Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone
NCT ID: NCT00626678
Last Updated: 2010-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2008-01-31
2010-09-30
Brief Summary
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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.
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Oral administration of prednisone and azathioprine throughout study
Azathioprine
It is given in a consistent dosage of 2.5 mg/kg/day throughout the study
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.
2
Oral administration of prednisone and placebo throughout study
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.
Placebo
Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study
Interventions
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Azathioprine
It is given in a consistent dosage of 2.5 mg/kg/day throughout the study
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.
Placebo
Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis confirmed by histology in terms of acantholysis within past month
* Positive DIF
Exclusion Criteria
* Any history of chronic diseases including liver disease, Chronic Renal Failure, Chronic Heart Failure or Ischemic Heart Disease
* Present diagnosis of hepatitis confirmed by serology or elevated hepatic enzymes;
* Clinically significant concurrent medical disease or laboratory abnormalities evidenced by one or more of the following:
* Hepatobiliary AST or ALT ≥ 1.5 × upper limit of normal (ULN);alkaline phosphatase ≥ 1.5 × ULN; or, total bilirubin \> 90% of the ULN;
* Renal serum creatinine \> 1.5 mg/dL; or, significant proteinuria \> 2+ on urinary dip test;
* Hematologic hemoglobin \< 11 mg/dL; leukocytes \< 3.5 × 109/L; neutrophils \< 1.5 × 109/L; or, platelets \< 100 × 109/L; Presence of anemia, leukopenia or thrombocytopenia
* Any sign of patient's non-compliance
* Known hypersensitivity to study drugs, prednisone or azathioprine
* Participating in another clinical trial at the time of screening and enrollment
10 Years
75 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Department of Dermatology, Tehran University of Medical Sciences
Principal Investigators
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Cheyda Chams-Davatchi, MD
Role: STUDY_CHAIR
Tehran University of Medical Sciences
Locations
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Department of Dermatology, Tehran University of Medical Sciences
Tehran, Tehran Province, Iran
Countries
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Other Identifiers
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87- 01-30 - 6907
Identifier Type: -
Identifier Source: org_study_id