Table 3. Schedule of trial activities.
| Screening (<3 months between screening and baseline) | Treatment period | Follow-up | Safety follow-up | ||||
|---|---|---|---|---|---|---|---|
|
Allowed visit window: + 3 days |
Visit 0 | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 |
| Baseline | (week 1) | (week 4) | (week 8) | (week 12) | (week 20) | ||
| Study enrolment | Treatment initiation | Treatment end | Study end | ||||
| Written informed consent | X | ||||||
| Inclusion/exclusion eligibility check and sign-off | X | X | |||||
| Demographics | X | ||||||
| Medical history | X | X | |||||
| Social history | X | ||||||
| Family history | X | ||||||
| PPP history | X | ||||||
| Clinical phenotyping of disease/concomitant psoriasis | X | ||||||
| Physical examination | X | ||||||
| Vital signs* | X | X | X | X | X | X | |
| PPPASI† (×2: blinded and unblinded assessment) | X | X | X | X | X | X | |
| Fresh pustule count† | X | X | X | X | X | X | |
| Total pustule count† | X | X | X | X | X | X | |
| PPP-IGA† (×2: blinded and unblinded assessment) | X | X | X | X | X | X | |
| PASI (plaque psoriasis only) | X | X | X | X | X | X | |
| BSA | X | X | X | X | X | X | |
| Patient global assessment | X | X | X | X | X | X | |
| DLQI | X | X | X | ||||
| EQ5D-5L | X | X | X | ||||
| DOSE-Nonadherence questionnaire | X | X | X | ||||
| Photography (palms and soles) | X | X | X | X | X | ||
| CXR‡ | X | ||||||
| T-Spot.TB§ | X | ||||||
| HIV, HBV and HCV | X | ||||||
| Safety bloods¶** | X†† | X†† | X | X | X | X | |
| bHCG (blood)‡‡ | X | X | X | X | |||
| Prescribing and dispensing trial IMP | X | X | |||||
| Retrieval of IMP packaging (pill count) | X | X | |||||
| Acceptability Questionnaire§§ | X | X | |||||
| RCT scoping question | X | ||||||
| Concomitant meds | X | X | X | X | X | X | X |
| Adverse events monitoring | X | X | X | X | X | X | |
| Integrated qualitative study | |||||||
| Trial participant interview | X | X | |||||
| Trial decliner interview | X | ||||||
| Healthcare professional interview | Interviews will take place with healthcare professionals throughout the duration of the trial (maximum one interview per healthcare professional) | ||||||
Vital signs include heart rate, blood pressure, oxygen saturations, respiratory rate and temperature.
Assessed by independent blinded assessor. PPPASI and PPP-IGA were also assessed by a second assessor.
CXR not indicated if participant has had a CXR in the previous 12 months for clinical purposes.
T-Spot.TB not indicated for those participants known to have been successfully treated for TB (completed the prescribed treatment courses) as screening test is not clinically indicated. If unsure, please seek specialist advice.
Safety bloods comprise WBC, Hb, platelet count, creatinine, urea, sodium, potassium, bilirubin, aspartate aminotransferase, alanine transaminase, HbA1c and cholesterol.
CRP to be collected at baseline (visit 1) only.
If the time between screening and baseline safety assessment bloods is >4 weeks (ie, for participants washing out for 3 months from biologic therapy) the participant should be asked to attend for additional safety assessment blood tests. If feasible, this should be on the same day as the baseline visit allowing for time to clinically review the results before the first treatment dose (in which case only one set of baseline safety assessment bloods should be taken); however, if not convenient, it should be scheduled within 4 weeks of the baseline visit (these may be taken by their GP). If the participant attends an extra visit for these tests, then they should also go on to complete the full baseline visit, that is, repeat the baseline safety assessment bloods as scheduled.
bHCG not indicated or applicable for postmenopausal women.
Acceptability questionnaires will be completed during Visits 1 and 5 for participants not taking part in the integrated qualitative study (qualitative study participants will complete the questionnaires during the interviews).
bHCG, beta-human chorionic gonadotropin; BSA, body surface area; CXR, chest X ray; DLQI, Dermatology Life Quality Index; EQ5D-5L, European Quality of Life 5 Dimensions 5 Level Version; Hb, haemoglobin; HBV, Hepatitis B virus; HCV, Hepatitis C virus; IMP, investigational medical product; PPP, palmoplantar pustulosis; PP-PASI, Palmoplantar Pustulosis Psoriasis Area and Severity Index; PPP-IGA, Palmoplantar Pustulosis-Investigator Global Assessment; RCT, randomised controlled trial; TB, tuberculosis.