Trial Outcomes & Findings for Interleukin-1 Trap to Treat Autoinflammatory Diseases (NCT NCT00094900)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

10 days for 4 patient, 6 days for 1 patient

Results posted on

2014-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	IL-1 Trap Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interleukin-1 Trap to Treat Autoinflammatory Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IL-1 Trap n=11 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Sex: Female, Male Female	4 Participants n=39 Participants
Sex: Female, Male Male	7 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	11 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants

PRIMARY outcome

Timeframe: 10 days for 4 patient, 6 days for 1 patient

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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).

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Daily Scores	-3.09 units on a scale Standard Error 1.03

PRIMARY outcome

Timeframe: 10 days for 4 patient, 6 days for 1 patient

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

ESR change from baseline to 10 days.The Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured to evaluate lab parameters of inflammation

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in ESR	-32.2 mm/hour Standard Error 7.31

PRIMARY outcome

Timeframe: 10 days for 4 patient, 6 days for 1 patient

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in hsCRP	-4.22 mg/dl Standard Error 0.98

PRIMARY outcome

Timeframe: 10 days for 4 patient, 6 days for 1 patient

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

SAA change from baseline to 10 days.The serum Amyloid A (SAA) is an acute phase reactant measured to evaluate lab parameters of inflammation

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SAA	-216.1 mg/liter Standard Error 92.14

PRIMARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease	3 participants

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS	-5.29 units on a scale Standard Error 0.67

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS	-2.56 units on a scale Standard Error 1.27

SECONDARY outcome

Timeframe: 9 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS	-2.63 units on a scale Standard Error 1.19

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS	-2.86 units on a scale Standard Error 1.24

SECONDARY outcome

Timeframe: 16 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS	-3.40 units on a scale Standard Error 0.98

SECONDARY outcome

Timeframe: 20 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS	-2.78 units on a scale Standard Error 1.13

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS	-2.33 units on a scale Standard Error 1.3

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Physician's Global Assessment, by VAS	-4.15 units on a scale Standard Error 0.89

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Physician's Global Assessment, by VAS	-4.27 units on a scale Standard Error 1.01

SECONDARY outcome

Timeframe: 9 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Physician's Global Assessment, by VAS	-4.71 units on a scale Standard Error 0.75

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Physician's Global Assessment, by VAS	-4.30 units on a scale Standard Error 0.9

SECONDARY outcome

Timeframe: 16 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Physician's Global Assessment, by VAS	-4.85 units on a scale Standard Error 0.95

SECONDARY outcome

Timeframe: 20 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Physician's Global Assessment, by VAS	-4.79 units on a scale Standard Error 0.66

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Physician's Global Assessment, by VAS	-4.54 units on a scale Standard Error 0.99

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Pain, by VAS	-5.43 units on a scale Standard Error 1.2

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Pain, by VAS	-4.24 units on a scale Standard Error 1.24

SECONDARY outcome

Timeframe: 9 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Pain, by VAS	-3.93 units on a scale Standard Error 1.28

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Pain, by VAS	-3.08 units on a scale Standard Error 2.28

SECONDARY outcome

Timeframe: 16 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Pain, by VAS	-5.65 units on a scale Standard Error 1.13

SECONDARY outcome

Timeframe: 20 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Pain, by VAS	-5.01 units on a scale Standard Error 1.22

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Pain, by VAS	-4.82 units on a scale Standard Error 1.22

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Fatigue, by VAS	-3.12 units on a scale Standard Error 1.04

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Fatigue, by VAS	-2.27 units on a scale Standard Error 1.15

SECONDARY outcome

Timeframe: 9 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Fatigue, by VAS	-2.41 units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Fatigue, by VAS	-2.04 units on a scale Standard Error 1.17

SECONDARY outcome

Timeframe: 16 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Fatigue, by VAS	-3.16 units on a scale Standard Error 0.67

SECONDARY outcome

Timeframe: 20 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Fatigue, by VAS	-2.38 units on a scale Standard Error 0.89

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Assessment of Fatigue, by VAS	-3.19 units on a scale Standard Error 1.63

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count	-5.70 tender joints Standard Error 3.49

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count.	-4.30 tender joints Standard Error 4.47

SECONDARY outcome

Timeframe: 9 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count	-4.80 tender joints Standard Error 4.73

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count	-7.40 tender joints Standard Error 5.33

SECONDARY outcome

Timeframe: 16 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count	-9.60 tender joints Standard Error 5.71

SECONDARY outcome

Timeframe: 20 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count	-8.40 tender joints Standard Error 4.77

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count	-6.80 tender joints Standard Error 5.53

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count	-7.90 swollen joints Standard Error 4.64

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count	-2.50 swollen joints Standard Error 3.66

SECONDARY outcome

Timeframe: 9 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count	-2.30 swollen joints Standard Error 3.33

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count	-6.10 swollen joints Standard Error 2.82

SECONDARY outcome

Timeframe: 16 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count	-9.00 swollen joints Standard Error 4.09

SECONDARY outcome

Timeframe: 20 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count	-9.40 swollen joints Standard Error 3.59

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count	-4.20 swollen joints Standard Error 4.45

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Physical Component Score	11.11 units on a scale Standard Error 3.74

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Physical Component Score	13.09 units on a scale Standard Deviation 3.19

SECONDARY outcome

Timeframe: 9 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Physical Component Score	10.38 units on a scale Standard Error 4.45

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Physical Component Score	13.28 units on a scale Standard Error 3.84

SECONDARY outcome

Timeframe: 16 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Physical Component Score	12.58 units on a scale Standard Error 3.23

SECONDARY outcome

Timeframe: 20 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Physical Component Score	10.12 units on a scale Standard Error 5.48

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Physical Component Score	10.22 units on a scale Standard Error 4.59

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Mental Component Score	7.56 units on a scale Standard Error 4.97

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Mental Component Score	5.95 units on a scale Standard Error 4.01

SECONDARY outcome

Timeframe: 9 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Mental Component Score	8.8 units on a scale Standard Error 4

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Mental Component Score	9.76 units on a scale Standard Error 3.46

SECONDARY outcome

Timeframe: 16 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Mental Component Score	11.74 units on a scale Standard Error 6.42

SECONDARY outcome

Timeframe: 20 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Mental Component Score	12.98 units on a scale Standard Error 3.96

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)

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.)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in SF-36 Mental Component Score	11.46 units on a scale Standard Error 6.46

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

White Blood Cell count change from baseline to 3 months

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in WBCs	0.57 x 10^3 cells/microliter Standard Error 1.17

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

White Blood Cell count change from baseline to 6 months

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in WBCs	-1.29 x 10^3 cells/microliter Standard Error 1.35

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

White Blood Cell count change from baseline to 12 months

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in WBCs	-0.87 x 10^3 cells/microliter Standard Error 1.08

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

White Blood Cell count change from baseline to 24 months

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in WBCs	-2.88 x 10^3 cells/microliter Standard Error 1.43

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Ferritin level change from baseline to 3 months

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Ferritin	-231.80 mcg/L Standard Error 138.11

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Ferritin level change from baseline to 6 months

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Ferritin	-184.80 mcg/L Standard Error 88.19

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Ferritin level change from baseline to 12 months

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Ferritin	331.80 mcg/L Standard Error 575.34

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Ferritin level change from baseline to 24 months

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Ferritin	-263.80 mcg/L Standard Error 114.69

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Serum Amyloid A	-117.80 mg/liter Standard Error 62.54

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Serum Amyloid A	-173.40 mg/liter Standard Error 80.56

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Serum Amyloid A	-274.20 mg/liter Standard Error 103.18

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Serum Amyloid A	-173.25 mg/liter Standard Error 115.86

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in C-Reactive Protein	-4.79 mg/dl Standard Error 2.71

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in C-Reactive Protein	-5.67 mg/dl Standard Error 2.62

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in C-Reactive Protein	-7.06 mg/dl Standard Error 2.38

