Trial · NCT03675308
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
NCT03675308, Phase 3, Active not recruiting, AbbVie; results first posted 2022-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy. Trials, record NCT03675308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03675308
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
- NCT number
- NCT03675308
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 964 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Psoriatic Arthritis
- Interventions
- Placebo, Risankizumab
- First posted
- 2018-09-18
- Last updated
- 2025-08-05
- Other registries' IDs
- eudract:2017-002465-22
- Results first posted
- 2022-02-24
Source ClinicalTrials.gov
Registered outcomes14
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 24 | Baseline and Week 24 | 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 24 | Baseline and Week 24 | 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 Psoriasis Area Severity Index (PASI) 90 Response at Week 24 | Baseline and Week 24 | 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 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from Baseline in PASI score. |
| Secondary | Percentage of Participants With an ACR20 Response at Week 16 | Baseline and Week 16 | 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 | 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 ≤ 15 (VAS from 0 to 100) * Patient's Global Assessment of disease activity ≤ 20 (VAS from 0 to 100) * 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, for an overall score range from 0 to 6) |
| Secondary | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24 | Baseline and Week 24 | The investigator assessed each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (\>30% of the nail), pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (\> 50 pits present), and nail plate crumbling on a scale of 0 (no crumbling) to 3 (\>50% of nail has crumbling) and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula. The mNAPSI score is calculated as the sum of all the components for all of the participant's fingernails giving a range of possible scores from 0 (absence of nail psoriasis) to 130 (the most severe nail psoriasis). A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Fingernail-Physician Global Assessment (PGA-F) | Baseline and Week 24 | The PGA-F is a clinician-rated outcomes assessment used to measure the severity of signs and symptoms associated with fingernail psoriasis. Participant's fingernails were assessed separately for nail bed signs and nail matrix signs of disease on a scale from 0 (clear) to 4 (severe). A participant's overall global score is the worse of the nail bed score and nail matrix score. For example, if a participant had a nail bed score '2' and a nail matrix score of '4,' this participant's overall score was '4.' A negative change from Baseline indicates improvement. |
| 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). To increase the sample size due to the smaller number of participants with enthesitis at Baseline, the pre-specified analysis of the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148). |
| Secondary | Percentage of Participants With Resolution of Dactylitis at Week 24 | Week 24 | Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0. LDI basic is a score based on finger circumference and tenderness, assessed across all digits. The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score (1 for tender, 0 for non-tender). If both sides of a digit are considered involved, or the circumference of the contralateral digit cannot be obtained, a standard reference table is used. Scores from each digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis. To increase sample size due to the smaller number of participants with dactylitis at Baseline, the pre-specified analysis of the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148). |
| Secondary | Change From Baseline in PsA Modified Total Sharp 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). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 24 | Baseline and Week 24 | Full analysis set; Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24 | Baseline and Week 24 | Full analysis set; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis (PsA) use that could meaningfully impact efficacy assessment, was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24 | Baseline and Week 24 | Full analysis set participants with Baseline psoriasis BSA involvement ≥ 3%; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR20 Response at Week 16 | Baseline and Week 16 | Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 | Week 24 | Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24 | Baseline and Week 24 | Full analysis set with nail psoriasis at Baseline; a mixed effect model repeat measurement analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis use that could meaningfully impact efficacy assessment, was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fingernail-Physician Global Assessment (PGA-F) | Baseline and Week 24 | Full analysis set with nail psoriasis at Baseline; a mixed effect model repeat measurement analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis use that could meaningfully impact efficacy assessment, was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Resolution of Enthesitis at Week 24 | Week 24 | Full analysis set participants with a Baseline LEI \> 0; Includes pooled data from KEEPsAKE 1 (this study) and the companion study M15-998 (NCT03671148; KEEPsAKE2). Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Resolution of Dactylitis at Week 24 | Week 24 | Full analysis set participants with a Baseline LDI \> 0; Includes pooled data from KEEPsAKE 1 (this study) and the companion study M15-998 (NCT03671148; KEEPsAKE2). Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in PsA Modified Total Sharp 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
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 24 | Placebo | 33.5 | 95% Confidence Interval 29.3 to 37.8 | percentage of participants | |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 | Risankizumab | 57.3 | 95% Confidence Interval 52.9 to 61.8 | percentage of participants | |
| Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24 | Placebo | -0.11 | 95% Confidence Interval -0.16 to -0.06 | score on a scale | |
| Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24 | Risankizumab | -0.31 | 95% Confidence Interval -0.36 to -0.27 | score on a scale | |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24 | Placebo | 9.9 | 95% Confidence Interval 6.4 to 13.5 | percentage of participants | |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24 | Risankizumab | 52.3 | 95% Confidence Interval 46.4 to 58.3 | percentage of participants | |
| Percentage of Participants With an ACR20 Response at Week 16 | Placebo | 33.4 | 95% Confidence Interval 28.9 to 37.9 | percentage of participants | |
| Percentage of Participants With an ACR20 Response at Week 16 | Risankizumab | 56.3 | 95% Confidence Interval 51.7 to 60.8 | percentage of participants | |
| Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 | Placebo | 10.2 | 95% Confidence Interval 7.5 to 12.9 | percentage of participants | |
| Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 | Risankizumab | 25.0 | 95% Confidence Interval 21.2 to 28.9 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 481 | |
| Overall Study | STARTED | Risankizumab | 483 | |
| Overall Study | COMPLETED | Placebo | 467 | |
| Overall Study | COMPLETED | Risankizumab | 473 | |
| Overall Study | NOT COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | Risankizumab | 10 |
Source ClinicalTrials.gov
Adverse events66
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 |
|---|---|---|---|---|---|---|
| serious | ANAEMIA | Blood and lymphatic system disorders | Placebo | 1 | 481 | 1 |
| serious | ANAEMIA | Blood and lymphatic system disorders | Risankizumab | 0 | 483 | 0 |
| serious | BLOOD LOSS ANAEMIA | Blood and lymphatic system disorders | Placebo | 0 | 481 | 0 |
| serious | BLOOD LOSS ANAEMIA | Blood and lymphatic system disorders | Risankizumab | 1 | 483 | 1 |
| serious | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Placebo | 1 | 481 | 1 |
| serious | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Risankizumab | 0 | 483 | 0 |
| serious | ANGINA UNSTABLE | Cardiac disorders | Placebo | 1 | 481 | 1 |
| serious | ANGINA UNSTABLE | Cardiac disorders | Risankizumab | 0 | 483 | 0 |
| serious | VERTIGO | Ear and labyrinth disorders | Placebo | 1 | 481 | 1 |
| serious | VERTIGO | Ear and labyrinth disorders | Risankizumab | 0 | 483 | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 481 |
| Total, all-cause mortality | Risankizumab | 1 | 483 |
| Total, other adverse events | Placebo | 0 | 481 |
| Total, other adverse events | Risankizumab | 0 | 483 |
| Total, serious adverse events | Placebo | 18 | 481 |
| Total, serious adverse events | Risankizumab | 12 | 483 |
Source ClinicalTrials.gov
Papers9
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Risankizumab vs Placebo: deaths from any cause | Trial comparisons |
| Risankizumab vs Placebo: serious adverse events | Trial comparisons |
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/NCT03675308
GET https://conductscience.org/api/trials/v1/NCT03675308/results?page=2