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Trial record 12 of 16 for:    "Muckle-Wells syndrome"

Interleukin-1 Trap to Treat Autoinflammatory Diseases

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ClinicalTrials.gov Identifier: NCT00094900
Recruitment Status : Completed
First Posted : October 28, 2004
Results First Posted : July 10, 2013
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Inflammation
Familial Mediterranean Fever
Still's Disease, Adult-Onset
Intervention Drug: IL-1 Trap
Enrollment 11

Recruitment Details  
Pre-assignment Details  
Arm/Group Title IL-1 Trap
Hide Arm/Group Description Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Arm/Group Title IL-1 Trap
Hide Arm/Group Description Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
4
  36.4%
Male
7
  63.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Hispanic or Latino
1
   9.1%
Not Hispanic or Latino
10
  90.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
11
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Mean Change in Daily Scores
Hide Description Daily scores change from baseline to 10 days. The clinical daily diary scores (a composite score that included fever, rash, and arthritis/arthralgia, with each of the 3 symptoms scored from 0 [no symptom] to 4 [worst symptom], with an overall range score of 0–12).
Time Frame 10 days for 4 patient, 6 days for 1 patient
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-3.09  (1.03)
2.Primary Outcome
Title Mean Change in ESR
Hide Description ESR change from baseline to 10 days.The Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured to evaluate lab parameters of inflammation
Time Frame 10 days for 4 patient, 6 days for 1 patient
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mm/hour
-32.2  (7.31)
3.Primary Outcome
Title Mean Change in hsCRP
Hide Description hsCRP change from baseline to 10 days.The high sensitivity C-reactive protein (hsCRP) is an acute phase reactant measured to evaluate lab parameters of inflammation
Time Frame 10 days for 4 patient, 6 days for 1 patient
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/dl
-4.22  (0.98)
4.Primary Outcome
Title Mean Change in SAA
Hide Description SAA change from baseline to 10 days.The serum Amyloid A (SAA) is an acute phase reactant measured to evaluate lab parameters of inflammation
Time Frame 10 days for 4 patient, 6 days for 1 patient
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/liter
-216.1  (92.14)
5.Primary Outcome
Title Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease
Hide Description At the 24 month post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures: Patient's pain assessment, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Patient self-assessed disability, Acute phase reactant.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
3
6.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS
Hide Description Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-5.29  (0.67)
7.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS
Hide Description Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-2.56  (1.27)
8.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS
Hide Description Patient's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-2.63  (1.19)
9.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS
Hide Description Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-2.86  (1.24)
10.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS
Hide Description Patient's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-3.40  (0.98)
11.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS
Hide Description Patient's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 20 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-2.78  (1.13)
12.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS
Hide Description Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-2.33  (1.3)
13.Secondary Outcome
Title Mean Change in Physician’s Global Assessment, by VAS
Hide Description Physician's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-4.15  (0.89)
14.Secondary Outcome
Title Mean Change in Physician’s Global Assessment, by VAS
Hide Description Physician's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-4.27  (1.01)
15.Secondary Outcome
Title Mean Change in Physician’s Global Assessment, by VAS
Hide Description Physician's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-4.71  (0.75)
16.Secondary Outcome
Title Mean Change in Physician’s Global Assessment, by VAS
Hide Description Physician's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-4.30  (0.9)
17.Secondary Outcome
Title Mean Change in Physician’s Global Assessment, by VAS
Hide Description Physician's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-4.85  (0.95)
18.Secondary Outcome
Title Mean Change in Physician’s Global Assessment, by VAS
