Granulomatosis With PolyangiitisRAVELOSNCT01586858
Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study
An observational study of Granulomatosis With Polyangiitis and Microscopic Polyangiitis, run by Johns Hopkins University at 8 sites in 2 countries.
Trial summary
Rituximab is the first drug approved by the United States Food and Drug Administration (FDA) for the treatment of patients with granulomatosis with polyangiitis (Wegener's granulomatosis) or microscopic polyangiitis. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Granulomatosis With Polyangiitis, Microscopic Polyangiitis
- What is being tested?
- Observational
- How many people
- 67 participants
- Where
- 8 sitesin 2 countries
- Study dates
- May 2012to 15 May 2014
- Phase
- Observational
- 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 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: RAVE study participants
Who may be able to join
- Enrollment in the RAVE trial
- Completion of RAVE Common Closeout Date visit
- Informed consent
Who cannot join
- Refusal to participate
- Inability to comply with standard-of-care, including routine clinical visits and testing.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Johns Hopkins University
Baltimore, Maryland, 21224
University of Alabama
Birmingham, Alabama, 35294
Boston University
Boston, Massachusetts, 02118
The Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27710
Hospital for Special Surgery
New York, New York, 10128
Mayo Clinic Foundation
Rochester, Minnesota, 55905
About this study
Official title: Rituximab for Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis (RAVE) Long-Term Follow-Up Study
Rituximab is the first drug approved by the United States Food and Drug Administration (FDA) for the treatment of patients with granulomatosis with polyangiitis (Wegener's granulomatosis) or microscopic polyangiitis. Because it is a relatively new medication, the long-term safety and efficacy of this drug is not yet clear. This study proposes to follow patients who were enrolled in the RAVE study to determine if treatment with rituximab influences long-term outcomes.
- Being tested
- Observational
- Keywords
- Vasculitis, ANCA, Rituximab, Small vessel vasculitis
- Medical subject headings
- Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational study of subjects previously enrolled in the RAVE trial
| Study group | Role | What they receive |
|---|---|---|
| RAVE subjects | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of rituximab for the treatment of ANCA-associated vasculitis
To determine the long-term safety of rituximab for the treatment of ANCA-associated vasculitis (granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis).
Measured: Four years
Secondary outcomes (5)
Disease activity
Disease activity, assessed by the proportion of patients with severe flares
Measured: Four years
Disease damage assessed by the increase in Vasculitis Damage Index (VDI)
The VDI is composed of 11 categories (e.g., musculoskeletal, pulmonary) and 64 individual damage items. The score ranges from 0 (no damage) to 64 (all individual damage items).
Measured: Four years
Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID)
The AVID has 12 categories and 112 individual damage items. The score ranges from 0 (no damage) to 129 (all individual damage items). Although there are 112 items, 17 items are related to eyes and ears and can be scored for left, right or both.
Measured: Four years
Renal survival
Renal survival, assessed by the proportion of patients doubling their serum creatinine, reaching Stage V Chronic Kidney Disease (defined as a glomerular filtration rate ≤15 ml/min), or both.
Measured: Four years
Malignancy
Proportion of patients with incident malignancies, including type of malignancy
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startMay 2012
- Primary completion15 May 2014
- Study completion15 May 2014
Why it stopped: Loss of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Boston University, Mayo Clinic, Duke University, The Cleveland Clinic, University Medical Center Groningen
- Responsible party
- Sponsor
- Investigators
- Philip Seo, MD, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586858
- Sponsor's protocol ID
- ML27815
- Acronym
- RAVELOS
- Status last verified
- Oct 2017
- First submitted
- 25 Apr 2012
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Stone 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 20647199
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab for Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis (RAVE) Long-Term Follow-Up Study
- ClinicalTrials.gov ID
- NCT01586858
- Acronym / sponsor ID
- RAVELOS / ML27815
- Keywords
- Vasculitis, ANCA, Rituximab, Small vessel vasculitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Loss of Funding
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Boston University, Mayo Clinic, Duke University, The Cleveland Clinic, University Medical Center Groningen
- Study start
- May 2012 (actual)
- Primary completion
- 15 May 2014 (actual)
- Study completion
- 15 May 2014 (actual)
- First posted
- 27 Apr 2012 (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.
Rituximab is the first drug approved by the United States Food and Drug Administration (FDA) for the treatment of patients with granulomatosis with polyangiitis (Wegener's granulomatosis) or microscopic polyangiitis. Because it is a relatively new medication, the long-term safety and efficacy of this drug is not yet clear. This study proposes to follow patients who were enrolled in the RAVE study to determine if treatment with rituximab influences long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAVE subjects | – | Other: Observational |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- RAVE study participants
Key inclusion criteria (3 listed)
- Enrollment in the RAVE trial
- Completion of RAVE Common Closeout Date visit
- Informed consent
Key exclusion criteria (2 listed)
- Refusal to participate
- Inability to comply with standard-of-care, including routine clinical visits and testing.
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 |
|---|---|---|
| ObservationalObservational study of subjects previously enrolled in the RAVE trial | Other | RAVE subjects |
Primary outcome
Long-term safety of rituximab for the treatment of ANCA-associated vasculitis
Time frame: Four years
To determine the long-term safety of rituximab for the treatment of ANCA-associated vasculitis (granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis).
5 secondary outcomes
Disease activity
Time frame: Four years
Disease damage assessed by the increase in Vasculitis Damage Index (VDI)
Time frame: Four years
Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID)
Time frame: Four years
Renal survival
Time frame: Four years
Malignancy
Time frame: Four years
Results and safety
The study was stopped early (reason given: Loss of Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- 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.
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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.
Philip Seo, MD study director
Johns Hopkins University
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Granulomatosis With Polyangiitis and Microscopic Polyangiitis, run by Johns Hopkins University at 8 sites in 2 countries.
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 3 inclusion and 2 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Loss of Funding). 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?
Long-term safety of rituximab for the treatment of ANCA-associated vasculitis (time frame: Four years). 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 NCT01586858, which also lists 1 linked publication.
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 27 Oct 2017.