Pemphigus VulgarisPhase 2NCT00626678
Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone
A Phase 2 study testing Azathioprine and Prednisone in people with Pemphigus Vulgaris, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Pemphigus Vulgaris
- What is being tested?
- Azathioprine and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- Jan 2008to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lesions clinically consistent with pemphigus vulgaris
- Diagnosis confirmed by histology in terms of acantholysis within past month
- Positive DIF
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Dermatology, Tehran University of Medical Sciences
Tehran, Tehran Province
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone
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.
Read the 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
- Conditions
- Pemphigus Vulgaris
- Being tested
- Azathioprine, Prednisone, Placebo
- Keywords
- Pemphigus Vulgaris, Azathioprine, Prednisone
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzathioprineDrug
Also called Imuran
It is given in a consistent dosage of 2.5 mg/kg/day throughout the study
PrednisoneDrug
Also called Meticorten ®, Deltasone®, Orasone®
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.
PlaceboDrug
Also called Vehicle
Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral administration of prednisone and azathioprine throughout study Receives: Drug: Azathioprine; Drug: Prednisone |
| 2 | Placebo comparator | Oral administration of prednisone and placebo throughout study Receives: Drug: Prednisone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Disease activity index
Measured: Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months
Secondary outcomes (4)
Total dose of corticosteroid
Measured: At the end of study
Occurence of any adverse event
Measured: Throughout study
Occurence of Grade 3 or higher treatment-related adverse event
Measured: Throughout study
Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigus VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Cheyda Chams-Davatchi, MD, Study chair, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626678
- Sponsor's protocol ID
- 87- 01-30 - 6907
- Status last verified
- Nov 2010
- First submitted
- 21 Feb 2008
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone
- ClinicalTrials.gov ID
- NCT00626678
- Acronym / sponsor ID
- 87- 01-30 - 6907
- Conditions
- Pemphigus Vulgaris
- Keywords
- Pemphigus Vulgaris, Azathioprine, Prednisone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Azathioprine, Drug: PrednisoneOral administration of prednisone and azathioprine throughout study |
| 2 | Placebo comparator | Drug: Prednisone, Drug: PlaceboOral administration of prednisone and placebo throughout study |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Lesions clinically consistent with pemphigus vulgaris
- Diagnosis confirmed by histology in terms of acantholysis within past month
- Positive DIF
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzathioprineAlso: ImuranIt is given in a consistent dosage of 2.5 mg/kg/day throughout the study | Drug | 1 |
| PrednisoneAlso: Meticorten ®, Deltasone®, Orasone®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 | 1, 2 |
| PlaceboAlso: VehiclePlacebo given in place of Azathioprine 2.5 mg/kg/day throughout the study | Drug | 2 |
Primary outcome
• Disease activity index
Time frame: Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months
4 secondary outcomes
Total dose of corticosteroid
Time frame: At the end of study
Occurence of any adverse event
Time frame: Throughout study
Occurence of Grade 3 or higher treatment-related adverse event
Time frame: Throughout study
Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheyda Chams-Davatchi, MD study chair
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azathioprine and Prednisone in people with Pemphigus Vulgaris, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Disease activity index (time frame: Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2010.