Bullous PemphigoidPhase 2NCT00431119
Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid
A Phase 2 study testing Azathioprine or Mycophenolate mofetil in people with Bullous Pemphigoid, run by University Hospital Muenster at 11 sites in Germany.
Trial summary
To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- Azathioprine or Mycophenolate mofetil
- How many people
- 70 participants
- Where
- 11 sitesGermany
- Study dates
- Oct 1997to Oct 2000
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical lesions suggestive of bullous pemphigoid
- subepidermal blistering upon histological analysis of skin biopsies
- linear deposition of IgG and C3 along the dermo-epidermal junction
- deposition of autoantibodies at the blister roof upon split-skin analysis
Who cannot join
- treatment with oral or topical corticosteroids, and other immunosuppressive drugs during the previous four weeks
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Dermatology, Univ. of Cologne
Cologne, 50931
Dermatology, Univ. of Dresden
Dresden, 01307
Dermatology, Univ. of Duesseldorf
Düsseldorf, 40225
Dermatology, Univ. of Goettingen
Göttingen, 37075
Dermatology, Univ. Hospital Hannover
Hanover, 30449
Dermatology, Univ. of Kiel
Kiel, 24105
Dermatology, Univ. of Magdeburg
Magdeburg, 39120
Dermatology, Medical Faculty Mannheim, Univ. of Heidelberg
Mannheim, 68167
Dermatology, Municipal Hospital Minden
Minden, 32423
Dermatology, Univ. of Ulm
Ulm, 89081
Dermatology, Univ. of Wuerzburg
Würzburg, 97080
About this study
Official title: A Comparison of Oral Methylprednisolone Plus Azathioprine or Mycophenolate Mofetil for the Treatment of Bullous Pemphigoid
To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid.
Read the detailed description
This multicenter randomized, non-blinded clinical trial compared two parallel groups of patients with bullous pemphigoid treated with oral methylprednisolone in combination with either azathioprine or mycophenolate mofetil. Patients were randomly assigned, irrespective of severity of disease, to receive either 0.5 mg per kg body weight (BW) methylprednisolone (Urbason®, Aventis Pharma, Bad Soden, Germany) with 2 mg per kg BW azathioprine sodium (Imurek®, GlaxoSmithKline, Munich, Germany) once daily or 0.5 mg per kg BW methylprednisolone once daily and 1,000 mg mycophenolate mofetil (CellCept® provided by Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany), given twice daily (2 g/d). The initial dose was maintained until blister formation ceased, crusts as well as erosions disappeared, and re-epithelialization of previous lesions started. The corticosteroid dose was then sequentially reduced by 10 mg every two weeks until a dose of 20 mg per day was reached followed by a reduction in 5 mg-steps every two weeks until 10 mg per day. Afterwards, corticosteroid reduction was performed in 2.5 mg-steps every two weeks until zero. After discontinuation of corticosteroids azathioprine or mycophenolate mofetil doses were maintained at the initial dosage as monotherapy for an additional 4 weeks. Subsequently, azathioprine was reduced by 0.5 mg per kg BW every four weeks to a dose of 100 mg per day. Thereafter, azathioprine was tapered in 25 mg-steps every four weeks until discontinuation of treatment. Mycophenolate mofetil was reduced in 500 mg/d-steps every four weeks to 1,000 mg per day. From then on the mycophenolate mofetil dosage was decreased in 250 mg-steps every four weeks until discontinuation of treatment.
- Conditions
- Bullous Pemphigoid
- Being tested
- Azathioprine or Mycophenolate mofetil
- Keywords
- bullous autoimmune disease, bullous pemphigoid, immunosuppressants, corticosteroids, mycophenolate mofetil
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azathioprine or Mycophenolate mofetilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative total methylprednisolone doses and rate of remission.
Secondary outcomes (1)
Secondary outcome measures were safety profiles and duration of remission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startOct 1997
- Study completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bullous PemphigoidStudies 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
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Stefan Beissert, MD, Principal investigator, Dermatology, Univ. of Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431119
- Sponsor's protocol ID
- Beissert-BP#1
- Status last verified
- Feb 2007
- First submitted
- 2 Feb 2007
- Last updated
- 5 Feb 2007
- Results posted
- No
Publications
Beissert S, Werfel T, Frieling U, Bohm M, Sticherling M, Stadler R, Zillikens D, Rzany B, Hunzelmann N, Meurer M, Gollnick H, Ruzicka T, Pillekamp H, Junghans V, Luger TA. A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of pemphigus. Arch Dermatol. 2006 Nov;142(11):1447-54. doi: 10.1001/archderm.142.11.1447.
PubMed 17116835Beissert S, Werfel T, Frieling U, Bohm M, Sticherling M, Stadler R, Zillikens D, Rzany B, Hunzelmann N, Meurer M, Gollnick H, Ruzicka T, Pillekamp H, Junghans V, Bonsmann G, Luger TA. A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid. Arch Dermatol. 2007 Dec;143(12):1536-42. doi: 10.1001/archderm.143.12.1536.
PubMed 18087004
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Oral Methylprednisolone Plus Azathioprine or Mycophenolate Mofetil for the Treatment of Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT00431119
- Acronym / sponsor ID
- Beissert-BP#1
- Conditions
- Bullous Pemphigoid
- Keywords
- bullous autoimmune disease, bullous pemphigoid, immunosuppressants, corticosteroids, mycophenolate mofetil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Oct 1997
- Study completion
- Oct 2000
- First posted
- 5 Feb 2007 (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.
To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid.
Detailed description
This multicenter randomized, non-blinded clinical trial compared two parallel groups of patients with bullous pemphigoid treated with oral methylprednisolone in combination with either azathioprine or mycophenolate mofetil. Patients were randomly assigned, irrespective of severity of disease, to receive either 0.5 mg per kg body weight (BW) methylprednisolone (Urbason®, Aventis Pharma, Bad Soden, Germany) with 2 mg per kg BW azathioprine sodium (Imurek®, GlaxoSmithKline, Munich, Germany) once daily or 0.5 mg per kg BW methylprednisolone once daily and 1,000 mg mycophenolate mofetil (CellCept® provided by Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany), given twice daily (2 g/d). The initial dose was maintained until blister formation ceased, crusts as well as erosions disappeared, and re-epithelialization of previous lesions started. The corticosteroid dose was then sequentially reduced by 10 mg every two weeks until a dose of 20 mg per day was reached followed by a reduction in 5 mg-steps every two weeks until 10 mg per day. Afterwards, corticosteroid reduction was performed in 2.5 mg-steps every two weeks until zero. After discontinuation of corticosteroids azathioprine or mycophenolate mofetil doses were maintained at the initial dosage as monotherapy for an additional 4 weeks. Subsequently, azathioprine was reduced by 0.5 mg per kg BW every four weeks to a dose of 100 mg per day. Thereafter, azathioprine was tapered in 25 mg-steps every four weeks until discontinuation of treatment. Mycophenolate mofetil was reduced in 500 mg/d-steps every four weeks to 1,000 mg per day. From then on the mycophenolate mofetil dosage was decreased in 250 mg-steps every four weeks until discontinuation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical lesions suggestive of bullous pemphigoid
- subepidermal blistering upon histological analysis of skin biopsies
- linear deposition of IgG and C3 along the dermo-epidermal junction
- deposition of autoantibodies at the blister roof upon split-skin analysis
Key exclusion criteria (1 listed)
- treatment with oral or topical corticosteroids, and other immunosuppressive drugs during the previous four weeks
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 |
|---|---|---|
| Azathioprine or Mycophenolate mofetil | Drug | – |
Primary outcome
The cumulative total methylprednisolone doses and rate of remission.
1 secondary outcome
Secondary outcome measures were safety profiles and duration of remission.
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 5 Feb 2007.
- Background: PubMed 17116835Beissert S, Werfel T, Frieling U, Bohm M, Sticherling M, Stadler R, Zillikens D, Rzany B, Hunzelmann N, Meurer M, Gollnick H, Ruzicka T, Pillekamp H, Junghans V, Luger TA. A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of pemphigus. Arch Dermatol. 2006 Nov;142(11):1447-54. doi: 10.1001/archderm.142.11.1447.
- Derived from this study: PubMed 18087004Beissert S, Werfel T, Frieling U, Bohm M, Sticherling M, Stadler R, Zillikens D, Rzany B, Hunzelmann N, Meurer M, Gollnick H, Ruzicka T, Pillekamp H, Junghans V, Bonsmann G, Luger TA. A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid. Arch Dermatol. 2007 Dec;143(12):1536-42. doi: 10.1001/archderm.143.12.1536.
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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.
Stefan Beissert, MD principal investigator
Dermatology, Univ. of Muenster, Germany
11 sites 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 or Mycophenolate mofetil in people with Bullous Pemphigoid, run by University Hospital Muenster at 11 sites in Germany.
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 4 inclusion and 1 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 5 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. 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. 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?
The cumulative total methylprednisolone doses and rate of remission.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00431119, which also lists 2 linked publications.
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 5 Feb 2007.