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REMICADE - Weight of Adult Patients in Clinical Trials

Last Updated: 01/11/2025

CLINICAL DATA

Clinical trials evaluating the safety and efficacy of REMICADE were conducted in 5706 REMICADE-treated and 1600 placebo-treated adult patients with rheumatoid arthritis (RA), Crohn's disease (CD), fistulizing CD, ankylosing spondylitis (AS), psoriastic arthritis (PsA), plaque psoriasis (PsO), and ulcerative colitis (UC).1

The majority of the data from clinical trials with REMICADE reflect both single- and repeat-dosing regimens, including chronic maintenance therapy. The average duration of follow-up for studies in RA, CD, fistulizing CD, AS, PsA, plaque PsO, and UC was 45.5 weeks for patients receiving REMICADE and 29.0 weeks for patients receiving placebo.1

In the following Table: Average Body Weight (kg) at Baseline in REMICADE Clinical Trials, you will find a summary of average body weight (kg) at baseline for adult patients enrolled in REMICADE clinical trials.


Average Body Weight (kg) at Baseline in REMICADE Clinical Trials2-13
Title
Treatment Groups
PBO±MTX
REM 3 mg/kg every 4 weeks±MTX
REM 3 mg/kg every 8 weeks±MTX
REM 5 mg/kg every 6 weeks±MTX
REM 5 mg/kg every 8 weeks±MTX
REM 6 mg/kg every 8 weeks±MTX
REM 10 mg/kg every 4 weeks±MTX
REM 10 mg/kg every 8 weeks±MTX
CROHN'S DISEASE
ACCENT 1
Patients Evaluated (n)
188



192


193
Mean±SD
74.2±19.8



68.3±
16.0


71.1±
18.7
Median (IQR)
72.0
(59.3, 84.0)



66.0 (56.3, 78.2)


68.3
(57.8, 79.5)
Range
(40.0, 157.3)



(38.0, 128.2)


(37.7, 156.8)
FISTULIZING CROHN'S DISEASE
ACCENT 2
Patients Evaluated (n)
143



139



Mean±SD
73.3±18.3



72.6±
16.9



Median (IQR)
70.7
(59.0, 82.0)



70.0
(60.9, 82.4)



Range
(37.5, 130.0)



(43.2, 130.0)



ULCERATIVE COLITIS
ACT 1
Patients Evaluated (n)
121



121


122
Mean±SD
76.8±16.2



80.0±
17.8


76.9±
17.1
Median (IQR)
75.0
(65.0, 86.0)



79.0
(67.0, 90.4)


76.1
(64.3, 87.3)

Range
(46.0, 128.0)



(40.0, 146.4)


(46.0, 159.0)
ACT 2
Patients Evaluated (n)
123



121


120
Mean±SD
76.1±17.4



78.4±
17.8


79.6±
20.6
Median (IQR)
74.7
(61.0, 87.1)



77.0
(64.3, 88.0)


75.0
(67.1, 91.9)

Range
(42.1, 126.0)



(48.0, 125.4)


(49.4, 177.3)
RHEUMATOID ARTHRITIS
ATTRACT
Patients Evaluated (n)
88
86
86



81
87
Mean±SD
73.9±18.6
75.4±
19.4
73.4±
18.6



75.5±
19.3
78.5±
20.4
Median (IQR)
70.9
(61.1, 82.5)
71.9
(60.8, 85.3)
69.6
(60.0, 86.3)



73.0
(63.5, 85.0)
75.0
(63.5, 89.3)

Range
(45.0, 143.0)
(46.8, 154.5)
(40.0, 120.0)



(48.0, 158.6)
(39.6, 150.5)
ASPIRE
Patients Evaluated (n)
296

372


376


Mean±SD
77.7±19.1

77.4±
17.1


78.5±
18.3


Median (IQR)
74.9
(64.5, 87.0)

75.0
(66.0, 85.9)


76.4
(65.0, 89.5)


Range
(40.9, 163.0)

(38.1, 147.7)


(43.0, 146.0)


START
Patients Evaluated (n)
362

360




361
Mean±SD
72.8±17.9

72.7±
16.7




73.8±
18.2
Median (IQR)
70.0
(60.0, 82.0)

70.0
(61.0, 83.0)




70.0
(61.0, 86.0)

Range
(38.0, 132.0)

(38.0, 156.0)




(40.0, 151.0)
PSORIATIC ARTHRITIS
IMPACT 2
Patients Evaluated (n)
100



100



Mean±SD
84.5±20.3



87.9±
16.5



Median (IQR)
81.9
(72.0, 96.4)



86.8
(74.6, 98.1)



Range
(46.8, 175.0)



(56.3, 155.5)



ANKYLOSING SPONDYLITIS
ASSERT
Patients Evaluated (n)
78


201




Mean±SD
79.5±15.8


77.5±
13.5




Median (IQR)
76.0
(68.0, 88.0)


77.0
(68.0, 86.0)




Range
(52.0, 133.4)


(43.0, 115.4)




PLAQUE PSORIASIS
EXPRESS
Patients Evaluated (n)
77



298



Mean±SD
89.3±18.7



85.9±
20.1



Median (IQR)
89.1
(76.0, 101.0)



85.0
(72.7, 95.9)



Range
(51.0, 138.0)



(43.0, 162.3)



EXPRESS II
Patients Evaluated (n)
208

313

314



Mean±SD
91.1±22.6

92.0±
22.5

92.2±
23.2



Median (IQR)
88.9
(75.4, 102.0)

88.9
(77.5, 104.7)

88.8
(75.9, 105.0)



Range
(49.9, 166.0)

(44.3, 184.2)

(48.6, 167.8)



SPIRIT
Patients Evaluated (n)
51

99

99



Mean±SD
95.3±26.6

90.2±
19.9

95.3±
24.7



Median (IQR)
92.5
(73.0, 110.0)

88.0
(77.0, 102.0)

92.5
(77.1, 108.0)



Range
(52.0, 187.0)

(52.0, 164.6)

(56.4, 175.0)



Abbreviations: IQR, interquartile range; MTX, methotrexate; PBO, placebo; REM, REMICADE; SD, standard deviation.

References

1 Centocor, Inc. Protocol ISS; DoF.
2 Centocor, Inc. Protocol C0168T21; page 1741; DoF; 2001.
3 Centocor, Inc. Protocol C0168T26; page 1072; DoF; 2002.
4 Centocor, Inc. Protocol C0168T37; page 66; DoF; 2005.
5 Centocor, Inc. Protocol C0168T46; page 63; DoF; 2005.
6 Centocor, Inc. Protocol C0168T22; page 59; DoF; 1998.
7 Centocor, Inc. Protocol C0168T29; page 83; DoF; 2003.
8 Centocor, Inc. Protocol C0168T41; page 144; DoF; 2004.
9 Centocor, Inc. Protocol C0168T50; page 75; DoF; 2004.
10 Centocor, Inc. Protocol C0168T51; page 58; DoF; 2004.
11 Centocor, Inc. Protocol C0168T38; page 65; DoF; 2004.
12 Centocor, Inc. Protocol C0168T44; page 70; DoF; 2005.
13 Centocor, Inc. Protocol C0168T31; page 86; DoF; 2003.