A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV) - Full Text View

Sponsors and Collaborators:	Hoffmann-La Roche Aspreva Pharmaceuticals
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00683930

Purpose

This study will assess the efficacy and safety of CellCept(1g or 1.5g po bid for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the study, patients will undergo gradual dose reduction of corticosteroids, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition	Intervention	Phase
Pemphigus Vulgaris (PV)	Drug: mycophenolate mofetil [Cellcept] Drug: mycophenolate mofetil [CellCept] Drug: Placebo	Phase III

MedlinePlus related topics: Pemphigus

Drug Information available for: Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Mult-Center, 52-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Achieve Remission With Reduced Corticosteroid in Subjects With Pemphigus Vulgaris.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients with responder status [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of days a patient maintains a prednisone dose of <= 10mg/dday, in the absence of a new persistent lesion [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Time to relapse [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Time to initial response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, lab parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	May 2004
Estimated Study Completion Date:	March 2007

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil [Cellcept] 1g po bid for 52 weeks
2: Experimental	Drug: mycophenolate mofetil [CellCept] 1.5g po bid for 52 weeks
3: Placebo Comparator	Drug: Placebo po bid for 52 weeks

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients 18 to 70 years of age;
diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids.

Exclusion Criteria:

female patients who are pregnant, breastfeeding, or lactating;
regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 8 weeks prior to randomization;
CellCept or other immunosuppressive therapy, except corticosteroids, exceeding 2 weeks total duration and within 8 weeks prior to randomization;
use of PV therapies other than those noted above, within 4 weeks prior to randomization;
use of topical corticosteroids within 2 weeks prior to randomization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683930

Locations

United States, Florida

Mianm, Florida, United States
United States, Michigan

Ann Arbor, Michigan, United States
Canada, Ontario

TORONTO, Ontario, Canada, M5T 3A9
Germany

MÜNSTER, Germany, 48149

HEIDELBERG, Germany, 69115
India

Ahmedabed, India

Chandigarh, India

Mumbai, India

New Delhi, India
Israel

HAIFA, Israel, 31096

PETACH TIKVA, Israel, 49100
Turkey

ANKARA, Turkey, 6100

ISTANBUL, Turkey

ANKARA, Turkey
Ukraine

UZHGOROD, Ukraine, 88011

KIEV, Ukraine, 252151

CRIMEA, Ukraine, 95006

LUGNANSK, Ukraine
United Kingdom

LONDON, United Kingdom, SE1 7EH

LEICESTER, United Kingdom, LE1 5WW

Sponsors and Collaborators

Hoffmann-La Roche

Aspreva Pharmaceuticals

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	WX17796
Study First Received:	May 19, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00683930 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Bacterial Agents
Pemphigus Vulgaris
Autoimmune Diseases
Immunologic Factors
Skin Diseases, Vesiculobullous

Skin Diseases
Mycophenolic Acid
Mycophenolate mofetil
Immunosuppressive Agents
Pemphigus

Additional relevant MeSH terms:

Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Skin Diseases, Vesiculobullous
Skin Diseases
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Mycophenolic Acid
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Pemphigus
Therapeutic Uses
Mycophenolate mofetil

ClinicalTrials.gov processed this record on May 07, 2009