Trial · NCT03671148
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
NCT03671148, Phase 3, Active not recruiting, AbbVie; results first posted 2022-03-02
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 Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies). Trials, record NCT03671148. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03671148
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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 Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
- NCT number
- NCT03671148
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 444 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Psoriatic Arthritis (PsA)
- Interventions
- Placebo, Risankizumab
- First posted
- 2018-09-14
- Last updated
- 2026-10-28
- Results first posted
- 2022-03-02
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 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 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Baseline and Week 24 | 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 summary is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from Baseline score indicates improvement. |
| Secondary | Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 | Baseline and Week 24 | 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 score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement. |
| Secondary | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24 | Baseline and Week 24 | 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 24 | Baseline and Week 24 | 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). |
| 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). |
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 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 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score 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 use that could meaningfully impact efficacy assessment, was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score 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 use that could meaningfully impact efficacy assessment, was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24 | Baseline and 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 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24 | Baseline and 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 | Percentage of Participants With Resolution of Enthesitis at Week 24 | Week 24 | Full analysis set participants with a Baseline LEI \> 0; 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
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 | 26.5 | 95% Confidence Interval 20.7 to 32.4 | percentage of participants | |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 | Risankizumab | 51.3 | 95% Confidence Interval 44.8 to 57.9 | percentage of participants | |
| Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | Placebo | -0.05 | 95% Confidence Interval -0.12 to 0.02 | score on a scale | |
| Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | Risankizumab | -0.22 | 95% Confidence Interval -0.28 to -0.15 | score on a scale | |
| Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24 | Placebo | 10.2 | 95% Confidence Interval 4.7 to 15.6 | percentage of participants | |
| Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24 | Risankizumab | 55.0 | 95% Confidence Interval 46.2 to 63.9 | percentage of participants | |
| Percentage of Participants With an ACR20 Response at Week 16 | Placebo | 25.3 | 95% Confidence Interval 19.4 to 31.2 | percentage of participants | |
| Percentage of Participants With an ACR20 Response at Week 16 | Risankizumab | 48.3 | 95% Confidence Interval 41.7 to 54.8 | percentage of participants | |
| Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 | Placebo | 11.4 | 95% Confidence Interval 7.2 to 15.6 | percentage of participants | |
| Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 | Risankizumab | 25.6 | 95% Confidence Interval 19.9 to 31.4 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 220 | |
| Overall Study | STARTED | Risankizumab | 224 | |
| Overall Study | Received Study Drug | Placebo | 219 | |
| Overall Study | Received Study Drug | Risankizumab | 224 | |
| Overall Study | COMPLETED | Placebo | 199 | |
| Overall Study | COMPLETED | Risankizumab | 215 | |
| Overall Study | NOT COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Risankizumab | 9 |
Source ClinicalTrials.gov
Adverse events58
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 | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Placebo | 11 | 219 | 13 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Risankizumab 150 mg | 17 | 224 | 17 |
| serious | ANAEMIA | Blood and lymphatic system disorders | Placebo | 1 | 219 | 1 |
| serious | ANAEMIA | Blood and lymphatic system disorders | Risankizumab 150 mg | 0 | 224 | 0 |
| serious | CARDIAC FAILURE CONGESTIVE | Cardiac disorders | Placebo | 1 | 219 | 1 |
| serious | CARDIAC FAILURE CONGESTIVE | Cardiac disorders | Risankizumab 150 mg | 0 | 224 | 0 |
| serious | CORONARY ARTERY DISEASE | Cardiac disorders | Placebo | 1 | 219 | 1 |
| serious | CORONARY ARTERY DISEASE | Cardiac disorders | Risankizumab 150 mg | 0 | 224 | 0 |
| serious | UMBILICAL HERNIA | Gastrointestinal disorders | Placebo | 1 | 219 | 1 |
| serious | UMBILICAL HERNIA | Gastrointestinal disorders | Risankizumab 150 mg | 0 | 224 | 0 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 219 |
| Total, all-cause mortality | Risankizumab 150 mg | 0 | 224 |
| Total, other adverse events | Placebo | 11 | 219 |
| Total, other adverse events | Risankizumab 150 mg | 17 | 224 |
| Total, serious adverse events | Placebo | 12 | 219 |
| Total, serious adverse events | Risankizumab 150 mg | 9 | 224 |
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 150 mg vs Placebo: deaths from any cause | Trial comparisons |
| Risankizumab 150 mg 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/NCT03671148
GET https://conductscience.org/api/trials/v1/NCT03671148/results?page=2