Trial · NCT00094900
Interleukin-1 Trap to Treat Autoinflammatory Diseases
NCT00094900, Phase 2, Completed, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); results first posted 2013-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Interleukin-1 Trap to Treat Autoinflammatory Diseases. Trials, record NCT00094900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00094900
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interleukin-1 Trap to Treat Autoinflammatory Diseases
- NCT number
- NCT00094900
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Conditions
- Inflammation, Familial Mediterranean Fever, Still's Disease, Adult-Onset
- Interventions
- IL-1 Trap
- First posted
- 2004-10-28
- Last updated
- 2014-03-04
- Results first posted
- 2013-07-10
- Limitations and caveats
Secondary outcome analyses will be stratified based on primary outcome results - responders and non-responders.~1 subject with Familial Mediterranean Fever (FMF) was recruited but outcomes were not collected due to insufficient accrual of FMF cases.
Source ClinicalTrials.gov
Registered outcomes97
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Daily Scores | 10 days for 4 patient, 6 days for 1 patient | 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). |
| Primary | Mean Change in ESR | 10 days for 4 patient, 6 days for 1 patient | ESR change from baseline to 10 days.The Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured to evaluate lab parameters of inflammation |
| Primary | Mean Change in hsCRP | 10 days for 4 patient, 6 days for 1 patient | 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 |
| Primary | Mean Change in SAA | 10 days for 4 patient, 6 days for 1 patient | SAA change from baseline to 10 days.The serum Amyloid A (SAA) is an acute phase reactant measured to evaluate lab parameters of inflammation |
| Primary | Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease | 24 months | 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. |
| Secondary | Mean Change in Patient's Global Assessment, by VAS | 3 months | 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. |
| Secondary | Mean Change in Patient's Global Assessment, by VAS | 6 months | 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. |
| Secondary | Mean Change in Patient's Global Assessment, by VAS | 9 months | 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. |
| Secondary | Mean Change in Patient's Global Assessment, by VAS | 12 months | 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. |
| Secondary | Mean Change in Patient's Global Assessment, by VAS | 16 months | 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. |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 registered outcomesOutcomes97
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Daily Scores | 10 days for 4 patient, 6 days for 1 patient | The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS) | units on a scale | MEAN |
| PRIMARY | Mean Change in ESR | 10 days for 4 patient, 6 days for 1 patient | The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS) | mm/hour | MEAN |
| PRIMARY | Mean Change in hsCRP | 10 days for 4 patient, 6 days for 1 patient | The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS) | mg/dl | MEAN |
| PRIMARY | Mean Change in SAA | 10 days for 4 patient, 6 days for 1 patient | The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS) | mg/liter | MEAN |
| PRIMARY | Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease | 24 months | The analyses included only those subjects with Adult Onset Still's Disease (AOSD) | participants | NUMBER |
| SECONDARY | Mean Change in Patient's Global Assessment, by VAS | 3 months | The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS) | units on a scale | MEAN |
| SECONDARY | Mean Change in Patient's Global Assessment, by VAS | 6 months | The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS) | units on a scale | MEAN |
| SECONDARY | Mean Change in Patient's Global Assessment, by VAS | 9 months | The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS) | units on a scale | MEAN |
| SECONDARY | Mean Change in Patient's Global Assessment, by VAS | 12 months | The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS) | units on a scale | MEAN |
| SECONDARY | Mean Change in Patient's Global Assessment, by VAS | 16 months | The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS) | units on a scale | MEAN |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 outcomesResults by group97
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Daily Scores | IL-1 Trap | -3.09 | Standard Error 1.03 | units on a scale | |
| Mean Change in ESR | IL-1 Trap | -32.2 | Standard Error 7.31 | mm/hour | |
| Mean Change in hsCRP | IL-1 Trap | -4.22 | Standard Error 0.98 | mg/dl | |
| Mean Change in SAA | IL-1 Trap | -216.1 | Standard Error 92.14 | mg/liter | |
| Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease | IL-1 Trap | 3 | participants | ||
| Mean Change in Patient's Global Assessment, by VAS | IL-1 Trap | -5.29 | Standard Error 0.67 | units on a scale | |
| Mean Change in Patient's Global Assessment, by VAS | IL-1 Trap | -2.56 | Standard Error 1.27 | units on a scale | |
| Mean Change in Patient's Global Assessment, by VAS | IL-1 Trap | -2.63 | Standard Error 1.19 | units on a scale | |
| Mean Change in Patient's Global Assessment, by VAS | IL-1 Trap | -2.86 | Standard Error 1.24 | units on a scale | |
| Mean Change in Patient's Global Assessment, by VAS | IL-1 Trap | -3.40 | Standard Error 0.98 | units on a scale |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IL-1 Trap | 11 | |
| Overall Study | COMPLETED | IL-1 Trap | 10 | |
| Overall Study | NOT COMPLETED | IL-1 Trap | 1 |
Source ClinicalTrials.gov
Adverse events85
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 | Anemia | Blood and lymphatic system disorders | IL-1 Trap | 1 | 11 | |
| other | Blood and lymphatic disorder- other (Iron Deficiency) | Blood and lymphatic system disorders | IL-1 Trap | 1 | 11 | |
| other | Ear disorder - congestion | Ear and labyrinth disorders | IL-1 Trap | 1 | 11 | |
| other | Hearing impaired | Ear and labyrinth disorders | IL-1 Trap | 1 | 11 | |
| other | Endocrine disorder - other (Inhomogeneous thyroid) | Endocrine disorders | IL-1 Trap | 1 | 11 | |
| other | Hypothyroidism | Endocrine disorders | IL-1 Trap | 1 | 11 | |
| other | Eye disorder - other (Hordeolum) | Eye disorders | IL-1 Trap | 1 | 11 | |
| other | Eye pain | Eye disorders | IL-1 Trap | 1 | 11 | |
| other | Diarrhea | Gastrointestinal disorders | IL-1 Trap | 5 | 11 | |
| other | Dry mouth | Gastrointestinal disorders | IL-1 Trap | 2 | 11 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IL-1 Trap | ||
| Total, other adverse events | IL-1 Trap | 11 | 11 |
| Total, serious adverse events | IL-1 Trap | 5 | 11 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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/NCT00094900
GET https://conductscience.org/api/trials/v1/NCT00094900/registered?page=2