XELJANZ(REGISTERED) TABLETS 5 MG SPECIAL INVESTIGATION(INVESTIGATION OF LONG-TERM USE IN PATIENTS WITH ULCERATIVE COLITIS)
Conditions: Ulcerative Colitis
Sponsor: Pfizer

Xeljanz 
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Version 5 (Amended 4), 17 December 20 19 
PFIZER CONFIDENTIAL 
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XELJANZ® Tablets 5 mg Special Investigation 
(Investigation of Long-term Use in Patients with Ulcerative Colitis) 
STUDY PROTOCOL SYNOPSIS 
 
 
 
 
 
 
 
 
 
 
 
Pfizer Inc. 
 
 
 
 
 
 
 
 
 
This document contains confidential information belonging to Pfizer. Except as 
otherwise agreed to in writing, by accepting or reviewing this document, you agree to 
hold this information in confidence and not copy or disclose it to others (except where 
required by applicable law) or use it for unauthorized purposes. In the event of any 
actual or suspected breach of this obligation, Pfizer must be promptly notified . 

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STUDY INFORMATION 
 
XELJANZ® Tablets 5 mg Special Investigation 
Title 
(Investigation of Long-term Use in Patients with Ulcerative 
Colitis) 
 
Protocol number 
A3921248 
 
Protocol version 
Version 5 
identifier 
Date of last 
version of 
17 September, 2019 (Version 4) 
protocol 
 
Active substance 
Tofacitinib  citrate 
 
 
Medicinal product 
XELJANZ® Tablets 5 mg 
 
Research question 
This investigation aims to examine the safety and effectiveness 
and objectives 
of XELJANZ Tablets in post-market ing clinical settings when it 
is administered chronically to patients with ulcerative colitis. 
 
Author 
PPD 
I 
I 
I 

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TABLE OF CONTENTS 
1. LIST OF ABBREVIATIONS ............................................................................................................. 5 
2. RESPONSIBLE PARTIES ................................................................................................................. 5 
3. AMENDMENTS AND UPDATES ..................................................................................................... 5 
4. MILESTONES ......................................................................................................................................................... 8 
5. RATIONALE AND BACKGROUND ................................................................................................ 8 
6. RESEARCH QUESTION AND OBJECTIVES .................................................................................. 9 
6.1. Safety  Specifications ............................................................................................................. 9 
6.1.1. Important identified risks ......................................................................................... 9 
6.1.2. Important potential risks .......................................................................................... 9 
6.1.3. Important missing information ................................................................................ 10 
7. RESEARCH METHODS ................................................................................................................... 10 
7.1. Study design ......................................................................................................................... 10 
7.2. Setting .................................................................................................................................. 10 
7.2.1. Registration  criteria ................................................................................................ 10 
7.2.2. Sites for this study .................................................................................................. 10 
7.2.3. Planned  investigation period ................................................................................... 10 
7.2.4. Study procedures ..................................................................................................... 11 
7.2.5. Observation period .................................................................................................. 11 
7.3. Variables .............................................................................................................................. 12 
7.3.1. Ba.ckground ............................................................................................................................. 13 
7.3.2. Pre-dosing observation ............................................................................................ 13 
7.3.3. XELJANZ use record .............................................................................................. 15 
7.3.4. Concomitant therapy  for ulcerative colitis .............................................................. 16 
7.3.5. Status of vaccination ............................................................................................... 16 
7.3.6. Status of prophylactic  treatment ............................................................................. 16 
7.3.7. Tests/clinical laboratory tests .................................................................................. 16 
7.3.8. Clinical evaluation on effectiveness ........................................................................ 18 
7.3.9. Status of pregnancy (female patients only) ............................................................. 18 
7.3.10. Status of treatment with XELJANZ ...................................................................... 19 
7.3.11. Adverse events ...................................................................................................... 19 
7.4. Data sources ........................................................................................................................ 20 
7.5. Study size ...............................................................................................................................................20 
7.5.1. Planned sample size ............................................................................................... 20 
7.5.2. Rationale for sample size ....................................................................................... 20 
7.6. Data management. ............................................................................................................... 20 
7.6.1. Case report forms (CRFs)/Data. collection tools (DCTs)/Electronic 
data. record .........................................................................................................................20 

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7.6.2. Record retention .................................................................................................................... 21 
7.6.3. Data collection method ........................................................................................................ 21 
7.6.4. Patient registration................................................................................................................ 21 
7.6.5. Reminders concerning completing, revising, and submission of case 
report form ....................................................................................................................... 22 
7.7. Data analysis ....................................................................................................................... 22 
7.7.1. Definition of analysis set. .................................................................................................... 22 
7.7.2. Method of analysis ............................................................................................................... 22 
7.8. OTHER NECESSARY MATTERS ................................................................................................. 23 
8. ORGANIZATIONAL SYSTEM FOR STUDY IMPLEMENTATION ................................................... 23 
9. NAME, ADDRESS AND OUTSOURCED OPERATIONS OF THE PERSON WHO 
WAS CONTRACTED WITH THE OPERATIONS ............................................................................ 23 
10. ADDITIONAL MEASURES THAT MAY BE IMPLEMENTED BASED ON THE 
STUDY RESULTS AND CRITERIA FOR DETERMINATION OF THE 
INITIATION ................................................................................................................................................. 23 
11. SCHEDULED TIMING OF MILESTONES AND THEIR RATIONALES FOR 
REPORTIN G OF STUDY IMPLEMENTATION STATUS AND EVALUATION 
OF OBTAINED RESULTS TO THE PMDA ....................................................................................... 24 
12. OTHER NECESSARY MATTERS ............................................................................................................. 24 
13. CONTACT INFORMATION ........................................................................................................................ 24 
13.1. Contact information for the contents of the study ....................................................................... 24 
13.2. Contact information for the EDC system (in the case of study using EDC).......................... 25 
14. REFERENCES.................................................................................................................................................. 25 
15. LIST OF TABLES ........................................................................................................................................... 25 
16. LIST OF FIGURES.......................................................................................................................................... 25 
17. LIST OF STAND ALONE DOCUMENTS ................................................................................................ 25 
18. ADDITIONAL INFORMATION ................................................................................................................. 25 
19. ADDITIONAL TABLE (NAME OF THE TABLE) ................................................................................. 25 

