Trial · NCT04537689
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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. |
| Secondary | Patient Acceptable Symptom State (PASS) | 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 proportion of patient defined acceptable state (acceptable/unacceptable) and whether the symptoms are worse than usual (yes/no) at various time points from baseline. |
| Secondary | Proportion of participants in ixekizumab treatment arm maintaining PASI 50 after ixekizumab withdrawal | 9, 12, 18, 24 and 30 months from baseline | For participants in the ixekizumab treatment arm, the investigators describe the following in additional: \- The proportion of participants maintaining PASI 50 at 3, 6, 12, 18 and 24 months after stopping ixekizumab treatment |
| Secondary | Proportion of participants in ixekizumab treatment arm maintaining PASI 75 after ixekizumab withdrawal | 9, 12, 18, 24 and 30 months from baseline | For participants in the ixekizumab treatment arm, the investigators describe the following in additional: \- The proportion of participants maintaining PASI 75 at 3, 6, 12, 18 and 24 months after stopping ixekizumab treatment |
| Secondary | Proportion of participants in ixekizumab treatment arm maintaining PASI 90 after ixekizumab withdrawal | 9, 12, 18, 24 and 30 months from baseline | For participants in the ixekizumab treatment arm, the investigators describe the following in additional: \- The proportion of participants maintaining PASI 90 at 3, 6, 12, 18 and 24 months after stopping ixekizumab treatment |
| Secondary | Proportion of participants in ixekizumab treatment arm maintaining clearance after ixekizumab withdrawal | 9, 12, 18, 24 and 30 months from baseline | For participants in the ixekizumab treatment arm, the investigators describe the following in additional: \- The proportion of participants maintaining PASI clearance at 3, 6, 12, 18 and 24 months after stopping ixekizumab treatment |
| Secondary | Proportion of participants in ixekizumab treatment arm flaring after ixekizumab withdrawal | 9, 12, 18, 24 and 30 months from baseline | For participants in the ixekizumab treatment arm, the investigators describe the following in additional: \- The proportion of participants who flare (defined as losing the PASI50 response) at 3, 6, 12, 18 and 24 months after stopping ixekizumab treatment |
| Secondary | Histological changes in the skin biopsies of participants in ixekizumab treatment arm who relapsed after ixekizumab withdrawal (or at 18 months if no relapse) | Baseline, 6 months, at relapse (or 18 months if no relapse) | For participants in the ixekizumab treatment arm, the investigators will evaluate the following outcomes at relapse (or at 12 months after stopping ixekizumab if no relapse): \- Histological sections of morphologically psoriasis (lesional) and morphologically no psoriasis (nonlesional) skin biopsies. Skin biopsies at relapse will be scored for the degree of histological improvement compared to that participant's disease at 6 months on a five point scale; -1 (worse) to +3 (excellent). |
| Secondary | Skin genomic profiles in the skin biopsies of participants in ixekizumab treatment arm who relapsed after ixekizumab withdrawal (or at 18 months if no relapse) | Baseline, 6 months, at relapse (or 18 months if no relapse) | For participants in the ixekizumab treatment arm, the investigators will evaluate the following outcomes at relapse (or at 12 months after stopping ixekizumab if no relapse): \- Whole RNA genome transcriptome of the skin biopsies will be studied. The change in transcriptomes at relapse compared to 6-month will be evaluated. |
| Secondary | Peripheral blood immunome profiles of participants in ixekizumab treatment arm who relapsed after ixekizumab withdrawal (or at 18 months if no relapse) | Baseline, 6 months, at relapse (or 18 months if no relapse) | For participants in the ixekizumab treatment arm, the investigators will evaluate the following outcomes at relapse (or at 12 months after stopping ixekizumab if no relapse): 1. The B-cell and T-cell subtypes in the peripheral blood will be evaluated using mass cytometry, and compared to that of baseline and 6 months. 2. The investigators will evaluate the change in B-cell and T-cell Subtypes at relapse compared to baseline and 6 months. |
| Secondary | Histological changes in the skin biopsies | Baseline and 6 months | In all participants, the investigators will evaluate the skin genomic profiles that differentiate between ixekizumab versus standard care control arms. \- Histological sections of morphologically psoriasis (lesional) and morphologically no psoriasis (non lesional) skin biopsies at baseline and 6 months will be examined. Skin biopsies at 6 month will be scored for the degree of histological improvement compared to that participant's baseline disease on a five point scale; -1 (worse) to +3 (excellent). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04537689/registered