Refractory Myasthenia GravisPhase 1/2NCT00619671
A Pilot Trial of Rituxan in Refractory Myasthenia Gravis
A Phase 1/2 study testing Rituximab (Rituxan) in people with Refractory Myasthenia Gravis, run by University of Vermont at 2 sites in United States.
Trial summary
Myasthenia gravis is a disease that happens because the immune system attacks the nervous system. The damage is caused by antibodies produced by B lymphocytes. These antibodies damage a special part of the muscle that helps transmit impulses from nerves to muscles to allow muscles to work properly. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Refractory Myasthenia Gravis
- What is being tested?
- Rituximab (Rituxan)
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2004to Mar 2009
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria for patient selection will be based upon the recent recommendations for clinical research standards by the Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America (Jaretzki et al, 2000).
- Patients will be included in the trial based upon fulfilling all the criteria given below, except that they will be required to fulfill criterion 3 OR 4:
- Patients must have a diagnosis of "Definite" MG (Seybold, 1999) as based on clinical, electrophysiological and serological criteria (Appendix 1)
- Patients must have disease predominantly affecting bulbar or respiratory muscles of moderate or severe degree (Osserman grades 2B, 3 without crisis, or 4 without crisis) (Osserman and Genkins, 1971 and Appendix 2) as listed in Appendix 3, and a Quantitative MG score of <25 (Appendix 7)
- Patients must have disease refractory to treatment for at least 12 months with prednisone at a dose of 15mg/day and/or immunosuppressive drugs (azathioprine or cyclophosphamide at a dose of 100mg/day or cyclosporine at a dose to produce trough levels of >50), with or without thymectomy and plasmapheresis/IVIG alone or in combination with above drugs at intervals of no more than once every 3 weeks, OR
- Patients must have experienced intolerance or unacceptable side-effects following treatment with corticosteroids, immunosuppressive drugs (azathioprine, cyclophosphamide or cyclosporine), plasmapheresis or IVIG
Show all 17Show fewer
- Patients must be between 18 years and 80 years old
- Patients must have adequate organ function / laboratory parameters as measured by the following criteria (values should be obtained within 2 weeks prior to enrollment):
- Documented CD20 + cells
- Absolute neutrophil count: >2000/mm3
- Platelets: >100,000/mm3
- Hemoglobin: >10 gm/dL
- Adequate renal function as indicated by normal BUN and creatinine levels
- Adequate liver function, as indicated by AST and ALT <2x Upper Limit of normal.
- Normal serum electrolytes
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for one year after completion of treatment
- Written informed consent.
Who cannot join
- Patients will be excluded from the trial based on the following criteria:
- Myasthenic crisis with a forced vital capacity (FVC) of <30% predicted, irrespective of need for respiratory support, or severe bulbar involvement (Appendix 3)
- Patients requiring maintenance plasmapheresis or IVIG infusions at intervals of less than once every three weeks
- Patients requiring respiratory support with invasive or non-invasive ventilation
- Severe, uncontrolled or untreated concomitant cardiac (New York Heart Classification III or IV disease), hepatic, pulmonary, renal, hematologic or psychiatric disease
- Toxicity grade 2 or more prior to treatment with rituximab in patients who failed prior treatments
Show all 16Show fewer
- Patients unwilling to attend for follow-up visits according to the study design
- Patients will be excluded based on the following criteria:
- History of HIV disease
- Active Hepatitis B infection
- Pregnancy (a serum pregnancy test will be performed for all women of childbearing potential immediately before treatment)
- Active infection
- Pregnant or breastfeeding women may not participate due to the lack of information on effects of rituximab on the fetus and developing child
- Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- No prior monoclonal antibody therapy.
- History of significant psychiatric disease that will interfere with the consenting procedure, research visits, treatment protocol or evaluation of patients in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Vermont Department of Neurology
Burlington, Vermont, 05405
State University of New York
Syracuse, New York, 13210
About this study
Official title: Phase 1-2 Pilot Study of Rituximab (Rituxan) in Refractory Myasthenia Gravis.
Myasthenia gravis is a disease that happens because the immune system attacks the nervous system. The damage is caused by antibodies produced by B lymphocytes. These antibodies damage a special part of the muscle that helps transmit impulses from nerves to muscles to allow muscles to work properly. This damage results in symptoms of myasthenia gravis. Participants are being asked to participate in this research study because their myasthenia gravis has either failed to respond to treatments commonly used in the disease, or they have had bad side-effects from such treatments.
