Clinical Trials List
2016-03-01 - 2023-10-31
Phase III
Terminated8
ICD-10M06.9
Rheumatoid arthritis, unspecified
ICD-10M05
Rheumatoid arthritis with rheumatoid factor
ICD-9714.0
Rheumatoid arthritis
A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
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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
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 黃建中 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 歐燦騰 風濕免疫科
- Wen Chan Tsai 風濕免疫科
- Sung Wan-Yu 風濕免疫科
- Jeng-Hsien Yen 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wei-Sheng Chen Division of Rheumatology
- Chang-Youh Tsai Division of Rheumatology
- Hsien-Tzung Liao Division of Rheumatology
The Actual Total Number of Participants Enrolled
3 Terminated
Audit
CRO
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Shue-Fen Lo Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- TianMing Zhan Division of Rheumatology
- Yao-Fan Fang Division of Rheumatology
- Ping-Han Tsai Division of Rheumatology
The Actual Total Number of Participants Enrolled
2 Terminated
Audit
None
Co-Principal Investigator
- Wen Chan Tsai 未分科
Audit
None
Co-Principal Investigator
- KO-JEN LI 風濕免疫科
- PING-NING HSU 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
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 Clinical Remission (CR) 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 clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 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 mm), 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 2.6 indicates clinical remission.
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 must have been on oral or parenteral MTX therapy ≥ 3 months and on a stable prescription
of 15 to 25 mg/week (or ≥ 10 mg/week in subjects intolerant of MTX at doses ≥ 15 mg/week) for
≥ 4 weeks prior to the first dose of study drug. In addition, all subjects should take a dietary
supplement of folic acid or folinic acid throughout the study participation.
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 ≥ 5 mg/L (central lab, ULN 2.87 mg/L) at Screening Visit.
5. Subject has at least one of the following at Screening:
a. ≥ 3 bone erosions on x-ray; or
b. ≥ 1 bone erosion and a positive rheumatoid factor; or
c. ≥ 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibody.
6. Subjects with prior exposure to only one bDMARD (except ADA) may be enrolled (up to 20% of
total study population) if they have documented evidence of intolerance to the bDMARD or limited
exposure (< 3 months).
7. Except for MTX, subject must have discontinued all csDMARDs. The washout period for
csDMARDs prior to the first dose of study is specified below or should be at least five times the
mean terminal elimination half-life of a drug:
≥ 4 weeks prior to first dose of study drug for minocycline, penicillamine, sulfasalazine,
hydroxychloroquine, chloroquine, azathioprine, gold formulations, cyclophosphamide,
tacrolimus, cyclosporine, mycophenolate;
≥ 8 weeks prior to first dose of study drug for leflunomide if no elimination procedure was
followed, or adhere to an elimination procedure (i.e., 11 days with colestyramine, or 30 days
washout with activated charcoal or as per local label).
Exclusion Criteria
1. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib,
baricitinib, and filgotinib).
2. Subjects who have been exposed to adalimumab or 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 × ULN; serum alanine transaminase > 2 × ULN;
estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease
formula < 40 mL/min/1.73m2
; 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
24 participants
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Global
1629 participants
