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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
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
Secondary ID [1] 0 0
2013-002358-57
Secondary ID [2] 0 0
M13-550
Universal Trial Number (UTN)
Trial acronym
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

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

Outcomes
Primary outcome [1] 0 0
Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Timepoint [1] 0 0
Baseline (Week 0) and Week 12
Secondary outcome [1] 0 0
Number of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
Timepoint [1] 0 0
Baseline (Week 0) and Week 12
Secondary outcome [2] 0 0
Number of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
Timepoint [2] 0 0
Baseline (Week 0) and Week 12
Secondary outcome [3] 0 0
Number of Subjects Achieving Low Disease Activity (LDA) Based on Disease Activity Score (DAS28) or Clinical Remission (CR) Based on (DAS28) at Week 12
Timepoint [3] 0 0
Baseline (Week 0) and Week 12
Secondary outcome [4] 0 0
Number of Subjects Achieving CR Based on DAS28 at Week 12
Timepoint [4] 0 0
Baseline (Week 0) and Week 12

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib,
baricitinib)

- Pregnant or breastfeeding female

- Ongoing or active infection.

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
Accrual to date
Final
276
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01960855
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.
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

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