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

Sponsored by:	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

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Prednisone Corticosteroids Azathioprine Azathioprine sodium salt

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone

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:	December 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 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.
2: Placebo Comparator 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. Drug: Placebo Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study

Arms

Assigned Interventions

1: Experimental

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

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.

2: Placebo Comparator

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.

Drug: Placebo

Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study

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

Contacts

Contact: Cheyda Chams-Davatchi, M.D.

00989121301062

cheyda@davatchi.net

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:	Department of Dermatology, Tehran University of Medical Sciences ( Cheyda Chams-Davatchi )
Study ID Numbers:	87- 01-30 - 6907
Study First Received:	February 21, 2008
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00626678
Health Authority:	Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:

Pemphigus Vulgaris
Azathioprine
Prednisone

Study placed in the following topic categories:

Prednisone
Pemphigus vulgaris
Azathioprine
Autoimmune Diseases
Skin Diseases, Vesiculobullous
Skin Diseases

Methylprednisolone
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone Hemisuccinate
Pemphigus

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents, Hormonal
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 16, 2009