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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 25 January 2021
Main ID:  NCT03086343
Date of registration: 20/03/2017
Prospective Registration: Yes
Primary sponsor: AbbVie
Public title: A Phase 3 Study to Compare Upadacitinib to Abatacept 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, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)
Date of first enrolment: May 9, 2017
Target sample size: 613
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Argentina Australia Belgium Brazil Bulgaria Canada Chile Colombia
Czechia Germany Greece Hungary Ireland Israel Italy Korea, Republic of
Latvia Mexico Netherlands New Zealand Poland Portugal Puerto Rico Romania
Russian Federation Slovakia Spain Sweden Switzerland Turkey United Kingdom United States
Name:     AbbVie Inc.
Affiliation:  AbbVie
Key inclusion & exclusion criteria

Main Inclusion Criteria:

- Diagnosis of rheumatoid arthritis (RA) for = 3 months who also fulfill the 2010
American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
classification criteria for RA

- Participants have been treated for = 3 months prior to the screening visit with = 1
bDMARD therapy, but continue to exhibit active RA or had to discontinue due to
intolerability or toxicity, irrespective of treatment duration and have never received
abatacept prior to the first dose of study drug

- Participants 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 and
high-sensitivity C-reactive protein (hsCRP) = 3 mg/L at Screening

Main Exclusion Criteria:

- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
upadacitinib, tofacitinib, baricitinib and filgotinib)

- Prior exposure to abatacept

- History of any arthritis with onset prior to age 17 years or current diagnosis of
inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's
Syndrome is permitted

- Laboratory values meeting the following criteria within the Screening period prior to
the first dose of study drug: serum aspartate transaminase > 2 × upper limit of normal
(ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by
simplified 4-variable Modification of Diet in Renal Disease formula < 40
mL/minute/1.73 meter (m)^2; total white blood cell count < 2,500/ µL; absolute
neutrophil count < 1,500/µL; platelet count < 100,000/µL; absolute lymphocyte count <
800/µL; and hemoglobin < 10 g/dL

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis (RA)
Drug: Abatacept
Drug: Placebo for abatacept
Drug: Placebo for upadacitinib
Drug: Upadacitinib
Primary Outcome(s)
Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Non-inferiority) [Time Frame: Baseline and Week 12]
Secondary Outcome(s)
Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority) [Time Frame: Baseline and Week 12]
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority) [Time Frame: At Week 12]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available: Yes
Date Posted: 04/06/2020
Date Completed:
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