Hide Description Physician's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 20 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-4.79  (0.66)
19.Secondary Outcome
Title Mean Change in Physician’s Global Assessment, by VAS
Hide Description Physician's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-4.54  (0.99)
20.Secondary Outcome
Title Mean Change in Patient’s Assessment of Pain, by VAS
Hide Description Patient's global assessment of pain by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-5.43  (1.2)
21.Secondary Outcome
Title Mean Change in Patient’s Assessment of Pain, by VAS
Hide Description Patient's global assessment of pain by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-4.24  (1.24)
22.Secondary Outcome
Title Mean Change in Patient’s Assessment of Pain, by VAS
Hide Description Patient's global assessment of pain by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-3.93  (1.28)
23.Secondary Outcome
Title Mean Change in Patient’s Assessment of Pain, by VAS
Hide Description Patient's global assessment of pain by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-3.08  (2.28)
24.Secondary Outcome
Title Mean Change in Patient’s Assessment of Pain, by VAS
Hide Description Patient's global assessment of pain by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-5.65  (1.13)
25.Secondary Outcome
Title Mean Change in Patient’s Assessment of Pain, by VAS
Hide Description Patient's global assessment of pain by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 20 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-5.01  (1.22)
26.Secondary Outcome
Title Mean Change in Patient’s Assessment of Pain, by VAS
Hide Description Patient's global assessment of pain by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-4.82  (1.22)
27.Secondary Outcome
Title Mean Change in Patient’s Assessment of Fatigue, by VAS
Hide Description Patient's assessment of fatigue by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-3.12  (1.04)
28.Secondary Outcome
Title Mean Change in Patient’s Assessment of Fatigue, by VAS
Hide Description Patient's assessment of fatigue by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-2.27  (1.15)
29.Secondary Outcome
Title Mean Change in Patient’s Assessment of Fatigue, by VAS
Hide Description Patient's assessment of fatigue by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-2.41  (1.1)
30.Secondary Outcome
Title Mean Change in Patient’s Assessment of Fatigue, by VAS
Hide Description Patient's assessment of fatigue by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-2.04  (1.17)
31.Secondary Outcome
Title Mean Change in Patient’s Assessment of Fatigue, by VAS
Hide Description Patient's assessment of fatigue by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-3.16  (0.67)
32.Secondary Outcome
Title Mean Change in Patient’s Assessment of Fatigue, by VAS
Hide Description Patient's assessment of fatigue by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 20 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-2.38  (0.89)
33.Secondary Outcome
Title Mean Change in Patient’s Assessment of Fatigue, by VAS
Hide Description Patient's assessment of fatigue by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-3.19  (1.63)
34.Secondary Outcome
Title Mean Change in Tender Joint Count
Hide Description Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
-5.70  (3.49)
35.Secondary Outcome
Title Mean Change in Tender Joint Count.
Hide Description Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
-4.30  (4.47)
36.Secondary Outcome
Title Mean Change in Tender Joint Count
Hide Description Count of tender joints in patient from baseline to 9 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
-4.80  (4.73)
37.Secondary Outcome
Title Mean Change in Tender Joint Count
Hide Description Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
-7.40  (5.33)
38.Secondary Outcome
Title Mean Change in Tender Joint Count
Hide Description Count of tender joints in patient from baseline to 16 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
-9.60  (5.71)
39.Secondary Outcome
Title Mean Change in Tender Joint Count
Hide Description Count of tender joints in patient from baseline to 20 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 20 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
-8.40  (4.77)
40.Secondary Outcome
Title Mean Change in Tender Joint Count
Hide Description Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
-6.80  (5.53)
41.Secondary Outcome
Title Mean Change in Swollen Joint Count
Hide Description Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
-7.90  (4.64)
42.Secondary Outcome
Title Mean Change in Swollen Joint Count
Hide Description Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
-2.50  (3.66)
43.Secondary Outcome
Title Mean Change in Swollen Joint Count
Hide Description Count of swollen joints in patient from baseline to 9 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
-2.30  (3.33)
44.Secondary Outcome
Title Mean Change in Swollen Joint Count
Hide Description Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
-6.10  (2.82)
45.Secondary Outcome
Title Mean Change in Swollen Joint Count
Hide Description Count of swollen joints in patient from baseline to 16 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
-9.00  (4.09)
46.Secondary Outcome
Title Mean Change in Swollen Joint Count
Hide Description Count of swollen joints in patient from baseline to 20 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 20 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
-9.40  (3.59)
47.Secondary Outcome
Title Mean Change in Swollen Joint Count
Hide Description Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
-4.20  (4.45)
48.Secondary Outcome
Title Mean Change in SF-36 Physical Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 3 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
11.11  (3.74)
49.Secondary Outcome
Title Mean Change in SF-36 Physical Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 6 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.09  (3.19)
50.Secondary Outcome
Title Mean Change in SF-36 Physical Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 9 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
10.38  (4.45)
51.Secondary Outcome
Title Mean Change in SF-36 Physical Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 12 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
13.28  (3.84)
52.Secondary Outcome
Title Mean Change in SF-36 Physical Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 16 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
12.58  (3.23)
53.Secondary Outcome
Title Mean Change in SF-36 Physical Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 20 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)
Time Frame 20 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
10.12  (5.48)
54.Secondary Outcome
Title Mean Change in SF-36 Physical Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 24 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
10.22  (4.59)
55.Secondary Outcome
Title Mean Change in SF-36 Mental Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 3 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
7.56  (4.97)
56.Secondary Outcome
Title Mean Change in SF-36 Mental Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 6 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
5.95  (4.01)
57.Secondary Outcome
Title Mean Change in SF-36 Mental Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 9 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
8.8  (4)
58.Secondary Outcome
Title Mean Change in SF-36 Mental Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 12 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
9.76  (3.46)
59.Secondary Outcome
Title Mean Change in SF-36 Mental Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 16 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
11.74  (6.42)
60.Secondary Outcome
Title Mean Change in SF-36 Mental Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 20 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)
Time Frame 20 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
12.98  (3.96)
61.Secondary Outcome
Title Mean Change in SF-36 Mental Component Score
Hide Description Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 24 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
11.46  (6.46)
62.Secondary Outcome
Title Mean Change in WBCs
Hide Description White Blood Cell count change from baseline to 3 months
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: x 10^3 cells/microliter
0.57  (1.17)
63.Secondary Outcome
Title Mean Change in WBCs
Hide Description White Blood Cell count change from baseline to 6 months
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: x 10^3 cells/microliter
-1.29  (1.35)
64.Secondary Outcome
Title Mean Change in WBCs
Hide Description White Blood Cell count change from baseline to 12 months
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: x 10^3 cells/microliter
-0.87  (1.08)
65.Secondary Outcome
Title Mean Change in WBCs
Hide Description White Blood Cell count change from baseline to 24 months
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: x 10^3 cells/microliter
-2.88  (1.43)
66.Secondary Outcome
Title Mean Change in Ferritin
Hide Description Ferritin level change from baseline to 3 months
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mcg/L
-231.80  (138.11)
67.Secondary Outcome
Title Mean Change in Ferritin
Hide Description Ferritin level change from baseline to 6 months
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mcg/L
-184.80  (88.19)
68.Secondary Outcome
Title Mean Change in Ferritin
Hide Description Ferritin level change from baseline to 12 months
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mcg/L
331.80  (575.34)
69.Secondary Outcome
Title Mean Change in Ferritin
Hide Description Ferritin level change from baseline to 24 months