This is a research study of a drug called Rituximab. Rituximab, also called Rituxan, is a mouse antibody that has been changed to make it similar to a human antibody. Antibodies are proteins that can protect the body from foreign invaders, such as bacteria and viruses, by binding to substances called antigens. Rituxan works by binding to a protein, called the CD20 protein. Rituxan helps to destroy white blood cells that produce antibodies in the body, called B-lymphocytes. It is a treatment given through a vein in the participant's arm over a period of approximately 4-6 hours. It has been approved by the Food and Drug Administration (FDA) for use in patients with a form of cancer of the lymph glands called Non-Hodgkin's Lymphoma (NHL). Rituximab is not approved for their myasthenia gravis.
Treatment with Rituximab is being tried in this research study because Rituximab decreases B lymphocytes. There is preliminary evidence that Rituximab helps some patients with chronic and otherwise difficult to treat myasthenia gravis.
Read the detailed description
Myasthenia gravis (MG) is an immune-mediated disorder of the neuromuscular junction diagnosed on the basis of clinical, electrophysiological and serological features. Cyclosporine as a disease-modifying therapy has been effective in a controlled study; corticosteroids, immunosuppressive agents such as azathioprine and cyclophosphamide, plasmapheresis and intravenous human immune globulin have shown benefit in uncontrolled trials. There are several drawbacks to currently used medical treatments, including serious and debilitating side-effects, prohibitive costs, and the need for continuous or periodical treatment. Almost 20-25% of patients with MG are unresponsive to commonly used therapies, resulting in significant burden and economic loss. Rituximab is a chimeric anti-CD20 monoclonal antibody which produces a substantial reduction in circulating plasma cells (CD19+) and B cells (CD20+) and provides targeted therapy for B-cell lymphomas. Recently, rituximab has been found to be effective in several antibody-mediated autoimmune processes, including immune thrombocytopenia, autoimmune hemolytic anemia, and IgM-related polyneuropathies. There is preliminary evidence in the literature that treatment of MG patients with rituximab is likely to be of benefit. These observations would strongly suggest that rituximab might benefit refractory MG and needs further study.
- Conditions
- Refractory Myasthenia Gravis
- Being tested
- Rituximab (Rituxan)
- Keywords
- Rituxan, Rituximab, Myasthenia Gravis, MG
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab (Rituxan)Drug
Also called Rituxan, Rituximab, MabThera
Four weekly IV infusions of Rituxan with dosage individually calculated per subject.
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the effects of rituximab on disease activity in MG patients with refractory disease.
Measured: Patients will be followed for one year
Secondary outcomes (1)
To determine the safety and tolerability of rituximab in MG patients with refractory disease.
Measured: Patients will be followed for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startApr 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Refractory Myasthenia GravisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Dr. Rup Tandan, M.D., F.R.C.P., University of Vermont
- Investigators
- Rup Tandan, MD, FRCP, Principal investigator, University of Vermont Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619671
- Sponsor's protocol ID
- RituxanMGPilot
- Other IDs
- BB-IND# 11403, Genentech #U2444S, UVM CHRMS #04-086
- Status last verified
- Jan 2013
- First submitted
- 14 Jan 2008
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
AAEM Quality Assurance Committee. American Association of Electrodiagnostic Medicine. Practice parameter for repetitive nerve stimulation and single fiber EMG evaluation of adults with suspected myasthenia gravis or Lambert-Eaton myasthenic syndrome: summary statement. Muscle Nerve. 2001 Sep;24(9):1236-8. doi: 10.1002/mus.1139. No abstract available.
PubMed 11494280Aranda JM Jr, Scornik JC, Normann SJ, Lottenberg R, Schofield RS, Pauly DF, Miles M, Hill JA, Sleasman JW, Skoda-Smith S. Anti-CD20 monoclonal antibody (rituximab) therapy for acute cardiac humoral rejection: a case report. Transplantation. 2002 Mar 27;73(6):907-10. doi: 10.1097/00007890-200203270-00013.
PubMed 11923690Barohn RJ, McIntire D, Herbelin L, Wolfe GI, Nations S, Bryan WW. Reliability testing of the quantitative myasthenia gravis score. Ann N Y Acad Sci. 1998 May 13;841:769-72. doi: 10.1111/j.1749-6632.1998.tb11015.x. No abstract available.
