An Investigation of Tofacitinib PsA Initiators in the CorEvitas SpA Registry
Conditions: Psoriatic Arthritis
Sponsor: Pfizer

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 of 1 9
N O N -I N T E R V E N TI O N A L (NI) S T U D Y P R O T O C O L
St u d y Inf or m ati o n
Title
A n I n vesti gati o n of T ofaciti ni b Ps A 
I nitiat ors i n t he C or E vitas S p A Re gistr y
Pr ot oc ol n u m ber
A 3 9 2 1 4 1 1
Pr ot oc ol versi o n i de ntifier
3 . 0
D ate
2 Oct 2 0 2 3
Acti ve s u bst a nce
L 0 4 A A 2 9
Me dici n al pr o d uct
Xelja nz ® (t ofaciti ni b I R/ X R)
Rese arc h q uesti o n a n d o bjecti ves
T he o bjecti ve s of t his st u d y  are as f oll o ws:
1.
T o descri be t he effecti ve ness of all
t ofaciti ni b i nitiat ors at 6 m o nt hs i n 
ps oriatic art hritis ( Ps A) patie nts .
2.
T o descri be t he effecti ve ness of all 
t ofaciti ni b i nitiat ors at 6 m o nt hs
stratifie d b y m o n o- a n d c o m bi nati o n 
t hera py of Ps A .
A ut h or
, P h D,   
, 
Pfizer I nc., 6 6 H u ds o n Bl v d East ; 
Ne w Y or k, N Y, 1 0 . 0 0 1, U S A
 
T his d oc u me nt c o ntai ns c o nfi de ntial i nf or mati o n bel o n gi n g t o Pfizer. E xce pt as ot her w ise a gree d t o i n writi n g, 
b y  acce pti n g or re vie wi n g t his d oc u me nt, y o u a gree t o h ol d t his i nf or mati o n i n c o nfi de nce a n d n ot c o p y or 
discl ose it t o ot hers (e xce pt w here re q uire d b y a p plica ble la w) or use it f or u na ut h orize d p ur p oses. I n t he e ve nt 
of a n y act ual or s us pecte d breac h of t his o bli gati o n, Pfizer m ust be pr o m ptl y n otifie d.
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)
P P D
P P D
P P D 
P P D

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 2 of 1 9
1. T A B L E O F C O N T E N T S
1. T A B L E O F C O N T E N T S .......................................................................................................2
2. LI S T O F A B B R E VI A T I O N S................................................................................................ 4
3. R E S P O N SI B L E P A R TI E S .................................................................................................... 7
4. A B S T R A C T ........................................................................................................................... 8
5. A M E N D M E N T S A N D U P D A T E S ....................................................................................... 9
6. M I L E S T O N E S..................................................................................................................... 1 0
7. R A TI O N A L E A N D B A C K G R O U N D ................................................................................ 1 0
8. R E S E A R C H Q U E S TI O N A N D O BJ E C TI V E S ................................................................. 1 1
9. R E S E A R C H M E T H O D S .................................................................................................... 1 1
9. 1. St u d y  Desi g n........................................................................................................... 1 1
9. 2. Setti n g ...................................................................................................................... 1 1
9. 2. 1. I ncl usi o n Criteria ........................................................................................ 1 2
9. 2. 2. E xcl usi o n Criteria ....................................................................................... 1 2
9. 3. Varia bles .................................................................................................................. 1 2
9. 4. Data S o urces ............................................................................................................ 1 5
9. 5. St u d y  Size................................................................................................................ 1 5
9. 6. Data Ma na ge me nt ................................................................................................... 1 5
9. 7. Dat a A nal ys is .......................................................................................................... 1 6
9. 8. Q ualit y  C o ntr ol........................................................................................................ 1 6
9. 9. L i mitati o ns of t he Researc h Met h o ds...................................................................... 1 7
9. 1 0. Ot her As pects ........................................................................................................ 1 7
1 0. P R O T E C TI O N O F H U M A N S U BJ E C T S ........................................................................ 1 7
1 0. 1. Patie nt I nf or mati o n ................................................................................................ 1 7
1 0. 2. Patie nt C o nse nt ...................................................................................................... 1 7
1 0. 3. I nstit uti o nal Re vie w B oar d (I R B)/I n de pe n de nt Et hics C o m mittee (I E C) ............ 1 7
1 0. 4. Et hical C o n d uct of t he St u d y ................................................................................ 1 7
1 1. M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S/ A D V E R S E 
R E A C TI O N S ...................................................................................................................... 1 8
1 2. P L A N S F O R DI S S E M I NA TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S ........1 8
1 3. R E F E R E N C E S ..................................................................................................................1 9
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 3 of 1 9
1 4. LI S T O F T A B L E S ............................................................................................................. 1 9
1 5. LI S T O F FI G U R E S ........................................................................................................... 1 9
A N N E X 1. LI S T O F S T A N D A L O N E D O C U M E N T S......................................................... 1 9
A N N E X 2. A D DI TI O N A L  I N F O R M A TI O N......................................................................... 1 9
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 4 of 1 9
2. LI S T O F A B B R E VI A TI O N S
A b bre vi ati o n
Defi niti o n
A C R
A merica n C olle ge of R he u mat ol o g y
A C R 2 0/ 5 0/ 7 0
A merica n C olle ge of R he u mat ol o g y 2 0/ 5 0/ 7 0
A E
ad verse eve nt
A N C O V A
A nal y sis of C o varia nce
A S
A n k y l osi n g S p o n d ylitis
b D M A R D
bi ol o gic Disease M o dif y i n g A ntir he u matic Dr u g
B S A
B o d y S urface Area
C A B G
C or o nar y  Arter y B ypass Grafti n g
C H F
C o n gesti ve Heart Fail ure
CI
C o nfi de nce I nter val
C R P
C- reacti ve Pr otei n
cs D M A R D
C o n ve nti o nal S y nt hetic Disease M o dif y i n g 
A ntir he u matic Dr u g
C V
car di o vasc ular
D A P S A
Disease Acti vit y  i n Ps oriatic Art hritis
D M A R D
Disease M o dif y i n g A ntir he u matic Dr u g
E Q - 5 D-5 L
E ur o pea n Q ualit y  of Li fe Fi ve Di me nsi o n Fi ve 
Le vel
F D A
F o o d a n d Dr u g A d mi nistrati o n
H A Q
Healt h Assess me nt Q uesti o n naire
H A Q -DI
Healt h Assess me nt Q uesti o n naire Disa bilit y  In de x
H A Q - S
Healt h Assess me nt Q uesti o n naire S pi ne Fle xi bilit y
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 5 of 1 9
A b bre vi ati o n
Defi niti o n
H E O R
Healt h Ec o n o mics a n d O utc o mes Researc h 
I E C
I n de pe n de nt Et hics C o m mittee
I RB
I nstit uti o nal Re vie w B oar d
J A K
Ja n us Ki nase
m A C R 2 0/ 5 0/ 7 0
M o difie d A merica n C olle ge of R he u mat ol o g y
2 0/ 5 0/ 7 0
M D A
Mi ni mal Disease Acti vit y 
MI
M y ocar dial I nfarcti o n 
P A S D A S
Ps A Disease Acti vit y Sc ore
P A S S
P ost A ut h orizati o n Safet y St u d y
P CI
Perc uta ne o us C or o nar y  I nter ve nti o n
Ps A
Ps oriatic Art hritis
Ps O
Ps oriasis
S A P
Statistical A nal y sis Pla n 
S M
S mall M olec ule
S p A
S p o n d y l oart hritis
S P A R C C
S p o n d y l oart hritis Researc h C o ns orti u m of Ca na da 
E nt hesitis I n de x
TI A
Tra nsie nt Isc he mic Attac k
T N Fi
t u m or necr osis fact or i n hi bit or
ts D M A R D
tar gete d sy nt hetic Disease M o dif y i n g 
A ntir he u matic Dr u g
U S
U nite d States
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 6 of 1 9
A b bre vi ati o n
Defi niti o n
V A S
Vis ual A nal o g ue Scale
W P AI
W or k Pr o d ucti vit y  In de x
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 8 of 1 9
4. A B S T R A C T
N ot a p plica ble .
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 9 of 1 9
5. A M E N D M E N T S A N D U P D A T E S
A m e n d me nt 
n u m ber
D ate 
Pr ot oc ol 
secti o n(s) 
c h a n ge d
S u m m ar y of a me n d me nt(s)
Re as o n
1
2 4 Ma y 2 0 2 3 
9. 3
A d mi nistrati ve c ha n ge re gar di n g C D AI 
a n d c D A P S A val ues
T he val ues f or C D AI  a n d 
c D A P S A are bei n g p ulle d fr o m 
t he data base. Pfizer will n ot d o
a n y recalc ulati o n p ost -h oc
1
2 4 Ma y 2 0 2 3 
9. 5
Pla n ne d sa m ple size re d uce d fr o m 1 0 0 
t o 8 0 patie nts per gr o u p
S u bsta ntial A me n d me nt
Base d o n C or E vitas esti mates a n d 
c urre nt e nr oll me nt patter n , it is 
esti mate d t hat it will ta ke 
a p pr o xi matel y 1 2 m o nt hs t o get t o 
at least 8 0 patie nts per gr o u p .
1
2 4 Ma y 
2 0 2 3
3
A d di n g A ut h or (
) 
ad dress a n d ne w
N Y Pfizer offices c ha n ge d
1
2 4 Ma y 
2 0 2 3
6
I nteri m re p ort 3 , e n d of data c ollecti o n, 
a n d fi nal st u d y re p ort dates were 
u p date d
U p date d ue t o t he a me n d me nt
2
0 2 Oct 2 0 2 3 
9. 5
Pla n ne d sa m ple size re d uce d fr o m 8 0 t o 
7 3 patie nts per gr o u p
S u bsta ntial A me n d me nt
Base d o n C or E vitas esti mates a n d 
c urre nt e nr oll me nt patter n , it is 
esti mate d t hat it will ta ke 
a p pr o xi matel y 1 2 m o nt hs t o get 
t o at least 7 3 patie nts per gr o u p .
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)
P P D
P P D
P P D

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 0 of 1 9
6. MI L E S T O N E S
Milest o ne
Pl a n ne d d ate *
Start of data c ollecti o n 
1 5 N o ve m ber 2 0 2 1
I nteri m Re p ort 1
1 5 Ja n uar y 2 0 2 2
I nteri m Re p ort 2
1 9 Dece m ber 2 0 2 2
I nteri m Re p ort 3
1 5 Se p 2 0 2 3
E n d of data c ollecti o n 
2 9 Marc h
2 0 2 4
Fi nal st u d y re p ort
2 8 J u ne 2 0 2 4
* T he i nteri m re p orts rel y o n reac hi n g t he a p pr o priate n u m ber of patie nts f or eac h a nal ysis. T hese dates ma y 
c ha n ge if t here are dela ys i n patie nt accr ual wit hi n t he re gistr y.
7. R A TI O N A L E A N D B A C K G R O U N D
Ps oriatic art hritis ( Ps A) is a n i m m u ne- me diate d s y ste mic i nfla m mat or y disease wit h m ulti ple 
disease ma nifestati o ns, i ncl u di n g peri p heral art hritis, e nt hesitis, dact y litis, a n d s p o n d ylitis, 
t o get her wit h s ki n a n d nail ps oriasis.1 Ps A ma y  be ass ociate d wit h p o or l o n g-ter m o utc o mes 
a n d si g nifica ntl y di mi nis he d q ualit y of life f or patie nts.2 Ps A affects me n a n d w o me n e q uall y 
wit h pea k o nset i n a d ults bet wee n 3 0 t o 5 0 ye ars of a ge.3 Pre vale nce esti mates i n t he 
U S ra n ge fr o m 0. 0 6 % t o 0. 2 5 %.4 T he i nci de nce of Ps A, ra n ges fr o m 3. 6 t o 7. 2 per 
1 0 0, 0 0 0 pers o n -ye ars. 4 Ps A is re p orte d t o occ ur i n u p t o 3 0 % of patie nts wit h Ps O .5 S ki n 
ma nifestati o ns prec e de t he Ps A i n 7 0 % of patie nts.
Acc or di n g t o e vi de nce -base d treat me nt rec o m me n dati o ns b y  t he Gr o u p f or Researc h a n d 
Assess me nt of Ps oriasis a n d Ps oriatic Art hritis a n d t he A merica n C olle ge of R he u mat ol o g y  
( A C R), n o n-ster oi dal a nti-i nfla m mat or y dr u gs a n d c on ve nti o nal s y nt hetic disease -m o dif y i n g 
a ntir he u matic dr u gs (cs D M A R Ds) s h o ul d be use d i n t he earl y treat me nt of Ps A. F or patie nts 
i n w h o m t hese are u ns uccessf ul, bi ol o gic D M A R Ds ( b D M A R Ds), s uc h as t u m or necr osis 
fact or i n hi bit ors, a n d tar gete d s ynt hetic D M A R Ds (ts D M A R Ds), s uc h as p h os p h o diesterase 
i n hi bit ors are rec o m me n de d.1 -6
T ofaciti ni b is a n oral Ja n us ki nase (J A K) i n hi bit or a p pr o ve d i n 2 0 1 7 b y t he U S F o o d a n d 
Dr u g A d mi nis trati o n ( F D A) f or t he treat me nt of a d ult patie nts wit h acti ve Ps A w h o ha ve ha d 
a n i na de q uate res p o nse or i nt olera nce t o met h ot re xate or ot her D M A R Ds. T ofaciti ni b is 
a p pr o ve d f or use i n c o m bi nati o n wit h n o n bi ol o gic disease m o dif y i n g a ntir he u matic dr u gs 
( D M A R Ds) i n ps oriatic art hritis. Si nce a p pr o val, little is k n o w n a b o ut t he patie nt pr ofile of 
t he Ps A p o p ulati o n treate d wit h t ofaciti ni b i n cli nical practice as well as t he real- w orl d 
effecti ve ness of t ofaciti ni b i n patie nts wit h ps oriatic art hritis . 
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 1 of 1 9
T he p ur p ose of t his st u d y is t o pr o vi de a characterizati o n of patie nts a n d effecti ve ness of 
t ofaciti ni b i n Ps A patie nts ne wl y i nitiati n g t ofaciti ni b i n t he U S C or E vitas
Ps A/ s p o n d yl oart hritis (S p A ) Re gistr y . T his st u d y is n ot desi g ne d as a p ost a ut h orizati o n 
safety st u d y ( P A S S) a n d is n ot a c o m mit me nt or re q uire me nt t o a n y re g ulat or y  a ut h orit y.
8. R E S E A R C H Q U E S TI O N A N D O B J E C TI V E S
T here are t w o pri mar y o bjecti ves f or t his st u d y:
1.
T o descri be t he effecti ve ness of all t ofaciti ni b i nitiat ors at 6 m o nt hs i n Ps A patie nts.
2.
T o descri be t he effecti ve ness of all t ofaciti ni b i nitiat ors at 6 m o nt hs stratifie d b y 
m o n o - a n d c o m bi nati o n t hera p y of Ps A .
9. R E S E A R C H M E T H O D S 
9. 1. St u d y D esi g n
T o meet t he st u d y  o bjecti ves, a n o bser vati o nal retr os pecti ve c o h ort st u d y will be c o n d ucte d 
usi n g patie nts e nr olle d i n t he C or E vitas Ps A/ S p A Re gistr y  i nitiati n g t ofaciti ni b o n or after 
1 4 Dece m ber 2 0 1 7. Patie nts recei vi n g t ofaciti ni b will be i ncl u de d t o assess t he effecti ve ness 
of t ofaciti ni b o verall a n d stratifie d b y  k e y varia bles of i nterest. F or f urt her details, please 
refer t o t he detaile d Statistical A nal ysis Pla n ( S A P) i ncl u de d as a sta n d-al o ne d oc u me nt. 
9. 2. Setti n g
T he C or E vitas S p A Re gistr y  is a pr os pecti ve, m ultice nter, o bser vati o nal disease-base d 
re gistr y la u nc he d i n Marc h 1 st, 2 0 1 3. T his re gistr y c o ntai ns cli nical data (e g, disease acti vit y  
sc ores, la b orat or y res ults, c o m or bi dities, i ma gin g res ults, patie nt -re p orte d o utc o mes data, 
etc.) t hat is n ot a vaila ble i n clai ms data bases. As of A u g ust 1, 2 0 2 0, t he C or E vitas dataset 
i ncl u des 6 4 pri vate a n d aca de mic acti ve cli nical sites wit h o ver 6 6 pr o vi ders t hr o u g h o ut 
3 0 states i n t he U S. T his re gistr y c ollects data fr o m b ot h t he pr o vi ders a n d t he patie nts at t he 
ti me of a re g ularl y-sc he d ule d office visit. C or E vitas has e nr olle d o ver 4, 0 0 0 patie nts wit h 
Ps A or s p o n d y l oart hritis. T he c ollecti o n of data fr o m C or E vitas re prese nts o ver 9, 8 0 0 patie nt 
ye ars of data.
T o be i ncl u de d i n t he C or E vitas Ps A/ S p A Re gistr y , patie nts m ust be at least 1 8 years of a ge 
a n d ha ve a dia g n osis of Ps A or A S b y  a r he u mat ol o gist. Patie nts are e xcl u de d fr o m t he 
re gistr y if t he y are u na ble or u n willi n g t o pr o vi de i nf or me d c onse nt. T he i ncl usi o n/e xcl usi o n 
criteria f or t his partic ular a nal ys is are descri be d i n Secti o n 9. 2. 1 . a n d Secti o n 9. 2. 2 .
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 2 of 1 9
9. 2. 1. I ncl usi o n C riteri a
Patie nts m ust meet all of t he f oll o wi n g i ncl usi o n criteria t o be eli gi ble f or i ncl usi o n i n t he 
st u d y:
1.
Ps A patie nts i n C or E vitas i nitiati n g t ofaciti ni b m o n ot hera p y or i n c o m bi nati o n wit h 
oral s mall m olec ules ( e g met h otre xate, lefl u n o mi de, s ulfasalazi ne, a pre milast) after 
1 4 Dece m ber 2 0 1 7 ( mar ket a p pr o val of tofaciti ni b i n t he U S) wit h n o pri or use of 
t ofaciti ni b. O nl y t he patie nt’s first i nitiati o n after Dec e m ber 1 4, 2 0 1 7 will be i ncl u de d 
i n t he a nalys is.
2.
Ha ve a 6 m o nt h f oll o w-u p visit ( wit h ± 3 m o nt h wi n d o w) .
9. 2. 2. E xcl usi o n C riteri a
Patie nts meeti n g a n y of t he f oll o wi n g criteria will n ot be i ncl u de d i n t he st u d y:
1.
Patie nts ta ki n g t ofaciti ni b i n c o m bi nati o n wit h a n y ot her b D M A R D
9. 3. V ari a bles
P atie nt c h ar acteristics at b aseli ne:

Ge n der, a ge, race , a n d et h nicit y;

D urati o n of Ps A ( A ge at o nset);

Ti me si nce Ps A d ia g n osis

Ti me si nce o nset of Ps O ;

C o m or bi dit y hist or y :

Car di o vasc ular disease: MI , str o ke, TI A ac ute c or o nar y sy n dr o me, c or o nar y 
arter y disease, C H F, re vasc ularizati o n pr oce d ure i ncl u di n g perc uta ne o us c or o nar y 
i nter ve nti o n [ P CI], c or o nar y arter y b ypass grafti n g [ C A B G] or c or o nar y  arter y 
ste nts, ve ntric ular arr hyt h mia, car diac arrest, u nsta ble a n gi na, ot her C V disease s, 
car oti d arter y disease, ot her c or o nar y disease, peri p heral arterial disease);

H y perte nsi o n ;

H y perli pi de mia ;

Seri o us i nfecti o ns ;

Mali g na nc y : l u n g ca ncer, breast ca ncer, l ym p h o ma, s ki n ca ncer ( mela n o ma a n d 
n ot mela n o ma ), a n d ot her ca ncer;
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 3 of 1 9

T hr o m b oe m b olic e ve nts ( Dee p vei n t hr o m b osis, peri p heral arterial 
t hr o m b oe m b olic a n d p ul m o nar y e m b olis m);

A n xiet y , de pressi o n, a n d ot her m o o d dis or ders;

Cr o h n’s Disease ;

Ps oriasis ;

Dia betes ;

Ulcerati ve c olitis;

U veitis ;

Meta b olic S y n dr o me ;

Ps oriatic Nail D y str o p h y;

Fi br o m yal gia .

S m o ki n g stat us;

Alc o h ol use ;

W or k stat us ;

Hei g ht a n d wei g ht ;

I ns ura nce ( patie nt re p orte d);

Pri or s mall m olec ule ( S M) use ;

Pri or b i ol o gic u se:

Pri or T N Fi use ;

Pri or n o n- T N Fi use .

C urre nt p re d nis o ne use (i ncl u di n g d ose).
Dise ase acti vit y me as ures:

P h y sicia n re p orte d:

Te n der J oi nt C o u nt ( 2 8 a n d 6 8);
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 4 of 1 9

S w olle n J oi nt C o u nt ( 2 8 a n d 6 6) ;

S P A R C C c o u nt ;

E nt hesitis ;

Dact yl itis;

L EI c o u nt ;

Dact yl itis c o u nt;

M D A ;

D A P S A ;

P A S D A S ;

A C R 2 0 / 5 0/ 7 0;

m A C R 2 0/ 5 0/ 7 0 ;

Nail V A S ;

B S A ;

C R P ;

S pi nal m o bilit y  meas ures ( occi p ut t o wall dista nce, left a n d ri g ht lateral l u m bar 
fle xi o n, m o difie d Sc h o ber);

Gl o bal assess me nt of Ps O .

Patie nt re p orte d :

Pai n ( V A S);

Fati g ue ( V A S);

Gl o bal S ki n Assess me nt;

H A Q -DI ;

H A Q - S;

E ur o pea n Q ualit y  of Li fe-5 Di me nsi o ns (E Q - 5 D-5 L );
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 5 of 1 9

