PemphigusRITAINCT00960713
The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders
An observational study of Pemphigus and Auto-immune Thrombocytopenic Purpura, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for various auto-immune diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigus, Auto-immune Thrombocytopenic Purpura, Hemolytic Auto-immune Anaemia
- What is being tested?
- Rituximab (MABTHERA® or RITUXAN®).
- Type of treatment
- Injection or infusion
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Jan 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (in the South of France) is eligible for the study
Who may be able to join
- Age over 18 years
- rituximab is prescribed off-label for an auto-immune disorder
- rituximab prescription is validated by an institutional board
- Patients have given their informed consent to be included in the cohort
Who cannot join
- Follow-up for 6 months presumably doubtful
- Rituximab is prescribed for rheumatoïd arthritis
- Rituximab is prescribed for lymphoma
- Pregnant or breath feeding women
Trial locations and contacts
1 site in 1 country.
France1 site
Service de médecine interne, hôpital Purpan, place du Dr Baylac
Toulouse, 31059
About this study
Official title: The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders
The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for various auto-immune diseases.
Read the detailed description
Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (France) is eligible for the study, whatever the dose and the number of planned infusions. The enrollment is definitive at the time the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Pharmacovigilance. Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco- immunological studies.
- Conditions
- Pemphigus, Auto-immune Thrombocytopenic Purpura, Hemolytic Auto-immune Anaemia, Cold Agglutinin Disease, Cryoglobulinemia
- Being tested
- Rituximab (MABTHERA® or RITUXAN®).
- Keywords
- observational cohort, rituximab, off-label use, auto-immunity, cytopenia
- Medical subject headings
- Pemphigus, Anemia, Hemolytic, Autoimmune, Cryoglobulinemia, Cytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab (MABTHERA® or RITUXAN®).Drug
patients can be included in the study whatever the dosage used. Most patients will receive a classical 375 mg/m2 dose every week during four times (J0-J7-J14-J21).
| Study group | Role | What they receive |
|---|---|---|
| The RITAI cohort | Every patient treated by rituximab off-label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (South of France) is eligible for the study, whatever the dose and planned infusions number. The enrolment is definitive when the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Department of Pharmacology Pharmacovigilance unit and to Health Authorities (AFSSAPS). Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco-immunological studies. Receives: Drug: Rituximab (MABTHERA® or RITUXAN®). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a serious adverse events
Measured: Day 14, Week 6, Month 6, Month 12 and Month 18
Secondary outcomes (2)
Type, severity and frequency of all other adverse events occurring in the year following rituximab
Measured: Day 14, Week 6, Month 6, Month 12 and Month 18
Factors that may influence the occurrence of infectious adverse events
Measured: Day 14, Week 6, Month 6, Month 12 and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PemphigusStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Sailler, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960713
- Sponsor's protocol ID
- 0816002
- Other IDs
- AOL 2008
- Acronym
- RITAI
- Status last verified
- Oct 2012
- First submitted
- 16 Jul 2009
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders
- ClinicalTrials.gov ID
- NCT00960713
- Acronym / sponsor ID
- RITAI / 0816002
- Conditions
- Pemphigus, Auto-immune Thrombocytopenic Purpura, Hemolytic Auto-immune Anaemia, Cold Agglutinin Disease, Cryoglobulinemia
- Keywords
- observational cohort, rituximab, off-label use, auto-immunity, cytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Aug 2009 (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 primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for various auto-immune diseases.
Detailed description
Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (France) is eligible for the study, whatever the dose and the number of planned infusions. The enrollment is definitive at the time the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Pharmacovigilance. Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco- immunological studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The RITAI cohort | – | Drug: Rituximab (MABTHERA® or RITUXAN®).Every patient treated by rituximab off-label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (South of France) is eligible for the study, whatever the dose and planned infusions number. The enrolment is definitive when the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Department of Pharmacology Pharmacovigilance unit and to Health Authorities (AFSSAPS). Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco-immunological studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (in the South of France) is eligible for the study
Key inclusion criteria (4 listed)
- Age over 18 years
- rituximab is prescribed off-label for an auto-immune disorder
- rituximab prescription is validated by an institutional board
- Patients have given their informed consent to be included in the cohort
Key exclusion criteria (4 listed)
- Follow-up for 6 months presumably doubtful
- Rituximab is prescribed for rheumatoïd arthritis
- Rituximab is prescribed for lymphoma
- Pregnant or breath feeding women
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 |
|---|---|---|
| Rituximab (MABTHERA® or RITUXAN®).patients can be included in the study whatever the dosage used. Most patients will receive a classical 375 mg/m2 dose every week during four times (J0-J7-J14-J21). | Drug | The RITAI cohort |
Primary outcome
Occurrence of a serious adverse events
Time frame: Day 14, Week 6, Month 6, Month 12 and Month 18
2 secondary outcomes
Type, severity and frequency of all other adverse events occurring in the year following rituximab
Time frame: Day 14, Week 6, Month 6, Month 12 and Month 18
Factors that may influence the occurrence of infectious adverse events
Time frame: Day 14, Week 6, Month 6, Month 12 and Month 18
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 23 Oct 2012.
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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.
Laurent Sailler principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pemphigus and Auto-immune Thrombocytopenic Purpura, run by University Hospital, Toulouse 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 23 Oct 2012. 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?
Occurrence of a serious adverse events (time frame: Day 14, Week 6, Month 6, Month 12 and Month 18). 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 23 Oct 2012.