Trial · NCT00104299
Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
NCT00104299, Phase 2, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2011-08-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis. Trials, record NCT00104299. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00104299
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
- NCT number
- NCT00104299
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 197 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis
- Interventions
- Rituximab plus cyclophosphamide placebo (rituximab group), Cyclophosphamide plus rituximab placebo (control group), Azathioprine, Methylprednisolone (or other glucocorticoid), Prednisone
- First posted
- 2005-02-25
- Last updated
- 2017-04-21
- Results first posted
- 2011-08-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Remission | 6 months post-randomization | A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease. |
| Secondary | Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy | Through common close-out (defined as 18 months after the last participant is enrolled in the trial) | The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident |
| Secondary | Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization | 6 months post-randomization | The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control \[1\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease |
| Secondary | The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups | 18 months post-randomization | Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing. \[1\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease |
| Secondary | The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups | 18 months post-randomization | Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing. |
| Secondary | Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups | 18 months post-randomization | Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0. \[1\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease |
| Secondary | Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups | 18 months post-randomization | Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and completing taper of glucocorticoid by 6 months post-randomization. \[1\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Remission | 6 months post-randomization | Intent-to-treat (ITT) sample with worst case imputation | Participants | NUMBER |
| SECONDARY | Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy | Through common close-out (defined as 18 months after the last participant is enrolled in the trial) | Safety Sample | participants | NUMBER |
| SECONDARY | Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization | 6 months post-randomization | Safety Sample | participants | NUMBER |
| SECONDARY | The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups | 18 months post-randomization | Intent-to-treat | Days | NUMBER |
| SECONDARY | The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups | 18 months post-randomization | Intent-to-treat | Days | NUMBER |
| SECONDARY | Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups | 18 months post-randomization | Intent-to-treat | Days | NUMBER |
| SECONDARY | Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups | 18 months post-randomization | Intent-to-treat | Days | NUMBER |
| POST_HOC | Number of Subjects Experiencing Serious Adverse Events | Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization) | Intent-to-treat | participants | NUMBER |
Source ClinicalTrials.gov
Results by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Remission | Rituximab | 63 | Participants | ||
| Disease Remission | Control Group | 52 | Participants | ||
| Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy | Rituximab | Death | 2 | participants | |
| Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy | Control Group | Death | 2 | participants | |
| Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy | Rituximab | Grade 2 or Higher Leukopenia | 7 | participants | |
| Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy | Control Group | Grade 2 or Higher Leukopenia | 23 | participants | |
| Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy | Rituximab | Grade 2 or Higher Thrombocytopenia | 4 | participants | |
| Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy | Control Group | Grade 2 or Higher Thrombocytopenia | 1 | participants | |
| Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy | Rituximab | Grade 3 or Higher Infections | 18 | participants | |
| Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy | Control Group | Grade 3 or Higher Infections | 16 | participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab | 99 | |
| Overall Study | STARTED | Control Group | 98 | |
| Overall Study | COMPLETED | Rituximab | 90 | |
| Overall Study | COMPLETED | Control Group | 88 | |
| Overall Study | NOT COMPLETED | Rituximab | 9 | |
| Overall Study | NOT COMPLETED | Control Group | 10 |
Source ClinicalTrials.gov
Adverse events364
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 | Rituximab | 22 | 99 | 28 |
| other | Anaemia | Blood and lymphatic system disorders | Control Group | 18 | 98 | 23 |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab | 13 | 99 | 30 |
| other | Leukopenia | Blood and lymphatic system disorders | Control Group | 39 | 98 | 80 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab | 9 | 99 | 13 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Control Group | 5 | 98 | 6 |
| other | Ear pain | Ear and labyrinth disorders | Rituximab | 7 | 99 | 8 |
| other | Ear pain | Ear and labyrinth disorders | Control Group | 5 | 98 | 5 |
| other | Cushingoid | Endocrine disorders | Rituximab | 5 | 99 | 6 |
| other | Cushingoid | Endocrine disorders | Control Group | 6 | 98 | 6 |
1 to 10 of 364Source ClinicalTrials.gov
See all 364 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab | ||
| Total, all-cause mortality | Control Group | ||
| Total, other adverse events | Rituximab | 97 | 99 |
| Total, other adverse events | Control Group | 97 | 98 |
| Total, serious adverse events | Rituximab | 60 | 99 |
| Total, serious adverse events | Control Group | 47 | 98 |
Source ClinicalTrials.gov
Papers12
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rituximab vs Control Group: Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization | Trial comparisons |
| Rituximab vs Control Group: Disease Remission | Trial comparisons |
| Rituximab vs Control Group: 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/NCT00104299
GET https://conductscience.org/api/trials/v1/NCT00104299/results?page=2