Not Signed In -
Prednisone Oral |
Deltasone |
Clinical Trial: CellCept® (Mycophenolate Mofetil) in Pemphigus Vulgaris
This study is currently recruiting patients.
Verified by Aspreva Pharmaceuticals August 2005
|
Purpose
Pemphigus vulgaris is a rare, severe, chronic autoimmune disease that causes blisters of the skin and mucous membranes. This study will test the safety and efficacy of adjunct mycophenolate mofetil (MMF) in association with reduced corticosteroids to achieve remission in subjects with active pemphigus vulgaris (PV).
| Condition | Intervention | Phase |
|---|---|---|
| Pemphigus Vulgaris | Drug: mycophenolate mofetil (oral) Drug: prednisone (oral) | Phase III |
MedlinePlus related topics: Autoimmune Diseases; Skin Conditions
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center, 52-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Achieve Remission with Reduced Corticosteroids in Subjects with Active Pemphigus Vulgaris
Further Study Details:
Primary Outcomes: Proportion of responders (minimal disease activity and low steroid dose)
Secondary Outcomes: Time to response; Lesion count; Prednisone dose; Global assessment; Antibody titre; Quality of life; Safety
Expected Total Enrollment: 72
Secondary Outcomes: Time to response; Lesion count; Prednisone dose; Global assessment; Antibody titre; Quality of life; Safety
Expected Total Enrollment: 72
Study start: June 2004
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Diagnosis of PV within the past 24 months
- Mild to moderate disease severity
- Potential to benefit from short-term high-dose oral prednisone therapy
Exclusion Criteria:
- Pregnant, breastfeeding or lactating
- Receiving regularly scheduled intravenous immunoglobulin or plasma exchange
- Receiving MMF, other immunosuppressants or other PV therapies other than prednisone
- Presence of paraneoplastic pemphigus or any other autoimmune blistering disease other than PV
- Presence or history of other severe or chronic medical condition
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00140127
Fiona Lisboa, at Aspreva Pharmaceuticals (250) 744 2488 flisboa@aspreva.com
Canada, British Columbia
For site info please contact Aspreva Pharmaceuticals, Victoria, British Columbia, Canada; Recruiting
Fiona Lisboa (250) 744-2488 flisboa@aspreva.com
More Information
Study ID Numbers: WX17796
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00140127
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00140127
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
Resources
- Deltasone (Drug Digest)
- Prednisone Oral (Drug Digest)
email this page
print this page
bookmark this page
feedback on this page