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1. LIST OF ABBREVIATIONS 
 
acronym 
Tittle 
k4ST (GOT) 
aspartate transaminase 
k4LT (GPT) 
alanine transaminase 
k4L-P 
alkaline phosphatase 
[ DH 
lactate dehydrogenase isozyme 
'iHDL-C 
high-density lipoprotein  cholesterol 
[ DL- C 
low-density  lipoprotein  cholesterol 
y-GTP 
y-glutamyl transpeptidase 
'iKL-6 
Krebs von den Lungen-6 (sialylated carbohydrate antigen) 
'!BUN 
blood urea nitrogen 
'!EDC 
electronic data capture 
l!AK 
Janus kinase 
WDA 
new drug application 
 
 
2. RESPONSIBLE PARTIES 
The Japan Good Post marketing Study Practice officer 
 
 
 
3. AMENDMENTS AND UPDATES 
Amendment 
number 
Date 
Substantial or 
administrative 
amendment 
Protocol section(s) changed 
Reason 
Version 5 
13 December 20 19 Other 
amendment(s) 
7.2.3Planned  investigation 
period 
7.6.1Case report forms 
(CRFs)/Data collection tools 
(DCTs)/Electronic data record 
7.6.4.1Procedures  for 
registration 
Change target of CRF 
collection 
Version 4 
17 September 2019 Other 
amendment(s) 
6.1.limportant identified 
risks 
9NAME, ADDRESS 
AND OUTSOURCED 
OPERATIONS  OF THE 
PERSON WHO WAS 
CONTRACTED  WITH 
THE  OPERATIONS 
Revistion of RMP 
Change of outsourced 
work 

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Amendment 
number 
Date 
Substantial or 
administrative 
amendment 
Protocol section(s) changed 
Reason 
Version 3 
17 April, 2019 
Other 
amendment(s) 
7.2.4.2 . Distribution 
management Deleted 
7.6Data    management 
13.2Contact  information 
for the EDC system (in 
the case of study using 
EDC) 
Change distribution 
meshod 
Improvements of 
descriptions 
Change mail addess 
Version 2 
01 December, 
2018 
Other 
amendment(s) 
9NAME, ADDRESS 
AND OUTSOURCED 
OPERATIONS  OF THE 
PERSON WHO WAS 
CONTRACTED  WITH 
THE  OPERATIONS 
Description  revision 
maintenance 
accompanying 
establishment of 
Pfizer R & D 
Final 
25 May, 2018 
Other 
amendment(s) 
6 RESEAR CH QUESTION 
AND OBJECTIVES 
7.3 Variables (Table 2) 
7.3. l Background 
7.3.2 Pre-dosing  observation 
7.3.3 XELJANZ use record 
7.3.4.l Drug therapy 
7.3.5 Status of vaccination 
7.3.7.1 Clinical laboratory 
tests 
7.3.7.6 Colonoscopy 
7.3.10 Status of treatment 
with XELJANZ 
9 NAME, ADDRESS AND 
OUTSOURCED 
OPERATIONS OF THE 
PERSON WHO WAS 
CONTRACTED WITH 
THE OPERATIONS 
14 REFERENCES 
Action against 
direction by the 
authorities 
Improvements of 
descriptions 
Improvements of 
descriptions 
Improvements of 
descriptions 
Improvements of 
descriptions 
Improvements of 
descriptions 
Improvements of 
descriptions 
Addition of footnotes 
Improvements of 
descriptions 
Improvements of 
descriptions 
Change in the 
outsourced  operations 
Improvements of 
descriptions 
NDA- 
Amended 3 
17 April, 2018 
Other 
amendment(s) 
"7.3.12 Major investigation 
items" deleted 
Direction by the 
authorities 
NDA_ 
Amended 2 
13 April, 2018 
Other 
amendment(s) 
5 RATIONALE AND 
BACKGROUND 
6.1 Safety Specifications 
Ordinance revision 
Change to RMP 

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Amendment 
number 
Date 
Substantial or 
administrative 
amendment 
Protocol section(s) changed 
Reason 
7.2.1 Registration criteria 
7.2.4.2Distribution 
management 
7.2.5 Observation period 
7.3 Variables (schedule) 
7.3 .3 XELJANZ use record 
7.3.9 9 Status of 
pregnancy (female 
patients  only) 
7.3.10 Status of treatment 
with XELJANZ 
7.3.11 Adverse events 
7.6 Data management 
9 NAME, ADDRESS AND 
OUTSOURCED 
OPERATIONS OF THE 
PERSON WHO WAS 
CONTRACTED WITH 
THE OPERATIONS 
13 CONTACT 
INFORMATION 
14 REFERENCES 
Improvements of 
descriptions 
Improvements of 
descriptions 
Action against PMDA 
inquiry 
Action against PMDA 
inquiry 
Action against PMDA 
inquiry 
Action against PMDA 
inquiry 
Action against PMDA 
inquiry 
Action against PMDA 
inquiry 
Improvements of 
descriptions 
Clarification of the 
outsourcing 
contractors 
Clarification of 
contact  information 
Addition of attached 
documents 
NDA_ 
Amended 1 
13 February, 2018 Other 
amendment(s) 
6.1 Safety Specifications 
7.3 .l Background 
7.3.2 Pre-dosing observation 
7.3.4 Concomitant therapy for 
ulcerative  colitis 
7.3.5 5 Status of vaccination 
7.3.7.1 Clinical laboratory 
tests 
7.3.7.6 Colonoscopy 
7.3.10 Status of treatment 
with XELJANZ 
Change to RMP 
Reconsidera tion of 
the variables 
Reconsideration  of 
the variables 
Reconsideration  of 
the variables 
Addition of an 
applicable  vaccine 
Reconsideration  of 
the parameters 
Reconsideration  of 
the parameters 
Reconsideration  of 
the variables 
NDA First 10 May, 2017 
ot applicable 
Not aoolicable 
Not aoolicable 