PubMed 9668327Besinger UA, Toyka KV, Homberg M, Heininger K, Hohlfeld R, Fateh-Moghadam A. Myasthenia gravis: long-term correlation of binding and bungarotoxin blocking antibodies against acetylcholine receptors with changes in disease severity. Neurology. 1983 Oct;33(10):1316-21. doi: 10.1212/wnl.33.10.1316.
PubMed 6684226Chemnitz J, Draube A, Scheid C, Staib P, Schulz A, Diehl V, Sohngen D. Successful treatment of severe thrombotic thrombocytopenic purpura with the monoclonal antibody rituximab. Am J Hematol. 2002 Oct;71(2):105-8. doi: 10.1002/ajh.10204.
PubMed 12353309Chiu HC, Chen WH, Yeh JH. The six year experience of plasmapheresis in patients with myasthenia gravis. Ther Apher. 2000 Aug;4(4):291-5. doi: 10.1046/j.1526-0968.2000.004004291.x.
PubMed 10975476Dallaire B, Leonard J, Varns C et al. IDEC-C2B8 (Rituximab): Biology and preclinical studies. J Mol Med 75:B230, 1997.
Davis TA, Grillo-Lopez AJ, White CA, McLaughlin P, Czuczman MS, Link BK, Maloney DG, Weaver RL, Rosenberg J, Levy R. Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lymphoma: safety and efficacy of re-treatment. J Clin Oncol. 2000 Sep;18(17):3135-43. doi: 10.1200/JCO.2000.18.17.3135.
PubMed 10963642Gajra A, Vajpayee N, Grethlein SJ. Response of myasthenia gravis to rituximab in a patient with non-Hodgkin lymphoma. Am J Hematol. 2004 Oct;77(2):196-7. doi: 10.1002/ajh.20169.
PubMed 15389902Grollo-Lopez A, Varns C, Waldichuk C et al. IDEC-C2B8 chimeric anti-CD20 antibody: Safety and clinical activity in the treatment of patients with relapsed low-grade or follicular (IWF:A-D) non-Hodgkin's lymphoma (NHL). Br J Haematol 93:283, 1996.
Grob D. Natural history of myasthenia gravis. In: Engel AG (ed). Myasthenia Gravis and Myasthenic Disorders. New York: Oxford University Press, 1999, pp 131-145.
Hilkevich O, Drory VE, Chapman J, Korczyn AD. The use of intravenous immunoglobulin as maintenance therapy in myasthenia gravis. Clin Neuropharmacol. 2001 May-Jun;24(3):173-6. doi: 10.1097/00002826-200105000-00010.
PubMed 11391130Jaretzki A 3rd, Barohn RJ, Ernstoff RM, Kaminski HJ, Keesey JC, Penn AS, Sanders DB. Myasthenia gravis: recommendations for clinical research standards. Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America. Neurology. 2000 Jul 12;55(1):16-23. doi: 10.1212/wnl.55.1.16. No abstract available.
PubMed 10891897Jenkins D, DiFrancesco L, Chaudhry A, Morris D, Gluck S, Jones A, Woodman R, Brown CB, Russell J, Stewart DA. Successful treatment of post-transplant lymphoproliferative disorder in autologous blood stem cell transplant recipients. Bone Marrow Transplant. 2002 Sep;30(5):321-6. doi: 10.1038/sj.bmt.1703603.
PubMed 12209355Leget GA, Czuczman MS. Use of rituximab, the new FDA-approved antibody. Curr Opin Oncol. 1998 Nov;10(6):548-51. doi: 10.1097/00001622-199811000-00012.
PubMed 9818234
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2 Pilot Study of Rituximab (Rituxan) in Refractory Myasthenia Gravis.
- ClinicalTrials.gov ID
- NCT00619671
- Acronym / sponsor ID
- RituxanMGPilot
- Conditions
- Refractory Myasthenia Gravis
- Keywords
- Rituxan, Rituximab, Myasthenia Gravis, MG
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Feb 2008 (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.
Myasthenia gravis is a disease that happens because the immune system attacks the nervous system. The damage is caused by antibodies produced by B lymphocytes. These antibodies damage a special part of the muscle that helps transmit impulses from nerves to muscles to allow muscles to work properly. This damage results in symptoms of myasthenia gravis. Participants are being asked to participate in this research study because their myasthenia gravis has either failed to respond to treatments commonly used in the disease, or they have had bad side-effects from such treatments.