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mcg/L
-263.80  (114.69)
70.Secondary Outcome
Title Mean Change in Serum Amyloid A
Hide Description [Not Specified]
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/liter
-117.80  (62.54)
71.Secondary Outcome
Title Mean Change in Serum Amyloid A
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/liter
-173.40  (80.56)
72.Secondary Outcome
Title Mean Change in Serum Amyloid A
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/liter
-274.20  (103.18)
73.Secondary Outcome
Title Mean Change in Serum Amyloid A
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/liter
-173.25  (115.86)
74.Secondary Outcome
Title Mean Change in C-Reactive Protein
Hide Description [Not Specified]
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/dl
-4.79  (2.71)
75.Secondary Outcome
Title Mean Change in C-Reactive Protein
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/dl
-5.67  (2.62)
76.Secondary Outcome
Title Mean Change in C-Reactive Protein
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/dl
-7.06  (2.38)
77.Secondary Outcome
Title Mean Change in C-Reactive Protein
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/dl
-4.91  (1.86)
78.Secondary Outcome
Title Mean Change in Erythrocyte Sedimentation Rate
Hide Description [Not Specified]
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mm/hour
-13.20  (10.85)
79.Secondary Outcome
Title Mean Change in Erythrocyte Sedimentation Rate
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mm/hour
-32.40  (11.12)
80.Secondary Outcome
Title Mean Change in Erythrocyte Sedimentation Rate
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mm/hour
-34.60  (14.26)
81.Secondary Outcome
Title Mean Change in Erythrocyte Sedimentation Rate
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mm/hour
-23.40  (15.02)
82.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects
Hide Description Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-0.16  (0.79)
83.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects
Hide Description Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-0.75  (0.60)
84.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects
Hide Description Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-0.97  (1.34)
85.Secondary Outcome
Title Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects
Hide Description Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: units on a scale
-1.03  (0.96)
86.Secondary Outcome
Title Mean Change in Tender Joint Count in AOSD Subjects
Hide Description Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
1.60  (2.98)
87.Secondary Outcome
Title Mean Change in Tender Joint Count in AOSD Subjects
Hide Description Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
-2.00  (1.48)
88.Secondary Outcome
Title Mean Change in Tender Joint Count in AOSD Subjects
Hide Description Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
-3.40  (3.06)
89.Secondary Outcome
Title Mean Change in Tender Joint Count in AOSD Subjects
Hide Description Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: tender joints
-6.80  (3.28)
90.Secondary Outcome
Title Mean Change in Swollen Joint Count in AOSD Subjects
Hide Description Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
1.20  (3.89)
91.Secondary Outcome
Title Mean Change in Swollen Joint Count in AOSD Subjects
Hide Description Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
0.60  (2.79)
92.Secondary Outcome
Title Mean Change in Swollen Joint Count in AOSD Subjects
Hide Description Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
-2.40  (2.60)
93.Secondary Outcome
Title Mean Change in Swollen Joint Count in AOSD Subjects
Hide Description Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: swollen joints
-2.60  (1.81)
94.Secondary Outcome
Title Mean Change in Prednisone Dose
Hide Description [Not Specified]
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/day
-0.50  (1.66)
95.Secondary Outcome
Title Mean Change in Prednisone Dose
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/day
-1.50  (7.81)
96.Secondary Outcome
Title Mean Change in Prednisone Dose
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/day
-4.10  (6.52)
97.Secondary Outcome
Title Mean Change in Prednisone Dose
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects with Adult Onset Still's Disease (AOSD)
Arm/Group Title IL-1 Trap
Hide Arm/Group Description:
Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Number of Participants Analyzed 5
Mean (Standard Error)
Unit of Measure: mg/day
-7.00  (7.20)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IL-1 Trap
Hide Arm/Group Description Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
All-Cause Mortality
IL-1 Trap
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IL-1 Trap
Affected / at Risk (%)
Total   5/11 (45.45%) 
Blood and lymphatic system disorders   
Blood and lymphatic system disorders - Other (Macrophage Activation Syndrome)  1/11 (9.09%) 
Infections and infestations   
Joint infection-mycobacterium  1/11 (9.09%) 
Skin Infection-mycobacterium  1/11 (9.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Prostate Cancer  1/11 (9.09%) 
Nervous system disorders   
Cerebrospinal fluid leakage  1/11 (9.09%) 
Renal and urinary disorders   
Kidney infection  1/11 (9.09%) 
Renal Calculi  2/11 (18.18%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IL-1 Trap
Affected / at Risk (%)
Total   11/11 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1/11 (9.09%) 
Blood and lymphatic disorder- other (Iron Deficiency)  1/11 (9.09%) 
Ear and labyrinth disorders   
Ear disorder - congestion  1/11 (9.09%) 
Hearing impaired  1/11 (9.09%) 
Endocrine disorders   
Endocrine disorder - other (Inhomogeneous thyroid)  1/11 (9.09%) 
Hypothyroidism  1/11 (9.09%) 
Eye disorders   
Eye disorder - other (Hordeolum)  1/11 (9.09%) 
Eye pain  1/11 (9.09%) 
Gastrointestinal disorders   
Diarrhea  5/11 (45.45%) 
Dry mouth  2/11 (18.18%) 
Dyspepsia  1/11 (9.09%) 
Gastritis  3/11 (27.27%) 
Nausea  2/11 (18.18%) 
Stomach pain  3/11 (27.27%) 
Toothache  2/11 (18.18%) 
General disorders   
Fatigue  1/11 (9.09%) 
Flu like symptoms  2/11 (18.18%) 
Non-cardiac chest pain  1/11 (9.09%) 
Immune system disorders   
Allergic reaction  1/11 (9.09%) 
Infections and infestations   
Bronchial infection  4/11 (36.36%) 
Enterocolitis infectious  1/11 (9.09%) 
Eye Infection  1/11 (9.09%) 
Joint infection  1/11 (9.09%) 
Kidney infection  2/11 (18.18%) 
Mucosal infection  2/11 (18.18%) 
Pharyngitis  3/11 (27.27%) 
Rhinitis  1/11 (9.09%) 
Sinusitis  7/11 (63.64%) 
Skin infection  4/11 (36.36%) 
Tooth infection  2/11 (18.18%) 
upper respiratory infection  6/11 (54.55%) 
Urinary Tract Infection  2/11 (18.18%) 
Vaginal Infection  1/11 (9.09%) 
Investigations   
Alanine aminotransferase increased  2/11 (18.18%) 
Aspartate aminotransferase increased  2/11 (18.18%) 
Blood gonadotrophin abnormal  1/11 (9.09%) 
Cholesterol high  3/11 (27.27%) 
High cholesterol  1/11 (9.09%) 
Lymphocyte count decreased  1/11 (9.09%) 
weight gain  3/11 (27.27%) 
Metabolism and nutrition disorders   
Glucose intolerance  1/11 (9.09%) 
Hypertriglyceridemia  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1/11 (9.09%) 
Back pain  3/11 (27.27%) 
Flank pain  1/11 (9.09%) 
Musculoskeletal and Connective tissue disorder - other (Flexion contracture)  1/11 (9.09%) 
Musculoskeletal and Connective tissue disorder - other (Ruptured Baker's cyst)  1/11 (9.09%) 
Musculoskeletal and Connective tissue disorder -other (Bursa fluid)  1/11 (9.09%) 
Musculoskeletal and Connective tissue disorder -other (Bursitis)  1/11 (9.09%) 
Musculoskeletal and Connective tissue disorder -other (Synovial cyst)  1/11 (9.09%) 
Myalgia  1/11 (9.09%) 
Neck pain  1/11 (9.09%) 
Pain in extremity  1/11 (9.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm, benign, malignant and unspecified (basal cell carcinoma)  1/11 (9.09%) 
Neoplasm, benign, malignant and unspecified (cysts and polyps) - Lung nodule  1/11 (9.09%) 
Neoplasm, benign, malignant and unspecified (cysts and polyps) - Pilonidal sinus  1/11 (9.09%) 
Nervous system disorders   
Dysgeusia  1/11 (9.09%) 
Headache  4/11 (36.36%) 
Memory Impairment  1/11 (9.09%) 
Psychiatric disorders   
Depression  1/11 (9.09%) 
Insomnia  2/11 (18.18%) 
Libido decreased  1/11 (9.09%) 
Renal and urinary disorders   
Hematuria  3/11 (27.27%) 
Renal Calculi  1/11 (9.09%) 
Urinary urgency  1/11 (9.09%) 
Reproductive system and breast disorders   
Erectile dysfunction  1/11 (9.09%) 
Irregular Menstruation  1/11 (9.09%) 
Testicular pain  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Cough  3/11 (27.27%) 
Nasal Congestion  3/11 (27.27%) 
Skin and subcutaneous tissue disorders   
hyperhidrosis  1/11 (9.09%) 
Photosensitivity  1/11 (9.09%) 
Pruritus  1/11 (9.09%) 
Rash Acneiform  1/11 (9.09%) 
Skin and subcutaneous tissue disorder - other (Increased skin fold)  1/11 (9.09%) 
Skin and subcutaneous tissue disorder - other (skin tear)  1/11 (9.09%) 
Vascular disorders   
Flushing  1/11 (9.09%) 
Hypertension  3/11 (27.27%) 

Secondary outcome analyses will be stratified based on primary outcome results - responders and non-responders.

1 subject with Familial Mediterranean Fever (FMF) was recruited but outcomes were not collected due to insufficient accrual of FMF cases.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Raphaela Goldbach-Mansky, MD
Organization: National Inst of Arthritis and Musculoskeletal and Skin Diseases
Phone: 13014356243
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )
ClinicalTrials.gov Identifier: NCT00094900     History of Changes
Other Study ID Numbers: 050014
05-AR-0014
First Submitted: October 28, 2004
First Posted: October 28, 2004
Results First Submitted: March 19, 2013
Results First Posted: July 10, 2013
Last Update Posted: March 4, 2014