Granulomatosis With Polyangiitis (Wegener's Granulomatosis)Phase 4RENTGPANCT02626845
Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis
A Phase 4 study testing Rituximab in people with Granulomatosis With Polyangiitis (Wegener's Granulomatosis), run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
This is a phase IV, single-center, randomized, placebo-controlled pilot study that will evaluate the efficacy of rituximab at inducing otolaryngologic remission in GPA patients with active otolaryngologic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulomatosis With Polyangiitis (Wegener's Granulomatosis)
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GPA Specific Inclusion:
- Patients must have met at least 2 of the 5 modified ACR classification criteria for GPA. These do not need to be present at the time of study entry. The modified ACR criteria are:
- Nasal or oral inflammation, defined as the development of painful or painless oral ulcers or purulent or bloody nasal discharge
- Abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates, or cavities
- Active urinary sediment, defined as microscopic hematuria (>5 red blood cells per high power field) or red blood cell casts
- Granulomatous inflammation on biopsy, defined as histologic changes showing granulomatous inflammation within the wall of an artery or in the perivascular or extravascular area (artery or arteriole)
Show all 26Show fewer
- Positive anti-neutrophil cytoplasmic antibody (ANCA) test specific for proteinase-3, measured by enzyme-linked immunoassay
- Active GPA in the ENT domain within 1 month prior to screening, where the active disease is defined as a score of ≥2 on a GPA ENT disease activity score (7 items scored as 1= present 0= absent) performed by direct endoscopic visualization of the upper airway and audiometric evaluation by a single expert otolaryngologist. Items included in the GPA ENT disease activity score are:
- Bloody rhinorrhea (Daily blood stained nasal discharge)
- Objective stridor (Stridor assessed by doctor)
- Inflammation on nasal examination (Ulcers, granulation, friable mucosa on rigid nasendoscopy. Excluding crusting)
- Inflammation on flexible laryngoscopy (Ulcers, granulation, friable mucosa in the larynx)
- Inflamed TM*/middle ear (Persistent inflammation or granulation tissue in tympanic membrane/middle ear)
- Sudden sensorineural hearing loss (30db drop in 3 frequencies within 72 hours)
- Other ENT/upper airway manifestations of active GPA observed during structured ENT exam including but not limited to lacrimal gland dacryocystitis and endobronchial disease
- General Medical Concerns:
- Age 18 and older
- Willing and able to comply with treatment and follow-up procedures
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment.
- Willing and able to provide written informed consent
- Rituximab-Specific Concerns:
- ANC: > 1000/mm3
- Platelets: > 100,000/mm3
- Hemoglobin: > 7 gm/dL
- Adequate renal function as indicated by Cr >4.0mg/dl
- Adequate liver function as defined by AST or ALT <2x Upper Limit of Normal unless related to primary disease.
Who cannot join
- Disease-Specific Concerns:
- Creatinine >4.0mg/dl
- Respiratory failure requiring mechanical ventilatory support
- Previous treatment with rituximab (Rituxan® ) within 6 months of screening
- History of severe allergic or anaphylactic reaction or serious infusion reaction while receiving rituximab
- Failure to respond to previous course of rituximab (Rituxan®) administered for treatment of GPA, as determined by the discretion of the PI
Show all 18Show fewer
- 5. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies 6. Use of the maintenance immunosuppressive agent (methotrexate, azathioprine, mycophenolate mofetil or leflunomide) within 5 drug half-lives prior to baseline 7. Treatment with any other biologic agent, including belimumab, within the past 3 months of screening 8. Treatment with cyclophosphamide (oral or intravenous) within the past 1 month of screening
- General Medical Concerns:
- Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment), or lactating.
- Inability to comply with study and/or follow-up procedures.
- Rituximab-Specific Concerns:
- History of HIV.
- Presence of active infection..
- New York Heart Association Classification III or IV heart disease (See Appendix D).
- Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of psychiatric disorder.
- At the Investigator's discretion, receipt of a live vaccine within 4 weeks prior to randomization.
- Positive hepatitis B or C serology is considered a potential exclusion criterion. Hepatitis B screening should include hepatitis B surface antigen (HBsAg) and core antibody (anti-HBc) in all patients. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during Rituxan treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 100214898
About this study
This is a phase IV, single-center, randomized, placebo-controlled pilot study that will evaluate the efficacy of rituximab at inducing otolaryngologic remission in GPA patients with active otolaryngologic disease.
