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| Name | Class |
|---|---|
| Post Graduate Institute of Medical Education and Research, Chandigarh | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Active Comparator | Inj Rituximab 1 gram IV given on day 0 and day 15 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab and Cyclophosphamide IV | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| upto 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | upto 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| To study the difference in relapse rate | upto 9 months | |
| to study the total cumulative dose of corticosteroids adminstered and adjuvants required among patients of the 2 treatment groups | upto 9 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shraddha Uprety, MBBS | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER | Chandigarh | Chandigarh | 160012 | India | ||
| Post-graduate Institute of Medical Education and Research |
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| ID | Term |
|---|---|
| D010392 | Pemphigus |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Chandigarh |
| Chandigarh |
| 160012 |
| India |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |