Trial · NCT02752776
A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.
NCT02752776, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2019-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis. Trials, record NCT02752776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02752776
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.
- NCT number
- NCT02752776
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,660 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Plaque Psoriasis
- Interventions
- Secukinumab
- First posted
- 2016-04-27
- Last updated
- 2019-09-25
- Other registries' IDs
- eudract:2015-003701-42
- Results first posted
- 2019-09-25
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 | 16 weeks | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. |
| Secondary | Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 | 52 weeks | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. |
| Secondary | Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 | 52 weeks | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. |
| Secondary | Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 | Week 16, Week 52 | PASI is a combined assessment of lesion severity \& affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself \& scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), \& severity is estimated by clinical signs, erythema, induration \& desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 \& 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. |
| Secondary | Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52 | Week 16, Week 52 | The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort \& anxiety/depression. The 5 dimensions have 5 response levels scored from 1 (best) to 5 (worst). The first 3 dimensions have the response levels lasting from no problems, slight problems, moderate problems, severe problems to unable; the last 2 dimensions have the 5 response levels lasting from no, slight, moderate, severe to extreme. From these 5 dimensions the Crosswalk-index is calculated by concatenating the responses \& choosing the corresponding country specific index value from the EQ-5D-5L\_Crosswalk\_Index\_Value\_Calculator.v2 excel file (https://euroqol.org/eq-5d-instruments/eq-5d-5labout/valuation-standard-value-sets/crosswalk-index-value-calculator/). This calculated participant-level index scores from -0.654 (worst health) to 1.0 (best health). |
| Secondary | Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52 | Week 16, Week 52 | A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state"). |
| Secondary | Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52 | Week 16 and Week 52 | The HAQ-DI (Health Assessment Questionnaire - Disability Index) assesses a patient's level of functional ability \& includes questions on fine movements of the upper extremity, locomotor activities of the lower extremity \& activities that involve both upper \& lower extremities. There are 20 items in 8 categories of functioning including dressing \& grooming, arising, eating, walking, hygiene, reach, grip \& usual activities. The stem of each item asks over the past week, "Are you able to..." perform a particular task. Each item is scored on a 4-point scale from 0 to 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) \& unable to do (3). The HAQ-DI also includes questions about the use of 'aids or devices' \& aid from other people to supplement the answers given to the 20 items. Total scores were calculated by averaging all scores and ranging from 0 (best) to 3 (worst). Subtracting the baseline value from the week 16 or 52 values results in the change. |
| Secondary | Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 | 16 and 52 weeks | Selfadministered 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching \& scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; \& Scaling: Overall, how severe was your psoriasis related scaling over the past 24 hours? Patients had to rate their pain, itching, \& scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) \& the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. |
| Secondary | Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 | 16 and 52 weeks | Treatment Satisfaction Questionnaire for Medication (TSQM) is general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug. |
| Secondary | Patient Benefit Index (PBI) at Week 16 and Week 52 | Week 16 and Week 52 | The questionnaire includes 23 items on patient-relevant therapy needs \& benefits. The first part of the instrument, the 'Patient Needs Questionnaire' (PNQ), is filled in by the patient before therapy. A 5-step Likert scale (0='not important at all' to 4='very important') records the individual relevance of the different items to the patients. The second part, the PBQ, is filled in by the patient during or after therapy. It comprises the same items as the PNQ, but in contrast, the patients evaluate the extent to which the treatment needs have been fulfilled by therapy (scaled from 0='treatment did not help at all' to 4='treatment helped a lot'). In addition, the Likert scale contains the option 'does not apply to me' in the PNQ \& the option 'did not apply to me' in the PBQ. The needs prior to treatment (PNQ) \& the benefits achieved by treatment (PBQ) are converted to a weighted index value, the PBI in the narrower sense. PBI can have a value from 0='no benefit' to 4='maximal benefit'. |
Source ClinicalTrials.gov
Outcomes10
