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Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00626678
First received: February 21, 2008
Last updated: November 26, 2010
Last verified: November 2010
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • • Disease activity index [ Time Frame: Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total dose of corticosteroid [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
  • Occurence of any adverse event [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Occurence of Grade 3 or higher treatment-related adverse event [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: January 2008
Study Completion Date: September 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   10 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: February 21, 2008
Last Updated: November 26, 2010
Health Authority: Iran: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 27, 2014