Trial · NCT03104400
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
NCT03104400, Phase 3, Completed, AbbVie; results first posted 2022-01-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD). Trials, record NCT03104400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03104400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
- NCT number
- NCT03104400
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,705 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Psoriatic Arthritis
- Interventions
- Adalimumab, Upadacitinib, Placebo to Upadacitinib, Placebo to Adalimumab
- First posted
- 2017-04-07
- Last updated
- 2025-09-22
- Other registries' IDs
- eudract:2016-004130-24
- Results first posted
- 2022-01-25
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Baseline and 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 Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP). |
| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | 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 Baseline in the overall score indicates improvement. |
| Secondary | Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16 | Baseline and Week 16 | The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe). |
| Secondary | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16 | Baseline and Week 16 | PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score, and was assessed in participants with Baseline psoriasis BSA involvement ≥ 3%. |
| Secondary | Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24 | Baseline and Week 24 | The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers. Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst). Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst). Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN. The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst). A negative change from Baseline indicates improvement in joint damage. |
| Secondary | Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 | Week 24 | A participant was classified as achieving MDA if 5 of the following 7 criteria were met: * Tender joint count (out of 68 joints) ≤ 1 * Swollen joint count (out of 66 joints) ≤ 1 * PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3% * Patient's assessment of pain ≤ 1.5 (NRS from 0 to 10) * Patient's Global Assessment of disease activity ≤ 2 (NRS from 0 to 10) * HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3) * Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6) |
| Secondary | Percentage of Participants With Resolution of Enthesitis at Week 24 | Week 24 | Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0. LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst). |
| Secondary | Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab | Baseline and 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 Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP). |
| Secondary | Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 | 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 the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement. |
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12 | Baseline and Week 12 | The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Baseline and Week 12 | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | Baseline and Week 12 | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16 | Baseline and Week 16 | Full analysis set participants with a Baseline sIGA score ≥ 2; participants who prematurely discontinued from study drug prior to Week 16 or for whom sIGA data were missing at Week 16 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16 | Baseline and Week 16 | Full analysis set participants with Baseline psoriasis BSA involvement ≥ 3%; participants who prematurely discontinued from study drug prior to Week 16 or for whom PASI data were missing at Week 16 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24 | Baseline and Week 24 | Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or who were rescued prior to Week 24. