Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

NCT00626678 | Completed Phase 2 DMC

• 1 other identifier: 87- 01-30 - 6907
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pemphigus Vulgaris

Keywords

Pemphigus Vulgaris; Azathioprine; Prednisone

Outcome Measures

Primary Outcomes (1)

• • Disease activity index

  Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months

Secondary Outcomes (4)

• Total dose of corticosteroid

  At the end of study

• Occurence of any adverse event

  Throughout study

• Occurence of Grade 3 or higher treatment-related adverse event

  Throughout study

• Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Oral administration of prednisone and azathioprine throughout study

Drug: Azathioprine; Drug: Prednisone

2

PLACEBO COMPARATOR

Oral administration of prednisone and placebo throughout study

Drug: Prednisone; Drug: Placebo

Interventions

Azathioprine DRUG

It is given in a consistent dosage of 2.5 mg/kg/day throughout the study

Also known as: Imuran

1

Prednisone DRUG

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.

Also known as: Meticorten ®, Deltasone®, Orasone®

1; 2

Placebo DRUG

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

Also known as: Vehicle

2

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Lesions clinically consistent with pemphigus vulgaris
• Diagnosis confirmed by histology in terms of acantholysis within past month
• Positive DIF

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Department of Dermatology, Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Pemphigus

Interventions

Azathioprine; Prednisone

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Cheyda Chams-Davatchi, MD

  Tehran University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2010
• Last Updated: November 30, 2010

Record last verified: 2010-11

Locations

IR (1)