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4. MILESTONES 
 
Milestone 
Planned date 
Start of data collection 
May 2018 
End of data collection 
June 2021 
Interim report 
At the time of submission of Japan Periodic Safety Report 
Final study report 
Augast 2022 
 
5. RATIONALE AND BACKGROUND 
XELJANZ® Tablets 5 mg (non-proprietary name: tofacitinib citrate) (hereinafter 
"XELJANZ") is a potent inhibitor of Janus kinase (JAK) created by Pfizer Inc. In 
Japan, XELJANZ received marketing approval for the indication of "rheumatoid 
arthritis with inadequate response to existing therapy" in March 2013 and the 
indication of "induction and maintenance therapy for moderate or severe active 
ulcerative colitis (limited to cases with inadequate response to existing therapy)" in 
May 2018. 
 
"XELJANZ® Tablets 5 mg Special Investigation (Investigation of Long-term Use in 
Patients with Ulcerative  Colitis)" (hereinafter "Investigation") will be conducted 
based on the approval conditions in order to understand the safety and effectiveness 
of long-term use of XELJANZ in patients with ulcerative colitis in clinical settings. 
Information obtained in this study shall be used to report Ministry of Health, Labour 
and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), and 
Pfizer Inc. which is the corporate parent of marketing authorization holder (or 
sponsor) of XELJANZ. And also, it shall be used for application of re-examination 
(including Japan Periodic Safety Report), re-evaluation, preparation of material for 
proper use information of XELJANZ, publications and activities for information 
service. 
This Study shall be conducted in strict compliance with the "MHLW Ordinance on 
the Standard for Post-Marketing Studies and Clinical Trials of Medical Products" 
(MHLW Ordinance No. 171, dated December 20, 2004), the "Enforcement of the 
MHLW Ordinance on the Standard for Post-marketing Studies and Clinical Trials of 
Medical Product s" (PFSB Notification No. 1220008, dated December 20, 2004), 
"MHLW Ordinance on the Partially Revision of the MHLW Ordinance on the 
Standard for Post-marketing Safety Control of Medical Products, Quasi-medical 
Products, Cosmetics, and Medical Devices and on the Partially Revision of the 
MHLW Ordinance on the Standard for Post-marketing Studies and Clinical Trials of 
Medical Product s" (MHLW Ordinance No. 26, dated March 11, 2013), the 
"Enforcement of the MHLW Ordinance on the Partially Revision of the MHLW 
Ordinance on the Standard for Post-marketing Safety Control of Medical Products, 
Quasi-medical Products, Cosmetics, and Medical Devices, and on the Partially 
Revision of the MHLW Ordinance on the Standard for Post-marketing Studies and 

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Version 5 (Amended 4), 17 December 2019 
 
 
Clinical Trials of Medical Products" (PFSB Notification No. 0311-7, dated March 11, 
2013), "MHLW Ordinance on the Partially Revision of the MHLW Ordinance on the 
Standard for Post-marketing Studies and Clinical Trials of Medical Products" 
(MHLW Ordinance No. 116, dated October 26, 2017), and "Announcement of the 
MHLW Ordinance on the Partially Revision of the MHLW Ordinance on the 
Standard for Post-marketing Studies and Clinical Trials of Medical Products 
(Regarding the MHLW Ordinance on the Standard for Post-Marketing Studies and 
Clinical Trials of Medical Products)" (PSEHB Notification No . 1026-1, dated 
October 26, 2017). 
 
6. RESEARCH QUESTION AND OBJECTIVES 
This investigation aims to examine the safety and effectiveness of XELJANZ in 
post-marketing clinical settings when it is administered chronically to patient s with 
ulcerative colitis, based on the approval conditions below . 
 
[Approval conditions] 
r•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••     , 
Ulcerative colitis 
Due to a very limited number of patients studied in clinical trials in Japan, a 
Drug Use Investigation in all patients should be conducted after launch until data 
are collected on a target number of patients to understand the background of 
patients using XELJANZ and collect data on the safety and effectiveness of 
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-!:.!.- -  - -!:x... --9E E..?..!: --!! - 
!E¥...  !.?.!! _ 9L !! P.E?.£ --  - -£f.. !! -!:- L 
6.1. Safety Specifications 
The safety specifications included in the Risk Management Plan of XELJANZ are as 
shown below. 
 
6.1.l. Important identified risks 
• Serious infection (including tuberculosis, pneumonia, Pneumocystis pneumonia, 
sepsis, and opportunistic infection) 
• Herpes zoster 
• Neutropenia, lymphopenia, oligochromemia 
• Hepatic impairment 
• Reactivation of hepatitis B virus 
• Gastrointestinal perforation 
• Interstitial lung disease 
• Venous thrombosis 
6.1.2. Important potential risks 
• Malignant tumor 
• Cardiovascular event 
• Rhabdomyolysis, myopathy 

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6.1.3. Important missing information 
Not applicable. 
7. RESEARCH METHODS 
 
