Wegener's GranulomatosisNCT00307593
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
A study testing Infliximab and Rituximab in people with Wegener's Granulomatosis and Churg-Strauss Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wegener's Granulomatosis, Churg-Strauss Syndrome, Microscopic Polyangiitis
- What is being tested?
- Infliximab and Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- May 2004to Jun 2007
- Phase
- Interventional
- 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
- Systemic ANCA positive (+) vasculitides
- Relapsing or refractory vasculitides, resistant to corticosteroids and reference immunosuppressant therapies
- Age >18 years old
- Written informed consent
Who cannot join
- Newly diagnosed patient
- Patient that had never received an immunosuppressant before to treat his/her vasculitis
- Malignancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides.
Read the detailed description
The aim of this study is to compare the efficacy of rituximab versus infliximab in relapsing or refractory forms of ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome).
- Being tested
- Infliximab, Rituximab
- Keywords
- Systemic ANCA+ vascularizes, Relapse, Corticosteroids, Immunosuppressant, Infliximab/rituximab, Patients with relapsing or refractory forms of ANCA, associated vasculitides Microscopic polyangiitis
- Medical subject headings
- Granulomatosis with Polyangiitis, Churg-Strauss Syndrome, Microscopic Polyangiitis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Infliximab
RituximabDrug
Rituximab
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Rituximab Receives: Drug: Rituximab |
| 2 | Active comparator | Infliximab Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial or complete remission of the vasculitides
Measured: one year
Secondary outcomes (4)
To study the safety and adverse effects of both regimens
Measured: one year
Microscopic polyangiitis
Measured: one year
Wegener's granulomatosis
Measured: one year
Churg-Strauss syndrome
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startMay 2004
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wegener's GranulomatosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Loïc GUILLEVIN, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307593
- Sponsor's protocol ID
- P020931
- Other IDs
- AOM02098
- Status last verified
- Mar 2007
- First submitted
- 24 Mar 2006
- Last updated
- 19 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
- ClinicalTrials.gov ID
- NCT00307593
- Acronym / sponsor ID
- P020931
- Keywords
- Systemic ANCA+ vascularizes, Relapse, Corticosteroids, Immunosuppressant, Infliximab/rituximab, Patients with relapsing or refractory forms of ANCA, associated vasculitides Microscopic polyangiitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Jun 2007 (actual)
- First posted
- 28 Mar 2006 (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.
The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides.
Detailed description
The aim of this study is to compare the efficacy of rituximab versus infliximab in relapsing or refractory forms of ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: RituximabRituximab |
| 2 | Active comparator | Drug: InfliximabInfliximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Systemic ANCA positive (+) vasculitides
- Relapsing or refractory vasculitides, resistant to corticosteroids and reference immunosuppressant therapies
- Age >18 years old
- Written informed consent
Key exclusion criteria (4 listed)
- Newly diagnosed patient
- Patient that had never received an immunosuppressant before to treat his/her vasculitis
- Malignancy
- Pregnancy
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 |
|---|---|---|
| InfliximabInfliximab | Drug | 2 |
| RituximabRituximab | Drug | 1 |
Primary outcome
Partial or complete remission of the vasculitides
Time frame: one year
4 secondary outcomes
To study the safety and adverse effects of both regimens
Time frame: one year
Microscopic polyangiitis
Time frame: one year
Wegener's granulomatosis
Time frame: one year
Churg-Strauss syndrome
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2007.
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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.
Loïc GUILLEVIN, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infliximab and Rituximab in people with Wegener's Granulomatosis and Churg-Strauss Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 19 Nov 2007. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Partial or complete remission of the vasculitides (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2007.