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 a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 | 16 weeks | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 | 52 weeks | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 | 52 weeks | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 | Week 16, Week 52 | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Percentage of participants | NUMBER |
| SECONDARY | Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52 | Week 16, Week 52 | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | scores on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52 | Week 16, Week 52 | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | scores on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52 | Week 16 and Week 52 | Full Analysis set - subset of patients with psoriatic arthritis at baseline: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | scores on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 | 16 and 52 weeks | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | scores on a scale | MEAN |
| SECONDARY | Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 | 16 and 52 weeks | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | scores on a scale | MEAN |
| SECONDARY | Patient Benefit Index (PBI) at Week 16 and Week 52 | Week 16 and Week 52 | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group160
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 a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 | Subpopulation A (Naive) | 74.7 | 95% Confidence Interval 71.2 to 78.0 | Percentage of participants | |
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 | Subpopulation B (Non-biologic) | 71.3 | 95% Confidence Interval 67.7 to 74.7 | Percentage of participants | |
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 | Subpopulation C (Biologic) | 61.7 | 95% Confidence Interval 56.1 to 67.0 | Percentage of participants | |
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 | All Participants | 70.8 | 95% Confidence Interval 68.5 to 73.0 | Percentage of participants | |
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 | Subpopulation A (Naive) | 75.3 | 95% Confidence Interval 71.7 to 78.5 | Percentage of participants | |
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 | Subpopulation B (Non-biologic) | 73.3 | 95% Confidence Interval 69.8 to 76.6 | Percentage of participants | |
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 | Subpopulation C (Biologic) | 62.0 | 95% Confidence Interval 56.5 to 67.3 | Percentage of participants | |
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 | All Participants | 71.9 | 95% Confidence Interval 69.6 to 74.0 | Percentage of participants | |
| Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 | Subpopulation A (Naive) | Wk 16: DLQI cat. score: 2-5 | 18.3 | 95% Confidence Interval 15.5 to 21.6 | Percentage of participants |
| Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 | Subpopulation B (Non-biologic) | Wk 16: DLQI cat. score: 2-5 | 19.1 | 95% Confidence Interval 16.2 to 22.3 | Percentage of participants |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Subpopulation A (Naive) | 663 | |
| Overall Study | STARTED | Subpopulation B (Non-biologic) | 673 | |
| Overall Study | STARTED | Subpopulation C (Biologic) | 324 | |
| Overall Study | COMPLETED | Subpopulation A (Naive) | 611 | |
| Overall Study | COMPLETED | Subpopulation B (Non-biologic) | 597 | |
| Overall Study | COMPLETED | Subpopulation C (Biologic) | 276 | |
| Overall Study | NOT COMPLETED | Subpopulation A (Naive) | 52 | |
| Overall Study | NOT COMPLETED | Subpopulation B (Non-biologic) | 76 | |
| Overall Study | NOT COMPLETED | Subpopulation C (Biologic) | 48 |
Source ClinicalTrials.gov
Adverse events684
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 | Subpopulation A (Naive) | 35 | 663 | |
| other | Diarrhoea | Gastrointestinal disorders | Subpopulation B (Non-biologic) | 30 | 673 | |
| other | Diarrhoea | Gastrointestinal disorders | Subpopulation C (Biologic) | 14 | 324 | |
| other | Diarrhoea | Gastrointestinal disorders | All Participants | 79 | 1,660 | |
| other | Toothache | Gastrointestinal disorders | Subpopulation A (Naive) | 14 | 663 | |
| other | Toothache | Gastrointestinal disorders | Subpopulation B (Non-biologic) | 15 | 673 | |
| other | Toothache | Gastrointestinal disorders | Subpopulation C (Biologic) | 5 | 324 | |
| other | Toothache | Gastrointestinal disorders | All Participants | 34 | 1,660 | |
| other | Asthenia | General disorders | Subpopulation A (Naive) | 16 | 663 | |
| other | Asthenia | General disorders | Subpopulation B (Non-biologic) | 10 | 673 |
1 to 10 of 684Source ClinicalTrials.gov
See all 684 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Subpopulation A (Naive) | 0 | 663 |
| Total, all-cause mortality | Subpopulation B (Non-biologic) | 0 | 673 |
| Total, all-cause mortality | Subpopulation C (Biologic) | 1 | 324 |
| Total, all-cause mortality | All Participants | 1 | 1,660 |
| Total, other adverse events | Subpopulation A (Naive) | 450 | 663 |
| Total, other adverse events | Subpopulation B (Non-biologic) | 474 | 673 |
| Total, other adverse events | Subpopulation C (Biologic) | 203 | 324 |
| Total, other adverse events | All Participants | 1,127 | 1,660 |
| Total, serious adverse events | Subpopulation A (Naive) | 43 | 663 |
| Total, serious adverse events | Subpopulation B (Non-biologic) | 44 | 673 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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.
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