PemphigusPhase 3NCT01974518
Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus
A Phase 3 study testing Rituximab and Cyclophosphamide IV in people with Pemphigus, run by Uprety Shraddha at 2 sites in India.
Trial summary
The purpose of this study is to compare the effectiveness of rituximab alone vs combination of rituximab and cyclophosphamide in the treatment of pemphigus not responding adequately to routine medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigus
- What is being tested?
- Rituximab and Cyclophosphamide IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIndia
- Study dates
- Nov 2013to Jun 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the diagnosis of pemphigus based on clinical, histopathological and immunological features the following:
- Refractory disease defined as continuing extension of old lesions, development of new lesion, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/day of prednisolone or its equivalent with or without the concurrent use of cyclophosphamide 2mg/kg/day for 12 weeks or azathioprine 2.5 mg/kg/day for 12 weeks. Patients who fail to respond to 6 DCP/DP are also considered as refractory disease.
Who cannot join
- Infections- Hepatitis B, Hepatitis C, HIV, active tuberculosis or sepsis.
- Abnormal liver function tests and renal function tests
- Known cardiac arrhythmia or conduction abnormality
- Systolic ejection fraction <40%
- Pregnancy and breast feeding
- Severely decreased bone marrow functions.
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- Known history of bladder cancer or hemorrhagic cystitis
- Known allergy to cyclophosphamide
- Patients of reproductive age group who haven't completed their family
- Known hypersensitivity to murine proteins.
- Patients who do not consent for the study.
Trial locations and contacts
2 sites in 1 country.
India2 sites
PGIMER
Chandigarh, Chandigarh, 160012
Post-graduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
About this study
Official title: A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS
The purpose of this study is to compare the effectiveness of rituximab alone vs combination of rituximab and cyclophosphamide in the treatment of pemphigus not responding adequately to routine medications.
- Conditions
- Pemphigus
- Being tested
- Rituximab and Cyclophosphamide IV
- Keywords
- Pemphigus, Rituximab, Rituximab and IV cyclophosphamide combination, B cell re-population characteristics following Rituximab
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab and Cyclophosphamide IVDrug
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Active comparator | Inj Rituximab 1 gram IV given on day 0 and day 15 Receives: Drug: Rituximab and Cyclophosphamide IV |
| Combination of Rituximab and Cyclophosphamide IV | Active comparator | IV Rituximab 1gram on day 0 and 15 750 mg IV cyclophosphamide in 250 ml of NS over 2-3 hr on day 1 and day 16 Receives: Drug: Rituximab and Cyclophosphamide IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the clinical efficacy of IV rituximab vs IV rituximab and IV cyclophosphamide combination for treatment of refractory pemphigus in terms of early and late end points as defined by the international pemphigus committee
Primary outcome measures being
- Time taken for control of disease activity
- Time taken for achievement of partial remission
- Time taken for achievement of complete remission
Measured: upto 9 months
Secondary outcomes (1)
Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab.
Flowcytometric analysis of CD19+ve27-ve naïve B cells count, CD19+ve27+ve memory B cells count and CD24highCD38high transitional cell count will be performed at baseline, 3rd month, 6th month and 9th month.
Measured: upto 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PemphigusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uprety Shraddha
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Responsible party
- Sponsor-investigator, Uprety Shraddha, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Shraddha Uprety, MBBS, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974518
- Sponsor's protocol ID
- 9187-PG-2012
- Status last verified
- Oct 2014
- First submitted
- 4 Oct 2013
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS
- ClinicalTrials.gov ID
- NCT01974518
- Acronym / sponsor ID
- 9187-PG-2012
- Conditions
- Pemphigus
- Keywords
- Pemphigus, Rituximab, Rituximab and IV cyclophosphamide combination, B cell re-population characteristics following Rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Uprety Shraddha
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 1 Nov 2013 (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.
The purpose of this study is to compare the effectiveness of rituximab alone vs combination of rituximab and cyclophosphamide in the treatment of pemphigus not responding adequately to routine medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Active comparator | Drug: Rituximab and Cyclophosphamide IVInj Rituximab 1 gram IV given on day 0 and day 15 |
| Combination of Rituximab and Cyclophosphamide IV | Active comparator | Drug: Rituximab and Cyclophosphamide IVIV Rituximab 1gram on day 0 and 15 750 mg IV cyclophosphamide in 250 ml of NS over 2-3 hr on day 1 and day 16 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with the diagnosis of pemphigus based on clinical, histopathological and immunological features the following:
- Refractory disease defined as continuing extension of old lesions, development of new lesion, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/day of prednisolone or its equivalent with or without the concurrent use of cyclophosphamide 2mg/kg/day for 12 weeks or azathioprine 2.5 mg/kg/day for 12 weeks. Patients who fail to respond to 6 DCP/DP are also considered as refractory disease.
Key exclusion criteria (11 listed)
- Infections- Hepatitis B, Hepatitis C, HIV, active tuberculosis or sepsis.
- Abnormal liver function tests and renal function tests
- Known cardiac arrhythmia or conduction abnormality
- Systolic ejection fraction <40%
- Pregnancy and breast feeding
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 |
|---|---|---|
| Rituximab and Cyclophosphamide IV | Drug | Combination of Rituximab and Cyclophosphamide IV, Rituximab |
Primary outcome
Study the clinical efficacy of IV rituximab vs IV rituximab and IV cyclophosphamide combination for treatment of refractory pemphigus in terms of early and late end points as defined by the international pemphigus committee
Time frame: upto 9 months
Primary outcome measures being 1. Time taken for control of disease activity 2. Time taken for achievement of partial remission 3. Time taken for achievement of complete remission
1 secondary outcome
Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab.
Time frame: upto 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
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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.
Shraddha Uprety, MBBS principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab and Cyclophosphamide IV in people with Pemphigus, run by Uprety Shraddha at 2 sites in India.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Study the clinical efficacy of IV rituximab vs IV rituximab and IV cyclophosphamide combination for treatment of refractory pemphigus in terms of early and late end points as defined by the international pemphigus committee (time frame: upto 9 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 Oct 2014.