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Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid

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ClinicalTrials.gov Identifier: NCT00584935
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : April 21, 2011
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
Genentech, Inc.
Biogen
Information provided by (Responsible Party):
Craig Elmets, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ocular Cicatricial Pemphigoid
Intervention Drug: Rituximab
Enrollment 3
Recruitment Details Three patients were recruited from the investigator's practice.
Pre-assignment Details Subjects must meet inclusion/exclusion criteria.
Arm/Group Title Rituximab
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Rituximab
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years 0
Between 18 and 65 years 2
>=65 years 1
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
61  (28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female 2
Male 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Number of Participants With no Evidence of Further Scarring (Fosters Staging) at 16 Weeks
Hide Description

Stages Characteristics I Subconjunctival scarring and fibrosis II Fornix foreshortening (a-d describes % loss of inferior fornix depth)

  1. 0-25%
  2. 25-50%
  3. 50-75%
  4. 75-100% III Presence of symblepharon and number (n) (a-d describes % of horizontal involvement by symblepharons and n is the number of symblepharons countable)

a. 0-25% b. 25-50% c. 50-75% d. 75-100% IV Ankyloblepharon, frozen globe
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this Outcome was not collected and due to the length of time, the records have been destroyed.
Arm/Group Title Rituximab
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title 2. The Proportion of Patients That Experience a Grade 3, Grade 4, or Grade 5 Toxicity Based Reaction on the NCI-CTC System at the Time of Their Infusions and During Follow-up Visits.
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this Outcome was not collected and due to the length of time, the records have been destroyed.
Arm/Group Title Rituximab
Hide Arm/Group Description:

The Rituximab dose is 1000 mg (1gm) given as an IV infusion every two weeks for 2 doses (Days 1 and 15).

Rituximab: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title 1. Stability of Visual Acuity (Snellen's Test) at 16 Weeks
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this Outcome was not collected and due to the length of time, the records have been destroyed.
Arm/Group Title Rituximab
Hide Arm/Group Description:

The Rituximab dose is 1000 mg (1gm) given as an IV infusion every two weeks for 2 doses (Days 1 and 15).

Rituximab: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title 2. Stability of Visual Acuity (Snellen's Test) at 24 Weeks
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this Outcome was not collected and due to the length of time, the records have been destroyed.
Arm/Group Title Rituximab
Hide Arm/Group Description:

The Rituximab dose is 1000 mg (1gm) given as an IV infusion every two weeks for 2 doses (Days 1 and 15).

Rituximab: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Rituximab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Rituximab
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab
Affected / at Risk (%)
Total   0/3 (0.00%) 
Genentech closed trial before site was able to enroll 5 patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator is required to submit the final manuscript to the sponsor prior to publication. The sponsor may suggest changes but investigator retains editorial rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Cantrell, CRNP
Organization: UAB Department of Dermatology
Phone: 205-502-9960
EMail: wcantrell@uabmc.edu
Layout table for additonal information
Responsible Party: Craig Elmets, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00584935    
Other Study ID Numbers: F060213003
First Submitted: December 26, 2007
First Posted: January 2, 2008
Results First Submitted: February 15, 2011
Results First Posted: April 21, 2011
Last Update Posted: February 7, 2018