Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex
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ClinicalTrials.gov Identifier: NCT01338103 |
Recruitment Status : Unknown
Verified March 2011 by Rabin Medical Center.
Recruitment status was: Recruiting
First Posted : April 19, 2011
Last Update Posted : May 2, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pemphigus | Drug: Rituximab | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex Test |
Study Start Date : | January 2010 |
Estimated Primary Completion Date : | June 2012 |
Estimated Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Rituximab |
Drug: Rituximab
intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks. |
- Complete or partial remission off treatment (based on the consensus statement for pemphigus) [ Time Frame: 6 months after treatment ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Pemphigus patients with moderate-severe disease
Exclusion Criteria:
- Pregnancy or lactation
- Woman of reproductive age not using birth control measures.
- Prior severe allergy or anaphylaxis with a human monoclonal antibody
- Heart failure
- Unstable angina or ischemic heart disease
- Uncontrolled arrhythmia
- HIV positive
- Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.
- Severe dementia or a psychiatric illness
- Active acute infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338103
Contact: Daniel Mimouni, MD | 972-3-9376658 |
Israel | |
Bullous diseases clinic, Department of dermatology, Rabin Medical Center | Recruiting |
Petah Tiqva, Israel, 49100 | |
Contact: Daniel Mimouni, MD |
Responsible Party: | Daniel Mimouni MD, Rabin Medical Center, Department of Dermatology |
ClinicalTrials.gov Identifier: | NCT01338103 |
Other Study ID Numbers: |
5474 |
First Posted: | April 19, 2011 Key Record Dates |
Last Update Posted: | May 2, 2011 |
Last Verified: | March 2011 |
Pemphigus Rituximab Cylex |
Pemphigus Skin Diseases, Vesiculobullous Skin Diseases Autoimmune Diseases Immune System Diseases Rituximab |
Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |