
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Accrual to date
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Final
276
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective is to compare the safety and efficacy of multiple doses of ABT-494
versus placebo in moderately to severely active RA subjects on stable background MTX therapy
with inadequate response or intolerance to anti-TNF biologic therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01960855
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Trial related presentations / publications
Kremer JM, Emery P, Camp HS, Friedman A, Wang L, Othman AA, Khan N, Pangan AL, Jungerwirth S, Keystone EC. A Phase IIb Study of ABT-494, a Selective JAK-1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Therapy. Arthritis Rheumatol. 2016 Dec;68(12):2867-2877. doi: 10.1002/art.39801.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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AbbVie Inc
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Address
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AbbVie
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01960855
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