A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
CompletedPhase 3Results postedLast updated 8 February 2023
What this trial tests
Phase 3 trial testing Placebo in Rheumatoid Arthritis in 499 participants. Completed in 8 February 2022.
Adults 18 to 99, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12Primary· 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:
1. ≥ 20% improvement in 68-tender joint count;
2. ≥ 20% improvement in 66-swollen joint count; and
3. ≥ 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
Group
Value
95% CI
Placebo
28.4
21.6 – 35.2
Upadacitinib 15 mg
64.6
57.3 – 72.0
Upadacitinib 30 mg
56.4
48.8 – 63.9
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12Primary· 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 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DA
Group
Value
95% CI
Placebo
14.2
8.9 – 19.5
Upadacitinib 15 mg
43.3
35.7 – 50.9
Upadacitinib 30 mg
42.4
34.9 – 50.0
Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12Secondary· Baseline and 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 negative change from baseline in DAS28 (CRP) indicates improvement in disease activity.
Group
Value
95% CI
Placebo
-1.02
-1.23 – -0.80
Upadacitinib 15 mg
-2.31
-2.52 – -2.10
Upadacitinib 30 mg
-2.29
-2.50 – -2.09
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12Secondary· Baseline and Week 12
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from B
Group
Value
95% CI
Placebo
-0.17
-0.26 – -0.08
Upadacitinib 15 mg
-0.39
-0.48 – -0.30
Upadacitinib 30 mg
-0.42
-0.51 – -0.33
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12Secondary· Baseline and Week 12
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and
Group
Value
95% CI
Placebo
2.39
1.14 – 3.64
Upadacitinib 15 mg
5.83
4.60 – 7.05
Upadacitinib 30 mg
7.02
5.78 – 8.25
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12Secondary· Baseline and Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
1. ≥ 50% improvement in 68-tender joint count;
2. ≥ 50% improvement in 66-swollen joint count; and
3. ≥ 50% 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).
Group
Value
95% CI
Placebo
11.8
7.0 – 16.7
Upadacitinib 15 mg
34.1
26.9 – 41.4
Upadacitinib 30 mg
35.8
28.4 – 43.1
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12Secondary· Baseline and Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
1. ≥ 70% improvement in 68-tender joint count;
2. ≥ 70% improvement in 66-swollen joint count; and
3. ≥ 70% 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).
Group
Value
95% CI
Placebo
6.5
2.8 – 10.2
Upadacitinib 15 mg
11.6
6.7 – 16.5
Upadacitinib 30 mg
23.0
16.6 – 29.5
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1Secondary· Baseline and week 1
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
1. ≥ 20% improvement in 68-tender joint count;
2. ≥ 20% improvement in 66-swollen joint count; and
3. ≥ 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).
Group
Value
95% CI
Placebo
10.7
6.0 – 15.3
Upadacitinib 15 mg
27.4
20.6 – 34.3
Upadacitinib 30 mg
24.8
18.3 – 31.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events are reported for Weeks 1 to 12 (all participants) and from Weeks 1 to 260 for participants who received upadacitinib..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.
The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07502339 — Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis
· Phase 4
· not yet recruiting
NCT07492251 — Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Ran
· Phase 2
· not yet recruiting
NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis
· not yet recruiting
NCT07546097 — Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（U
· Phase 4
· recruiting
NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
· Phase 4
· recruiting
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis
· Phase 1
· recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis
· recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
· Phase 1
· recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel
· EARLY_PHASE1
· recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
· Phase 1
· recruiting
Other AbbVie trials
Trials by the same sponsor.
NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants
· Phase 1
· completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W
· Phase 3
· withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult
· Phase 1
· completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China
· completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 8 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02706847.