7.1. Study design 
This is a multicenter cohort investigation to be conducted in patients with ulcerative 
colitis treated with XELJANZ  in clinical settings. 
7.2. Setting 
7.2.l. Registration criteria 
Patients must meet all of the following inclusion criteria to be eligible for inclusion 
in the study: 
• Patients with ulcerative colitis treated with XELJANZ 
• Patients naive to XELJANZ in the treatment of ulcerative colitis 
For the "indications" and "dosage and administration" of XELJANZ, refer to the 
latest package insert of the drug. 
7.2.2. Sites for this study 
This investigation is planned to be conducted at approximately 500 medical 
institutions of gastrointestinal medicine or gastrointestinal surgery that satisfy the 
following requirements. 
7.2.2.l. Site requirements 
• Sites that are able to cooperate with this investigation 
• Sites that are sufficiently capable of taking emergency actions (including those 
that are capable of such actions in collaboration with other institutions*) 
*: If the diagnosis and treatment are conducted in collaboration with other institutions, the 
information on safety measures , procedures of adverse reactions, etc. of XELJANZ must 
be shared with the sites in collaboration and the cooperation system must be confirmed . 
• Sites with physicians who satisfy the investigator requirements below: 
[Investigator requirements] 
• Physicians with sufficient knowledge of XELJANZ (including knowledge of 
adverse reactions) 
• Physicians with experience in treatment of ulcerative colitis 
• Physicians who are able to cooperate with this investigation 
• Physicians who can have an interview with Sponsor 
7.2.3. Planned investigation period 
The planned period covered by this study is as follows. 
• Investigation period: May 2018 to June 2021 

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• Registration period: May 2018 to until the approval conditions for all cases 
investigations are lifted 
However, when PMDA has accepted to continuing registration only, it is not 
necessary to enter new CRF. 
7.2.4. Study procedures 
7.2.4.l. Study method 
This investigation will be conducted with all patients surveillance system that 
register all patients treated with XELJANZ for ulcerative colitis. 
This investigation will study patients who use XELJANZ at contract sites after the 
date of approval of the dosage and administration for ulcerative colitis. 
7.2.4.2. Distribution management 
Sponsor, upon confirming the completion of contract for this study, shall set up 
logistics necessary to deliver XELJANZ to the site. 
7.2.5. Observation period 
The duration of observation will be 60 weeks (14 months) from the date of treatment 
commencement (Day 1). However, patients who are treated with XELJANZ for more 
than 60 weeks after the date of treatment commencement will be continuously 
followed up until the end of the investigation period * (June 2021). For patients who 
discontinue XELJANZ, information until the discontinuation will be collected. 
 
*: Date of the last observation before June 2021 
 
This study will be conducted using booklet type CRF. Investigator will complete 
each booklet of CRFs for each observation period in Table 1. However, for patients 
who discontinue XELJANZ, information until the discontinuation will be collected. 
Table  1. Name of CRF and observation period 
 
Name of CRF 
Observation period 
Booklet 1 
Treatment commencement to Week 26 (Month 6) of treatment 
Booklet 2 
Week 27 (Month 7) to Week 60 (Month 14) of treatment 
Booklet 3 
Week 61 (Month 15) to end of the investigation period (June 2021) 

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• • 
only) 
Smoking history 
• 
Height, body weight 
• 
• 
Planned first day of treatment with • 
Disease history 
• 
Information on ulcerative colitis 
• 
XELJANZ  use  record 
..... 
-
/ 
.... -
..... 
/ 
.....
,. 
....
 
7.3. Variable s 
This study will be conducted according to the schedule of observation in Table 2. 
However, when PMDA accepted to continuing the case registration only, the 
information in 7.3.2 to 7.3.11 does not need to be entered in the new CRF. 
 
Table 2. 
Schedule of observation 
 
Date of 
Patient 
End of 
treatment  Week 26 of Week 60 of 
Observation item 
registrat Baseline11  
investigation 
commence  treatment 11   treatment 11 
ion1 
period11 
ment11 
ID number, gender, age2 
• 
XELJANZ3 
Confirmation of eligibility for 
XELJANZ treatment 
Confirmation of eligibility for the 
investigation 
 
4 
Status of pregnancy  (female patients 
• 
Prior treatment for ulcerative colitis 
• 
Family history of malignant tumor 
including lymphoma) 
/ 
.... 
Concomitant therapy for ulcerative 
..... 
colitis 
Status  of vaccination5 
,,. 
.... 
Status of prophylact ic treatment 6 
/..... 
.-
... 
Clinical laboratory tests 
,,. 
.,.,.... 
Chest X-ray or chest CT7 
/..... 
.-
.... 
Tuberculosis  screening tests 
..... 
- 
Blood pressure 
/..... 
Hepatitis B and C virus tests 
/..... 
.,.,.... ' 
Colonoscopy8 
..... 
,. 
Clinical evaluation  on effectiveness9 
,,. 
..... 
Status of treatment with XELJANZ 
..... 
- 
All adverse events 
',. 
Malignant tumor and adverse events 
;;ii 
leading to discontinuation 10 
1. Record the information in the registration form 
2. Age at the time when the treatment of XELJANZ is commenced 
3. Date when treatment with the commercial product of XELJANZ is started for patients who participated in 
clinical  trials 

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 Version 5 (Amended 4). 17 December 2019  
 
 
4. Name and durat ion of the disease. extent of the lesion, severity. status of refractory ulcerative colitis based on 
treatmen t response 
5. Information on vaccination with herpes zoster vaccine and pneumococcal vaccine from baseline to the date of 
completion of the observation period (or date of discontinuation) 
6. Information on prophylactic treatment for tuberculosis. Pneumocystis jiroveci i pneumonia and hepatitis B 
given from 3 months before commenceme nt of XELJANZ treatment to the date of completion of the 
observation period (or date of discontinuation) 
7. lofonnation on chest X-ray and chest CT conducted from 3 months before commencement of XELJANZ 
treatment to the date of completion of the observat ion period (or date of discontinuation) 
8. Information on colonoscopy conducted from 6 months before commencement of XELJANZ treatment to the 
date of completion of the observation period (or date of discontinuation) 
9. Frequency of defecation. rectal bleeding. findings of colonoscopy (if conducted), and investigator 's global 
assessment 
10. For patients who continue treatment beyond Week  60 of treatment. collect information on malignant tumor 
and adverse events leading to treatment discontinu ation that occur at and after Week 61 of treatment 
11. When PMDA has accepted to continuing registration only, it is not necessary to enter new CRF. 
7.3.1. Backgrou nd 
The following info1mation should be recorded in the registration fom1for patient 
registration (see 7.6.4). 
1. ID number 
2. Gender 
3. Month of birth or age (at the time when the trea tment of XELJANZ is planned 
to be commenced) 
4. Planned first day of treatment with XELJANZ• 
*: Date when trea tment with the couunercial product of XELJANZ is started for patients who 
participated in clinical trials 
 
5. .  Confirmation of eligibility for XELJANZ treatment (confirm that patients 
do not meet the contraindications in the latest packa ge insert) 
6. Confirmation of eligibility for the investigation 
7.3.2. Pre-dosing observation 
The following information should be recorded in CRF. 
1. Height 
2. . Body weight 
3. Information on ulcerative colitis 
a. Name of the disease 
b. Date of diagnosis or duration of the disease 
c. Extent of the lesion· (total colitis, left-sided colitis, proctitis, right-sided or 
segmental colitis) 
d. Severity* (sever, moderate, mild; See Table 3.) 
 
Table 3. Classifica tion of ulcerative colitis by severity• 
Severe 
Moderate 
Mild .. 
l) Frequency 
of stool 
6 times or more 
Intermed iate 
4 times or less 

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2) Obvious 
bloody stool 
(+++) 
between severe 
and mild 
(+) to (-) 
3) Fever 
37.5°C or higher 
(-) 
4) Tachycardia 
90/min or more 
(-) 
5) Anemia 
Hb 10 g/dL or less 
(-) 
6) Erythrocyte 
sedimentation 
rate 
30 mm/h or more 
Normal 
Note: 
• 
Rated as severe when criteria 1), 2), and one of the systemic symptoms 3) 
a11d 4) are satisfied, and at least 4 of the 6 criteria are satisfied. 
• Rated as mild when all of the 6 c1·iteria are satisfied. 
• Among patients with severe disease, those showing extremely  severe 
symptoms are classified as having fu lulinant disease, and, depending on the 
rapidity of the disease onset. fuhninant disease is subdivided  into acute 
fuhninant and relapsing fuhninan t d isease. 
• Patients satisfying all of the following 5 criteria are classified as having 
fulminant d isease. 
1. Satisfying the criteria for severe disease 
2. Bloody diarrhea occurring at a frequency of 15 times/day or more 
3. Persistent high fever (38°C or higher) 
4. Increase of the leukocyte count to 10,000 /mm3 or more 
5. Severe abdominal pa in 
*: Criteria for diagnosis and treatment strategy for ulcerative colitis and Crohn's disease 2016 
revised version (supplementary volume of the 2016 annual report of "Research Group of 
Intractable Inflammatory Bowel Disease" [Suzuki Group], Research on Policy Planning 
and Evaluation for Rare and Intractable Disea ses, Health and Labom Sciences Research 
Grants) 
**: Patients with nlild d isease a1·e not eligible for XELJANZ treatment. 
e. Status of refractory ulcera tive colitis based on treatment response (statu s of 
steroid dependency or resistance in the last episode before commencement 
of XELJANZ treatment) 
4. Status of pregnancy (female patients only) 
5. Medical history (name of disease or syndrome (diagnosis], classification of 
history·or  concurrent   disease..) 
* History: 
Chronic disease (including allergy), disease requiring treatment, disease or 
disorder with surgery, hospitalization or sequelae, and other relevant disease or 
syndrome that are cured before commencement of XELJANZ treatment (no 
treatment and no symptoms) 
 
* Concurrent  disease: Chronic disease (including  allergy), disease requiring  treatment. disease 
or disorder with  surgery, hospitalization or sequelae, and other relevant disease 
or syndrome that require any treatment or requ ire no treatment  but have residual 
symptoms at the time of commencement of XELJANZ treatment 

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6. Prior treatment for ulcerative colitis 
The status of prior treatment (drug and non-drug therapy) for the last episode 
before commencement of XELJANZ treatment (an episode treated with 
XELJANZ) should be recorded . 
 
For biological products , the status of use throughout the past treatment of 
ulcerative colitis should be recorded, and if any biological product was used, 
the name of the product and the classification of primary failure or secondary 
failure• should be recorded. 
 
*: Primary failure: Lack of effectiveness or insufficient effectiveness with treatment  for an 
appropriate period at the approved dosage and administration 
Secondary failure: Loss of effectiveness (relapse) with continued treatment after achieving a 
clinical response (remission) with treatment for an appropriate period at the 
approved dosage and administration 
Indeterminate: Treatment is discontinued due to any reason other than "not effective" (e.g., 
adverse events) and determination whether it is primary failure or secondary 
failure cannot be made 
7. Smoking history (status of smoking at the start of the investigation) 
8. Family history of malignant tumor (including lymphoma) 
7.3.3. XELJANZ use record 
The record of the status of XELJANZ treatment from the date of treatment 
commencement to the date of completion of the observation period (or date of 
XELJANZ discontinuation) should include the following information. 
However, for patient s who are treated with XELJANZ for more than 60 weeks after 
the date of treatment commencement, information until the end of the investigation 
period (or date of XELJANZ discontinuation) should also be recorded . 
1. Dose 
2. Number of doses per day 
3. Reason for change or intenuption• 
*: Reason for a change in the dose or the number of doses per day if any 
4. Duration of treatment 
5. Reason for continued treatment at Week 16 of treatment* 
*: Reason for continuation of XELJANZ treatment beyond Week  16 despite no therapeutic 
response in induction therapy at Week  16 based on clinical symptoms, endoscopy and 
other  findings 

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7.3.4. Concomitant therapy for ulcerative colitis 
7.3.4.l. Drug therapy 
The record of treatments• for ulcerative colitis used from the date of commencement 
of XELJANZ treatment to the date of completion of the observation period (or date 
of XELJANZ discontinuation) should include the following information. 
1. Drug name 
2. Route of administration 
3. Dosage form (topical agents only) 
4.  Duration of treatment 
*: 5-ASAs (oral, enema, suppository), steroids (oral, enema, suppository, injection), 
immunomodulators (oral, injecti on), biological products (injection) 
7.3.4.2. Non-drug therapy 
The record of non-drug treatments given from the date of commencement of 
XELJANZ treatment to the date of completion of the observation period (or date of 
XELJANZ discontinuation) should include the following information. 
1. Name of the therapy 
2. Period of administration 
3. Reason for the administration of non-drug therapy 
 
7.3.5. Statu s of vaccination 
The record of vaccines given in relation to the treatment of ulcerative colitis should 
include the following information from baseline to the date of completion of the 
observation period (or date of XELJANZ discontinuation). 
1. Herpes zoster vaccine: Status and date of vaccination, drug name (vaccine 
name) 
2. Pneumococcal vaccine: Status and date of vaccination 
 
7.3.6. Status of prophylactic treatment 
The record of the status of prophylactic treatment given from 3 months before the 
commencement of XELJANZ treatment to the date of completion of the observation 
period (or date of XELJANZ discontinuation) should include the following 
information. 
1. Classification: Tuberculosis, Pneumocystis j irovecii pneumonia, hepatitis B 
2. Drug name (product name) 
3. Duration of treatment 
 
7.3.7. Tests/clinical laboratory tests 
The record of the following tests conducted from baseline to the date of completion 
of the observation period (or date of XELJANZ discontinuation) should include the 
status, dates and results (or findings) of the tests. If the abnormal change is clinically 

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significant compared to the baseline value, this information should also be recorded 
in the adverse event field. 
7.3.7.l. Clinical laboratory tests 
Results of the following clinical laboratory tests conducted from baseline (within 1 
month before treatment commencement, including the date of treatment 
commencement*) to the date of completion of the observation period (or date of 
XELJANZ discontinuation). 
1. Hematology 
White blood cell count, neutrophil, eosinophil, lymphocyte , 
monocyte, red blood cell count, platelet count, hemoglobin 
2. Blood chemistry AST (GOT), ALT (GPT), AL-P, LDH, total cholesterol, 
HDL-C, LDL-C, y-GTP, total bilirubin, triglyceride, serum 
creatinine, creatine kinase, albumin 
3. Other tests 
KL-6, -D-glucan, BUN, fecal calprotectin, CRP 
*: Within 3 months before treatment commencement for fecal calprotectin 
7.3.7.2. Chest X-ray test or chest CT test 
Findings of chest X-ray or chest CT conducted from baseline (within 3 months 
before treatment commencement, including the date of treatment commencement) to 
the date of completion of the observation period (or date of XELJANZ 
discontinuation). 
 
7.3.7.3. Tuberculosis screening tests 
Results of the following tests conducted from baseline (within 6 months before 
treatment commencement, including the date of treatment commencement) to the 
date of completion of the observation period (or date of XELJANZ discontinuation). 
1. Interferon y release assay (QuantiFERON, T-SPOT) 
2.  Tuberculin skin test 
 
7.3.7.4. Blood pressure (systolic/diastolic) 
Results of measurements from baseline to the date of completion of the observation 
period (or date of XELJANZ discontinuation). 
 
7.3.7.5. Hepatitis B and C virus tests 
Results of the following tests conducted within 3 months before treatment 
commencement should be recorded. For patients who are HBV carriers, the status of 
HBV-DNA test conducted up to the completion of the observation period (or date of 
XELJANZ discontinuation) should be recorded. 
1. Hepatitis B virus test: HBs antigen, HBs antibody, HBc antibody, and 
HBV-DNA test 
2. Hepatitis C virus test: HCV antibody 

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7.3.7.6. Colonoscopy 
Results of colonoscopy (inflammation site and findings) conducted from 6 months 
before commencement of XELJANZ treatment to the date of completion of the 
observation period (or date of XELJANZ discontinuation). 
 
7.3.8. Clinical evaluation on effectiveness 
The record of the clinical evaluation on effectiveness against ulcerative colitis from 
baseline (including the date of treatment commencement) to the date of completion 
of the observation period (or date of XELJANZ discontinuation) should include the 
results of evaluations based on the following rating scales. 
 
1. Stool frequency: 
0 point = Normal number of stools for the patient 
1 point = 1-2 stools more than normal 
2 points = 3-4 stools more than normal 
3 points = 5 or more stools more than normal 
2. Rectal bleeding: 
0 point = No blood seen 
1 point = Slight of blood with stool less than half the time 
2 points =Obvious blood with stool most of the time 
3 points = Blood alone passed 
3. Findings of flexible sigmoidoscopy: 
0 point = Normal or inactive disease 
1 point = Mild disease (erythema, decreased vascular pattern, mild fragility) 
2 points = Moderate disease (marked erythema, absent vascular pattern, any 
friability, erosion) 
3 points = Severe disease (spontaneous bleeding, ulceration) 
4. Physician's  global assessment: 
0 point = Normal 
1 point = Mild disease 
2 points = Moderate disease 
3 points = Severe disease 
7.3.9. Status of pregnancy (female patient s only) 
The status of pregnancy from the date of commencement of XELJANZ treatment to 
the date of completion of the observation period (or date of XELJANZ 
discontinuation) should be recorded. However, for patients who are treated with 
XELJANZ for more than 60 weeks after the date of treatment commencement, the 
status of pregnancy until the end of the investigation period (or date of XELJANZ 
discontinuation) should also be recorded. 

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7.3.10. Status of treatment with XELJANZ 
The status of treatment with XELJANZ at the completion of the observation period 
for each booklet (Week 26, Week 60, end of the investigation) should be confirmed, 
and the following information should be recorded. Ifthe reason for discontinuation 
at the last observation is an adverse event or patient's death, its details should be 
recorded in the adverse event field. 
1. Date of the last observation 
2. Completion of treatment or reason for discontinuation 
• Completed (treatment continued) 
• Adverse events (Record the details in the adverse event field) 
• Patient's death (Record the date of death) 
• Remission 
• Insufficient clinical effectiveness 
• Failure to show up 
• Other 
7.3.11. Adverse events 
The status of occurrence of adverse events from the date of commencement of 
XELJANZ treatment to the date of completion of the observation period (or date of 
XELJANZ discontinuation) should be confirmed, and the following information 
should be recorded. However, for patients who are treated with XELJANZ for more 
than 60 weeks after the date of treatment commencement, the record of malignant 
tumor and adverse events leading to discontinuation that occur at and after Week 61 
should include the following information. 
 
Occurrence of a serious adverse reaction, an unexpected adverse reaction or other 
adverse reactions should be separately investigated in detail if determined necessary 
by Sponsor. 
• Presence/absence of adverse event 
• Name of adverse event 
• Diagnosis of malignant tumor (only if malignant tumor occurs) 
• Date of occurrence 
• Intervention 
• Seriousness 
• Outcome at the completion of observation period 
• Causal relationship 
If the adverse event is associated with abnormal laboratory values, i.e., clinical 
laboratory tests, the following information should also be recorded. 
• Laboratory parameter 
• Site reference value 
• Unit 
• Date measured 

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• Results 
Supplemental remarks: An adverse event is any unfavorable event (including a 
clinically significant abnormal laboratory change) occurring after 
administration of XELJANZ, whether or not related to XELJANZ. A serious 
adverse event is any event that results in death, is life-threatening, requires 
inpatient hospitalization or prolongation of existing hospitalization, results in 
persistent or significant disability/incapacity, is a congenital anomaly/birth 
defect, or any other medically important event that may lead to disability. 
7.4. Data sources 
In this study, the investigators extract the necessary information using medical 
charts, medical records and other information in accordance with the protocol. 
 
7.5. Study size 
7.5.l. Planned sample size 
470 to be collected in the safety analysis set (495 to be registered•) 
 
7.5.2. Rationale for sample size 
Based on the results of clinical studies conducted up to approval, the incidence of 
herpes zoster in Japanese patients with ulcerative colitis chronically treated with 
XELJANZ was higher than that in the overall population of the studies. Therefore, 
on the assumption that the true incidence of herpes zoster in Japanese patients with 
ulcerative colitis is 8/100 person-years, the sample size will be 470 when the 
probability of the lower limit of 95% confidence interval for the incidence of herpes 
zoster not falling below 4/100 person-years (results for the overall population of the 
studies) is 80%. 
 
*: If it is assumed that 5% of the registered patients are unevaluable for the safety due to failure to 
show up or other reasons, 495 patients need to be registered to ensure that 470 patients are 
included in the safety analysis set. 
 
7.6. Data management 
7.6.l. Case report forms (CRFs)/Data collection tools (DCTs)/Electronic data record 
As used in this protocol, the term CRF[/DCT] should be understood to refer to either a paper 
form or an electronic data record, or both, depending on the data collection method used in this 
study (when PMDA has accepted to continuing registration only, it is not necessa1y to enter new 
CRF). 
 
A CRF[/DCT] is required and should be completed for each included patient. The completed 
original CRFs[/DCTs] are the sole property of Pfizer and should not be made available in any 
form to third parties, except for authorized representatives of Pfizer or appropriate regulatory 

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authorities, without written permission from Pfizer. The investigator shall ensure that the 
CRFs[/DCTs] are securely stored at the study site in encrypted electronic and/or paper form and 
will be password protected or secured in a locked room to prevent access by unauthorized third 
parties. 
 
The investigator has ultimate responsibility for the collection and reporting of all clinical, 
safety, and laboratory data entered on the CRFs[/DCTs] and any other data collection forms 
(source documents) and ensuring that they are accurate, authentic/original, attributable, 
complete, consistent, legible, timely (contemporaneous), enduring, and available  when required. 
The CRFs[/DCTs] must be signed by the investigator or by an authorized staff member to attest 
that the data contained on the CRFs[/DCTs] are true . 
Any corrections to entries made in the 
CRFs[/DCTs] or source documents must be dated, initialed , and explained (if necessary) and 
should not obscure the original entry. 
 
The source documents are the hospital or the physician's chart. 
In these cases, data collected 
on the CRFs[/DCTs] must match those charts. 
 
7.6.2. Record retention 
The records related to this study should be retained at the study site until the End of Study 
Letter by Pfizer is received or during the period defined by the study site, whichever is longer. 
 
7.6.3. Data collection method 
The data for this study will be collected and confirmed by using electronic data 
capture (EDC). However, if EDC is not available, designated paper registration form 
and CRF provided by Sponsor will be used to collect data. 
 
7.6.4. Patient registration 
7.6.4.l. Procedures for registration 
Necessary information should be recorded in EDC registration form (patient 
registration screen), and patients should be registered at least 1 week before the 
commencement of XELJANZ treatment in principle . 
 
If EDC is not available and when the PMDA has accepted to continuing the case 
registration only, information should be recorded in a paper registration form, and 
the form should be faxed to the Patient Registration Center at least 1 week before the 
commencement of XELJANZ treatment in principle . 
 
In addition, as this investigation will be conducted with all patients surveillance 
system, all patients who are confirmed to be treated with XELJANZ should be 
registered. 

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7.6.5. Reminders concerning completing, revising, and submission of case report 
form 
7.6.5.l. Completin g 
The investigator shall, upon confirming the study items, input the data in this system 
based on medical charts, and save the data. If EDC is not available, data should be 
recorded in a paper CRF. 
 
7.6.5.2. Revising 
Upon receiving Sponsor's inquiry on the contents of the CRF (query forms), the 
investigator will again confirm the contents of medical records, and as required, 
correct relevant sections. 
 
7.6.5.3. Submittin g 
After completing and revising the CRF, the investigator will again confirm the 
completed CRF and the contents of confirmation and affix an electronic signature. If 
EDC is not available, signature or name/ seal should be affixed to the cover page of a 
paper CRF after the completion of the observation period for each booklet, and the 
CRF should be sent to Sponsor using a designated envelop. 
 
7.7. Data analysis 
7.7.l. Definition of analysis set 
The safety analysis set will include a group of patients who receive at least 1 dose of 
XELJANZ and have post-treatment information. The effectiveness analysis set will 
be a set of patients for whom the efficacy evaluation is considered possible among 
the safety analysis set according to the separately prescribed Statistical Analysis 
Plan (SAP). 
 
7.7.2. Method of analysis 
7.7.2.l. Analysis for safety evaluation 
In the safety analysis set, the onset of major adverse reactions (adverse events for 
which the causal relationship with XELJANZ cannot be ruled out), incidence of 
adverse reactions (number/percentage of patients with adverse reactions), and 
incidence of adverse events per duration of exposure (100 x number of patients with 
adverse reactions I total duration of exposure I 100 person-years) will be set as 
primary analysis items. In addition, factors that may affect the onset of adverse 
reactions will also be examined by conducting subgroup analyses based on patient 
background and other factors. 
 
7.7.2.2. Analysis for effectiveness evaluation 
In the effectiveness analysis set, the rate of remission based on partial Mayo score 
will be set as primary analysis items. 

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Detailed methodology for summary and statistical analyses of data collected in this 
study will be documented in a Statistical Analysis Plan (SAP), which will be dated, 
filed and maintained by the sponsor. The SAP may modify the plans outlined in the 
protocol ; any major modifications of primary endpoint definitions or their analyses 
would be reflected in a protocol amendment. 
 
7.8. OTHER NECESSARY MATTERS 
Not applicable. 
 
8. ORGANIZATIONAL SYSTEM FOR STUDY IMPLEMENTATION 
Regarding the organizational system in this study, refer to the appendix I of "the risk 
management plan". 
 
9. NAME, ADDRESS AND OUTSOURCED OPERATIONS OF THE PERSON 
WHO WAS CONTRACTED WITH THE OPERATIONS 
 
 
Scope of the outsourced operations: Drafting of study protocol and management of 
operation study, etc. 
Name: PPD 
Address:--
P-
U 
-- 
Scope of the outsourced operations: Establishment, operation and maintenance of the 
EDC system. 
 
 
Scope of the outsourced operations: Contract-related operations, reception of 
registration forms, delivery/reception of CRFs, data management , medical writing 
etc. 
 
 
Scope of the outsourced operations: Establishment of the EDC system, data 
management , tabulation analysis 
 
10. ADDITIONAL MEASURES THAT MAY BE IMPLEMENTED BASED ON 
THE STUDY RESULTS AND CRITERIA FOR DETERMINATION OF THE 
INITIATION 
Review the risk management plan including the following contents at the scheduled 
timing of milestones. 
I .  Review the necessity for changing the contents of risk minimization activities 
for the current safety specifications. 

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2. Review the necessity for changing the contents of this study plan including the 
presence or absence of new safety specifications (continuation of the study, 
implementation of additional study, etc.). 
3. Review the necessity for formulating risk minimization measures for new safety 
specifications. 
11. SCHEDULED TIMING OF MILESTONES AND THEIR RATIONALES FOR 
REPORTING OF STUDY IMPLEMENTATION STATUS AND EVALUATION 
OF OBTAINED RESULTS TO THE PMDA 
Review and report the safety and effectiveness at the time of reporting the Periodic 
Safety Reports and completion of the study. 
 
12. OTHER NECESSARY MATTERS 
I .  Amendment of the Study Protocol 
Based on the new knowledge to be obtained according to the progress of this study, 
the need for amendment of the protocol will be examined and the Study Protocol 
will be amended if necessary. Also, the need for amendment of the Study Protocol 
will be examined and the protocol will be amended even if the partial change in 
the dosage and administration or indication is approved during the reexamination 
period (except the case when the reexamination period is newly designated), etc. 
2.  Actions to be taken if any problem or question is observed 
In the cases where the onset of any serious and unknown adverse reaction is 
suggested, a significant increase in the frequency of adverse reactions is observed, 
any problem is found in the effectiveness and safety of the drug compared to those 
prior to the approval, the onset of a different kind of adverse reaction is suggested, 
etc., the amendment of the package insert and implementation of a new Special 
Investigation or Post-marketing Clinical Trial should be considered. 
13. CONTACT  INFORMATION 
 
 
Name 
rpn
I 
Address 
FAX 
13.l. Contact information for the contents of the study 
rPD 
I
f PD
I 
E-mail address 
rPD 
I 

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13.2. Contact information for the EDC system (in the case of study using EDC) 
 
 
 
14. REFERENCES 
1. Clinical practice guidelines for inflammatory bowel disease (IBD) 2016 (The 
Japanese Society of Gastroenterology) 
2. Criteria for diagnosis and treatment strategy for ulcerative colitis and Crohn's 
disease 2016 revised version (supplementary volume of the 2016 annual report of 
"Research Group of Intractable Inflammatory Bowel Disease" [Suzuki Group], 
Research on Policy Planning and Evaluation for Rare and Intractable Diseases, 
Health and Labour Sciences Research Grants) 
3. Special Investigation protocol 
4. Special Investigation registration form 
5. Special Investigation case record form 
 
15. LIST OF TABLES 
Page 11 Table 1 Name of CRF and observation period 
Page 12 Table 2 Schedule of observation 
Page 13 Table 3 Classification of ulcerative colitis by severity 
 
 
16. LIST OF FIGURES 
Not applicable. 
 
17. LIST OF STAND ALONE DOCUMENTS 
Not applicable. 
 
18. ADDITIONAL INFORMATION 
Not applicable. 
 
19. ADDITIONAL TABLE (NAME OF THE TABLE) 
Not applicable. 
Name 
Open Hours 
TEL 
E-mail address