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in C-Reactive Protein	-4.91 mg/dl Standard Error 1.86

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Erythrocyte Sedimentation Rate	-13.20 mm/hour Standard Error 10.85

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Erythrocyte Sedimentation Rate	-32.40 mm/hour Standard Error 11.12

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Erythrocyte Sedimentation Rate	-34.60 mm/hour Standard Error 14.26

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Erythrocyte Sedimentation Rate	-23.40 mm/hour Standard Error 15.02

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects	-0.16 units on a scale Standard Error 0.79

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects	-0.75 units on a scale Standard Error 0.60

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects	-0.97 units on a scale Standard Error 1.34

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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.

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects	-1.03 units on a scale Standard Error 0.96

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count in AOSD Subjects	1.60 tender joints Standard Error 2.98

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count in AOSD Subjects	-2.00 tender joints Standard Error 1.48

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count in AOSD Subjects	-3.40 tender joints Standard Error 3.06

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Tender Joint Count in AOSD Subjects	-6.80 tender joints Standard Error 3.28

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count in AOSD Subjects	1.20 swollen joints Standard Error 3.89

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count in AOSD Subjects	0.60 swollen joints Standard Error 2.79

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count in AOSD Subjects	-2.40 swollen joints Standard Error 2.60

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

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)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Swollen Joint Count in AOSD Subjects	-2.60 swollen joints Standard Error 1.81

SECONDARY outcome

Timeframe: 3 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Prednisone Dose	-0.50 mg/day Standard Error 1.66

SECONDARY outcome

Timeframe: 6 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Prednisone Dose	-1.50 mg/day Standard Error 7.81

SECONDARY outcome

Timeframe: 12 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Prednisone Dose	-4.10 mg/day Standard Error 6.52

SECONDARY outcome

Timeframe: 24 months

Population: The analyses included only those subjects with Adult Onset Still's Disease (AOSD)

Outcome measures

Outcome measures
Measure	IL-1 Trap n=5 Participants Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Mean Change in Prednisone Dose	-7.00 mg/day Standard Error 7.20

Adverse Events

IL-1 Trap

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IL-1 Trap n=11 participants at risk Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other (Macrophage Activation Syndrome)	9.1% 1/11
Infections and infestations Joint infection-mycobacterium	9.1% 1/11
Infections and infestations Skin Infection-mycobacterium	9.1% 1/11
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	9.1% 1/11
Nervous system disorders Cerebrospinal fluid leakage	9.1% 1/11
Renal and urinary disorders Kidney infection	9.1% 1/11
Renal and urinary disorders Renal Calculi	18.2% 2/11

Other adverse events

Other adverse events
Measure	IL-1 Trap n=11 participants at risk Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
Blood and lymphatic system disorders Anemia	9.1% 1/11
Blood and lymphatic system disorders Blood and lymphatic disorder- other (Iron Deficiency)	9.1% 1/11
Ear and labyrinth disorders Ear disorder - congestion	9.1% 1/11
Ear and labyrinth disorders Hearing impaired	9.1% 1/11
Endocrine disorders Endocrine disorder - other (Inhomogeneous thyroid)	9.1% 1/11
Endocrine disorders Hypothyroidism	9.1% 1/11
Eye disorders Eye disorder - other (Hordeolum)	9.1% 1/11
Eye disorders Eye pain	9.1% 1/11
Gastrointestinal disorders Diarrhea	45.5% 5/11
Gastrointestinal disorders Dry mouth	18.2% 2/11
Gastrointestinal disorders Dyspepsia	9.1% 1/11
Gastrointestinal disorders Gastritis	27.3% 3/11
Gastrointestinal disorders Nausea	18.2% 2/11
Gastrointestinal disorders Stomach pain	27.3% 3/11
Gastrointestinal disorders Toothache	18.2% 2/11
General disorders Fatigue	9.1% 1/11
General disorders Flu like symptoms	18.2% 2/11
General disorders Non-cardiac chest pain	9.1% 1/11
Immune system disorders Allergic reaction	9.1% 1/11
Infections and infestations Bronchial infection	36.4% 4/11
Infections and infestations Enterocolitis infectious	9.1% 1/11
Infections and infestations Eye Infection	9.1% 1/11
Infections and infestations Joint infection	9.1% 1/11
Infections and infestations Kidney infection	18.2% 2/11
Infections and infestations Mucosal infection	18.2% 2/11
Infections and infestations Pharyngitis	27.3% 3/11
Infections and infestations Rhinitis	9.1% 1/11
Infections and infestations Sinusitis	63.6% 7/11
Infections and infestations Skin infection	36.4% 4/11
Infections and infestations Tooth infection	18.2% 2/11
Infections and infestations upper respiratory infection	54.5% 6/11
Infections and infestations Urinary Tract Infection	18.2% 2/11
Infections and infestations Vaginal Infection	9.1% 1/11
Investigations Alanine aminotransferase increased	18.2% 2/11
Investigations Aspartate aminotransferase increased	18.2% 2/11
Investigations Blood gonadotrophin abnormal	9.1% 1/11
Investigations Cholesterol high	27.3% 3/11
Investigations High cholesterol	9.1% 1/11
Investigations Lymphocyte count decreased	9.1% 1/11
Investigations weight gain	27.3% 3/11
Metabolism and nutrition disorders Glucose intolerance	9.1% 1/11
Metabolism and nutrition disorders Hypertriglyceridemia	9.1% 1/11
Musculoskeletal and connective tissue disorders Arthritis	9.1% 1/11
Musculoskeletal and connective tissue disorders Back pain	27.3% 3/11
Musculoskeletal and connective tissue disorders Flank pain	9.1% 1/11
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective tissue disorder - other (Flexion contracture)	9.1% 1/11
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective tissue disorder - other (Ruptured Baker's cyst)	9.1% 1/11
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective tissue disorder -other (Bursa fluid)	9.1% 1/11
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective tissue disorder -other (Bursitis)	9.1% 1/11
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective tissue disorder -other (Synovial cyst)	9.1% 1/11
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11
Musculoskeletal and connective tissue disorders Neck pain	9.1% 1/11
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 1/11
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm, benign, malignant and unspecified (basal cell carcinoma)	9.1% 1/11
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm, benign, malignant and unspecified (cysts and polyps) - Lung nodule	9.1% 1/11
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm, benign, malignant and unspecified (cysts and polyps) - Pilonidal sinus	9.1% 1/11
Nervous system disorders Dysgeusia	9.1% 1/11
Nervous system disorders Headache	36.4% 4/11
Nervous system disorders Memory Impairment	9.1% 1/11
Psychiatric disorders Depression	9.1% 1/11
Psychiatric disorders Insomnia	18.2% 2/11
Psychiatric disorders Libido decreased	9.1% 1/11
Renal and urinary disorders Hematuria	27.3% 3/11
Renal and urinary disorders Renal Calculi	9.1% 1/11
Renal and urinary disorders Urinary urgency	9.1% 1/11
Reproductive system and breast disorders Erectile dysfunction	9.1% 1/11
Reproductive system and breast disorders Irregular Menstruation	9.1% 1/11
Reproductive system and breast disorders Testicular pain	9.1% 1/11
Respiratory, thoracic and mediastinal disorders Cough	27.3% 3/11
Respiratory, thoracic and mediastinal disorders Nasal Congestion	27.3% 3/11
Skin and subcutaneous tissue disorders hyperhidrosis	9.1% 1/11
Skin and subcutaneous tissue disorders Photosensitivity	9.1% 1/11
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11
Skin and subcutaneous tissue disorders Rash Acneiform	9.1% 1/11
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorder - other (Increased skin fold)	9.1% 1/11
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorder - other (skin tear)	9.1% 1/11
Vascular disorders Flushing	9.1% 1/11
Vascular disorders Hypertension	27.3% 3/11

Additional Information

Raphaela Goldbach-Mansky, MD

National Inst of Arthritis and Musculoskeletal and Skin Diseases

Phone: 13014356243

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place