Trial · NCT00069329
Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease
NCT00069329, Phase 1, Phase 2, Terminated, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); results first posted 2016-12-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease. Trials, record NCT00069329. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00069329
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease
- NCT number
- NCT00069329
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Conditions
- Nervous System Malformations, Arthropathy, Neurogenic, Urticaria, Papilledema
- Interventions
- anakinra
- First posted
- 2003-09-23
- Last updated
- 2016-12-01
- Results first posted
- 2016-12-01
- Limitations and caveats
- Data reported is on 26 patients who completed their 3 year assessment and 20 of these patients also completed their 5 year assessment.
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | Baseline | "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." |
| Primary | Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | 36 months | "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." |
| Primary | Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | 60 months | "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." |
| Primary | Patient / Parent Global Score of Overall Disease Activity | Baseline | 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). |
| Primary | Patient / Parent Global Score of Overall Disease Activity | 36 months | 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). |
| Primary | Patient / Parent Global Score of Overall Disease Activity | 60 months | 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). |
| Primary | Parent /Patient Pain Rating | Baseline | 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). |
| Primary | Parent /Patient Pain Rating | 36 months | 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). |
| Primary | Parent /Patient Pain Rating | 60 months | 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). |
| Primary | Childhood Health Assessment Questionnaire (CHAQ) | Baseline | 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). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | Baseline | 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. | units on a scale | MEAN |
| PRIMARY | Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | 36 months | 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. | units on a scale | MEAN |
| PRIMARY | Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | 60 months | 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. | units on a scale | MEAN |
| PRIMARY | Patient / Parent Global Score of Overall Disease Activity | Baseline | 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. | units on a scale | MEAN |
| PRIMARY | Patient / Parent Global Score of Overall Disease Activity | 36 months | 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. | units on a scale | MEAN |
| PRIMARY | Patient / Parent Global Score of Overall Disease Activity | 60 months | 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. | units on a scale | MEAN |
| PRIMARY | Parent /Patient Pain Rating | Baseline | 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. | units on a scale | MEAN |
| PRIMARY | Parent /Patient Pain Rating | 36 months | 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. | units on a scale | MEAN |
| PRIMARY | Parent /Patient Pain Rating | 60 months | 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. | units on a scale | MEAN |
| PRIMARY | Childhood Health Assessment Questionnaire (CHAQ) | Baseline | 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. | units on a scale | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | NOMID | 0.75741904 | Standard Deviation 0.08370955 | units on a scale | |
| Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | NOMID | 0.08704545 | Standard Deviation 0.02470396 | units on a scale | |
| Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | NOMID | 0.10768421 | Standard Deviation 0.04158048 | units on a scale | |
| Patient / Parent Global Score of Overall Disease Activity | NOMID | 40.22381 | Standard Deviation 4.6242215 | units on a scale | |
| Patient / Parent Global Score of Overall Disease Activity | NOMID | 8.1923077 | Standard Deviation 2.7291978 | units on a scale | |
| Patient / Parent Global Score of Overall Disease Activity | NOMID | 11.1 | Standard Deviation 3.6322025 | units on a scale | |
| Parent /Patient Pain Rating | NOMID | 41.22381 | Standard Deviation 4.9988185 | units on a scale | |
| Parent /Patient Pain Rating | NOMID | 8.9423077 | Standard Deviation 2.892075 | units on a scale | |
| Parent /Patient Pain Rating | NOMID | 9.8525 | Standard Deviation 3.1635745 | units on a scale | |
| Childhood Health Assessment Questionnaire (CHAQ) | NOMID | 1.1051429 | Standard Deviation 0.21122155 | units on a scale |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NOMID | 43 | |
| Overall Study | COMPLETED | NOMID | 41 | |
| Overall Study | NOT COMPLETED | NOMID | 2 |
Source ClinicalTrials.gov
Adverse events297
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angiodema Right ring finger | Cardiac disorders | NOMID | 1 | 43 | |
| other | Chest wall pain | Cardiac disorders | NOMID | 4 | 43 | |
| other | Hypertension | Cardiac disorders | NOMID | 1 | 43 | |
| other | Palpitations | Cardiac disorders | NOMID | 1 | 43 | |
| other | Sinus tachycardia | Cardiac disorders | NOMID | 1 | 43 | |
| other | Vasovagal reaction | Cardiac disorders | NOMID | 2 | 43 | |
| other | ear drainage | Ear and labyrinth disorders | NOMID | 1 | 43 | |
| other | ear pain | Ear and labyrinth disorders | NOMID | 1 | 43 | |
| other | Hearing impaired | Ear and labyrinth disorders | NOMID | 2 | 43 | |
| other | Tinnitus | Ear and labyrinth disorders | NOMID | 1 | 43 |
1 to 10 of 297Source ClinicalTrials.gov
See all 297 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NOMID | ||
| Total, other adverse events | NOMID | 43 | 43 |
| Total, serious adverse events | NOMID | 18 | 43 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| ZIAAR041138 | Pathogenesis and treatment of autoinflammatory diseases i.e.NOMID,DIRA,CANDLE, SAVI and others | GOLDBACH-MANSKY, RAPHAELA | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2009 to 2016 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00069329
GET https://conductscience.org/api/trials/v1/NCT00069329/registered?page=2