Trial · NCT01276314
Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions
NCT01276314, Not applicable, Completed, Chang Gung Memorial Hospital; results first posted 2017-12-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions. Trials, record NCT01276314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01276314
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions
- NCT number
- NCT01276314
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 135 participants, actual
- Lead sponsor
- Chang Gung Memorial Hospital
- Conditions
- Drug Hypersensitivity
- Interventions
- anti- TNF-a, Prednisolone
- First posted
- 2011-01-13
- Last updated
- 2017-12-19
- Results first posted
- 2017-12-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Skin Healing Time | One to two months for SJS/TEN cases, and one to six months for DRESS cases. | Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Skin Healing Time | One to two months for SJS/TEN cases, and one to six months for DRESS cases. | We determined if the enrolled participants had SJS/TEN and DRESS using the criteria and histopathological examinations. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Skin Healing Time | Anti- TNF-a Treatment (SJS/TEN) | 13.75 | Full Range 4 to 41 | days | |
| Skin Healing Time | Control Group (SJS/TEN) | 19 | Full Range 7 to 42 | days | |
| Skin Healing Time | Anti- TNF-a Treatment (DRESS) | 40.5 | Full Range 18 to 117 | days | |
| Skin Healing Time | Control Group (DRESS) | 34 | Full Range 9 to 165 | days |
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 | Anti- TNF-a Treatment (SJS/TEN) | 48 | |
| Overall Study | STARTED | Control Group (SJS/TEN) | 43 | |
| Overall Study | STARTED | Anti- TNF-a Treatment (DRESS) | 22 | |
| Overall Study | STARTED | Control Group (DRESS) | 22 | |
| Overall Study | COMPLETED | Anti- TNF-a Treatment (SJS/TEN) | 38 | |
| Overall Study | COMPLETED | Control Group (SJS/TEN) | 33 | |
| Overall Study | COMPLETED | Anti- TNF-a Treatment (DRESS) | 18 | |
| Overall Study | COMPLETED | Control Group (DRESS) | 17 | |
| Overall Study | NOT COMPLETED | Anti- TNF-a Treatment (SJS/TEN) | 10 | |
| Overall Study | NOT COMPLETED | Control Group (SJS/TEN) | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
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 | Hypertension | Vascular disorders | Anti- TNF-a Treatment (SJS/TEN) | 6 | 48 | 6 |
| other | Hypertension | Vascular disorders | Control Group (SJS/TEN) | 5 | 43 | 5 |
| other | Hypertension | Vascular disorders | Anti- TNF-a Treatment (DRESS) | 3 | 22 | 3 |
| other | Hypertension | Vascular disorders | Control Group (DRESS) | 2 | 22 | 2 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Anti- TNF-a Treatment (SJS/TEN) | 8 | 48 | 8 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Control Group (SJS/TEN) | 8 | 43 | 8 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Anti- TNF-a Treatment (DRESS) | 4 | 22 | 4 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Control Group (DRESS) | 3 | 22 | 3 |
| other | GI hemorrhage (grade 2) | Gastrointestinal disorders | Anti- TNF-a Treatment (SJS/TEN) | 1 | 48 | 1 |
| other | GI hemorrhage (grade 2) | Gastrointestinal disorders | Control Group (SJS/TEN) | 6 | 43 | 6 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anti- TNF-a Treatment (SJS/TEN) | ||
| Total, all-cause mortality | Control Group (SJS/TEN) | ||
| Total, all-cause mortality | Anti- TNF-a Treatment (DRESS) | ||
| Total, all-cause mortality | Control Group (DRESS) | ||
| Total, other adverse events | Anti- TNF-a Treatment (SJS/TEN) | 15 | 48 |
| Total, other adverse events | Control Group (SJS/TEN) | 19 | 43 |
| Total, other adverse events | Anti- TNF-a Treatment (DRESS) | 8 | 22 |
| Total, other adverse events | Control Group (DRESS) | 8 | 22 |
| Total, serious adverse events | Anti- TNF-a Treatment (SJS/TEN) | 5 | 48 |
| Total, serious adverse events | Control Group (SJS/TEN) | 9 | 43 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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/NCT01276314
GET https://conductscience.org/api/trials/v1/NCT01276314/events?page=2