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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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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-002391-14-GB |
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Date of registration:
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23/08/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pulsed Intravenous Methylprednisolone for Ocular Pemphigoid- A Pilot Study - IVMP for ocular pemphigoid
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Scientific title:
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Pulsed Intravenous Methylprednisolone for Ocular Pemphigoid- A Pilot Study - IVMP for ocular pemphigoid |
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Date of first enrolment:
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29/09/2005 |
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Target sample size:
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20 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002391-14 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patients with clinical features consistent with ocular MMP i.e. progressive conjunctival cicatrisation and inflammation, with or without a positive result on direct immunofluorescence microscopy of a conjunctival, mucosal or skin biopsy showing linear basement membrane deposition of IgG, IgA, or C3, and/or a positive result on testing for anti-basement membrane zone antibodies.
2. All patients with bilateral or unilateral ‘severe’ (grade 4) ocular inflammation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. other causes of progressive conjunctival scarring (drug-induced pemphigoid with negative direct immunofluorescence biopsy, atopic keratoconjunctivitis, Sjogren’s syndrome, Stevens Johnson syndrome, chemical injury)
2. active secondary malignancy
3. HIV infection
4. pregnancy or breastfeeding.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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ocular mucous membrane pemphigoid
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Intervention(s)
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Trade Name: Solu-Medrone
Pharmaceutical Form: Powder for infusion*
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): The proportion of eyes achieving control of inflammation to grade 0 (nil) or grade 1 (minimal) at 2 months.
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Secondary Objective: To investigate the hypothesis that intravenous methylprednisolone results in improved outcome in patients with severe ocular pemphigoid who are commencing cyclophosphamide.
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Main Objective: To investigate the hypothesis that intravenous methylprednisolone induces more rapid control of ocular inflammation in patients with severe ocular pemphigoid who are commencing cyclophosphamide.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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