Trial Outcomes & Findings for Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease (NCT NCT00069329)
NCT ID: NCT00069329
Last Updated: 2016-12-01
Results Overview
"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."
TERMINATED
PHASE1/PHASE2
43 participants
Baseline
2016-12-01
Participant Flow
Participant milestones
| Measure |
NOMID
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease
Baseline characteristics by cohort
| Measure |
NOMID
n=43 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Age, Categorical
<=18 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)
|
0.75741904 units on a scale
Standard Deviation 0.08370955
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)
|
0.08704545 units on a scale
Standard Deviation 0.02470396
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.
"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."
Outcome measures
| Measure |
NOMID
n=20 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)
|
0.10768421 units on a scale
Standard Deviation 0.04158048
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Patient / Parent Global Score of Overall Disease Activity
|
40.22381 units on a scale
Standard Deviation 4.6242215
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Patient / Parent Global Score of Overall Disease Activity
|
8.1923077 units on a scale
Standard Deviation 2.7291978
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.
Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).
Outcome measures
| Measure |
NOMID
n=20 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Patient / Parent Global Score of Overall Disease Activity
|
11.1 units on a scale
Standard Deviation 3.6322025
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Parent /Patient Pain Rating
|
41.22381 units on a scale
Standard Deviation 4.9988185
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Parent /Patient Pain Rating
|
8.9423077 units on a scale
Standard Deviation 2.892075
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.
Visual Analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).
Outcome measures
| Measure |
NOMID
n=20 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Parent /Patient Pain Rating
|
9.8525 units on a scale
Standard Deviation 3.1635745
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Childhood Health Assessment Questionnaire (CHAQ)
|
1.1051429 units on a scale
Standard Deviation 0.21122155
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Childhood Health Assessment Questionnaire (CHAQ)
|
0.66346154 units on a scale
Standard Deviation 0.15898857
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.
Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).
Outcome measures
| Measure |
NOMID
n=20 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Childhood Health Assessment Questionnaire (CHAQ)
|
0.590625 units on a scale
Standard Deviation 0.180202
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Serum Amyloid A (SAA) Measurement
|
220.28077 mg/liter
Standard Deviation 38.27684
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Serum Amyloid A (SAA) Measurement
|
22.333333 mg/liter
Standard Deviation 7.5122284
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.
Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.
Outcome measures
| Measure |
NOMID
n=20 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Serum Amyloid A (SAA) Measurement
|
21.3125 mg/liter
Standard Deviation 11.586169
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
C-reactive Protein (CRP) Measurement
|
57.703077 mg/dl
Standard Deviation 7.2213655
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
C-reactive Protein (CRP) Measurement
|
8.7511538 mg/dl
Standard Deviation 2.2674947
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.
C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.
Outcome measures
| Measure |
NOMID
n=20 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
C-reactive Protein (CRP) Measurement
|
6.0585 mg/dl
Standard Deviation 2.3462251
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR) Measurement
|
56.923077 mm/hour
Standard Deviation 6.3138244
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.
Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.
Outcome measures
| Measure |
NOMID
n=26 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR) Measurement
|
11.576923 mm/hour
Standard Deviation 1.3222045
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.
Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.