Read the detailed description
Patients with GPA and active ENT disease in at least two ENT domains, as defined after endoscopic visualization of the upper airway and audiometric evaluation by a single otolaryngologist using a validated GPA ENT disease activity score, will be eligible for inclusion. ENT disease may be new, grumbling or relapsing.
All patients entering the trial will receive standard induction therapy with rituximab (375mg/m2 per week x 4). At week 16, patients will be randomized to receive maintenance rituximab (1000mg) every 4 months or placebo infusions. The primary outcome will be assessed at week 52. Patients will be treated with a standardized prednisone taper according to whether they had severe or limited disease at study entry, prednisone taper will be completed at week 16.
The investigators plan to enroll 28 patients who will be randomized in a 1:1 fashion to rituximab or placebo. The investigators estimate accrual of these subjects will take 18 months from study initiation. Once enrolled, subjects are followed for 52 weeks until the primary endpoint is assessed.
- Being tested
- Rituximab, Placebo
- Keywords
- Granulomatosis with Polyangiitis, Wegener's Granulomatosis, GPA, Rituximab, Rituxan, ENT GPA
- Medical subject headings
- Granulomatosis with Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
Standard of care induction with Rituximab: 375mg/m2 weekly x 4 weeks. Once randomized, the rituximab dose will be 1000mg IV every 4 months x 2.
PlaceboOther
Will be given at two time-points (week 16 and week 32) to subjects in the Placebo Arm.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab Arm | Active comparator | All subjects in this arm will receive standard of care induction therapy, and then will receive two additional rituximab infusions at week 16 and week 32. Receives: Drug: Rituximab |
| Placebo Arm | Placebo comparator | All subjects in this arm will receive standard of care induction therapy, and then will receive two additional placebo infusions at week 16 and week 32. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in ENT remission without relapse at week 52 in each treatment group.
ENT remission is defined as a GPA ENT disease activity score of 0.
Measured: Assessed at week 52
Secondary outcomes (9)
Comparison of mean ENT disease activity scores between treatment arms
Measured: Assessed at week 52
Cumulative steroid dose
Measured: Assessed at week 52
Duration of steroid free remission
Measured: Assessed at week 52
Proportion of subject in remission without relapse and completed steroid taper
Measured: Assessed at week 52
Quality of Life as measured by the SNOT-22 Questionnaire
Measured: Assessed at week 0, 16, and 52
Change in VDI in the ENT domain
Measured: Assessed at week 52
Number of surgical procedures in the ENT domain required during the study period
Measured: Assessed at week 52
Number of ENT flares as measured by the ENT GPA DAS
Measured: Assessed at week 52
Number of GPA flares as measured by BVAS-WG
Measured: Assessed at week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Granulomatosis With Polyangiitis (Wegener's Granulomatosis)Studies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Robert F Spiera, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626845
- Sponsor's protocol ID
- 2015-424
- Acronym
- RENTGPA
- Status last verified
- Mar 2018
- First submitted
- 8 Dec 2015
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Seo P, Min YI, Holbrook JT, Hoffman GS, Merkel PA, Spiera R, Davis JC, Ytterberg SR, St Clair EW, McCune WJ, Specks U, Allen NB, Luqmani RA, Stone JH; WGET Research Group. Damage caused by Wegener's granulomatosis and its treatment: prospective data from the Wegener's Granulomatosis Etanercept Trial (WGET). Arthritis Rheum. 2005 Jul;52(7):2168-78. doi: 10.1002/art.21117.
PubMed 15986348Hogan SL, Falk RJ, Chin H, Cai J, Jennette CE, Jennette JC, Nachman PH. Predictors of relapse and treatment resistance in antineutrophil cytoplasmic antibody-associated small-vessel vasculitis. Ann Intern Med. 2005 Nov 1;143(9):621-31. doi: 10.7326/0003-4819-143-9-200511010-00005.
PubMed 16263884Srouji IA, Andrews P, Edwards C, Lund VJ. General and rhinosinusitis-related quality of life in patients with Wegener's granulomatosis. Laryngoscope. 2006 Sep;116(9):1621-5. doi: 10.1097/01.mlg.0000230440.83375.4b.
