A Phase 2/3 interventional study of Rituximab plus cyclophosphamide placebo (rituximab group) and Cyclophosphamide plus rituximab placebo (control group) in Vasculitis, Wegener's Granulomatosis and Microscopic Polyangiitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 8 sites in 2 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2017-04-21.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2/3, Interventional, and Treatment
Among 13 studies testing rituximab in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis — 3 open to participants now, 3 under way, 1 of them phase 3. Rituximab · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Among the 13 studies testing rituximab in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, this one has the largest enrollment, is the only one that started in 2005, is the only one in phase 2/3, and was the 1st registered.
157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.
This study's enrollment of 197 is above the median of 34 across 116 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →3 of the 13 studies testing rituximab in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis are open now, in 3 countries. Each count lists the studies.
Rituximab: first FDA approval 1997 (RITUXAN), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →
Of the 56 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies recruiting now, 21 (38%) set no upper age limit and 28 (50%) stop at 75 or younger; 9 take children under 18; 7 take healthy volunteers.
This study: 15 Years and older · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2005.
Median enrollment 115 across the 13 interventional studies. Of the 9 that completed or were terminated, 4 (44%) have results posted.
None of the 13 has an industry lead sponsor. The 7 most frequent:
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
National Institute of Allergy and Infectious Diseases (NIAID) has 2 studies filed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis — fewer than ten, so there is no comparison to draw.
1 of the studies testing rituximab in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06611696Chiba UniversityAvacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis | 2027-03-31 |
Among the 13 studies testing rituximab in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, from their registry updates:
Nothing recorded among them since 2026-09-25.
Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA.
Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.
Current conventional therapies for ANCA-associated vasculitis (AAV) are associated with high incidences of treatment failure, disease relapse, substantial toxicity, and patient morbidity and mortality. Rituximab is a monoclonal antibody used to treat non-Hodgkin's lymphoma. This study will evaluate the efficacy of rituximab with glucocorticoids in inducing disease remission in patients with severe forms of AAV (WG and MPA).
The study consists of two phases: a 6-month remission induction phase, followed by a 12-month remission maintenance phase. All participants will receive at least 1 g of pulse intravenous methylprednisolone or a dose-equivalent of another glucocorticoid preparation. Depending on the participant's condition, he or she may receive up to 3 days of intravenous methylprednisolone for a total of 3 g of methylprednisolone (or a dose-equivalent). During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.
Next, participants will be randomly assigned to one of two arms. Arm 1 participants will receive rituximab (375 mg/m\^2) infusions once weekly for 4 weeks and cyclophosphamide (CYC) placebo daily for 3 to 6 months. Arm 2 participants will receive rituximab placebo infusions once weekly for 4 weeks and CYC daily for 3 to 6 months. During the remission maintenance phase, participants in Arm 1 will discontinue CYC placebo and start oral azathioprine (AZA) placebo daily until Month 18. Participants in Arm 2 will discontinue CYC and start AZA daily until Month 18. Participants who fail treatment before Month 6 will be crossed over to the other treatment arm unless there are specific contraindications. Participants in either group who reach clinical remission before they complete 6 months of therapy may switch from CYC/placebo to AZA/placebo if directed by their physicians.
All participants will be followed for at least 18 months. Initially, study visits are weekly, progressing to monthly and then quarterly visits as the study proceeds. Blood collection will occur at each study visit.
157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.
This study's enrollment of 197 is above the median of 34 across 116 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Compared within Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vasculitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Rituximab plus cyclophosphamide placebo (rituximab group) · Drug: Methylprednisolone (or other glucocorticoid) · Drug: Prednisone
Drug: Cyclophosphamide plus rituximab placebo (control group) · Drug: Azathioprine · Drug: Methylprednisolone (or other glucocorticoid) · Drug: Prednisone
Drug page: Rituximab
375 mg/m\^2 infusions once weekly for 4 week
Also known as: Rituxan
Drug page: Cyclophosphamide
2 mg/kg/day orally for months 1-3
Also known as: Cytoxan
2 mg/kg/day orally for months 4-6
Also known as: imuran
1 g/day intravenously for up to 3 days within 14 days prior to receiving rituximab
Also known as: Medrol
During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.