Outcome measures
| Measure |
NOMID
n=20 Participants
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR) Measurement
|
11.35 mm/hour
Standard Deviation 2.4355103
|
Adverse Events
NOMID
Serious adverse events
| Measure |
NOMID
n=43 participants at risk
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Cardiac disorders
hospital admission for cardiac catheterization
|
2.3%
1/43
|
|
Eye disorders
Uveitis
|
2.3%
1/43
|
|
Gastrointestinal disorders
diarrhea
|
2.3%
1/43
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
1/43
|
|
Gastrointestinal disorders
vomiting
|
2.3%
1/43
|
|
Immune system disorders
Cytokine release syndrome
|
2.3%
1/43
|
|
Infections and infestations
Acute Tonsillitis/tooth abscess
|
2.3%
1/43
|
|
Infections and infestations
Appendicitis
|
2.3%
1/43
|
|
Infections and infestations
Arthritis
|
2.3%
1/43
|
|
Infections and infestations
Cellulitis Right lower extremity
|
2.3%
1/43
|
|
Infections and infestations
Left cervical lymphadenitis
|
2.3%
1/43
|
|
Infections and infestations
Lung infection
|
4.7%
2/43
|
|
Infections and infestations
Meningitis
|
2.3%
1/43
|
|
Infections and infestations
Pneumonitis
|
2.3%
1/43
|
|
Infections and infestations
Right ankle cellulitis
|
2.3%
1/43
|
|
Infections and infestations
Wound infection
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Metabolic toxicity
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Pain
|
2.3%
1/43
|
|
Nervous system disorders
Headache
|
11.6%
5/43
|
|
Nervous system disorders
Meningitis
|
2.3%
1/43
|
|
Nervous system disorders
Pain
|
2.3%
1/43
|
|
Nervous system disorders
Seizure
|
2.3%
1/43
|
|
Renal and urinary disorders
Renal calculi
|
2.3%
1/43
|
|
Reproductive system and breast disorders
Double Mastectomy
|
2.3%
1/43
|
|
Reproductive system and breast disorders
Low grade focal ductal carcinoma in-situ of left breast
|
2.3%
1/43
|
|
Reproductive system and breast disorders
Right breast inflammation post surgery
|
2.3%
1/43
|
|
Reproductive system and breast disorders
Right breast scar/fibrotic tissue excised from inplant capsule
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Hospitalized for Rash
|
2.3%
1/43
|
|
Surgical and medical procedures
Bilateral Capsulectomy with permenant implants
|
2.3%
1/43
|
|
Surgical and medical procedures
L ureter stent placed
|
2.3%
1/43
|
|
Surgical and medical procedures
Left renal stent removal
|
2.3%
1/43
|
|
Surgical and medical procedures
Lithotripsy
|
2.3%
1/43
|
|
Surgical and medical procedures
Post-Surgery Pneumonia
|
2.3%
1/43
|
|
Surgical and medical procedures
Suicidal ideation
|
2.3%
1/43
|
Other adverse events
| Measure |
NOMID
n=43 participants at risk
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
|
|---|---|
|
Renal and urinary disorders
Hematuria
|
2.3%
1/43
|
|
Renal and urinary disorders
Ketonuria
|
2.3%
1/43
|
|
Renal and urinary disorders
metabolic (elevated BUN)
|
2.3%
1/43
|
|
Renal and urinary disorders
metabolic / Laboratory - Other - elevated Blood Urea Nitrogen
|
2.3%
1/43
|
|
Renal and urinary disorders
Proteinuria
|
2.3%
1/43
|
|
Renal and urinary disorders
Renal calculi
|
4.7%
2/43
|
|
Renal and urinary disorders
Renal colic
|
2.3%
1/43
|
|
Renal and urinary disorders
Upper respiratory infection
|
4.7%
2/43
|
|
Renal and urinary disorders
Urinary incontinence
|
2.3%
1/43
|
|
Renal and urinary disorders
Urinary tract infection
|
7.0%
3/43
|
|
Renal and urinary disorders
Urinary tract pain
|
4.7%
2/43
|
|
Reproductive system and breast disorders
Breakthrough bleeding (menstrual)
|
2.3%
1/43
|
|
Reproductive system and breast disorders
Phantom pain of breats bilateraly
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.3%
1/43
|
|
Cardiac disorders
Angiodema Right ring finger
|
2.3%
1/43
|
|
Cardiac disorders
Chest wall pain
|
9.3%
4/43
|
|
Cardiac disorders
Hypertension
|
2.3%
