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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00584935 |
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Date of registration:
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26/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid
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Scientific title:
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Phase I/II Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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3 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00584935 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Craig A Elmets |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Clinical diagnosis of ocular cicatricial pemphigoid (symptoms of conjunctivitis,
irritation, burning, increased lacrimation, photophobia, dryness of the eyes along
with conjunctival inflammation, trichiasis, and scarring
2. One of the following:
- Failed response to the use of one or more conventional treatments for a minimum
of 10 weeks; or
- Minimal conventional medication doses, with a significant adverse effects,
contradiction to use, or progressive disease despite treatment
3. Adults age 19 and older
4. Adequate renal function as indicated by serum creatinine levels less than 1.5
Exclusion Criteria:
1. known hypersensitivity to rituximab or its components
2. Age less than 19 years
3. Any other condition deemed by the investigator to be a significant hazard to the
subject if the investigational therapy were initiated.
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ocular Cicatricial Pemphigoid
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Intervention(s)
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Drug: Rituximab
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Primary Outcome(s)
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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.
[Time Frame: 16 weeks]
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Number of Participants With no Evidence of Further Scarring (Fosters Staging) at 16 Weeks
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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2. Stability of Visual Acuity (Snellen's Test) at 24 Weeks
[Time Frame: 24 weeks]
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1. Stability of Visual Acuity (Snellen's Test) at 16 Weeks
[Time Frame: 16 weeks]
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Secondary ID(s)
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F060213003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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