Trial · NCT00286325
Rituximab in the Treatment of Patients With Bullous Pemphigoid
NCT00286325, Phase 1, Phase 2, Completed, Duke University; results first posted 2012-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab in the Treatment of Patients With Bullous Pemphigoid. Trials, record NCT00286325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00286325
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab in the Treatment of Patients With Bullous Pemphigoid
- NCT number
- NCT00286325
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Bullous Pemphigoid
- Interventions
- Rituximab
- First posted
- 2006-02-03
- Last updated
- 2013-04-11
- Results first posted
- 2012-10-22
- Limitations and caveats
- Open label trial of rituximab in the treatment of 7 patients with the autoimmune blistering disease bullous pemphigoid.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Safety Endpoint | 1 year | The primary safety endpoint is the occurrence of treatment emergent adverse events including infections, infusion reactions and disease progression. These were determined by clinical evaluation and laboratory questions. Disease progression is defined as development of new blisters despite therapy. These are reported as the number of participants with a study related SAE. |
| Secondary | Number of Days to Cessation of New Blister | 1 year | The first study visit in which patient reported and was confirmed to have no new blister or lesion formation . |
| Secondary | Systemic Corticosteroid Dose of 25% of Starting Dose or 10 mg/Day by Week 24 | 24 weeks | Subject systemic corticosteroid dosage at week 24 was 25% of starting dose or 10 mg/day of prednisone or less |
| Secondary | IgG Anti Bullous Pemphigoid (BP) 180 Measured in Units by ELISA at Week 24. | Week 0 and at 24 weeks | IgG antibodies against BP 180 measured in units (by ELISA) for each participant at week 0 compared to value at week 24, |
| Secondary | B Cell Number at Week 24 | Week 0 and at 24 weeks | Peripheral blood B cell number at week 24 compared to B cell number at week 0 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Days to Cessation of New Blister | 1 year | Excluded subject with diagnosis of epidermolysis bullosa acquisita , made after study entry. | Days | MEDIAN |
| PRIMARY | Primary Safety Endpoint | 1 year | The safety analysis was performed on all subjects | participants | NUMBER |
| SECONDARY | Systemic Corticosteroid Dose of 25% of Starting Dose or 10 mg/Day by Week 24 | 24 weeks | Excluded subject with epidermolysis bullosa acquisita diagnosed after study entry. | participants | NUMBER |
| SECONDARY | IgG Anti Bullous Pemphigoid (BP) 180 Measured in Units by ELISA at Week 24. | Week 0 and at 24 weeks | Excluded subject with diagnosis of epidermolysis bullosa acquisita made after study entry, excluded one subject with no circulating antibodies measured at either time point. | Elisa Units | MEDIAN |
| SECONDARY | B Cell Number at Week 24 | Week 0 and at 24 weeks | excluded subject with epidermolysis bullosa acquisita diagnosed after study entry | B cells per microliter | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Days to Cessation of New Blister | Treated | 57 | Full Range 13 to 163 | Days | |
| Primary Safety Endpoint | Treated | Treatment emergent adverse events | 0 | participants | |
| Primary Safety Endpoint | Treated | Infusion reactions | 0 | participants | |
| Primary Safety Endpoint | Treated | Disease Progression | 1 | participants | |
| Systemic Corticosteroid Dose of 25% of Starting Dose or 10 mg/Day by Week 24 | Treated | 7 | participants | ||
| IgG Anti Bullous Pemphigoid (BP) 180 Measured in Units by ELISA at Week 24. | Treated | 40.5 | Full Range 6 to 72 | Elisa Units | |
| B Cell Number at Week 24 | Treated | 3.99 | Full Range 1.41 to 137.6 | B cells per microliter |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treated | 8 | |
| Overall Study | COMPLETED | Treated | 8 | |
| Overall Study | NOT COMPLETED | Treated | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treated | ||
| Total, other adverse events | Treated | 0 | 8 |
| Total, serious adverse events | Treated | 0 | 8 |
Source ClinicalTrials.gov
Papers30
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/NCT00286325
GET https://conductscience.org/api/trials/v1/NCT00286325/papers?page=2