Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe AA in the US
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Patient demographics characteristics: raceBaseline
Number of percentages of patients by race
- Patient demographics characteristics: sex, age at initial AA diagnosis, geographic location of patient's treating dermatologist, insurance type"Baseline" or "Day 1"
Number of percentages of patients by sex
- Patient demographics characteristics: age at initial AA diagnosis"Baseline" or "Day 1"
Number of percentages of patients by age at initial AA diagnosis
- Patient demographics characteristics: geographic location of patient's treating dermatologist"Baseline" or "Day 1"
Number of percentages of patients by geographic location of patient's treating dermatologist
- Patient demographics characteristics: insurance type"Baseline" or "Day 1"
Number of percentages of patients by insurance type
- Patient clinical characteristics at initial AA diagnosis: AA disease activity"Baseline" or "Day 1"
Number of percentages of Patient clinical characteristics at initial AA diagnosis: AA disease activity
- Patient clinical characteristics at initial AA diagnosis: SALT score"Baseline" or "Day 1"
Number of percentages of Patient clinical characteristics at initial AA diagnosis: SALT score
- Patient clinical characteristics at initial AA diagnosis: dermatology life quality index (DLQI) score"Baseline" or "Day 1"
Number of percentages of Patient clinical characteristics at initial AA diagnosis: dermatology life quality index (DLQI) score
- Patient clinical characteristics at initial AA diagnosis: eyebrow involvement"Baseline" or "Day 1"
Number of percentages of Patient clinical characteristics at initial AA diagnosis: eyebrow involvement
- Patient clinical characteristics at initial AA diagnosis: eyelash involvement"Baseline" or "Day 1"
Number of percentages of Patient clinical characteristics at initial AA diagnosis: eyelash involvement
- Patient clinical characteristics at initial AA diagnosis: beard involvement"Baseline" or "Day 1"
Number of percentages of Patient clinical characteristics at initial AA diagnosis: beard involvement
- Patient clinical characteristics at initial AA diagnosis: AA involvement at other body locations"Baseline" or "Day 1"
Number of percentages of Patient clinical characteristics at initial AA diagnosis: AA involvement at other body locations
- Patient treatment history: Additional treatment classes received during ritlecitinib treatment, additional treatment classes received after discontinuation of ritlecitinib, duration of each treatment class"Day 1 through study completion, a minimum of 6-months follow-up"
- Characteristics of ritlecitinib treatment: Total duration of ritlecitinib exposure, reasons for ritlecitinib discontinuation (if ritlecitinib treatment stopped before last known clinic visit),"Day 1 through study completion, a minimum of 6-months follow-up"
- Real-world clinical outcomes of ritlecitinib treatment: AA disease activity"Day 1 through study completion, a minimum of 6-months follow-up"
AA disease activity reported as active hair loss or inactive hair loss
- Real-world clinical outcomes of ritlecitinib treatment: SALT score overall change from baseline"Day 1 through study completion, a minimum of 6-months follow-up"
SALT score overall change from baseline (i.e., to last observed clinic visit), as well as change from baseline to predefined post-index time points (6-, 12-, 18-, and 24-months post-index, or other relevant timepoints based on actual distribution of data). Numeric and Categorical Data: no reduction from baseline, \>0%-≤25% SALT reduction, \>25%-≤50% SALT reduction, \>50%-≤75% SALT reduction, \>75% SALT reduction; Yes/No indicator for ≥30% SALT reduction; other categories/thresholds may also be applied.
- Real-world clinical outcomes of ritlecitinib treatment: SALT score"Day 1 through study completion, a minimum of 6-months follow-up"
Numeric data, with categorical values of \<50. 50-75, 75-100, and additional categories for ≥50 (to define severe AA) and 95-100 (to defined very severe AA); alternative categories may also be applied.
- Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving SALT ≤20 and ≤10"Day 1 through study completion, a minimum of 6-months follow-up"
Landmark probabilities of achieving SALT≤20 and SALT≤10 at 6-, 12-, 18-, and 24-months post-index date, or other relevant timepoints based on actual distribution of data.
- Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving a sustained SALT response"Day 1 through study completion, a minimum of 6-months follow-up"
Landmark probabilities of achieving a sustained SALT response at 6-, 12-, 18-, and 24-months post-index date, or other relevant timepoints based on actual distribution of data
- Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving ≥30% SALT score reduction from baseline at 6-, 12-, 18-, and 24-months post-index date"Day 1 through study completion, a minimum of 6-months follow-up"
- Real-world clinical outcomes of ritlecitinib treatment: beard involvement"Day 1 through study completion, a minimum of 6-months follow-up"
Categorical; none; minimal bear hair loss; moderate beard hair loss; severe beard hair loss; very severe or complete beard hair loss
- Real-world clinical outcomes of ritlecitinib treatment: eyebrow and eyelash involvement"Day 1 through study completion, a minimum of 6-months follow-up"
Categorical data with values of 0 (no involvement), 1 (minimal gaps), 2 (significant gaps), or 3 (complete loss)
- Real-world clinical outcomes of ritlecitinib treatment: AA involvement at other body locations"Day 1 through study completion, a minimum of 6-months follow-up"
Yes/no indicator for involvement at each of the following body sites: Extremities (arms, hands, legs, feet); Torso (chest, back, stomach); Pubic areas; Nasal hair; Nails
- Real-world clinical outcomes of ritlecitinib treatment: DLQI score"Day 1 through study completion, a minimum of 6-months follow-up"
- Real-world clinical outcomes of ritlecitinib treatment: Patient report of feeling embarrassed or self-conscious because of AA"Day 1 through study completion, a minimum of 6-months follow-up"
Yes; no; as documented by the physician at each clinic visit in the post-index date period
- Real-world clinical outcomes of ritlecitinib treatment: DLQI score overall change from baseline"Day 1 through study completion, a minimum of 6-months follow-up"
- Real-world clinical outcomes of ritlecitinib treatment: patient report of AA affecting social or leisure activities"Day 1 through study completion, a minimum of 6-months follow-up"
Yes; no; as documented by the physician at each clinic visit in the post-index date period
- Real-world clinical outcomes of ritlecitinib treatment: mental health comorbidities present at last known clinic visit"Day 1 through study completion, a minimum of 6-months follow-up"
Yes; No; indicators for presence of specific psychiatric disorders examined in a prior systematic literature review by Lee et al. (2019)