Also known as: Deltasone, Liquid Pred, Meticorten, Orasone
Disease Remission
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.
Time frame: 6 months post-randomization
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
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
Time frame: Through common close-out (defined as 18 months after the last participant is enrolled in the trial)
Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 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
Time frame: 6 months post-randomization
The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
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
Time frame: 18 months post-randomization
The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
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.
Time frame: 18 months post-randomization
Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups
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
Time frame: 18 months post-randomization
Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups
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
Time frame: 18 months post-randomization
Eight centers in the United States and one center in the Netherlands (Groningen) enrolled 197 Antineutrophil cytoplasmic antibodies (ANCA)-positive patients with either Wegener's granulomatosis or microscopic polyangiitis between December 30, 2004 and June 30, 2008.
| Milestone | Rituximab | Control Group |
|---|---|---|
| Started | 99 | 98 |
| Completed | 90 | 88 |
| Not completed | 9 | 10 |
| Withdrew: Adverse event | 3 | 1 |
| Withdrew: Death | 2 | 2 |
| Withdrew: Withdrawal by subject | 2 | 6 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: To have renal transplant | 1 | 0 |
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.
| Participants | Rituximab | Control Group |
|---|---|---|
| Disease Remission | 63 | 52 |
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
| participants | Rituximab | Control Group |
|---|---|---|
| Death | 2 | 2 |
| Grade 2 or Higher Leukopenia | 7 | 23 |
| Grade 2 or Higher Thrombocytopenia | 4 | 1 |
| Grade 3 or Higher Infections | 18 | 16 |
| Hemorrhagic Cystitis (Grade 2 or Lower) | 2 | 1 |
| Malignancy | 5 | 2 |
| Venous Thromboembolic Event | 6 | 8 |
| Hospitalization Resulting from the Disease | 16 | 7 |
| Cerebrovascular Accident (CVA) | 1 | 1 |
| Infusion Reactions Leading to Infusion Disc. | 1 | 0 |
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
| participants | Rituximab | 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 | 62 | 51 |
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
| Days | Rituximab | Control Group |
|---|---|---|
| 25% Quartile (95%CI) | 243 (172 to NA) | 230 (145 to NA) |
| 50% Quartile (95%CI) | NA (NA to NA) | NA (NA to NA) |
| 75% Quartile (95%CI) | NA (NA to NA) | NA (NA to NA) |
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.
| Days | Rituximab | Control Group |
|---|---|---|
| 25% Quartile (95%CI) | 246 (152 to 335) | 168 (141 to 300) |
| 50% Quartile (95%CI) | NA (403 to NA) | NA (353 to NA) |
| 75% Quartile (95%CI) | NA (NA to NA) | NA (NA to NA) |
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
| Days | Rituximab | Control Group |
|---|---|---|
| 25% Quartile (95%CI) | 30 (29 to 34) | 29 (NA to NA) |
| 50% Quartile (95%CI) | 57 (41 to 63) | 43 (30 to 58) |
| 75% Quartile (95%CI) | 119 (69 to 123) | 112 (61 to 120) |
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
| Days | Rituximab | Control Group |
|---|---|---|
| 25% Quartile (95%CI) | 176 (173 to 177) | 177 (175 to 178) |
| 50% Quartile (95%CI) | 180 (178 to 182) | 183 (180 to 187) |
| 75% Quartile (95%CI) | 189 (183 to 253) | 266 (190 to 287) |
Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC.
