NCT02059291 · OUTCOME

Percentage of Participants With Normalized Serum Amyloid A (SAA) Level

Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers · Source last updated 2018-05-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Percentage of participants
Interval / dispersion: Not reported
Time frame: 16 weeks

What was measured

Normalized SAA was defined as SAA \<= 10 mg/L.

Analysis population: The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.

Groups in this outcome

Epoch 2: crFMF: 150 mg

During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.

Epoch 2: crCMF: Placebo

During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab. 150mg, participants were uptitrated to open-label canakinumab 300 mg

Epoch 2: HIDS/MKD: 150 mg

Epoch 2: HIDS/MKD: Placebo

During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.

Epoch 2: TRAPS: 150 mg

Epoch 2: TRAPS: Placebo

During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Epoch 2: crFMF: 150 mg	31
Epoch 2: crCMF: Placebo	32
Epoch 2: HIDS/MKD: 150 mg	37
Epoch 2: HIDS/MKD: Placebo	35
Epoch 2: TRAPS: 150 mg	22
Epoch 2: TRAPS: Placebo	24

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Epoch 2: crFMF: 150 mg	25.81	Not reported	Not reported	Not reported	Not reported
Epoch 2: crCMF: Placebo	0.00	Not reported	Not reported	Not reported	Not reported
Epoch 2: HIDS/MKD: 150 mg	13.51	Not reported	Not reported	Not reported	Not reported
Epoch 2: HIDS/MKD: Placebo	2.86	Not reported	Not reported	Not reported	Not reported
Epoch 2: TRAPS: 150 mg	27.27	Not reported	Not reported	Not reported	Not reported
Epoch 2: TRAPS: Placebo	0.00	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.92
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
332.92
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0286
param Type
Odds Ratio (OR)
param Value
17.46
statistical Method
Regression, Logistic
ci Lower Limit
0.53
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
51.97
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0778
param Type
Odds Ratio (OR)
param Value
5.26
statistical Method
Regression, Logistic
ci Lower Limit
1.04
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
268.50
group Ids
OG004
OG005
non Inferiority Type
SUPERIORITY
p Value
0.0235
param Type
Odds Ratio (OR)
param Value
16.69
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
0.92
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
332.92
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0286
param Type
Odds Ratio (OR)
param Value
17.46
statistical Method
Regression, Logistic
ci Lower Limit
0.53
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
51.97
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0778
param Type
Odds Ratio (OR)
param Value
5.26
statistical Method
Regression, Logistic
ci Lower Limit
1.04
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
268.50
group Ids
OG004
OG005
non Inferiority Type
SUPERIORITY
p Value
0.0235
param Type
Odds Ratio (OR)
param Value
16.69
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
value
25.81
group Id
OG001
value
0.00
group Id
OG002
value
13.51
group Id
OG003
value
2.86
group Id
OG004
value
27.27
group Id
OG005
value
0.00

denoms

counts
group Id
OG000
value
31
group Id
OG001
value
32
group Id
OG002
value
37
group Id
OG003
value
35
group Id
OG004
value
22
group Id
OG005
value
24
units
Participants

description

Normalized SAA was defined as SAA \<= 10 mg/L.

groups

description
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
id
OG000
title
Epoch 2: crFMF: 150 mg
description
During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab. 150mg, participants were uptitrated to open-label canakinumab 300 mg
id
OG001
title
Epoch 2: crCMF: Placebo
description
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
id
OG002
title
Epoch 2: HIDS/MKD: 150 mg
description
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
id
OG003
title
Epoch 2: HIDS/MKD: Placebo
description
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
id
OG004
title
Epoch 2: TRAPS: 150 mg
description
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
id
OG005
title
Epoch 2: TRAPS: Placebo

param Type

NUMBER

population Description

The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.

reporting Status

POSTED

time Frame

16 weeks

title

Percentage of Participants With Normalized Serum Amyloid A (SAA) Level

type

SECONDARY

unit Of Measure

Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice