Development and Implementation of a Double-Blind Corticosteroid-Tapering Regimen for a Clinical Trial

Table 1

Snapshot of guidance documents (a) and patient diary (b).

(a)

Prednisone dispensed at visit

When medication dispensed should be used by patient

Visit name

(Additional prednisone may be dispensed at some study visits to; allow for the maximum study; visit window and duration; between study visits)

IxRS reference

eCRF reference

Patient diary reference

Prednisone

Prednisone taken by patient at corresponding patient diary study; week number

Type

Comments

Visit folder

Study week number

Study week number

Wallet number (taper week) blinded part only

Type

Number per day

Number of tablets remaining

Medication returned at end of 7 days

Baseline

1 open label 10 mg bottle containing 100 tablets

Baseline to study week 1

Baseline

0

0

1

Open-label taper 60 mg/d

6 tablets per day

58 tablets remaining

No continue to use tablets in study week 1

Study week 1 to study week 2

Week 1

1

1

2

Open-label taper 50 mg/d

5 tablets per day

23 tablets remaining

Yes return at study week 2 visit

Study week 1

1 open label 10 mg bottle containing 100 tablets

Study week 2 to study week 3

Week 2

2

2

3

Open-label taper 40 mg/d

4 tablets per day

72 tablets remaining

Yes return at study week 3 visit

Study week 2

2 open label 5 mg wallet (wallet contains 40 capsules)

Study week 3 to study week 4

Week 3

3

3

4

Open-label taper 35 mg/d

7 capsules per day

31 capsules remaining

No continue to use capsules in study week 4

(b)

Record of steroid medication capsules	Blinded steroids		Part 1 of the study
Study week number	Wallet number/date wallet started dd/mm/yyyy	Were any capsules missed?	Comments
—	Prednisone Wallet Number_________	No_____  Yes_____	Please provide the reasons for any capsules missed and any other information about your steroid medication this week.
		If Yes, please provide the number of capsules that were missed this week.
	Date started; ___/___/___	___________capsule(s) missed	_____________________________________; _____________________________________
—	Prednisone Wallet Number_______________	No____  Yes____	Please provide the reasons for any capsules missed and any other information about your steroid medication this week.
		If Yes, please provide the number of capsules that were missed this week.
	Date started; ___/___/___	___________capsule(s) missed	_____________________________________; _____________________________________
Record of steroid medication tablets	Open label 60 mg steroids/per day		Part 1 of the Study
Study week number	Date weekly tablets started; dd/mm/yyyy	Were any tablets missed?	Comments
—	Prednisone Wallet Number_________	No___  Yes___	Please provide the reasons for any tablets missed and any other information about your steroid medication this week.
		If Yes, please provide the number of tablets that were missed this week.
	Date started; ___/___/___	________tablet(s) missed	______________________________________; ______________________________________