Trial · NCT03104374
A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
NCT03104374, 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 in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug. Trials, record NCT03104374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03104374
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 in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
- NCT number
- NCT03104374
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 642 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Psoriatic Arthritis
- Interventions
- Placebo, Upadacitinib
- First posted
- 2017-04-07
- Last updated
- 2025-09-11
- Other registries' IDs
- eudract:2016-004152-30
- Results first posted
- 2022-01-25
Source ClinicalTrials.gov
Registered outcomes11
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. |
| 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. |
| 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 | Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16 | Baseline and Week 16 | The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement. |
| Secondary | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | 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). |
| Secondary | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 | 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). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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. | score 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 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 |
| 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 rescue criteria at Week 16 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16 | Baseline and Week 16 | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 16 was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With an American College of Rheumatology 50% (ACR50) 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 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group33
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 | 24.1 | 95% Confidence Interval 18.3 to 29.8 | percentage of participants | |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Upadacitinib 15 mg | 56.9 | 95% Confidence Interval 50.2 to 63.6 | percentage of participants | |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Upadacitinib 30 mg | 63.8 | 95% Confidence Interval 57.4 to 70.1 | percentage of participants | |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | Placebo | -0.10 | 95% Confidence Interval -0.16 to -0.03 | score on a scale | |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | Upadacitinib 15 mg | -0.30 | 95% Confidence Interval -0.37 to -0.24 | score on a scale | |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | Upadacitinib 30 mg | -0.41 | 95% Confidence Interval -0.47 to -0.35 | score 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 | 9.2 | 95% Confidence Interval 4.8 to 13.6 | 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 | Upadacitinib 15 mg | 36.8 | 95% Confidence Interval 29.6 to 44.1 | 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 | Upadacitinib 30 mg | 40.2 | 95% Confidence Interval 32.7 to 47.7 | percentage of participants | |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16 | Placebo | 16.0 | 95% Confidence Interval 9.7 to 22.3 | percentage of participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Placebo / Upadacitinib 15 mg | 106 | |
| Period 1 | STARTED | Placebo / Upadacitinib 30 mg | 106 | |
| Period 1 | STARTED | Upadacitinib 15 mg | 211 | |
| Period 1 | STARTED | Upadacitinib 30 mg | 219 | |
| Period 1 | Received Study Drug | Placebo / Upadacitinib 15 mg | 106 | |
| Period 1 | Received Study Drug | Placebo / Upadacitinib 30 mg | 106 | |
| Period 1 | Received Study Drug | Upadacitinib 15 mg | 211 | |
| Period 1 | Received Study Drug | Upadacitinib 30 mg | 218 | |
| Period 1 | Completed Week 24 | Placebo / Upadacitinib 15 mg | 81 | |
| Period 1 | Completed Week 24 | Placebo / Upadacitinib 30 mg | 92 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,550
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 | DIARRHOEA | Gastrointestinal disorders | Period 1: Upadacitinib 15 mg (ICF to Week 56) | 8 | 211 | 8 |
| other | DIARRHOEA | Gastrointestinal disorders | Period 1: Upadacitinib 30 mg (ICF to Week 56) | 15 | 219 | 18 |
| other | DIARRHOEA | Gastrointestinal disorders | Period 1: Pooled Placebo (ICF to Week 24) | 12 | 212 | 13 |
| other | DIARRHOEA | Gastrointestinal disorders | Period 1: Placebo / Upadacitinib 15 mg (Week 24 to Week 56) | 3 | 79 | 4 |
| other | DIARRHOEA | Gastrointestinal disorders | Period 1: Placebo / Upadacitinib 30 mg (Week 24 to Week 56) | 3 | 90 | 3 |
| other | DIARRHOEA | Gastrointestinal disorders | Period 2: Upadacitinib 15 mg (Week 56 to EOS) | 5 | 167 | 5 |
| other | DIARRHOEA | Gastrointestinal disorders | Period 2: Upadacitinib 30 mg (Week 56 to EOS) | 3 | 165 | 5 |
| other | DIARRHOEA | Gastrointestinal disorders | Period 2: Placebo / Upadacitinib 15 mg (Week 56 to Week EOS) | 1 | 69 | 1 |
| other | DIARRHOEA | Gastrointestinal disorders | Period 2: Placebo / Upadacitinib 30 mg (Week 56 to EOS) | 2 | 77 | 2 |
| other | DIARRHOEA | Gastrointestinal disorders | Period 2: Pooled Upadacitinib Groups Who Switched From 30 mg to 15 mg in Period 2 | 4 | 87 | 4 |
1 to 10 of 1,550Source ClinicalTrials.gov
See all 1,550 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Period 1: Upadacitinib 15 mg (ICF to Week 56) | 0 | 211 |
| Total, all-cause mortality | Period 1: Upadacitinib 30 mg (ICF to Week 56) | 0 | 219 |
| Total, all-cause mortality | Period 1: Pooled Placebo (ICF to Week 24) | 1 | 212 |
| Total, all-cause mortality | Period 1: Placebo / Upadacitinib 15 mg (Week 24 to Week 56) | 0 | 79 |
| Total, all-cause mortality | Period 1: Placebo / Upadacitinib 30 mg (Week 24 to Week 56) | 0 | 90 |
| Total, all-cause mortality | Period 2: Upadacitinib 15 mg (Week 56 to EOS) | 5 | 167 |
| Total, all-cause mortality | Period 2: Upadacitinib 30 mg (Week 56 to EOS) | 0 | 165 |
| Total, all-cause mortality | Period 2: Placebo / Upadacitinib 15 mg (Week 56 to Week EOS) | 0 | 69 |
| Total, all-cause mortality | Period 2: Placebo / Upadacitinib 30 mg (Week 56 to EOS) | 2 | 77 |
| Total, all-cause mortality | Period 2: Pooled Upadacitinib Groups Who Switched From 30 mg to 15 mg in Period 2 | 0 | 87 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers15
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/NCT03104374
GET https://conductscience.org/api/trials/v1/NCT03104374/results?page=2