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 | Week 24 | Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom data were missing at Week 24, or who met the rescue criteria at Week 16 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Resolution of Enthesitis at Week 24 | Week 24 | Full analysis set participants with a Baseline LEI \> 0; participants who prematurely discontinued from study drug prior to Week 24 or for whom data were missing at Week 24, or who met the rescue criteria at Week 16 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab | Baseline and Week 12 | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 | Baseline and Week 12 | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12 | Baseline and Week 12 | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Placebo | 36.2 | 95% Confidence Interval 31.6 to 40.7 | percentage of participants | |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Adalimumab 40 mg | 65.0 | 95% Confidence Interval 60.5 to 69.5 | percentage of participants | |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Upadacitinib 15 mg | 70.6 | 95% Confidence Interval 66.3 to 74.9 | percentage of participants | |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Upadacitinib 30 mg | 78.5 | 95% Confidence Interval 74.6 to 82.4 | percentage of participants | |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | Placebo | -0.14 | 95% Confidence Interval -0.18 to -0.09 | units on a scale | |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | Adalimumab 40 mg | -0.34 | 95% Confidence Interval -0.38 to -0.29 | units on a scale | |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | Upadacitinib 15 mg | -0.42 | 95% Confidence Interval -0.47 to -0.37 | units on a scale | |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | Upadacitinib 30 mg | -0.47 | 95% Confidence Interval -0.52 to -0.42 | units on a scale | |
| Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16 | Placebo | 10.9 | 95% Confidence Interval 7.4 to 14.3 | percentage of participants | |
| Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16 | Adalimumab 40 mg | 38.5 | 95% Confidence Interval 33.2 to 43.7 | percentage of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Week 1 - 56) | STARTED | Placebo / Upadacitinib 15 mg | 211 | |
| Period 1 (Week 1 - 56) | STARTED | Placebo / Upadacitinib 30 mg | 212 | |
| Period 1 (Week 1 - 56) | STARTED | Adalimumab 40 mg | 429 | |
| Period 1 (Week 1 - 56) | STARTED | Upadacitinib 15 mg | 430 | |
| Period 1 (Week 1 - 56) | STARTED | Upadacitinib 30 mg | 423 | |
| Period 1 (Week 1 - 56) | STARTED | Placebo / Upadacitinib 15 mg Period 2 (Weeks 56 to 260) | 0 | |
| Period 1 (Week 1 - 56) | STARTED | Placebo / Upadacitinib 30 mg Period 2 (Weeks 56 to 260) | 0 | |
| Period 1 (Week 1 - 56) | STARTED | Adalimumab 40 mg Period 2 (Weeks 56 to 260) | 0 | |
| Period 1 (Week 1 - 56) | STARTED | Upadacitinib 15 mg Period 2 (Weeks 56 to 260) | 0 | |
| Period 1 (Week 1 - 56) | STARTED | Upadacitinib 30 mg Period 2 (Weeks 56 to 260) | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events4,272
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | LEUKOPENIA | Blood and lymphatic system disorders | Upadacitinib 15 mg Period 1 (Weeks 1 to 56) | 16 | 430 | 19 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Upadacitinib 30 mg Period 1 (Weeks 1 to 56) | 15 | 423 | 20 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Adalimumab 40 mg Period 1 (Weeks 1 to 56) | 8 | 429 | 10 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Placebo Period 1 (Weeks 1 to 24) | 4 | 423 | 4 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Placebo / Upadacitinib 15 mg Period 1 (Weeks 24 to 56) | 1 | 188 | 1 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Placebo / Upadacitinib 30 mg Period 1 (Weeks 24 to 56) | 3 | 190 | 8 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Upadacitinib 15 mg Period 2 (Weeks 56 to 260) | 21 | 378 | 30 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Upadacitinib 30 mg Period 2 (Weeks 56 to 260) | 10 | 366 | 14 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Adalimumab 40 mg Period 2 (Weeks 56 to 260) | 9 | 366 | 15 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Placebo / Upadacitinib 15 mg Period 2 (Weeks 56 to 260) | 10 | 177 | 16 |
1 to 10 of 4,272Source ClinicalTrials.gov
See all 4,272 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Upadacitinib 15 mg Period 1 (Weeks 1 to 56) | 3 | 430 |
| Total, all-cause mortality | Upadacitinib 30 mg Period 1 (Weeks 1 to 56) | 1 | 423 |
| Total, all-cause mortality | Adalimumab 40 mg Period 1 (Weeks 1 to 56) | 1 | 429 |
| Total, all-cause mortality | Placebo Period 1 (Weeks 1 to 24) | 1 | 423 |
| Total, all-cause mortality | Placebo / Upadacitinib 15 mg Period 1 (Weeks 24 to 56) | 0 | 188 |
| Total, all-cause mortality | Placebo / Upadacitinib 30 mg Period 1 (Weeks 24 to 56) | 0 | 190 |
| Total, all-cause mortality | Upadacitinib 15 mg Period 2 (Weeks 56 to 260) | 14 | 378 |
| Total, all-cause mortality | Upadacitinib 30 mg Period 2 (Weeks 56 to 260) | 8 | 366 |
| Total, all-cause mortality | Adalimumab 40 mg Period 2 (Weeks 56 to 260) | 4 | 366 |
| Total, all-cause mortality | Placebo / Upadacitinib 15 mg Period 2 (Weeks 56 to 260) | 3 | 177 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03104400
GET https://conductscience.org/api/trials/v1/NCT03104400/results?page=2