PubMed 16954992Hoffman GS, Kerr GS, Leavitt RY, Hallahan CW, Lebovics RS, Travis WD, Rottem M, Fauci AS. Wegener granulomatosis: an analysis of 158 patients. Ann Intern Med. 1992 Mar 15;116(6):488-98. doi: 10.7326/0003-4819-116-6-488.
PubMed 1739240Stone JH; Wegener's Granulomatosis Etanercept Trial Research Group. Limited versus severe Wegener's granulomatosis: baseline data on patients in the Wegener's granulomatosis etanercept trial. Arthritis Rheum. 2003 Aug;48(8):2299-309. doi: 10.1002/art.11075.
PubMed 12905485De Groot K, Rasmussen N, Bacon PA, Tervaert JW, Feighery C, Gregorini G, Gross WL, Luqmani R, Jayne DR. Randomized trial of cyclophosphamide versus methotrexate for induction of remission in early systemic antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum. 2005 Aug;52(8):2461-9. doi: 10.1002/art.21142.
PubMed 16052573Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905.
PubMed 20647199Jones RB, Furuta S, Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA, Savage CO, Segelmark M, Tesar V, van Paassen P, Walsh M, Westman K, Jayne DR; European Vasculitis Society (EUVAS). Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial. Ann Rheum Dis. 2015 Jun;74(6):1178-82. doi: 10.1136/annrheumdis-2014-206404. Epub 2015 Mar 4.
PubMed 25739829Specks U, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Fessler BJ, Ding L, Viviano L, Tchao NK, Phippard DJ, Asare AL, Lim N, Ikle D, Jepson B, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh K, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Mueller M, Sejismundo LP, Mieras K, Stone JH; RAVE-ITN Research Group. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013 Aug 1;369(5):417-27. doi: 10.1056/NEJMoa1213277.
PubMed 23902481Aries PM, Hellmich B, Voswinkel J, Both M, Nolle B, Holl-Ulrich K, Lamprecht P, Gross WL. Lack of efficacy of rituximab in Wegener's granulomatosis with refractory granulomatous manifestations. Ann Rheum Dis. 2006 Jul;65(7):853-8. doi: 10.1136/ard.2005.044420. Epub 2005 Nov 3.
PubMed 16269425Seo P, Specks U, Keogh KA. Efficacy of rituximab in limited Wegener's granulomatosis with refractory granulomatous manifestations. J Rheumatol. 2008 Oct;35(10):2017-23. Epub 2008 Aug 1.
PubMed 18688911Martinez Del Pero M, Chaudhry A, Jones RB, Sivasothy P, Jani P, Jayne D. B-cell depletion with rituximab for refractory head and neck Wegener's granulomatosis: a cohort study. Clin Otolaryngol. 2009 Aug;34(4):328-35. doi: 10.1111/j.1749-4486.2009.01968.x.
PubMed 19673980Lally L, Lebovics RS, Huang WT, Spiera RF. Effectiveness of rituximab for the otolaryngologic manifestations of granulomatosis with polyangiitis (Wegener's). Arthritis Care Res (Hoboken). 2014 Sep;66(9):1403-9. doi: 10.1002/acr.22311.
PubMed 25299002Zhao Y, Odell E, Choong LM, Barone F, Fields P, Wilkins B, Tungekar FM, Patel P, Sanderson JD, Sangle S, D'Cruz D, Spencer J. Granulomatosis with polyangiitis involves sustained mucosal inflammation that is rich in B-cell survival factors and autoantigen. Rheumatology (Oxford). 2012 Sep;51(9):1580-6. doi: 10.1093/rheumatology/kes123. Epub 2012 May 23.
PubMed 22627727Voswinkel J, Mueller A, Kraemer JA, Lamprecht P, Herlyn K, Holl-Ulrich K, Feller AC, Pitann S, Gause A, Gross WL. B lymphocyte maturation in Wegener's granulomatosis: a comparative analysis of VH genes from endonasal lesions. Ann Rheum Dis. 2006 Jul;65(7):859-64. doi: 10.1136/ard.2005.044909. Epub 2005 Nov 16.
PubMed 16291812
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis
- ClinicalTrials.gov ID
- NCT02626845
- Acronym / sponsor ID
- RENTGPA / 2015-424
- Keywords
- Granulomatosis with Polyangiitis, Wegener's Granulomatosis, GPA, Rituximab, Rituxan, ENT GPA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Genentech, Inc., Roche Pharma AG
- Study start
- Dec 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IV, single-center, randomized, placebo-controlled pilot study that will evaluate the efficacy of rituximab at inducing otolaryngologic remission in GPA patients with active otolaryngologic disease.
