Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01338103
Other study ID # 5474
Secondary ID
Status Recruiting
Phase N/A
First received April 17, 2011
Last updated April 29, 2011
Start date January 2010
Est. completion date June 2012

Study information

Verified date March 2011
Source Rabin Medical Center
Contact Daniel Mimouni, MD
Phone 972-3-9376658
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Rituximab, in the same doses as used in rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function via the Cylex assay in pemphigus patients before and after treatment with RItuximab.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Pemphigus patients with moderate-severe disease

Exclusion Criteria:

1. Pregnancy or lactation

2. Woman of reproductive age not using birth control measures.

3. Prior severe allergy or anaphylaxis with a human monoclonal antibody

4. Heart failure

5. Unstable angina or ischemic heart disease

6. Uncontrolled arrhythmia

7. HIV positive

8. Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.

9. Severe dementia or a psychiatric illness

10. Active acute infection

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Rituximab
intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.

Locations

Country Name City State
Israel Bullous diseases clinic, Department of dermatology, Rabin Medical Center Petah Tiqva

Sponsors (2)

Lead Sponsor Collaborator
Rabin Medical Center Leumit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete or partial remission off treatment (based on the consensus statement for pemphigus) 6 months after treatment No
See also
  Status Clinical Trial Phase
Recruiting NCT05534776 - Validation of 5-Point Investigator Global Assessments for Pemphigus
Terminated NCT00278642 - Hematopoietic Stem Cell Support in Patients With Autoimmune Bullous Skin Disorders Phase 1
Not yet recruiting NCT05898308 - Comparison of a Personalized Maintenance Therapy With the Standard Treatment in Pemphigus Phase 4
Terminated NCT01559155 - Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid
Active, not recruiting NCT01974518 - Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus Phase 3
Recruiting NCT05284929 - Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
Recruiting NCT05954416 - FARD (RaDiCo Cohort) (RaDiCo-FARD)
Completed NCT00283712 - Use of Infliximab for the Treatment of Pemphigus Vulgaris Phase 2
Not yet recruiting NCT06285435 - Coagulation Activation in Patients With Pemphigus
Completed NCT01299857 - Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab Phase 3
Completed NCT00960713 - The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders N/A
Completed NCT00213512 - Effect of Anti CD20 in Pemphigus Desease Phase 2/Phase 3
Active, not recruiting NCT04400994 - IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus Phase 2
Recruiting NCT02237313 - Identification of Vulnerability Factors in the Course of Pemphigus Patients N/A
Terminated NCT03075904 - A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus) Phase 1/Phase 2
Terminated NCT03762265 - A Study of PRN1008 in Patients With Pemphigus Phase 3
Recruiting NCT02365675 - Wound Dressings for Pemphigus and Pemphigoid N/A
Active, not recruiting NCT00656656 - Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus Phase 2
Completed NCT00127764 - European Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus Phase 2/Phase 3
Recruiting NCT01313923 - Evaluating Sirolimus to Treat Autoimmune Blistering Dermatosis Pemphigus Phase 0