1/43
|
|
Cardiac disorders
Palpitations
|
2.3%
1/43
|
|
Cardiac disorders
Sinus tachycardia
|
2.3%
1/43
|
|
Cardiac disorders
Vasovagal reaction
|
4.7%
2/43
|
|
Ear and labyrinth disorders
ear drainage
|
2.3%
1/43
|
|
Ear and labyrinth disorders
ear pain
|
2.3%
1/43
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.7%
2/43
|
|
Ear and labyrinth disorders
Tinnitus
|
2.3%
1/43
|
|
Endocrine disorders
Hypothyroidism
|
2.3%
1/43
|
|
Endocrine disorders
weight gain
|
4.7%
2/43
|
|
Eye disorders
Conjunctivitis
|
37.2%
16/43
|
|
Eye disorders
Dry eye
|
2.3%
1/43
|
|
Eye disorders
Eye infection
|
2.3%
1/43
|
|
Eye disorders
eye inflammation (left)
|
2.3%
1/43
|
|
Eye disorders
Eye pain
|
9.3%
4/43
|
|
Eye disorders
eye throbbing
|
2.3%
1/43
|
|
Eye disorders
foreign body in eye
|
2.3%
1/43
|
|
Eye disorders
Glaucoma
|
2.3%
1/43
|
|
Eye disorders
hemmorage in eye
|
2.3%
1/43
|
|
Eye disorders
itchy eyes
|
2.3%
1/43
|
|
Eye disorders
Nystagmus
|
4.7%
2/43
|
|
Eye disorders
Pain in extremity
|
2.3%
1/43
|
|
Eye disorders
sty on left eye
|
2.3%
1/43
|
|
Eye disorders
vision - eye twitch
|
2.3%
1/43
|
|
Gastrointestinal disorders
Abdominal pain
|
16.3%
7/43
|
|
Gastrointestinal disorders
Alanine aminotransferase increased
|
4.7%
2/43
|
|
Gastrointestinal disorders
Anorexia
|
2.3%
1/43
|
|
Gastrointestinal disorders
Aspartate aminotransferase increased
|
2.3%
1/43
|
|
Gastrointestinal disorders
canker sore
|
2.3%
1/43
|
|
Gastrointestinal disorders
Cold Sore on Gums
|
2.3%
1/43
|
|
Gastrointestinal disorders
Constipation
|
9.3%
4/43
|
|
Gastrointestinal disorders
Diarrhea
|
23.3%
10/43
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
1/43
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
1/43
|
|
Gastrointestinal disorders
Gastritis
|
14.0%
6/43
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
14.0%
6/43
|
|
Gastrointestinal disorders
Increased Liver Enzymes
|
2.3%
1/43
|
|
Gastrointestinal disorders
Nausea
|
14.0%
6/43
|
|
Gastrointestinal disorders
Uveitis
|
2.3%
1/43
|
|
Gastrointestinal disorders
vomiting
|
20.9%
9/43
|
|
Gastrointestinal disorders
Weight loss
|
2.3%
1/43
|
|
General disorders
Disease Flare
|
2.3%
1/43
|
|
General disorders
Fatigue
|
16.3%
7/43
|
|
General disorders
Flare Symptoms (pt had 1 week of no anakinra)
|
2.3%
1/43
|
|
General disorders
Flare, ran out of anakinra
|
2.3%
1/43
|
|
General disorders
Insomnia
|
16.3%
7/43
|
|
General disorders
Irritability
|
2.3%
1/43
|
|
General disorders
Malaise
|
4.7%
2/43
|
|
General disorders
NOMID Flare
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
bicarbonate
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
blood / Bone Marrow - Other - elevated Hematocrit
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
blood / Bone Marrow - Other - eosinophilia
|
4.7%
2/43
|
|
Blood and lymphatic system disorders
blood / Bone Marrow - Other - low reticulocyte count
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
Bruising
|
9.3%
4/43
|
|
Blood and lymphatic system disorders
Epistaxis
|
9.3%
4/43
|
|
Blood and lymphatic system disorders
hemoglobin
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
Hyponatremia
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
Proteinuria
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
Transient elevation of LFT's
|
2.3%
1/43
|
|
Immune system disorders
Allergic reaction
|
4.7%
2/43
|
|
Immune system disorders
Allergic rhinitis
|
2.3%
1/43
|
|
Infections and infestations
Allergic rhinitis
|
7.0%
3/43
|
|
Infections and infestations
Blastocystis Hominis Infection
|
2.3%
1/43
|
|
Infections and infestations
bowel abcess
|
2.3%
1/43
|
|
Infections and infestations
Bronchial infection
|
11.6%
5/43
|
|
Infections and infestations
Candida on palms and soles of feet bilaterally
|
2.3%
1/43
|
|
Infections and infestations
C-Diff Recurrence
|
2.3%