Detailed description
Patients with GPA and active ENT disease in at least two ENT domains, as defined after endoscopic visualization of the upper airway and audiometric evaluation by a single otolaryngologist using a validated GPA ENT disease activity score, will be eligible for inclusion. ENT disease may be new, grumbling or relapsing.
All patients entering the trial will receive standard induction therapy with rituximab (375mg/m2 per week x 4). At week 16, patients will be randomized to receive maintenance rituximab (1000mg) every 4 months or placebo infusions. The primary outcome will be assessed at week 52. Patients will be treated with a standardized prednisone taper according to whether they had severe or limited disease at study entry, prednisone taper will be completed at week 16.
The investigators plan to enroll 28 patients who will be randomized in a 1:1 fashion to rituximab or placebo. The investigators estimate accrual of these subjects will take 18 months from study initiation. Once enrolled, subjects are followed for 52 weeks until the primary endpoint is assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab Arm | Active comparator | Drug: RituximabAll subjects in this arm will receive standard of care induction therapy, and then will receive two additional rituximab infusions at week 16 and week 32. |
| Placebo Arm | Placebo comparator | Other: PlaceboAll subjects in this arm will receive standard of care induction therapy, and then will receive two additional placebo infusions at week 16 and week 32. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients must have met at least 2 of the 5 modified ACR classification criteria for GPA. These do not need to be present at the time of study entry. The modified ACR criteria are:
- Active GPA in the ENT domain within 1 month prior to screening, where the active disease is defined as a score of ≥2 on a GPA ENT disease activity score (7 items scored as 1= present 0= absent) performed by direct endoscopic visualization of the upper airway and audiometric evaluation by a single expert otolaryngologist. Items included in the GPA ENT disease activity score are:
- Age 18 and older
- Willing and able to comply with treatment and follow-up procedures
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment.
Key exclusion criteria (18 listed)
- Creatinine >4.0mg/dl
- Respiratory failure requiring mechanical ventilatory support
- Previous treatment with rituximab (Rituxan® ) within 6 months of screening
- History of severe allergic or anaphylactic reaction or serious infusion reaction while receiving rituximab
- Failure to respond to previous course of rituximab (Rituxan®) administered for treatment of GPA, as determined by the discretion of the PI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: RituxanStandard of care induction with Rituximab: 375mg/m2 weekly x 4 weeks. Once randomized, the rituximab dose will be 1000mg IV every 4 months x 2. | Drug | Rituximab Arm |
| PlaceboWill be given at two time-points (week 16 and week 32) to subjects in the Placebo Arm. | Other | Placebo Arm |
Primary outcome
Proportion of patients in ENT remission without relapse at week 52 in each treatment group.
Time frame: Assessed at week 52
ENT remission is defined as a GPA ENT disease activity score of 0.
9 secondary outcomes
Comparison of mean ENT disease activity scores between treatment arms
Time frame: Assessed at week 52
Cumulative steroid dose
Time frame: Assessed at week 52
Duration of steroid free remission
Time frame: Assessed at week 52
Proportion of subject in remission without relapse and completed steroid taper
Time frame: Assessed at week 52
Quality of Life as measured by the SNOT-22 Questionnaire
Time frame: Assessed at week 0, 16, and 52
Change in VDI in the ENT domain
Time frame: Assessed at week 52
Number of surgical procedures in the ENT domain required during the study period
Time frame: Assessed at week 52
Number of ENT flares as measured by the ENT GPA DAS
Time frame: Assessed at week 52
Number of GPA flares as measured by BVAS-WG
Time frame: Assessed at week 52
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Background: PubMed 15986348Seo P, Min YI, Holbrook JT, Hoffman GS, Merkel PA, Spiera R, Davis JC, Ytterberg SR, St Clair EW, McCune WJ, Specks U, Allen NB, Luqmani RA, Stone JH; WGET Research Group. Damage caused by Wegener's granulomatosis and its treatment: prospective data from the Wegener's Granulomatosis Etanercept Trial (WGET). Arthritis Rheum. 2005 Jul;52(7):2168-78. doi: 10.1002/art.21117.
