Clinical Trials List
2016-06-06 - 2022-03-10
Phase III
Terminated7
ICD-10M06.9
Rheumatoid arthritis, unspecified
ICD-10M46.90
Unspecified inflammatory spondylopathy, site unspecified
ICD-9714.0
Rheumatoid arthritis
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 洪偉哲 風濕免疫科
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chien-Chih Lai Division of Rheumatology
- Wei-Sheng Chen Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 張婷惠 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳俊欣 Division of General Internal Medicine
- Chia-Tse Weng Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
- KO-JEN LI Division of Rheumatology
- CHIEH-YU SHEN Division of Rheumatology
- PING-NING HSU Division of Rheumatology
- 郭佑民 Division of Rheumatology
- CHENG-HAN WU Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Extended-Release Tablet
Dosage
30 mg
Endpoints
1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Baseline and week 12 ]
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
a. ≥ 20% improvement in 68-tender joint count;
b. ≥ 20% improvement in 66-swollen joint count; and
c. ≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
2. Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 [ Time Frame: Week 12 ]
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at week 12.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than or equal to 3.2 indicates low disease activity.
Inclution Criteria
1. Adult male or female, at least 18 years old.
2. Diagnosis of RA for ≥ 3 months who also fulfill either the 1987-revised ACR classification criteria
or the 2010 ACR/EULAR classification criteria for RA.
3. Subjects have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks
prior to the first dose of study drug.
Subjects must have failed at least one of the following: MTX, sulfasalazine, or leflunomide.
Subjects with inadequate response to hydroxychloroquine and/or chloroquine can only be
included if they have also failed MTX, sulfasalazine, or leflunomide.
The following csDMARDs are allowed (stable dose for ≥ 4 weeks prior to the first dose of study
drug): oral or parenteral MTX (15 to 25 mg/week; or ≥ 10 mg/week in subjects who are
intolerant of MTX at doses ≥ 15 mg/week), sulfasalazine (≤ 3000 mg/day), hydroxychloroquine
(≤ 400 mg/day), chloroquine (≤ 250 mg/day), and leflunomide (≤ 20 mg/day).
A combination of up to two background csDMARDs is allowed EXCEPT the combination of
MTX and leflunomide
4. Subject meets both of the following disease activity criteria:
a. ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at
Screening and Baseline Visits; and
b. hsCRP ≥ 3 mg/L (central lab) at Screening Visit.
5. Subjects with prior exposure to at most one bDMARD may be enrolled (up to 20% of study
population) if they have documented evidence of intolerance to the bDMARD or limited exposure
(≤ 3 months).
Exclusion Criteria
1. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib,
baricitinib, and filgotinib).
2. Subjects who are considered inadequate responders to bDMARD therapy as determined by the
Investigator.
3. History of inflammatory joint disease other than RA (including but not limited to gout, systemic
lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and
non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases,
scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms], or any
arthritis with onset prior to age 17 years). History of secondary Sjogren's Syndrome is permitted.
4. 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/min/1.73 m2
; total white blood cell count < 2,500/µL;
absolute neutrophil count < 1,500/µL; platelet count < 100,000/µL; absolute lymphocyte count
< 850/µL; and hemoglobin < 10 g/dL.
The Estimated Number of Participants
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Taiwan
42 participants
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Global
600 participants