1/43
|
|
Infections and infestations
Chest Infection (?Pneumonia)
|
2.3%
1/43
|
|
Infections and infestations
Chest wall pain
|
2.3%
1/43
|
|
Infections and infestations
Chills
|
2.3%
1/43
|
|
Infections and infestations
Conjunctivitis
|
9.3%
4/43
|
|
Infections and infestations
Croup
|
2.3%
1/43
|
|
Infections and infestations
ear drainage
|
2.3%
1/43
|
|
Infections and infestations
Ear pain
|
2.3%
1/43
|
|
Infections and infestations
Eczema / Atopic Dermatitis
|
2.3%
1/43
|
|
Infections and infestations
External ear inflammation
|
32.6%
14/43
|
|
Infections and infestations
Fever
|
37.2%
16/43
|
|
Infections and infestations
Flu like symptoms
|
34.9%
15/43
|
|
Infections and infestations
Folliculitis - L-Groin
|
2.3%
1/43
|
|
Infections and infestations
G Tube Infection
|
2.3%
1/43
|
|
Infections and infestations
Gastritis
|
16.3%
7/43
|
|
Infections and infestations
Gastrointestinal pain
|
2.3%
1/43
|
|
Infections and infestations
Hand-Foot-Mouth Disease
|
2.3%
1/43
|
|
Infections and infestations
Headache
|
2.3%
1/43
|
|
Infections and infestations
Hearing impaired
|
4.7%
2/43
|
|
Infections and infestations
Hypopyon - Left eye
|
2.3%
1/43
|
|
Infections and infestations
infected finger
|
2.3%
1/43
|
|
Infections and infestations
infection without Neutropenia
|
2.3%
1/43
|
|
Infections and infestations
infection without Neutropenia - (yeast)
|
2.3%
1/43
|
|
Infections and infestations
infection without Neutropenia - Left arm thrombophlebitis
|
2.3%
1/43
|
|
Infections and infestations
infection without Neutropenia - tonsillitis with sore throat
|
2.3%
1/43
|
|
Infections and infestations
infection without Neutropenia (tooth abcess)
|
2.3%
1/43
|
|
Infections and infestations
itchy
|
2.3%
1/43
|
|
Infections and infestations
Lice
|
2.3%
1/43
|
|
Infections and infestations
Lung infection
|
7.0%
3/43
|
|
Infections and infestations
Mouth Infection
|
2.3%
1/43
|
|
Infections and infestations
mouth sores
|
2.3%
1/43
|
|
Infections and infestations
Nasal congestion
|
20.9%
9/43
|
|
Infections and infestations
Oral Ulcer
|
2.3%
1/43
|
|
Infections and infestations
Otitis externa
|
4.7%
2/43
|
|
Infections and infestations
Otitis media
|
23.3%
10/43
|
|
Infections and infestations
Pharyngitis
|
7.0%
3/43
|
|
Infections and infestations
Pneumonitis
|
2.3%
1/43
|
|
Infections and infestations
R ear D/C
|
2.3%
1/43
|
|
Infections and infestations
Red & burning sensation on bottom of feet
|
2.3%
1/43
|
|
Infections and infestations
ringworm
|
2.3%
1/43
|
|
Infections and infestations
Rotaviral Infection
|
2.3%
1/43
|
|
Infections and infestations
RSV (Resp. Syncytial Virus)
|
2.3%
1/43
|
|
Infections and infestations
RSV infection
|
2.3%
1/43
|
|
Infections and infestations
Scalp Lesion (? Tinea capitis)
|
2.3%
1/43
|
|
Infections and infestations
scarlett fever
|
2.3%
1/43
|
|
Infections and infestations
Shingles
|
2.3%
1/43
|
|
Infections and infestations
Sinusitis
|
34.9%
15/43
|
|
Infections and infestations
Skin infection
|
2.3%
1/43
|
|
Infections and infestations
sore throat
|
23.3%
10/43
|
|
Infections and infestations
Strep throat
|
4.7%
2/43
|
|
Infections and infestations
strep throat (2x)
|
2.3%
1/43
|
|
Infections and infestations
Stye
|
2.3%
1/43
|
|
Infections and infestations
Throat infection
|
2.3%
1/43
|
|
Infections and infestations
Tooth infection (?abscess)
|
2.3%
1/43
|
|
Infections and infestations
Upper respiratory infection
|
44.2%
19/43
|
|
Infections and infestations
Urinary tract infection
|
9.3%
4/43
|
|
Infections and infestations
Urinary tract pain
|
11.6%
5/43
|
|
Infections and infestations
Viral Illness
|
4.7%
2/43
|
|
Infections and infestations
Viral Illness Dehydration
|
2.3%
1/43
|
|
Infections and infestations
Viral Infection
|
9.3%
4/43
|
|
Infections and infestations
Viral Infection Fever, Lethargy
|
2.3%
1/43
|
|
