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BASELINE CRF Biomarkers of Systemic Treatment Outcomes in Psoriasis Longitudinal Sites

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BASELINE CRF Biomarkers of Systemic Treatment Outcomes in Psoriasis Longitudinal Sites
Biomarkers of Systemic Treatment Outcomes in Psoriasis
B-STOP ID:
BASELINE CRF
Longitudinal Sites
B S T
Version 8
BADBIR ID:
Initials:
D.O.B:
d
d
m
m
y
Gender:
y
Male
Female
ETHNICITY (Please circle): White / Black or Black British / Asian or Asian British / Chinese / Mixed background / Other
If Mixed Background / Other, please specify:
1. PATIENT CONSENT
1a. Is the patient due to enrol onto BADBIR or already on BADBIR? YES
NO
(Not eligible for recruitment)
1b. Has the patient given written Informed Consent for B-STOP?
NO
(Not eligible for recruitment)
1c. Date of Consent to B-STOP :
d
d
m m
y
YES
y
1d. Does this patient consent to Psoriasis Biobank? (see Q.8 on Consent Form)
YES
NO
1e. Does this patient consent to being recalled? (see Q.9 on Consent Form)
YES
NO
2. PATIENT PATHWAY
2a. At what stage in the patient's treatment pathway are they being recruited to B-STOP?
Please tick
Please invite the patient back for the following visits:
Before switching or starting a new treatment
4 weeks, 12 weeks and 6 months after treatment start
and then every 6 months
Up to 4 weeks after switching or starting
a new treatment
12 weeks and 6 months after treatment start and then
every 6 months
Up to 8 weeks after switching or starting
a new treatment
12 weeks and 6 months after treatment start and then
every 6 months
Up to 16 weeks after switching or starting
a new treatment
6 months after treatment start and then every 6 months
Patient is not starting/switching treatment
Every 6 months
3. TREATMENT DETAILS
3a. Please tick the boxes and complete details for all the patient’s current or expected Psoriasis treatments:
Please give details of most recent dose, if applicable
Biologic drugs
Drug name
Dose (mg) Frequency
Date started
Date of dose
Time of dose
Adalimumab
d
d
m m
y
y
d
d
m m
y
y
h
h
m m
Ustekinumab
d
d
m m
y
y
d
d
m m
y
y
h
h
m m
Other - write name
d
d
m m
y
y
d
d
m m
y
y
h
h
m m
Conventional drugs
Drug name
Please give details of most recent dose, if applicable
Dose (mg) Frequency
Date started
Date of most recent dose
Time of dose
Methotrexate
d
d
m
m
y
y
d
d
m
m
y
y
h
h
m
m
Other - write name
d
d
m
m
y
y
d
d
m
m
y
y
h
h
m
m
3b. If the patient is taking Methotrexate, is this being taken subcutaneously (by injection)? YES
Version 8, 14/01/2015
page 1
NO
Biomarkers of Systemic Treatment Outcomes in Psoriasis
BASELINE CRF
Longitudinal Sites
B S T
B-STOP ID:
Version 8
Initials:
4. CURRENT STATUS - Please indicate the current disease severity
4a. PASI
3b. DLQI
Date of assessment:
d
d
m m
y
y
4c. Psoriasis Global Assessment
Severe
Moderate to Severe
Moderate
Mild
Clear
Almost Clear
5. SAMPLE COLLECTION
Please tick boxes to confirm collection
5a FOR ALL PATIENTS - DNA SAMPLE
2 x 6ml PINK TOP tube
1
2
2 x 5ml YELLOW TOP tube
1
2
1 x 5ml YELLOW TOP tube
1
1 x 4ml PURPLE TOP tube
1
Freeze within 4 hours (or post with methotrexate sample if collected)
5b FOR PATIENTS ON OR STARTING BIOLOGIC THERAPY
Ideally collect at trough (before dosing)
Spin in centrifuge at 1000g for 10 minutes, pipette into micro-tube
Freeze within 4 hours
5c FOR PATIENTS ON OR STARTING CONVENTIONAL THERAPY
Process as 5b above
5d FOR PATIENTS ONLY ON METHOTREXATE THERAPY
NOT REQUIRED FOR PATIENTS ALSO ON A BIOLOGIC THERAPY
Not required before treatment has commenced
DO NOT FREEZE, place in blue Royal Mail Safebox and mail to Guy’s Hospital
Clinician’s Name:_________________________________________
Clinician’s Signature:______________________________________
Version 8, 14/01/2015
page 2
Date: d
d
m m
y
y
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