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Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

Primary Purpose

Pemphigus Vulgaris

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Azathioprine
Prednisone
Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pemphigus Vulgaris focused on measuring Pemphigus Vulgaris, Azathioprine, Prednisone

Eligibility Criteria

10 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Lesions clinically consistent with pemphigus vulgaris
  • Diagnosis confirmed by histology in terms of acantholysis within past month
  • Positive DIF

Exclusion Criteria:

  • Any nursing or pregnant woman
  • 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

Sites / Locations

  • Department of Dermatology, Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Oral administration of prednisone and azathioprine throughout study

Oral administration of prednisone and placebo throughout study

Outcomes

Primary Outcome Measures

• Disease activity index

Secondary Outcome Measures

Total dose of corticosteroid
Occurence of any adverse event
Occurence of Grade 3 or higher treatment-related adverse event
Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment

Full Information

First Posted
February 21, 2008
Last Updated
November 26, 2010
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00626678
Brief Title
Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pemphigus Vulgaris
Keywords
Pemphigus Vulgaris, Azathioprine, Prednisone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Oral administration of prednisone and azathioprine throughout study
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Oral administration of prednisone and placebo throughout study
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Other Intervention Name(s)
Imuran
Intervention Description
It is given in a consistent dosage of 2.5 mg/kg/day throughout the study
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Meticorten ®, Deltasone®, Orasone®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study
Primary Outcome Measure Information:
Title
• Disease activity index
Time Frame
Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months
Secondary Outcome Measure Information:
Title
Total dose of corticosteroid
Time Frame
At the end of study
Title
Occurence of any adverse event
Time Frame
Throughout study
Title
Occurence of Grade 3 or higher treatment-related adverse event
Time Frame
Throughout study
Title
Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lesions clinically consistent with pemphigus vulgaris Diagnosis confirmed by histology in terms of acantholysis within past month Positive DIF Exclusion Criteria: Any nursing or pregnant woman 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheyda Chams-Davatchi, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Dermatology, Tehran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

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