Infections and infestations
Vision loss
|
2.3%
1/43
|
|
Infections and infestations
yeast infection
|
2.3%
1/43
|
|
Injury, poisoning and procedural complications
Auto Accident
|
2.3%
1/43
|
|
Injury, poisoning and procedural complications
Fall
|
16.3%
7/43
|
|
Injury, poisoning and procedural complications
Physical Assault
|
2.3%
1/43
|
|
Investigations
CPK increased
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Weight gain
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Anxiety
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.2%
16/43
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.3%
7/43
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Conjunctivitis
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Dysmenorrhea
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Edema limbs
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
11.6%
5/43
|
|
Musculoskeletal and connective tissue disorders
Flu like symptoms
|
4.7%
2/43
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
7.0%
3/43
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
9.3%
4/43
|
|
Musculoskeletal and connective tissue disorders
Malaise
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
3/43
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.3%
7/43
|
|
Musculoskeletal and connective tissue disorders
Osgood-Schlatter
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
pain
|
14.0%
6/43
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
32.6%
14/43
|
|
Musculoskeletal and connective tissue disorders
restless leg syndrome
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
S/P L Knee growth plate fixation/fever thematoma
|
2.3%
1/43
|
|
Nervous system disorders
A.D.D.
|
2.3%
1/43
|
|
Nervous system disorders
Allergic reaction
|
2.3%
1/43
|
|
Nervous system disorders
Anxiety
|
2.3%
1/43
|
|
Nervous system disorders
Blurred vision
|
4.7%
2/43
|
|
Nervous system disorders
carpal tunnel - right
|
2.3%
1/43
|
|
Nervous system disorders
cerebrospinal fluid leakage
|
2.3%
1/43
|
|
Nervous system disorders
Dizziness
|
9.3%
4/43
|
|
Nervous system disorders
External ear pain
|
2.3%
1/43
|
|
Nervous system disorders
Fever
|
2.3%
1/43
|
|
Nervous system disorders
Generalized muscle weakness
|
2.3%
1/43
|
|
Nervous system disorders
Glaucoma
|
2.3%
1/43
|
|
Nervous system disorders
Headache
|
53.5%
23/43
|
|
Nervous system disorders
Hearing impaired
|
7.0%
3/43
|
|
Nervous system disorders
Hoarseness
|
2.3%
1/43
|
|
Nervous system disorders
Nausea
|
2.3%
1/43
|
|
Nervous system disorders
Neck pain
|
2.3%
1/43
|
|
Nervous system disorders
Pain in extremity
|
2.3%
1/43
|
|
Nervous system disorders
Paresthesia of R hand suggestive of carpel tunnel
|
2.3%
1/43
|
|
Nervous system disorders
Saccadic Pursuit Neuropathy - Cranial
|
2.3%
1/43
|
|
Nervous system disorders
Seizure
|
2.3%
1/43
|
|
Nervous system disorders
Uveitis
|
2.3%
1/43
|
|
Nervous system disorders
Vertigo
|
7.0%
3/43
|
|
Nervous system disorders
vomiting
|
2.3%
1/43
|
|
Renal and urinary disorders
Bladder infection
|
4.7%
2/43
|
|
Renal and urinary disorders
Catheter related infection
|
2.3%
1/43
|
|
Renal and urinary disorders
Flank pain
|
2.3%
1/43
|
|
Renal and urinary disorders
glucosuria
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.9%
9/43
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
2/43
|
|
Respiratory, thoracic and mediastinal disorders
Gait disturbance
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.7%
2/43
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
4.7%
2/43
|
|
Skin and subcutaneous tissue disorders
bug bite
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
cyst on Right cheek
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
3/43
|
|
Skin and subcutaneous tissue disorders
Eczema (contact dermatitis)
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
eczematous reaction to injection
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Erythema Left Foot
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
eye swollen
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
fungal rash
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
hive
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
hives
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Hot/diaphoretic in summer months - rash at beltline
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Ingrown toenail
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
23.3%
10/43
|
|
Skin and subcutaneous tissue disorders
Intermittent rash on body
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
lesion on scrotum
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Oral Ulcers
|
4.7%
2/43
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Penile pain
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Perineal pain
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
R. 2nd toenail injury with ingrown nail
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.2%
13/43
|
|
Skin and subcutaneous tissue disorders
Rash - (contact dermatitis)
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Rash - adhesive (IV site)
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Rash - Bugbite - R ear
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Rash - Lichenified rash on glutial crack
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Rash - Reaction to U-bag
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Rash (viral infection)
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
rash / desquamation
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Rash arms, trunk, legs
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Rash on Arms
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Rash on Right Leg
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
rashes
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
red cheeks
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Red Dots
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
red dots - rash
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Red Dots on Arm
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
2.3%
1/43
|
|
Surgical and medical procedures
Cesarean Section
|
2.3%
1/43
|
|
Surgical and medical procedures
Dental Surgery Outpatient
|
2.3%
1/43
|
|
Surgical and medical procedures
Elective L cochlear implant surgery
|
2.3%
1/43
|
|
Surgical and medical procedures
Elective Osteotomy
|
2.3%
1/43
|
|
Surgical and medical procedures
Endoscopy to replace G Tube
|
2.3%
1/43
|
|
Surgical and medical procedures
eye surgery
|
2.3%
1/43
|
|
Surgical and medical procedures
hand surgery - carpal tunnel
|
2.3%
1/43
|
|
Surgical and medical procedures
Kidney Stent removal
|
2.3%
1/43
|
|
Surgical and medical procedures
Lithotripsy/stent removed
|
2.3%
1/43
|
|
Surgical and medical procedures
Placement of BMT (tubes)
|
2.3%
1/43
|
|
Surgical and medical procedures
staples in knee (surgery)
|
2.3%
1/43
|
|
Surgical and medical procedures
Surgery Adenoidectomy, Placement of bilateral myringotomy tubes
|
2.3%
1/43
|
|
Surgical and medical procedures
surgery for cyst removal
|
2.3%
1/43
|
|
Surgical and medical procedures
surgery on right knee
|
2.3%
1/43
|
|
Surgical and medical procedures
surgery on wrist
|
2.3%
1/43
|
|
Surgical and medical procedures
Tonsillectomy
|
2.3%
1/43
|
|
Surgical and medical procedures
Ureteral stent for renal calculi - Right kidney
|
2.3%
1/43
|
|
Surgical and medical procedures
Wisdom Teeth Extraction
|
2.3%
1/43
|
|
Vascular disorders
hypertension
|
2.3%
1/43
|
Additional Information
Goldbach-Mansky, Raphaela
National Inst of Arthritis and Musculoskeletal and Skin Diseases
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place