A Phase 4 interventional study of Glucocorticoids and Rituximab in Granulomatosis With Polyangiitis and Microscopic Polyangiitis, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-06-25.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
The purpose of this pilot study is to test whether an 8-week course of glucocorticoids, combined with rituximab, is effective in treating ANCA-associated vasculitis.
The primary aim of this pilot study is to examine whether an 8 week course of glucocorticoids, in combination with rituximab, is effective in inducing and maintaining disease remission for up to 6 months in a subset of patients with ANCA-associated vasculitis (AAV) who have a more favorable prognosis.
This pilot study will enroll 20 patients with active AAV. Close patient follow-up will insure that any patients who require courses of glucocorticoids longer than two months will receive longer therapy, if appropriate for their well-being.
104 studies on the registry are indexed under Granulomatosis with Polyangiitis; 16 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 69 interventional studies indexed under Granulomatosis with Polyangiitis.
Browse Granulomatosis with Polyangiitis studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
This is a single-arm trial. All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.
Drug: Glucocorticoids · Drug: Rituximab
Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days. Prednisone will be tapered over 8 weeks as follows: * 60mg for 2 weeks * 40mg for 2 weeks * 30mg for 1 week * 20mg for 1 week * 10mg for 1 week * 5mg for 1 week
Also known as: Prednisone
Rituximab will be administered in four weekly doses at 375mg/m2
Also known as: Rituxan
Complete Remission
We examined whether an 8-week glucocorticoid course in combination with rituximab (RTX) would induce disease remission in patients with AAV. The primary outcome was disease remission off steroids at 6 months.
Time frame: 6 months
Disease Response
Number of patients achieving disease response defined as, no new disease manifestations; no worsening of existing disease; stable or improved BVAS/WG score at 4 weeks.
Time frame: 4 weeks
Partial Remission
Number of patients entering partial remission, defined as no new disease manifestations, no worsening of existing disease and BVAS/WG \< 3.
Time frame: 8 weeks
Sustained Complete Remission
Number of patients entering sustained remission defined as BVAS/WG = 0, prednisone dose = 0 and no disease flares during the study period.
Time frame: 6 months
Limited Flares
Number of limited flares defined as a new occurrence or worsening of one or more minor BVAS/WG items and a total BVAS/WG ≤ 3
Time frame: 6 months
Severe Flares
Number of severe flares defined as flare with BVAS/WG \> 3 or experiencing one of the major BVAS/WG items
Time frame: 6 months
Early Treatment Failures
Number of early treatment failures defined as patients who have new or worsening disease manifestations assessed at 4 weeks after study entry
Time frame: 4 weeks
Vasculitis Damage Index (VDI)
The Vasculitis Damage Index (VDI) is a single-page catalog of damage items separated into 11 groupings of items by organ system. There are a total of 60 items. Each item is recorded if it occurred since the onset of vasculitis, has been present for at least 3 months, or occurred at least 3 months ago. Each item of damage is scored as present (1) or absent (0), yielding a maximum score of 60.
Time frame: 24 months
* New diagnosis or flare of previously diagnosed disease in patients followed in the Massachusetts General Hospital (MGH) Rheumatology or Nephrology Units. * New diagnosis or flare of previously diagnosed disease in patients hospitalized at MGH.
| Milestone | Glucocorticoids and Rituximab |
|---|---|
| Started | 20 |
| Completed | 14 |
| Not completed | 6 |
| Withdrew: Lack of efficacy | 6 |
We examined whether an 8-week glucocorticoid course in combination with rituximab (RTX) would induce disease remission in patients with AAV. The primary outcome was disease remission off steroids at 6 months.
| Participants | Glucocorticoids and Rituximab |
|---|---|
| Complete Remission | 14 |
Number of patients achieving disease response defined as, no new disease manifestations; no worsening of existing disease; stable or improved BVAS/WG score at 4 weeks.
| Participants | Rituximab and Glucocorticoids |
|---|---|
| Disease Response | 20 |
Number of patients entering partial remission, defined as no new disease manifestations, no worsening of existing disease and BVAS/WG \< 3.
| Participants | Glucocorticoids and Rituximab |
|---|---|
| Partial Remission | 20 |
Number of patients entering sustained remission defined as BVAS/WG = 0, prednisone dose = 0 and no disease flares during the study period.
| Participants | Glucocorticoids and Rituximab |
|---|---|
| Sustained Complete Remission | 14 |
Number of limited flares defined as a new occurrence or worsening of one or more minor BVAS/WG items and a total BVAS/WG ≤ 3
| Participants | Glucocorticoids and Rituximab |
|---|---|
| Limited Flares | 2 |
Number of severe flares defined as flare with BVAS/WG \> 3 or experiencing one of the major BVAS/WG items
| Participants | Glucocorticoids and Rituximab |
|---|---|
| Severe Flares | 5 |
Number of early treatment failures defined as patients who have new or worsening disease manifestations assessed at 4 weeks after study entry
| Participants | Glucocorticoids and Rituximab |
|---|---|
| Early Treatment Failures | 0 |
The Vasculitis Damage Index (VDI) is a single-page catalog of damage items separated into 11 groupings of items by organ system. There are a total of 60 items. Each item is recorded if it occurred since the onset of vasculitis, has been present for at least 3 months, or occurred at least 3 months ago. Each item of damage is scored as present (1) or absent (0), yielding a maximum score of 60.
| units on a scale | Glucocorticoids and Rituximab |
|---|---|
| Baseline VDI score | 0 (0 to 1) |
| 24 month VDI score | 0.5 (0 to 2) |
Collected over Reports of unanticipated problems involving risks to subjects or others are to be submitted to the IRB within 5 working days/7 calendar days of the date the investigator first becomes aware of the problem. Adverse events were collected through the 6 month study duration.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glucocorticoids and Rituximab | 0/20 (0%) | 11/20 (55%) | 0/20 (0%) |
| Event | Glucocorticoids and Rituximab |
|---|---|
| Severe flaresImmune system disorders | 5/20 |
| Thyroid maligancyEndocrine disorders | 2/20 |
| myocardial infarctionCardiac disorders | 1/20 |
| atrial fibrillation,Cardiac disorders | 1/20 |
| syncopeImmune system disorders | 1/20 |
| Uterine malignancyReproductive system and breast disorders | 1/20 |
| Age, Categorical(Participants) | Glucocorticoids and Rituximab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 4 |
| Sex: Female, Male(Participants) | Glucocorticoids and Rituximab |
|---|---|
| Female | 13 |
| Male | 7 |
| Region of Enrollment(Participants) | Glucocorticoids and Rituximab |
|---|---|
| United States | 20 |
| Birmingham Vasculitis Activity Score for Wegener's Granulomatosis(BVAS/WG)(units on a scale) | Glucocorticoids and Rituximab |
|---|---|
| Mean | 5 (3 to 11) |
| Disease group(Participants) | Glucocorticoids and Rituximab |
|---|---|
| Granulomatosis with polyangiitis (GPA) | 14 |
| Microscopic polyangiitis (MPA) | 6 |
| Indeterminate | 0 |
| anti-neutrophil cytoplasmic antibody (ANCA)(Participants) | Glucocorticoids and Rituximab |
|---|---|
| myeloperoxidase (MPO) | 11 |
| proteinase (PR3) | 7 |
| Negative | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data will be shared upon request - without personal health information - following completion of the analysis. Inquiries should be directed to the Principal Investigator.
The record gives a start of Jun 2014, a primary completion of Aug 2016 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2018, 2 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Corticosteroids · Rituximab
Granulomatosis with Polyangiitis →
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