This is a research study of a drug called Rituximab. Rituximab, also called Rituxan, is a mouse antibody that has been changed to make it similar to a human antibody. Antibodies are proteins that can protect the body from foreign invaders, such as bacteria and viruses, by binding to substances called antigens. Rituxan works by binding to a protein, called the CD20 protein. Rituxan helps to destroy white blood cells that produce antibodies in the body, called B-lymphocytes. It is a treatment given through a vein in the participant's arm over a period of approximately 4-6 hours. It has been approved by the Food and Drug Administration (FDA) for use in patients with a form of cancer of the lymph glands called Non-Hodgkin's Lymphoma (NHL). Rituximab is not approved for their myasthenia gravis.
Treatment with Rituximab is being tried in this research study because Rituximab decreases B lymphocytes. There is preliminary evidence that Rituximab helps some patients with chronic and otherwise difficult to treat myasthenia gravis.
Detailed description
Myasthenia gravis (MG) is an immune-mediated disorder of the neuromuscular junction diagnosed on the basis of clinical, electrophysiological and serological features. Cyclosporine as a disease-modifying therapy has been effective in a controlled study; corticosteroids, immunosuppressive agents such as azathioprine and cyclophosphamide, plasmapheresis and intravenous human immune globulin have shown benefit in uncontrolled trials. There are several drawbacks to currently used medical treatments, including serious and debilitating side-effects, prohibitive costs, and the need for continuous or periodical treatment. Almost 20-25% of patients with MG are unresponsive to commonly used therapies, resulting in significant burden and economic loss. Rituximab is a chimeric anti-CD20 monoclonal antibody which produces a substantial reduction in circulating plasma cells (CD19+) and B cells (CD20+) and provides targeted therapy for B-cell lymphomas. Recently, rituximab has been found to be effective in several antibody-mediated autoimmune processes, including immune thrombocytopenia, autoimmune hemolytic anemia, and IgM-related polyneuropathies. There is preliminary evidence in the literature that treatment of MG patients with rituximab is likely to be of benefit. These observations would strongly suggest that rituximab might benefit refractory MG and needs further study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Criteria for patient selection will be based upon the recent recommendations for clinical research standards by the Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America (Jaretzki et al, 2000).
- Patients will be included in the trial based upon fulfilling all the criteria given below, except that they will be required to fulfill criterion 3 OR 4:
- Patients must have a diagnosis of "Definite" MG (Seybold, 1999) as based on clinical, electrophysiological and serological criteria (Appendix 1)
- Patients must have disease predominantly affecting bulbar or respiratory muscles of moderate or severe degree (Osserman grades 2B, 3 without crisis, or 4 without crisis) (Osserman and Genkins, 1971 and Appendix 2) as listed in Appendix 3, and a Quantitative MG score of <25 (Appendix 7)
- Patients must have disease refractory to treatment for at least 12 months with prednisone at a dose of 15mg/day and/or immunosuppressive drugs (azathioprine or cyclophosphamide at a dose of 100mg/day or cyclosporine at a dose to produce trough levels of >50), with or without thymectomy and plasmapheresis/IVIG alone or in combination with above drugs at intervals of no more than once every 3 weeks, OR
Key exclusion criteria (16 listed)
- Myasthenic crisis with a forced vital capacity (FVC) of <30% predicted, irrespective of need for respiratory support, or severe bulbar involvement (Appendix 3)
- Patients requiring maintenance plasmapheresis or IVIG infusions at intervals of less than once every three weeks
- Patients requiring respiratory support with invasive or non-invasive ventilation
- Severe, uncontrolled or untreated concomitant cardiac (New York Heart Classification III or IV disease), hepatic, pulmonary, renal, hematologic or psychiatric disease
- Toxicity grade 2 or more prior to treatment with rituximab in patients who failed prior treatments
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 (Rituxan)Also: Rituxan, Rituximab, MabTheraFour weekly IV infusions of Rituxan with dosage individually calculated per subject. | Drug | – |
Primary outcome
To examine the effects of rituximab on disease activity in MG patients with refractory disease.
Time frame: Patients will be followed for one year
1 secondary outcome
To determine the safety and tolerability of rituximab in MG patients with refractory disease.
