Main
|
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. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT02955212 |
Date of registration:
|
02/11/2016 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)
|
Scientific title:
|
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) |
Date of first enrolment:
|
January 3, 2018 |
Target sample size:
|
338 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02955212 |
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
|
Brazil
|
China
|
Korea, Republic of
| | | | | |
Contacts
|
Name:
|
AbbVie Inc. |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
AbbVie |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Diagnosis of 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 receiving csDMARD therapy = 3 months and on a stable dose for =
4 weeks prior to the first dose of study drug.
1. Participants must have failed (lack of efficacy) at least one of the following:
methotrexate (MTX), sulfasalazine, or leflunomide.
2. The following csDMARDs are allowed: oral or parenteral MTX, sulfasalazine,
hydroxychloroquine, chloroquine, and leflunomide.
3. A combination of up to two background csDMARDs is allowed except the combination
of MTX and leflunomide.
- Participant meets both of the following disease activity criteria:
1. = 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on 68
joint counts) at Screening and Baseline Visits; and
2. High-sensitivity C-Reactive Protein (hsCRP) = 3 mg/L at Screening
- Participants with prior exposure to at most one biological disease-modifying
anti-rheumatic drugs (bDMARD) may be enrolled (up to 20% of total number of subjects).
Specifically, prior to enrollment:
1. Participants with limited exposure to bDMARD (< 3 months) OR
2. Participants who are responding to a bDMARD therapy but had to discontinue due to
intolerability (regardless of treatment duration).
- Participants must have discontinued bDMARD therapy prior to the first dose of study
drug.
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
tofacitinib, baricitinib, and filgotinib).
- Participants who are considered inadequate responders (lack of efficacy) to bDMARD
therapy as defined by the Investigator.
- History of any arthritis with onset prior to age 17 years or current diagnosis 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]. Current diagnosis of secondary Sjogren's Syndrome is
permitted.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Rheumatoid Arthritis (RA)
|
Intervention(s)
|
Drug: Upadacitinib
|
Drug: Placebo
|
Primary Outcome(s)
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
[Time Frame: Baseline and Week 12]
|
Secondary Outcome(s)
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
[Time Frame: Week 12]
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
[Time Frame: Baseline and Week 12]
|
Percentage of Participants Achieving Low Disease Activity Based on Clinical Disease Activity Index (CDAI) at Week 12
[Time Frame: Week 12]
|
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
[Time Frame: Baseline and Week 12]
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
[Time Frame: Baseline and Week 12]
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
[Time Frame: Baseline and Week 1]
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) at Week 12
[Time Frame: Baseline and Week 12]
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
[Time Frame: Baseline and Week 12]
|
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12
[Time Frame: Week 12]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
|