Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

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

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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

• Responsible Party: Cheyda Chams-Davatchi, Department of Dermatology, Tehran University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT00626678
• Other Study ID Numbers: 87- 01-30 - 6907
• First Posted: February 29, 2008
• 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