Trial · NCT01794117
Anakinra for Inflammatory Pustular Skin Diseases
NCT01794117, Phase 2, Completed, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); results first posted 2021-04-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Anakinra for Inflammatory Pustular Skin Diseases. Trials, record NCT01794117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01794117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anakinra for Inflammatory Pustular Skin Diseases
- NCT number
- NCT01794117
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Conditions
- Sneddon-Wilkinson, Acrodermatitis Continua of Hallopeau, Pustular Psoriasis, Palmoplantar Pustulosis
- Interventions
- Anakinra
- First posted
- 2013-02-18
- Last updated
- 2021-04-30
- Results first posted
- 2021-04-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Treated With Anakinra Who Achieve 50% Disease Improvement by the End of Week 12, as Measured by Total Body Surface Area Involvement (TBSAI50) | 12 Weeks | Total Body Surface Area Involvement (TBSAI) is defined as the amount of total amount of active disease involvement on a given patient. 50% improvement was the amount of change that we judged at the start of the study would qualify as significant improvement. |
| Other | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Other | Average Change in Total Body Surface Area Index (TBSAI) | Baseline and 12 Weeks | Median difference in affected area of plaque and pustular disease between baseline and week 12. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Treated With Anakinra Who Achieve 50% Disease Improvement by the End of Week 12, as Measured by Total Body Surface Area Involvement (TBSAI50) | 12 Weeks | 14/18 were analyzed because 4 pts did not meet the study primary endpoint (stayed on treatment until 12 wks). The study was not powered nor intended to study/compare differences between dose levels. The dose escalation was done for safety purposes rather than dose finding. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Average Change in Total Body Surface Area Index (TBSAI) | Baseline and 12 Weeks | The study was not powered nor intended to study/compare differences between dose levels. The dose escalation was done for safety purposes rather than dose finding. | Percentage of total skin involvement | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Treated With Anakinra Who Achieve 50% Disease Improvement by the End of Week 12, as Measured by Total Body Surface Area Involvement (TBSAI50) | All Participants | 7 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Week 4 Level 1 Only | 1 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Week 4 Level 1 Followed by Week 8 Level 2 | 3 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2 | 2 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3 | 12 | Participants | ||
| Average Change in Total Body Surface Area Index (TBSAI) | All Participants | -0.9 | Inter-Quartile Range -1.8 to 0.0 | Percentage of total skin involvement |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Week 4 Level 1 Only | 1 | |
| Overall Study | STARTED | Week 4 Level 1 Followed by Week 8 Level 2 | 3 | |
| Overall Study | STARTED | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2 | 2 | |
| Overall Study | STARTED | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3 | 12 | |
| Overall Study | COMPLETED | Week 4 Level 1 Only | 0 | |
| Overall Study | COMPLETED | Week 4 Level 1 Followed by Week 8 Level 2 | 0 | |
| Overall Study | COMPLETED | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2 | 2 | |
| Overall Study | COMPLETED | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3 | 12 | |
| Overall Study | NOT COMPLETED | Week 4 Level 1 Only | 1 | |
| Overall Study | NOT COMPLETED | Week 4 Level 1 Followed by Week 8 Level 2 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events248
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 | Week 4 Level 1 Only | 1 | 1 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Week 4 Level 1 Followed by Week 8 Level 2 | 0 | 3 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2 | 0 | 2 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3 | 0 | 12 | 0 |
| other | Chills | General disorders | Week 4 Level 1 Only | 1 | 1 | 1 |
| other | Chills | General disorders | Week 4 Level 1 Followed by Week 8 Level 2 | 0 | 3 | 0 |
| other | Chills | General disorders | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2 | 0 | 2 | 0 |
| other | Chills | General disorders | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3 | 1 | 12 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Week 4 Level 1 Only | 1 | 1 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Week 4 Level 1 Followed by Week 8 Level 2 | 1 | 3 | 1 |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Week 4 Level 1 Only | 0 | 1 |
| Total, all-cause mortality | Week 4 Level 1 Followed by Week 8 Level 2 | 0 | 3 |
| Total, all-cause mortality | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2 | 0 | 2 |
| Total, all-cause mortality | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3 | 0 | 12 |
| Total, other adverse events | Week 4 Level 1 Only | 1 | 1 |
| Total, other adverse events | Week 4 Level 1 Followed by Week 8 Level 2 | 3 | 3 |
| Total, other adverse events | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2 | 2 | 2 |
| Total, other adverse events | Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3 | 12 | 12 |
| Total, serious adverse events | Week 4 Level 1 Only | 1 | 1 |
| Total, serious adverse events | Week 4 Level 1 Followed by Week 8 Level 2 | 0 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01794117
GET https://conductscience.org/api/trials/v1/NCT01794117/events?page=2