Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone - Full Text View

Sponsor:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00626678

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 II

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:

MedlinePlus related topics: Pemphigus

Drug Information available for: Prednisone Azathioprine sodium salt Azathioprine

U.S. FDA Resources

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

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

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
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Azathioprine
Prednisone
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic

Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012