Trial · NCT03151551
A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
NCT03151551, Phase 4, Completed, Eli Lilly and Company; results first posted 2019-04-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis. Trials, record NCT03151551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03151551
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
- NCT number
- NCT03151551
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 566 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Psoriatic Arthritis
- Interventions
- Ixekizumab, Adalimumab
- First posted
- 2017-05-12
- Last updated
- 2020-11-03
- Other registries' IDs
- eudract:2016-004585-25
- Results first posted
- 2019-04-02
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100) | Week 24 | ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)\& swollen joint count (SJC)\& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \& BSA=0 at week 24. |
| Secondary | Percentage of Participants Achieving ACR50 | Week 24 | ACR50 response is defined as a ≥50% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of joint pain Visual Analog Scale (VAS), Participant's Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP). |
| Secondary | Percentage of Participants Achieving PASI100 | Week 24 | PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA ≥3% and PASI = 0 at baseline were considered PASI100 responders if \& only if they had achieved PASI=0 \& BSA=0 at week 24. |
| Other | Change From Baseline in Tender Joint Count (TJC) | Baseline, Week 52 | TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. |
| Other | Change From Baseline in Swollen Joint Count (SJC) | Baseline, Week 52 | SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. |
| Other | Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS) | Baseline, Week 52 | The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. |
| Other | Change From Baseline in Participant's Global Assessment of Disease Activity | Baseline, Week 52 | The patient's overall assessment of his or her PsA activity was recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. |
| Other | Change From Baseline in Physician's Global Assessment of Disease Activity | Baseline, Week 52 | The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. |
| Other | Change From Baseline in C-Reactive Protein (CRP) | Baseline, Week 52 | CRP is the ACR Core Set laboratory measure of acute-phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on the participant's PsA. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. |
| Other | Change From Baseline in HAQ-DI | Baseline, Week 52 | HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100) | Week 24 | All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ACR50 | Week 24 | All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI100 | Week 24 | All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Tender Joint Count (TJC) | Baseline, Week 52 | All randomized participants who had a baseline and at least one post-baseline TJC value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. | score on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Swollen Joint Count (SJC) | Baseline, Week 52 | All randomized participants who had a baseline and at least one post-baseline SJC value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. | score on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS) | Baseline, Week 52 | All randomized participants who had a baseline and at least one post-baseline VAS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. | millimeters (mm) | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Participant's Global Assessment of Disease Activity | Baseline, Week 52 | All randomized participants who had a baseline and at least one post-baseline VAS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. | Millimeter (mm) | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Physician's Global Assessment of Disease Activity | Baseline, Week 52 | All randomized participants who had a baseline and at least one post-baseline VAS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. | Millimeter (mm) | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in C-Reactive Protein (CRP) | Baseline, Week 52 | All randomized participants who had a baseline and at least one post-baseline CRP value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. | Milligram per Liter (mg/L) | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in HAQ-DI | Baseline, Week 52 | All randomized participants who had a baseline and at least one post-baseline HAQ-DI value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100) | Ixekizumab | 36 | 95% Confidence Interval 30.4 to 41.6 | percentage of participants | |
| Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100) | Adalimumab | 27.9 | 95% Confidence Interval 22.7 to 33.1 | percentage of participants | |
| Percentage of Participants Achieving ACR50 | Ixekizumab | 50.5 | 95% Confidence Interval 44.7 to 56.4 | percentage of participants | |
| Percentage of Participants Achieving ACR50 | Adalimumab | 46.6 | 95% Confidence Interval 40.8 to 52.5 | percentage of participants | |
| Percentage of Participants Achieving PASI100 | Ixekizumab | 60.1 | 95% Confidence Interval 54.4 to 65.8 | percentage of participants | |
| Percentage of Participants Achieving PASI100 | Adalimumab | 46.6 | 95% Confidence Interval 40.8 to 52.5 | percentage of participants | |
| Change From Baseline in Tender Joint Count (TJC) | Ixekizumab | -15.91 | Standard Error 0.566 | score on a scale | |
| Change From Baseline in Tender Joint Count (TJC) | Adalimumab | -14.88 | Standard Error 0.569 | score on a scale | |
| Change From Baseline in Swollen Joint Count (SJC) | Ixekizumab | -9.58 | Standard Error 0.196 | score on a scale | |
| Change From Baseline in Swollen Joint Count (SJC) | Adalimumab | -9.53 | Standard Error 0.198 | score on a scale |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label Treatment Period | STARTED | Ixekizumab | 283 | |
| Open-Label Treatment Period | STARTED | Adalimumab | 283 | |
| Open-Label Treatment Period | Received at Least One Dose of Study Drug | Ixekizumab | 283 | |
| Open-Label Treatment Period | Received at Least One Dose of Study Drug | Adalimumab | 283 | |
| Open-Label Treatment Period | IXE 160 mg at Baseline, 80 mg Q2W/Q4W | Ixekizumab | 49 | |
| Open-Label Treatment Period | IXE 160 mg at Baseline, 80 mg Q2W/Q4W | Adalimumab | 0 | |
| Open-Label Treatment Period | IXE 160 mg at Baseline, 80 mg Q4W | Ixekizumab | 218 | |
| Open-Label Treatment Period | IXE 160 mg at Baseline, 80 mg Q4W | Adalimumab | 0 | |
| Open-Label Treatment Period | ADA 80 mg at Baseline, 40 mg Q2W | Ixekizumab | 0 | |
| Open-Label Treatment Period | ADA 80 mg at Baseline, 40 mg Q2W | Adalimumab | 51 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse events268
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 | Injection site reaction | General disorders | Ixekizumab | 16 | 283 | 30 |
| other | Injection site reaction | General disorders | Adalimumab | 4 | 283 | 9 |
| other | Injection site reaction | General disorders | Ixekizumab Follow-up | 0 | 265 | 0 |
| other | Injection site reaction | General disorders | Adalimumab Follow-up | 0 | 260 | 0 |
| other | Nasopharyngitis | Infections and infestations | Ixekizumab | 38 | 283 | 46 |
| other | Nasopharyngitis | Infections and infestations | Adalimumab | 23 | 283 | 26 |
| other | Nasopharyngitis | Infections and infestations | Ixekizumab Follow-up | 5 | 265 | 5 |
| other | Nasopharyngitis | Infections and infestations | Adalimumab Follow-up | 3 | 260 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Ixekizumab | 18 | 283 | 21 |
| other | Upper respiratory tract infection | Infections and infestations | Adalimumab | 18 | 283 | 23 |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixekizumab | 0 | 283 |
| Total, all-cause mortality | Adalimumab | 0 | 283 |
| Total, all-cause mortality | Ixekizumab Follow-up | 0 | 265 |
| Total, all-cause mortality | Adalimumab Follow-up | 0 | 260 |
| Total, other adverse events | Ixekizumab | 65 | 283 |
| Total, other adverse events | Adalimumab | 44 | 283 |
| Total, other adverse events | Ixekizumab Follow-up | 8 | 265 |
| Total, other adverse events | Adalimumab Follow-up | 5 | 260 |
| Total, serious adverse events | Ixekizumab | 12 | 283 |
| Total, serious adverse events | Adalimumab | 35 | 283 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ixekizumab vs Adalimumab: Number of Participants Who Answered Yes to Any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS) |
Source 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/NCT03151551
GET https://conductscience.org/api/trials/v1/NCT03151551/registered?page=2