W P AI  d o mai ns ( 4 cate g ories).
9. 4. D at a S o urces
Patie nts are e nr olle d i n t he C or E vitas Ps A/ S p A Re gistr y  d uri n g re g ularly -sc he d ule d office 
visits. U p o n e nr oll me nt, pr o vi ders c o m plete a set of E nr oll me nt Q uesti o n naires o n Ps A
patie nts. Patie nts als o c o m plete a n E nr oll me nt Q uesti o n naire, w hic h ca pt ures se veral data 
ele me nts, i ncl u di n g t he Healt h Assess me nt Q uesti o n naire ( H A Q) a n d t he E u r o pea n Q ualit y 
of L ife-5 Di me nsi o ns ( E Q - 5 D-5 L ). B ot h patie nt a n d pr o vi der re p orte d disease acti vity 
meas ures o btai ne d at eac h visit are ca pt ure d i n C or E vitas ; t his i ncl u des te n der a n d s w olle n 
j oi nt c o u nts ( 2 8 a n d 6 6/ 6 8 j oi nt c o u nts), patie nt a n d p h ysicia n gl o bal disease assess me nt, 
patie nt pai n assess me nt a n d H A Q sc ores. Pr o vi ders a n d patie nts c o m plete F oll o w -U p 
Q uesti o n naires a p pr o xi matel y  e ver y 6 m o nt hs. D uri n g t he c o urse of a re g ularl y -sc he d ule d 
office visit, t he pr o vi der perf or ms assess me nts as ma n date d o n t he C or E vitas Pr o vi der 
Q uesti o n naires wit h rec or di n g of perti ne nt data. Res ults fr o m certai n la b orat or y  tests are 
i ncl u de d, b ut n ot ma n date d. Li ke wise, d uri n g re g ularl y-sc he d ule d office visits, patie nts are 
as ke d t o c o m plete Q uesti o n naires desi g ne d t o ca pt ure i nf or mati o n ra n gi n g fr o m t heir ge neral 
de m o gra p hics a n d e x perie nce wit h prescri pti o n dr u g use t o a n o verall gl o bal assess me nt of 
t heir disease. Early foll o w - up visits occ ur a n d q uesti o n naires are c o m plete d w he ne ver a 
re gistr y patie nt is bei n g prescri be d or recei vi n g a first d ose of a ne w ( differe nt) eli gi ble 
me dicati o n at a re g ularly -sc he d ule d office visit. Eli gi ble me dicati o ns are bi ol o gics, 
bi osi milars, a n d J A K i n hi bit ors F D A -a p pr o ve d f or t he treat me nt of Ps A . T he ne xt re g ularly-
sc he d ule d visit is calc ulate d fr o m t he pre vi o us visit. Data are c ollecte d o n patie nts f or as l o n g 
as t he y c o nse nt t o re mai n i n t he re gistr y.
9. 5. St u d y S ize
T his is a n esti mati o n st u d y a n d n ot h y p ot hesis testi n g st u d y. Precisi o n esti mates i n dicate t hat 
a p pr o xi matel y 8 0 7 3 patie nts wit h 1 2 m o nt hs of f oll o w - u p are nee de d per gr o u p t o ac hie ve 
reas o na bly precise esti mates f or t he o utc o mes of i nterest. F or bi n o mial pr o p orti o ns, a sa m ple 
size of 8 0 7 3 patie nts per gr o u p w o ul d yiel d a half wi dt h of t he 2 -si de d 9 5 % c o nfi de nce 
i nterval ( CI) t o be less t ha n 1 1 perce nta ge p oi nts f or t he bi n o mial pr o p orti o ns, a n d less t ha n 
1 6 perce nta ge p oi nts f or t he differe nce i n 2 bi n o mial pr o p orti o ns. 
As of Oct o ber 1, 2 0 2 0, t here are 1 6 0 t ofaciti ni b i nitiat ors wit hi n t he C or E vitas re gistr y of 
w h o m 9 3 ha ve a 6 m o nt h f oll o w -u p visit . T he first o bjecti ve of t he st u dy will be assesse d 
usi n g t he latest data c ut a vaila ble o nce t he pr ot oc ol is a p pr o ve d a n d will be re p orte d i n t he 
first i nteri m re p ort. T he stratificati o ns b y m o n o a n d c o m bi nati o n t hera p yliste d i n t he sec o n d 
o bjecti ve will be re p orte d i n s u bse q ue nt i nteri m re p orts as sa m ple sizes reac h a p pr o priate 
t hres h ol ds. F or c o m parati ve a nalys es, t his will be at least 8 0 7 3 patie nts per ar m . Precisi o n 
esti mates will be use d t o deter mi ne a p pr o priate sa m ple sizes f or t he descri pti ve a nalys es. T he 
fi nal re p ort will be iss ue d o nce all s u b gr o u ps reac h t he mi ni mal sa m ple sizes t o e ns ure 
s ufficie nt precisi o n i n t he esti mates of t he o utc o mes.
9. 6. D at a M a n a ge me nt 
All a nal y ses will be carrie d o ut u n der t he directi o n of bi ostatisticia ns of C or E vitas. 
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 6 of 1 9
9. 7. D at a A n al ysis 
Detaile d met h o d ol o g y  f or s u m mar y a n d statistical a nalys es of data c ollecte d i n t his st u d y will 
be d oc u me nte d i n a statistical a nal ys is pla n ( S A P), w hic h will be date d, file d a n d mai ntai ne d 
b y  t he s p o ns or. T he S A P ma y m o dif y t he pla ns o utli ne d i n t he pr ot oc ol; a n y maj or 
m o dificati o ns of e n d p oi nt defi niti o ns or t heir a nal yses w o ul d be reflecte d i n a pr ot oc ol 
a me n d me nt.
I n ge neral, t he data f or all c o nti n u o us e n d p oi nts will be s u m marize d b y  ti me p oi nt a n d 
treat me nt gr o u p i n ta bles c o ntai ni n g descri pti ve statistics ( N, mea n, sta n dar d de viati o n, 
sta n dar d err or of t he mea n, mi ni m u m, 1 st, 2n d (ie, me dia n) a n d 3r d q uartiles a n d ma xi m u m) 
f or baseli ne a n d c ha n ge fr o m baseli ne /perce nt c ha n ge fr o m baseli ne f or t h ose e n d p oi nts 
meas ure d at baseli ne. T he data f or all cate g orical e n d p oi nts will be s u m marize d b y  
c o nti n ge nc y ta bles t hat s h o w t he c o u nts/fre q ue nc y i n t he vari o us cate g ories b y treat me nt 
gr o u p at eac h ti me p oi nt. 
F or bi nar y  e n d p oi nts, 9 5 % CI usi n g n or mal a p pr o xi mati o n t o bi n o mial pr o p orti o ns will be 
pr o vi de d f or eac h gr o u p. T he 9 5 % CI will als o be pr o vi de d f or c o m paris o ns bet wee n gr o u ps 
usi n g n or mal a p pr o xi mati o n f or t he differe nce i n bi n o mial pr o p orti o ns .
C o nti n u o us e n d p oi nts (e g, H A Q -DI ) at m o nt h 6 will be a nalyz e d as c ha n ge fr o m baseli ne 
wit h a n a nal ys is of c o varia nce ( A N C O V A) m o del t hat i ncl u des treat me nt a n d baseli ne val ue 
as c o variates. C o m paris o ns bet wee n gr o u ps will be perf or me d usi n g 9 5 % CI .
9. 8. Q u alit y C o ntr o l
C or E vitas or its desi g nee m o nit ors t he c o n d uct of t he re gistr y  at eac h i n vesti gati ve site. 
M o nit ori n g is pri maril y  c o n d ucte d re m otely. O nsite m o nit ori n g visits are c o n d ucte d o nce 
e ver y 3 ye ars, as nee de d, or as re q ueste d. A re vie w of re gistr y  rec or ds i ncl u di n g, b ut n ot 
li mite d t o, t he i nf or me d c o nse nt f or ms, Q uesti o n naires, ori gi nal s o urce d oc u me nts s uc h as 
s u p p orti n g me dical rec or ds a n d office n otes, patie nt st u d y files, a n d a ny ot her re gistr y 
d oc u me ntati o n is c o n d ucte d i n acc or da nce wit h a p plica ble re g u lat or y g ui deli nes a n d t he 
pr ot oc ol. C or E vitas a n d its desi g nees are re q uire d t o mai ntai n t he c o nfi de ntialit y  of all 
patie nts d uri n g a n d after a n o n- site m o nit ori n g visit. 
Q ualit y  c o ntr ol c hec ks are b uilt i nt o t he o n-scree n data e ntr y sys te ms i n a n atte m pt t o re d uce 
q ueries a n d pr o vi de i m me diate fee d bac k t o t he i n vesti gat or re gar di n g i na d verte nt o missi o ns 
a n d o ut of ra n ge or n o nc o m plia nt val ues. C ha n ges ma de at a n y ti me are rec or de d i n a n a u dit 
trail t hat i ncl u des t he date, ti me, a n d electr o nic I D of t he pers o n ma ki n g t he c ha n ge.
C or E vitas will a d dress a n d res ol ve discre pa ncies b y re q uesti n g clarificati o ns a n d/ or missi n g 
data fr o m t he i n vesti gat or as nee de d. Eac h i n vesti gat or is e x pecte d t o desi g nate a p oi nt of 
c o ntact t o a d dress s uc h i n q uiries a n d t o pr o m pt l y a d dress a n d res ol ve iss ues. Re prese ntati ves 
or desi g nees fr o m C or E vitas reser ve t he ri g ht t o perf or m ra n d o m or sys te matic a u dits of 
C or E vitas Q uesti o n naires at a n i n vesti gat or’s site i n or der t o assess t he acc urac y  of t he 
re p orte d data c o m pare d t o t he inf or mati o n c o ntai ne d i n t he ori gi nal me dical rec or ds.
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 7 of 1 9
9. 9. Li mit ati o ns of t he R ese arc h M et h o ds
T he C or E vitas Ps A/ S p A Re gistr y  i ncl u des a sa m ple of a d ult patie nts wit h Ps A t hat are n ot 
necessaril y  re prese ntati ve of all a d ults wit h Ps A i n t he U S. In partic ular, t h ese are Ps A
patie nts wit h re g ularly- sc he d ule d visits wit h r he u mat ol o gists. Patie nts are recr uite d b y 
r he u mat ol o gists w h o are re q uire d t o i n dicate dia g n osis u p o n e nr oll me nt of t he patie nt i nt o 
t he C or E vitas Ps A/ S p A Re gistr y . I n a d diti o n, hist or y of me dicati o n use pri or t o e nr oll me nt is 
deri ve d fr o m w hat is re p orte d b y  patie nts a n d t heir c urre nt r he u mat ol o gist wit hi n t he re gistr y. 
Si nce re gistr y  re p orti n g is n ot base d o n a fi xe d visit sc he d ule, e xact ti mi n g of visits t o fit 6, 
1 2, 2 4, or 3 6 m o nt hs of p ost i n d e x data is n ot a vaila ble f or all patie nts s o wi n d o ws of ti me 
are use d t o deter mi ne eli gi ble visits. T he “ca use” of visits is n ot ca pt ure d, alt h o u g h t he 
ass u m pti o n ca n li kel y be ma de t hat t he r he u mat ol o gist visit is “ Ps A -relate d.” T he re gistr y  
ca pt ures pr o v i der re p orte d prescri bi n g; t here are n o meas ures of patie nt a d here nce.
As t his is a real-w orl d st u d y , missi n g data c o ul d be e x pecte d f or de m o gra p hic c haracteristics 
(e g, a ge, etc.); h o we ver, t he n u m ber of patie nts wit h missi n g data is e x pecte d t o be ver y 
small. Wit h m ulti ple ti me p oi nts, s o me visits ma y  ha ve missi n g D A P S A (
9. 1 0. Ot her A s pects
N ot a p plica ble.
1 0. P R O T E C TI O N O F H U M A N S U B J E C T S
1 0. 1. P atie nt Inf or m ati o n 
T his st u d y  i n v ol ves data t hat e xist i n a n o n ymize d str uct ure d f or mat a n d c o ntai n n o patie nt 
pers o nal i nf or mati o n. 
1 0. 2. P atie nt C o nse nt
As t his st u d y  i n v ol ves a n o n ymize d str uct ure d data, w hic h acc or di n g t o a p plica ble le gal 
re q uire me nts d o n ot c o ntai n data s u bject t o pri vac y la ws, o btai ni n g i nf or me d c o nse nt fr o m 
patie nts b y  Pfizer is n ot re q uire d.
1 0. 3. I nstit uti o n al R e vie w B o ar d (I R B)/I n de pe n de nt Et hics C o m mittee (I E C)
T his d ata base d oes n ot c o ntai n a n y  patie nt i de ntificati o n i nf or mati o n (e g, na me) a n d is 
e xe m pt fr o m IR B re vie w.
1 0. 4. Et hic al C o n d uct of t he S t u d y
T he st u d y  will be c o n d ucte d i n acc or da nce wit h le gal a n d re g ulat or y re q uire me nts, as well as 
wit h scie ntific p ur p ose, val ue a n d ri g or a n d f oll o w ge nerall y acce pte d researc h practices 
descri be d i n C T 2 4 -WI -G L 0 2 -R F 0 2.
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 8 of 1 9
1 1. M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S/ A D V E R S E 
R E A C TI O N S 
T his st u d y  i n v ol ves data t hat e xist as str uct ure d data b y  t he ti me of st u d y start. I n t hese data 
s o urces, i n di vi d ual patie nt data are n ot retrie ve d or vali date d, a n d it is n ot p ossi ble t o li n k 
(ie, i de ntif y a p ote ntial ass ociati o n bet wee n) a partic ular pr o d uct a n d me dical e ve nt f or a ny 
i n di vi d ual. T h us, t he mi ni m u m criteria f or re p orti n g a n a d verse e ve nt ( A E) (ie, i de ntifia ble 
patie nt, i de ntifia ble re p orter, a s us pect pr o d uct, a n d e ve nt) ca n n ot b e met. 
1 2. P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S
F or all p u blicati o ns relati n g t o t he st u d y, Pfizer will c o m pl y wit h rec o g nize d et hical
sta n dar ds c o ncer ni n g p u blicati o ns a n d a ut h ors hi p, i ncl u di n g Secti o n II - “ Et hical
C o nsi derati o ns i n t he C o n d uct a n d Re p orti n g of Researc h” of t he U nif or m Re q uire me nts f or 
Ma n uscri pts S u b mitte d t o Bi o me dical J o ur nals, htt p:// w w w.ic mje. or g/i n de x. ht ml #a ut h ors hi p, 
esta blis he d b y t he I nter nati o nal C o m mittee of Me dical J o ur nal E dit ors.
I n t he e ve nt of a ny pr o hi bit i o n or restricti o n i m p ose d (e g, cli nical h ol d) b y a n a p plica ble 
c o m pete nt a ut h orit y i n a n y area of t he w orl d, or if t he C ore vitas is a ware of a ny ne w 
i nf or mati o n w hic h mi g ht i nfl ue nce t he e val uati o n of t he be nefits a n d ris ks of a Pfizer 
pr o d uct, Pfizer s h o ul d be i nf or me d i m me diatel y . 
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

Xelja nz (t ofaciti ni b I R/ X R)
A 3 9 2 1 4 1 1 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L
Versi o n 3 . 0: 2 Oct 2 0 2 3 
P FI Z E R C O N FI D E N TI A L
C T 2 4 -WI -G L 0 2 -R F 0 2 4. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate F or Sec o n dar y Data C ollecti o n St u d y
0 1 -J u n-2 0 2 2
Pa ge 1 9 of 1 9
1 3. R E F E R E N C E S
1. 
C oates L C, Ka va na u g h A, Mease PJ, et al. Gr o u p f or Researc h a n d Assess me nt of 
Ps oriasis a n d Ps oriatic Art hritis 2 0 1 5 treat me nt rec o m me n dati o ns f or ps oriatic art hritis. 
Art hritis R he u mat ol. 2 0 1 6; 6 8( 5): 1 0 6 0- 7 1.
2. 
Helli w ell P S, C oates LC, C ha n dra n V, et al. Q ualif y i n g u n met nee ds a n d i m pr o vi n g 
sta n dar ds of care i n ps oriatic art hritis. Art hritis Care Res. 2 0 1 4; 6 6: 1 7 5 9- 6 6.
3. 
Gla d ma n D D, A nt o ni C, Mease P, et al. Ps oriatic art hritis: e pi de mi ol o g y , cli nical
feat ures, c o urse, a nd o utc o me. A n n R he u m Dis. 2 0 0 5; 6 4 S u p pl 2:ii 1 4 - 1 7.
4. 
O g die A, Weiss P. T he e pi de mi ol o g y  of ps oriatic art hritis. R he u m Dis Cli n N A m. 2 0 1 5 
( 4 1): 5 4 5– 6 8.
5.   
Gla d ma n D D. Cli nical feat ures a n d dia g n ostic c o nsi derati o ns i n ps oriatic art hritis. 
R he u m Dis Cli n N A m. 2 0 1 5; 4 1: 5 6 9 – 7 9.
6. 
G ossec L, S m ole n J S, et al. E ur o pea n Lea g ue A gai nst R he u matis m ( E U L A R) 
rec o m me n dati o ns f or t he ma na ge me nt of ps oriatic art hritis wit h p har mac ol o gical 
t hera pies: 2 0 1 5 u p date. A n n R he u m Dis. 2 0 1 6; 7 5: 4 9 9 - 5 1 0.
1 4. LI S T O F T A B L E S 
Ta ble s hells are i ncl u de d i n t he S A P.
1 5. LI S T O F FI G U R E S
Fi g ures are i ncl u de d i n t he S A P.
A N N E X 1. LI S T O F S T A N D A L O N E D O C U M E N T S
N u m ber
D ate
Title
1
2 0 A u g ust 2 0 2 1
A nal ysis of t ofaciti ni b i nitiat ors w it h Ps A S A P
A N N E X 2. A D DI TI O N A L I N F O R M A TI O N
N ot ap plica ble .
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)

D o c u m e nt A p pr o v al R e c or d
D o c u m e nt N a m e:
D o c u m e nt Titl e:
Si g n e d B y:
D at e( G M T)
Si g ni n g C a p a cit y
0 9 0 1 7 7 e 1 a 1 b e 4 e 9 e\ A p pr o v e d\ A p pr o v e d O n: 3 0- S e p- 2 0 2 4 1 6: 3 0 ( G M T)
P P D