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Sponsored by: |
Tehran University of Medical Sciences |
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Information provided by: | Tehran University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00626678 |
Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease with unknown etiology that affects mucosa and skin of patients with significant morbidity and mortality.
The treatment back-bone is based on prednisolone administration. There are controversies on the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid sparing drugs. For others, they are disease modifying drugs.
The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.
Condition | Intervention | Phase |
---|---|---|
Pemphigus Vulgaris |
Drug: Azathioprine Drug: Prednisone Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone |
Estimated Enrollment: | 48 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Oral administration of prednisone and azathioprine throughout study
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Drug: Azathioprine
It is given in a consistent dosage of 2.5 mg/kg/day throughout the study
Drug: Prednisone
Oral corticosteroid initiated at 2 mg/kg/day dosage. Dosage may be tapered primarily by 1/3 total dosage if no new blister, then 5 mg every three days to reach the daily dosage of 30 mg then tapered by 1.25 mg every week to reach daily dosage of 20 mg/day, then tapered by 1.25 mg every two weeks to reach daily dosage of 10 mg, then tapered by 1.25 mg monthly to reach daily dosage of 7.5 mg and continue this dosage for six months then tapered to 5 mg/day if no new lesions are observed as determined by clinical assessment of the investigator.
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2: Placebo Comparator
Oral administration of prednisone and placebo throughout study
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Drug: Prednisone
Oral corticosteroid initiated at 2 mg/kg/day dosage. Dosage may be tapered primarily by 1/3 total dosage if no new blister, then 5 mg every three days to reach the daily dosage of 30 mg then tapered by 1.25 mg every week to reach daily dosage of 20 mg/day, then tapered by 1.25 mg every two weeks to reach daily dosage of 10 mg, then tapered by 1.25 mg monthly to reach daily dosage of 7.5 mg and continue this dosage for six months then tapered to 5 mg/day if no new lesions are observed as determined by clinical assessment of the investigator.
Drug: Placebo
Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study
|
The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.
Official Title: Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Azathioprine in New Cases of Pemphigus Vulgaris Receiving Prednisolone
Randomized Double Blind Controlled Trial of Azathioprine versus Placebo in new cases of Pemphigus Vulgaris treated with Prednisolone
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Controlled, Parallel Assignment, Safety/Efficacy Study
Condition Intervention Phase Pemphigus Vulgaris Drug: Azathioprine Drug: Prednisolone Other: Placebo Phase II
Ages Eligible for Study: | 10 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cheyda Chams-Davatchi, M.D. | 00989121301062 | cheyda@davatchi.net |
Iran, Islamic Republic of | |
Department of Dermatology, Tehran University of Medical Sciences | |
Tehran, Iran, Islamic Republic of |
Study Chair: | Cheyda Chams-Davatchi, MD | Tehran University of Medical Sciences |
Responsible Party: | Department of Dermatology, Tehran University of Medical Sciences ( Cheyda Chams-Davatchi ) |
Study ID Numbers: | 87- 01-30 - 6907 |
Study First Received: | February 21, 2008 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00626678 |
Health Authority: | Iran: Ethics Committee |
Pemphigus Vulgaris Azathioprine Prednisone |
Prednisone Pemphigus vulgaris Azathioprine Autoimmune Diseases Skin Diseases, Vesiculobullous Skin Diseases |
Methylprednisolone Prednisolone Methylprednisolone acetate Prednisolone acetate Methylprednisolone Hemisuccinate Pemphigus |
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents, Hormonal Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Glucocorticoids Hormones Pharmacologic Actions Therapeutic Uses Antirheumatic Agents |