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Trial record 3 of 19 for:    "Pemphigus vulgaris"

Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

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ClinicalTrials.gov Identifier: NCT00626678
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : November 30, 2010
Sponsor:
Information provided by:
Tehran University of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Pemphigus Vulgaris Drug: Azathioprine Drug: Prednisone Drug: Placebo Phase 2

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone
Study Start Date : January 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2010


Arm Intervention/treatment
Experimental: 1
Oral administration of prednisone and azathioprine throughout study
Drug: Azathioprine
It is given in a consistent dosage of 2.5 mg/kg/day throughout the study
Other Name: Imuran

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.
Other Names:
  • Meticorten ®
  • Deltasone®
  • Orasone®

Placebo Comparator: 2
Oral administration of prednisone and placebo throughout 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.
Other Names:
  • Meticorten ®
  • Deltasone®
  • Orasone®

Drug: Placebo
Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study
Other Name: Vehicle




Primary Outcome Measures :
  1. • Disease activity index [ Time Frame: Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months ]

Secondary Outcome Measures :
  1. Total dose of corticosteroid [ Time Frame: At the end of study ]
  2. Occurence of any adverse event [ Time Frame: Throughout study ]
  3. Occurence of Grade 3 or higher treatment-related adverse event [ Time Frame: Throughout study ]
  4. Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment [ Time Frame: Throughout study ]


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Ages Eligible for Study:   10 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626678


Locations
Iran, Islamic Republic of
Department of Dermatology, Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Cheyda Chams-Davatchi, MD Tehran University of Medical Sciences

Responsible Party: Cheyda Chams-Davatchi, Department of Dermatology, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00626678     History of Changes
Other Study ID Numbers: 87- 01-30 - 6907
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: November 2010

Keywords provided by Tehran University of Medical Sciences:
Pemphigus Vulgaris
Azathioprine
Prednisone

Additional relevant MeSH terms:
Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Azathioprine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents