Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
WI-NRS change |
Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6. |
Week 0 |
|
Primary |
WI-NRS change |
Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6. |
Week 6 |
|
Secondary |
WI-NRS change from W0 to W2 |
- Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2. |
Week 0 |
|
Secondary |
WI-NRS change from W0 to W2 |
- Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion (= Week 0) visit to week 2. |
Week 2 |
|
Secondary |
ItchyQoL change from W0 to W2 |
- Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 0 |
|
Secondary |
ItchyQoL change from W0 to W2 |
- Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 2 |
|
Secondary |
ItchyQoL change from W0 to W2 |
- Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 0 |
|
Secondary |
ItchyQoL change from W0 to W2 |
- Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 2(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 2 |
|
Secondary |
ItchyQoL change from W0 to W6 |
- Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 0 |
|
Secondary |
ItchyQoL change from W0 to W6 |
- Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 2 |
|
Secondary |
ItchyQoL change from W0 to W6 |
- Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 4 |
|
Secondary |
ItchyQoL change from W0 to W6 |
- Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 6 |
|
Secondary |
ItchyQoL percent change from W0 to W6 |
- Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 0 |
|
Secondary |
ItchyQoL percent change from W0 to W6 |
- Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 2 |
|
Secondary |
ItchyQoL percent change from W0 to W6 |
- Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 4 |
|
Secondary |
ItchyQoL percent change from W0 to W6 |
- Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) |
Week 6 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W2 |
- Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 0 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W2 |
- Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 2 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W2 |
- Percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 0 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W2 |
- Percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 2 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W6 |
- Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 0 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W6 |
- Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 2 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W6 |
- Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 4 |
|
Secondary |
Chronic Itch Burden Scale evolution from W0 to W6 |
- Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6. (10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 6 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W6 |
- Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 0 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W6 |
- Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 2 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W6 |
- Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 4 |
|
Secondary |
Chronic Itch Burden Scale change from W0 to W6 |
- Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching) |
Week 6 |
|
Secondary |
Treatment adverse events |
- Incidence and severity of treatment-emergent adverse events. |
Week 0 |
|
Secondary |
Treatment adverse events |
- Incidence and severity of treatment-emergent adverse events. |
Week 2 |
|
Secondary |
Treatment adverse events |
- Incidence and severity of treatment-emergent adverse events. |
Week 4 |
|
Secondary |
Treatment adverse events |
- Incidence and severity of treatment-emergent adverse events. |
Week 6 |
|
Secondary |
Treatment adverse events |
- Incidence and severity of treatment-emergent adverse events. |
Week 8 |
|