Trial · NCT00283712
Use of Infliximab for the Treatment of Pemphigus Vulgaris
NCT00283712, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2013-01-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Use of Infliximab for the Treatment of Pemphigus Vulgaris. Trials, record NCT00283712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00283712
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Infliximab for the Treatment of Pemphigus Vulgaris
- NCT number
- NCT00283712
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Pemphigus
- Interventions
- Infliximab, Placebo Comparator
- First posted
- 2006-01-30
- Last updated
- 2017-12-06
- Results first posted
- 2013-01-31
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participant Response to Treatment at Week 18 | Baseline to Week 18 | Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage \<= 25% of the initial starting dose or \<= 10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks. |
| Primary | Treatment-Related Adverse Events >= Grade 3 On or Before Week 18 | Baseline to Week 18 | Grades were based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0. An adverse event (AE) was considered treatment-related if it was classified as unlikely, possibly, probably, or definitely related to study treatment. Participants who experienced at least one treatment-related, grade 3 or higher AE were counted only once. AEs of skin including rash, skin ulceration, and chelitis as defined by the NCI-CTCAE V3.0 System Organ Class of "Skin and Subcutaneous Tissues Disorders" were excluded. |
| Secondary | Participant Response to Treatment at Week 18 | Baseline to Week 18 | Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage \<= 25% of the initial starting dose or \<=10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks. |
| Secondary | Participant Modified Response Status at Week 18 | Baseline to Week 18 | Modified responder status was defined as participants achieving a prednisone dosage \<=25% of the initial starting dose or \<=10 mg/day (whichever is greater) at Week 18 regardless of status on new blister formation during the previous 4 weeks. |
| Secondary | Participant Time to Cessation of New Blisters | Baseline to Week 26 | Time to cessation of new blisters was defined as the time from a participant's first treatment infusion date to the first date where that date and all subsequent dates had no new blisters. Participant diaries were used to assess new blister formation. To achieve cessation, participants had to be free of new blisters at least 3 weeks prior to their last assessment. In order to analyze missing or incomplete data, the data was censored at the date where a participant had no more data or on the date where 50% of the participant's data was missing past that point. |
| Secondary | Time to 80% Lesion Healing | Baseline to Week 26 | Time to 80% healing of existing erosions/ulcerations at time of enrollment was assessed using the SAGE II computerized burn-mapping system. The date of 80% healing of existing erosions/ulcerations at time of enrollment was defined as follows: the first date at which the percent of total body surface area (BSA) involved is at least 80% less than the percent of total BSA calculated at the time of enrollment, where the baseline percent of total BSA must be greater than zero percent. If a participant had missing post-baseline assessments, their data was censored at their last non-missing assessment date. |
| Secondary | Total Prednisone Dosage Required for Participants to Achieve Cessation of New Blisters | Baseline to Week 26 | Each participant's prednisone dose was summed from the time of enrollment until the date of cessation of new blisters. Actual prednisone use per day was computed as the average over all days in the week. |
| Secondary | Total Prednisone Dosage Required for Participants to Achieve 80% Healing of Existing Erosions | Baseline to Week 26 | Each participant's prednisone dose was summed from the time of enrollment until the date of 80% healing of existing erosions. Actual prednisone use per day was computed as the average over all days in the week. |
| Secondary | Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18 | Baseline to Week 18 | The Medical Outcome Study Short Form 36 (MOS SF-36) measures health -related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 18 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening. |
| Secondary | Participant Dermatology-Related Quality of Life Changes From Baseline to Week 18 | Baseline to Week 18 | The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire with a weighted value to each question. The DLQI score was calculated by summing the score of each question, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the greater quality of life is impaired. Change from baseline values (defined as the visit value - baseline value) were calculated. A negative change indicates better quality of life; a positive change indicates poorer quality of life. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participant Response to Treatment at Week 18 | Baseline to Week 18 | Intent-to-Treat | Participants | NUMBER |
| PRIMARY | Treatment-Related Adverse Events >= Grade 3 On or Before Week 18 | Baseline to Week 18 | Safety Population | Participants | NUMBER |
| SECONDARY | Participant Response to Treatment at Week 18 | Baseline to Week 18 | Per-protocol | Participants | NUMBER |
| SECONDARY | Participant Modified Response Status at Week 18 | Baseline to Week 18 | Intent-to-Treat | Participants | NUMBER |
| SECONDARY | Participant Time to Cessation of New Blisters | Baseline to Week 26 | Subset of Intent-to-Treat Who Experienced Cessation | Days | MEAN |
| SECONDARY | Time to 80% Lesion Healing | Baseline to Week 26 | Subset of Intent-to-Treat Who Experienced Lesion Healing | Days | MEAN |
| SECONDARY | Total Prednisone Dosage Required for Participants to Achieve Cessation of New Blisters | Baseline to Week 26 | Subset of Intent-to-Treat Who Experienced Lesion Cessation | mg | MEAN |
| SECONDARY | Total Prednisone Dosage Required for Participants to Achieve 80% Healing of Existing Erosions | Baseline to Week 26 | Subset of Intent-to-Treat Who Experienced Erosion Healing | mg | MEAN |
| SECONDARY | Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18 | Baseline to Week 18 | Intent-to-Treat with available data | units on a scale | MEAN |
| SECONDARY | Participant Dermatology-Related Quality of Life Changes From Baseline to Week 18 | Baseline to Week 18 | Intent-to-Treat with available data | units on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participant Response to Treatment at Week 18 | Experimental: Infliximab (Remicade, Revellex) | 1 | Participants | ||
| Participant Response to Treatment at Week 18 | Placebo Comparator: Placebo | 1 | Participants | ||
| Treatment-Related Adverse Events >= Grade 3 On or Before Week 18 | Experimental: Infliximab (Remicade, Revellex) | 0 | Participants | ||
| Treatment-Related Adverse Events >= Grade 3 On or Before Week 18 | Placebo Comparator: Placebo | 10 | Participants | ||
| Participant Response to Treatment at Week 18 | Experimental: Infliximab (Remicade, Revellex) | 1 | Participants | ||
| Participant Response to Treatment at Week 18 | Placebo Comparator: Placebo | 1 | Participants | ||
| Participant Modified Response Status at Week 18 | Experimental: Infliximab (Remicade, Revellex) | 5 | Participants | ||
| Participant Modified Response Status at Week 18 | Placebo Comparator: Placebo | 3 | Participants | ||
| Participant Time to Cessation of New Blisters | Experimental: Infliximab (Remicade, Revellex) | 133.0 | Standard Deviation 31.7 | Days | |
| Participant Time to Cessation of New Blisters | Placebo Comparator: Placebo | 98.0 | Standard Deviation 49.5 | Days |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental: Infliximab (Remicade, Revellex) | 10 | |
| Overall Study | STARTED | Placebo Comparator: Placebo | 10 | |
| Overall Study | Intent-to-treat Sample | Experimental: Infliximab (Remicade, Revellex) | 10 | |
| Overall Study | Intent-to-treat Sample | Placebo Comparator: Placebo | 10 | |
| Overall Study | Safety Sample | Experimental: Infliximab (Remicade, Revellex) | 10 | |
| Overall Study | Safety Sample | Placebo Comparator: Placebo | 10 | |
| Overall Study | Per-Protocol Sample | Experimental: Infliximab (Remicade, Revellex) | 6 | |
| Overall Study | Per-Protocol Sample | Placebo Comparator: Placebo | 7 | |
| Overall Study | COMPLETED | Experimental: Infliximab (Remicade, Revellex) | 10 | |
| Overall Study | COMPLETED | Placebo Comparator: Placebo | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events198
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 | Anaemia | Blood and lymphatic system disorders | Infliximab | 1 | 10 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 10 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Infliximab | 1 | 10 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | Placebo | 0 | 10 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Infliximab | 1 | 10 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo | 0 | 10 | 0 |
| other | Bradycardia | Cardiac disorders | Infliximab | 1 | 10 | 1 |
| other | Bradycardia | Cardiac disorders | Placebo | 0 | 10 | 0 |
| other | Tachycardia | Cardiac disorders | Infliximab | 0 | 10 | 0 |
| other | Tachycardia | Cardiac disorders | Placebo | 1 | 10 | 1 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infliximab | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Infliximab | 9 | 10 |
| Total, other adverse events | Placebo | 10 | 10 |
| Total, serious adverse events | Infliximab | 1 | 10 |
| Total, serious adverse events | Placebo | 2 | 10 |
Source ClinicalTrials.gov
Papers5
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental: Infliximab (Remicade, Revellex) vs Placebo Comparator: Placebo: Participant Response to Treatment at Week 18 | Trial comparisons |
| Experimental: Infliximab (Remicade, Revellex) vs Placebo Comparator: Placebo: Participant Modified Response Status at Week 18 | Trial comparisons |
| Experimental: Infliximab (Remicade, Revellex) vs Placebo Comparator: Placebo: Adverse Events Resulting in Treatment Discontinuation | Trial comparisons |
| Experimental: Infliximab (Remicade, Revellex) vs Placebo Comparator: Placebo: Participants Who Experienced Severe Infectious Complications | Trial comparisons |
| Experimental: Infliximab (Remicade, Revellex) vs Placebo Comparator: Placebo: Treatment-Related Adverse Events >= Grade 3 On or Before Week 18 | Trial comparisons |
| Experimental: Infliximab (Remicade, Revellex) vs Placebo Comparator: Placebo: Participants Who Experienced Severe Infusion Reactions | Trial comparisons |
| Experimental: Infliximab (Remicade, Revellex) vs Placebo Comparator: Placebo: Participant Response to Treatment at Week 18 | Trial comparisons |
| Infliximab vs Placebo: serious adverse events | Trial comparisons |
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/NCT00283712
GET https://conductscience.org/api/trials/v1/NCT00283712/results?page=2