Phase 3
Completed N=338
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)
Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT02955212 ↗
Enrolled (actual)
338
Serious AEs
10.9%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 — 31.4; 71.6 percentage of participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The study objectives of Period 1 of this study were to compare the efficacy, safety, and tolerability of upadacitinib versus placebo for the treatment of signs and symptoms of subjects from China and selected countries including Brazil and South Korea with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs.
The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in subjects with RA who have completed Period 1.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 |
31.4; 71.6 | <0.001 sig |
| SECONDARY Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) at Week 12 |
-0.95; -2.56 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 |
-0.18; -0.62 | <0.001 sig |
| SECONDARY Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 |
3.36; 8.93 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12 |
13.6; 46.2 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12 |
5.3; 29.6 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Low Disease Activity Based on Clinical Disease Activity Index (CDAI) at Week 12 |
11.2; 35.5 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 |
8.3; 40.8 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 |
3.6; 21.3 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1 |
5.9; 25.4 | <0.001 sig |
Eligibility 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.
- Participants must have failed (lack of efficacy) at least one of the following: methotrexate (MTX), sulfasalazine, or leflunomide.
- The following csDMARDs are allowed: oral or parenteral MTX, sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
- 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:
- ≥ 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
- 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:
- Participants with limited exposure to bDMARD (< 3 months) OR
- 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.
Data sourced from ClinicalTrials.gov (NCT02955212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.