Time frame: Patients will be followed for 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 16 Jan 2013.
- Background: PubMed 11494280AAEM Quality Assurance Committee. American Association of Electrodiagnostic Medicine. Practice parameter for repetitive nerve stimulation and single fiber EMG evaluation of adults with suspected myasthenia gravis or Lambert-Eaton myasthenic syndrome: summary statement. Muscle Nerve. 2001 Sep;24(9):1236-8. doi: 10.1002/mus.1139. No abstract available.
- Background: PubMed 11923690Aranda JM Jr, Scornik JC, Normann SJ, Lottenberg R, Schofield RS, Pauly DF, Miles M, Hill JA, Sleasman JW, Skoda-Smith S. Anti-CD20 monoclonal antibody (rituximab) therapy for acute cardiac humoral rejection: a case report. Transplantation. 2002 Mar 27;73(6):907-10. doi: 10.1097/00007890-200203270-00013.
- Background: PubMed 9668327Barohn RJ, McIntire D, Herbelin L, Wolfe GI, Nations S, Bryan WW. Reliability testing of the quantitative myasthenia gravis score. Ann N Y Acad Sci. 1998 May 13;841:769-72. doi: 10.1111/j.1749-6632.1998.tb11015.x. No abstract available.
- Background: PubMed 6684226Besinger UA, Toyka KV, Homberg M, Heininger K, Hohlfeld R, Fateh-Moghadam A. Myasthenia gravis: long-term correlation of binding and bungarotoxin blocking antibodies against acetylcholine receptors with changes in disease severity. Neurology. 1983 Oct;33(10):1316-21. doi: 10.1212/wnl.33.10.1316.
- Background: PubMed 12353309Chemnitz J, Draube A, Scheid C, Staib P, Schulz A, Diehl V, Sohngen D. Successful treatment of severe thrombotic thrombocytopenic purpura with the monoclonal antibody rituximab. Am J Hematol. 2002 Oct;71(2):105-8. doi: 10.1002/ajh.10204.
- Background: PubMed 10975476Chiu HC, Chen WH, Yeh JH. The six year experience of plasmapheresis in patients with myasthenia gravis. Ther Apher. 2000 Aug;4(4):291-5. doi: 10.1046/j.1526-0968.2000.004004291.x.
- BackgroundDallaire B, Leonard J, Varns C et al. IDEC-C2B8 (Rituximab): Biology and preclinical studies. J Mol Med 75:B230, 1997.
- Background: PubMed 10963642Davis TA, Grillo-Lopez AJ, White CA, McLaughlin P, Czuczman MS, Link BK, Maloney DG, Weaver RL, Rosenberg J, Levy R. Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lymphoma: safety and efficacy of re-treatment. J Clin Oncol. 2000 Sep;18(17):3135-43. doi: 10.1200/JCO.2000.18.17.3135.
- Background: PubMed 15389902Gajra A, Vajpayee N, Grethlein SJ. Response of myasthenia gravis to rituximab in a patient with non-Hodgkin lymphoma. Am J Hematol. 2004 Oct;77(2):196-7. doi: 10.1002/ajh.20169.
- BackgroundGrollo-Lopez A, Varns C, Waldichuk C et al. IDEC-C2B8 chimeric anti-CD20 antibody: Safety and clinical activity in the treatment of patients with relapsed low-grade or follicular (IWF:A-D) non-Hodgkin's lymphoma (NHL). Br J Haematol 93:283, 1996.
- BackgroundGrob D. Natural history of myasthenia gravis. In: Engel AG (ed). Myasthenia Gravis and Myasthenic Disorders. New York: Oxford University Press, 1999, pp 131-145.
- Background: PubMed 11391130Hilkevich O, Drory VE, Chapman J, Korczyn AD. The use of intravenous immunoglobulin as maintenance therapy in myasthenia gravis. Clin Neuropharmacol. 2001 May-Jun;24(3):173-6. doi: 10.1097/00002826-200105000-00010.
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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.
Rup Tandan, MD, FRCP principal investigator
University of Vermont Department of Neurology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rituximab (Rituxan) in people with Refractory Myasthenia Gravis, run by University of Vermont at 2 sites 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 17 inclusion and 16 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 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
To examine the effects of rituximab on disease activity in MG patients with refractory disease. (time frame: Patients will be followed for one year). 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 NCT00619671, which also lists 28 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 16 Jan 2013.