- Background: PubMed 16263884Hogan SL, Falk RJ, Chin H, Cai J, Jennette CE, Jennette JC, Nachman PH. Predictors of relapse and treatment resistance in antineutrophil cytoplasmic antibody-associated small-vessel vasculitis. Ann Intern Med. 2005 Nov 1;143(9):621-31. doi: 10.7326/0003-4819-143-9-200511010-00005.
- Background: PubMed 16954992Srouji IA, Andrews P, Edwards C, Lund VJ. General and rhinosinusitis-related quality of life in patients with Wegener's granulomatosis. Laryngoscope. 2006 Sep;116(9):1621-5. doi: 10.1097/01.mlg.0000230440.83375.4b.
- Background: PubMed 1739240Hoffman GS, Kerr GS, Leavitt RY, Hallahan CW, Lebovics RS, Travis WD, Rottem M, Fauci AS. Wegener granulomatosis: an analysis of 158 patients. Ann Intern Med. 1992 Mar 15;116(6):488-98. doi: 10.7326/0003-4819-116-6-488.
- Background: PubMed 12905485Stone JH; Wegener's Granulomatosis Etanercept Trial Research Group. Limited versus severe Wegener's granulomatosis: baseline data on patients in the Wegener's granulomatosis etanercept trial. Arthritis Rheum. 2003 Aug;48(8):2299-309. doi: 10.1002/art.11075.
- Background: PubMed 16052573De Groot K, Rasmussen N, Bacon PA, Tervaert JW, Feighery C, Gregorini G, Gross WL, Luqmani R, Jayne DR. Randomized trial of cyclophosphamide versus methotrexate for induction of remission in early systemic antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum. 2005 Aug;52(8):2461-9. doi: 10.1002/art.21142.
- Background: PubMed 20647199Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905.
- Background: PubMed 25739829Jones RB, Furuta S, Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA, Savage CO, Segelmark M, Tesar V, van Paassen P, Walsh M, Westman K, Jayne DR; European Vasculitis Society (EUVAS). Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial. Ann Rheum Dis. 2015 Jun;74(6):1178-82. doi: 10.1136/annrheumdis-2014-206404. Epub 2015 Mar 4.
- Background: PubMed 23902481Specks U, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Fessler BJ, Ding L, Viviano L, Tchao NK, Phippard DJ, Asare AL, Lim N, Ikle D, Jepson B, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh K, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Mueller M, Sejismundo LP, Mieras K, Stone JH; RAVE-ITN Research Group. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013 Aug 1;369(5):417-27. doi: 10.1056/NEJMoa1213277.
- Background: PubMed 16269425Aries PM, Hellmich B, Voswinkel J, Both M, Nolle B, Holl-Ulrich K, Lamprecht P, Gross WL. Lack of efficacy of rituximab in Wegener's granulomatosis with refractory granulomatous manifestations. Ann Rheum Dis. 2006 Jul;65(7):853-8. doi: 10.1136/ard.2005.044420. Epub 2005 Nov 3.
- Background: PubMed 18688911Seo P, Specks U, Keogh KA. Efficacy of rituximab in limited Wegener's granulomatosis with refractory granulomatous manifestations. J Rheumatol. 2008 Oct;35(10):2017-23. Epub 2008 Aug 1.
- Background: PubMed 19673980Martinez Del Pero M, Chaudhry A, Jones RB, Sivasothy P, Jani P, Jayne D. B-cell depletion with rituximab for refractory head and neck Wegener's granulomatosis: a cohort study. Clin Otolaryngol. 2009 Aug;34(4):328-35. doi: 10.1111/j.1749-4486.2009.01968.x.
- Individual participant dataSharing planned: No
Related trials for Granulomatosis With Polyangiitis (Wegener's Granulomatosis)
RecruitingPhase 3
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilia Syndrome (HES)
RecruitingPhase 3
Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Active, not recruitingPhase 1/2
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Lupus Nephritis, Immunoglobulin A Nephropathy
Active, not recruitingPhase 2
Iptacopan in Patients With ANCA Associated Vasculitis
Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
Active, not recruitingPhase 1/2
TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis
Granulomatosis With Polyangiitis, Wegener Granulomatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert F Spiera, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rituximab in people with Granulomatosis With Polyangiitis (Wegener's Granulomatosis), run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in ENT remission without relapse at week 52 in each treatment group. (time frame: Assessed at week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02626845, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.