| participants | Rituximab | Control Group |
|---|---|---|
| # Participants with at least one SAE | 42 | 37 |
| Blood and Lymphatic System Disorders | 4 | 5 |
| Cardiac Disorders | 2 | 2 |
| Eye Disorders | 1 | 1 |
| Gastrointestinal Disorders | 4 | 1 |
| General Disorders and Administration Site | 5 | 3 |
| Immune System Disorders | 2 | 2 |
| Infections and Infestations | 12 | 12 |
| Injury, Poisoning, and Procedural Complications | 2 | 0 |
| Investigations | 2 | 0 |
| Metabolism and Nutrition Disorders | 2 | 2 |
| Musculoskeletal and Connective Tissue Disorders | 2 | 3 |
| Neoplasms Benign, Malignant, and Unspecified | 1 | 2 |
| Nervous System Disorders | 1 | 0 |
| Pregnancy, Puerperium, and Perinatal Conditions | 1 | 0 |
| Psychiatric Disorders | 1 | 1 |
| Renal and Urinary Disorders | 4 | 3 |
| Respiratory, Thoracic, and Mediastinal Disorders | 8 | 8 |
| Vascular Disorders | 1 | 7 |
Collected over From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rituximab | — | 60/99 (60.6%) | 97/99 (98%) |
| Control Group | — | 47/98 (48%) | 97/98 (99%) |
| Event | Rituximab | Control Group |
|---|---|---|
| PneumoniaInfections and infestations | 8/99 | 10/98 |
| Deep vein thrombosisVascular disorders | 1/99 | 8/98 |
| Wegener's granulomatosisRespiratory, thoracic and mediastinal disorders | 8/99 | 4/98 |
| AnaemiaBlood and lymphatic system disorders | 3/99 | 4/98 |
| Renal failureRenal and urinary disorders | 4/99 | 2/98 |
| Renal failure acuteRenal and urinary disorders | 2/99 | 3/98 |
| LeukopeniaBlood and lymphatic system disorders | 3/99 | 0/98 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 3/99 | 2/98 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/99 | 2/98 |
| Pancreatitis acuteGastrointestinal disorders | 0/99 | 2/98 |
| Event | Rituximab | Control Group |
|---|---|---|
| LeukopeniaBlood and lymphatic system disorders | 13/99 | 39/98 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 34/99 | 24/98 |
| CoughRespiratory, thoracic and mediastinal disorders | 32/99 | 24/98 |
| NauseaGastrointestinal disorders | 25/99 | 31/98 |
| FatigueGeneral disorders | 26/99 | 30/98 |
| Upper respiratory tract infectionInfections and infestations | 29/99 | 24/98 |
| HeadacheNervous system disorders | 28/99 | 25/98 |
| DiarrhoeaGastrointestinal disorders | 27/99 | 20/98 |
| RashSkin and subcutaneous tissue disorders | 14/99 | 23/98 |
| Alanine aminotransferase increasedInvestigations | 15/99 | 22/98 |
| Age, Categorical(Participants) | Rituximab | Control Group | Total |
|---|---|---|---|
| <=18 years | 3 | 3 | 6 |
| Between 18 and 65 years | 60 | 76 | 136 |
| >=65 years | 36 | 19 | 55 |
| Age, Continuous(years) | Rituximab | Control Group | Total |
|---|---|---|---|
| Mean | 54.0 ± 16.8 | 51.5 ± 14.1 | 52.8 ± 15.5 |
| Sex: Female, Male(Participants) | Rituximab | Control Group | Total |
|---|---|---|---|
| Female | 52 | 45 | 97 |
| Male | 47 | 53 | 100 |
| Region of Enrollment(participants) | Rituximab | Control Group | Total |
|---|---|---|---|
| United States | 91 | 90 | 181 |
| Netherlands | 8 | 8 | 16 |
| BVAS/WG(score units) | Rituximab | Control Group | Total |
|---|---|---|---|
| Mean | 8.1 ± 2.8 | 8.0 ± 3.4 | 8.0 ± 3.1 |
| VDI(score units) | Rituximab | Control Group | Total |
|---|---|---|---|
| Mean | 1.4 ± 1.8 | 1.0 ± 1.4 | 1.2 ± 1.7 |
Plan to share: Yes — Participant level data and additional relevant materials are available to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rituximab
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis →
National Institute of Allergy and Infectious Diseases (NIAID) →