Trial · NCT04537689
Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis
NCT04537689, Phase 4, Recruiting, Singapore General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis. Trials, record NCT04537689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04537689
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis
- NCT number
- NCT04537689
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Singapore General Hospital
- Conditions
- Plaque Psoriasis
- Interventions
- Ixekizumab, Methotrexate, Cyclosporin A, Acitretin
- First posted
- 2020-09-03
- Last updated
- 2022-11-25
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of ixekizumab treated PsO participants free of relapse after ixekizumab withdrawal | 12 months from ixekizumab withdrawal or 18 months from baseline. | The investigators will describe the proportion of ixekizumab treated PsO participants free of relapse at 12 months after ixekizumab withdrawal. |
| Secondary | Proportion of ixekizumab treated PsO participants free of relapse after ixekizumab withdrawal | 15, 18, and 24 months from ixekizumab withdrawal or 21, 24, and 30 months from baseline. | The investigators will describe the proportion of ixekizumab treated PsO participants free of relapse at 15, 18, and 24 months after ixekizumab withdrawal. |
| Secondary | Proportion of participants achieving PASI 50 | 3 months and 6 months | Psoriasis is assessed by using the Psoriasis Area Severity Index (PASI) that measures the severity (intensity of redness, thickness and scaling is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4)) and percentage of affected area in four regions of the body (head and neck, upper limbs, trunk, lower limbs, expressed as nil (0), 1-9% (1), 10-29% (2), 30-49% (3), 50-69% (4), 70-89% (5) or 90-100% (6)). The score ranges from 0 (no psoriasis) to 72 (severe psoriasis). Percentage of improvement of PASI at 3 month and 6 month time points will be calculated from baseline. PASI 50 indicates a 50% improvement of PASI scores. |
| Secondary | Proportion of participants achieving PASI 75 | 3 months and 6 months | Psoriasis is assessed by using the Psoriasis Area Severity Index (PASI) that measures the severity (intensity of redness, thickness and scaling is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4)) and percentage of affected area in four regions of the body (head and neck, upper limbs, trunk, lower limbs, expressed as nil (0), 1-9% (1), 10-29% (2), 30-49% (3), 50-69% (4), 70-89% (5) or 90-100% (6)). The score ranges from 0 (no psoriasis) to 72 (severe psoriasis). Percentage of improvement of PASI at 3 month and 6 month time points will be calculated from baseline. PASI 75 indicates a 75% improvement of PASI scores. |
| Secondary | Proportion of participants achieving PASI 90 | 3 months and 6 months | Psoriasis is assessed by using the Psoriasis Area Severity Index (PASI) that measures the severity (intensity of redness, thickness and scaling is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4)) and percentage of affected area in four regions of the body (head and neck, upper limbs, trunk, lower limbs, expressed as nil (0), 1-9% (1), 10-29% (2), 30-49% (3), 50-69% (4), 70-89% (5) or 90-100% (6)). The score ranges from 0 (no psoriasis) to 72 (severe psoriasis). Percentage of improvement of PASI at 3 month and 6 month time points will be calculated from baseline. PASI 90 indicates a 90% improvement of PASI scores. |
| Secondary | Proportion of participants achieving clearance | 3 months and 6 months | Psoriasis is assessed by using the Psoriasis Area Severity Index (PASI) that measures the severity (intensity of redness, thickness and scaling is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4)) and percentage of affected area in four regions of the body (head and neck, upper limbs, trunk, lower limbs, expressed as nil (0), 1-9% (1), 10-29% (2), 30-49% (3), 50-69% (4), 70-89% (5) or 90-100% (6)). The score ranges from 0 (no psoriasis) to 72 (severe psoriasis). Percentage of improvement of PASI at 3 month and 6 month time points will be calculated from baseline. Clearance indicates a 100% improvement of PASI scores. |
| Secondary | Quality of life 1 (EuroQoL-5D-5L) | 3, 6, 9, 12, 15, 18, 24 and 30 months | In all participants (both ixekizumab treated and standard care) the investigators will describe the following: Every 3-6 monthly till end of 30 months, investigators will evaluate the change scores of Quality of Life (EQ5D-5L). It consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions. Each dimension is measured on a scale of 1-5, with '1' indicating no problem, '2' indicating slight problems, '3' indicating moderate problems, '4' indicating severe problems, and '5' indicating unable to/extreme problems. The highest and the lowest scores for both EQ-5D-5L indices were 1.00 (best imaginable health) and -0.769 respectively; where negative values are valued as worse than dead. EQ VAS records the patient's self-rated health on a vertical visual analogue scale from 0-100 with '0' indicating worst health one can imagine and '100' indicating best health one can imagine. |
| Secondary | Quality of life 2 (Dermatology Life Quality Index - DLQI) | 3, 6, 9, 12, 15, 18, 24 and 30 months | In all participants (both ixekizumab treated and standard care) the investigators will describe the following: \- Questionnaires on health status and quality of life every 3-6 monthly till end of 30 months. The investigators will evaluate the change scores of Dermatology Life Quality Index (DLQI) at various time points from baseline. DLQI is measured on a scale of 0-3 or not relevant, with '0' indicating not relevant or not at all, '1' indicating a little, '2' indicating a lot, '3' indicating very much. The final score ranges from 0 (minimal effect on quality of life) to 30 (maximum effect on quality of life). |
| Secondary | Quality of life 3 (Hospital Anxiety and Depression Scale - HADS) | 3, 6, 9, 12, 15, 18, 24 and 30 months | n all participants (both ixekizumab treated and standard care) the investigators will describe the following: \- Questionnaires on health status and quality of life every 3-6 monthly till end of 30 months. The investigators will evaluate the change scores of Hospital Anxiety and Depression Scale (HADS) at various time points from baseline. HADS is a 14 item scale with 7 of the items related to anxiety and the other 7 related to depression. Each item on the questionnaire is scored from 0-3, resulting in anxiety and depression scores each of 0 (no anxiety/depression) to 21 (severe anxiety/depression). |
| Secondary | Patient Global Assessment | 3, 6, 9, 12, 15, 18, 24 and 30 months | In all participants (both ixekizumab treated and standard care) the investigators will describe the following: \- Questionnaires on health status and quality of life every 3-6 monthly till end of 30 months. The investigators will evaluate the change scores of Patient Global Assessment (0-10) at various time points from baseline, with higher scores meaning worse outcome. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04537689
GET https://conductscience.org/api/trials/v1/NCT04537689/registered?page=2