TriangleNCT03570749 · OUTCOME
Percent Change From Baseline in SALT Score - Phase 3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- percent change
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, Week 36
What was measured
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (\< 4 years versus ≥4 years), treatment group, and baseline value in the model.
Analysis population: All randomized phase 3 participants with non-missing baseline and at least one post-baseline measurement who had evaluable data for this outcome measure.A modified last observation carried forward (mLOCF) imputation technique was used to replace missing data with the most recent non-missing post-baseline assessment.
Groups in this outcome
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
| Group | Source count |
|---|---|
| Placebo Phase 3 | 185 |
| 2 mg Baricitinib Phase 3 | 180 |
| 4 mg Baricitinib Phase 3 | 278 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Phase 3 | -8.13 | 3.100 | Not reported | Not reported | Not reported |
| 2 mg Baricitinib Phase 3 | -31.23 | 3.157 | Not reported | Not reported | Not reported |
| 4 mg Baricitinib Phase 3 | -45.79 | 2.663 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -30.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -15.63
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.806
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Mean Difference (Final Values)
- param Value
- -23.10
- statistical Method
- ANCOVA
- ci Lower Limit
- -44.24
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -30.89
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.447
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Mean Difference (Final Values)
- param Value
- -37.65
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -30.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -15.63
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.806
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Mean Difference (Final Values)
- param Value
- -23.10
- statistical Method
- ANCOVA
- ci Lower Limit
- -44.24
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -30.89
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.447
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Mean Difference (Final Values)
- param Value
- -37.65
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.100
- value
- -8.13
- group Id
- OG001
- spread
- 3.157
- value
- -31.23
- group Id
- OG002
- spread
- 2.663
- value
- -45.79
- denoms
- counts
- group Id
- OG000
- value
- 185
- group Id
- OG001
- value
- 180
- group Id
- OG002
- value
- 278
- units
- Participants
- description
- The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (\< 4 years versus ≥4 years), treatment group, and baseline value in the model.
- dispersion Type
- Standard Error
- groups
- description
- Participants received two placebo tablets administered orally QD.
- id
- OG000
- title
- Placebo Phase 3
- description
- Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
- id
- OG001
- title
- 2 mg Baricitinib Phase 3
- description
- Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
- id
- OG002
- title
- 4 mg Baricitinib Phase 3
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized phase 3 participants with non-missing baseline and at least one post-baseline measurement who had evaluable data for this outcome measure.A modified last observation carried forward (mLOCF) imputation technique was used to replace missing data with the most recent non-missing post-baseline assessment.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 36
- title
- Percent Change From Baseline in SALT Score - Phase 3
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice