A Study to Evaluate Efficacy and Safety of Abatacept in Participants of Pemphigus Vulgaris (PV)
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|ClinicalTrials.gov Identifier: NCT05303272|
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : March 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pemphigus Vulgaris||Drug: Abatacept Prefilled Syringe Drug: Mycophenolate Mofetil 500Mg Tab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||A Crossover, Randomized and Multi-center Study to Evaluate the Efficacy and Safety of Abatacept Versus Mycophenolate Mofetil (MMF) in Treatment of PV|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||September 1, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Subject received subcutaneous administration of abatacept 125 mg once every week through the 52 week double blind period.
Drug: Abatacept Prefilled Syringe
Abatacept (Orencia) was provided in prefilled glass syringes initial syringes contained 0.6ml (60mg) of concentration 100 mg/m: drug product subsequently modified to 0.4 mL (20mg) concentration (50mg/ML) drug product. Combined with standard of care prednisone 10-40mg qd
Other Name: Orencia
Active Comparator: Mycophenolate mofetil
Subject received subcutaneous administration of matching placebo of abatacept once a weeks through the 24 week double blind period. A washout period of MMF for 4 weeks (24 th-28th week) is used to ensure data integrity. Subsequently,subject were administered subcutaneous administration of abatacept 125 mg once every week through the 28-52 week open label period.
Drug: Mycophenolate Mofetil 500Mg Tab
MMF will be administered at a starting dose of 1000 milligrams (mg) Q12H and the dose will be tapered to achieve a goal of 0.5-1.0 gram (gm) Q12H. Combined with standard of care prednisone 10-40mg qd through 52 weeks.
Other Name: MMF,CellCept
- Percentage of Participants Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score [ Time Frame: 24 Weeks ]PADAI and ABSIS was proposed by the German Blistering Disease Group in 2007 which was accepted as the most sensitive and reliable systems for evaluation of pemphigus severity. PADAI was developed by the International Pemphigus Definitions Group in 2009
- Percentage of Participants Who Achieved Sustained Complete Remission, Evaluated byAutoimmune bullous skin disorder intensity score (ABSIS) [ Time Frame: 24 Weeks ]PADAI and ABSIS was proposed by the German Blistering Disease Group in 2007 which was accepted as the most sensitive and reliable systems for evaluation of pemphigus severity. PADAI was developed by the International Pemphigus Definitions Group in 2009
- Cumulative Oral Corticosteroid Dose [ Time Frame: From 12th, 24th, 36th and 52th Week ]Calculate the Cumulative Oral Corticosteroid Dose during 52 week
- Ulcer Severity Score (USS) for the assessment of skin, oral ulcer improvement [ Time Frame: From baseline up to 4th, 8th,12th, 24th, 36th and 52th Week ]The USS incorporates six ulcer characteristics: number, size, duration, ulcer-free period, site, and pain. This scoring template may be of value to future studies assessing treatment efficacy.
- Physician global assessment (PGA) [ Time Frame: From baseline up to 4th, 8th,12th, 24th, 36th and 52th Week ]Physician global assessment was assessed by an individual researcher
- Autoimmune bullous disease quality of life (ABQoL) [ Time Frame: From baseline up to 4th, 8th,12th, 24th, 36th and 52th Week ]Total ABQoL scores range from 0 to 30 with higher DLQI scores reflecting greater impairment in a participant's health-related quality of life. The ABQoL score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The measure type mean is the estimated mean from adjusted MMRM.
- Anti-desmoglein 1 (anti-Dsg1) and anti-Dsg3 autoantibody titers [ Time Frame: From Baseline up to 12th, 24th and 52th Week ]anti-Dsg1 and anti-Dsg3 will be performed using ELISA
- Change From Baseline for CD19+ B Cell Count [ Time Frame: From Baseline up to 12th, 24th and 52th Week ]CD19+ B cell count will be performed using Flow Cytometry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05303272
|Contact: YIKAI YU||+1 firstname.lastname@example.org|
|Wuhan, Hubei, China, 430030|
|Contact: AIHUA DU, M.D +86 2783662886|
|Principal Investigator: YIKAI YU, M.D|
|Sub-Investigator: SHAOXIAN HU, M.D|
|Sub-Investigator: JIJUN YANG, M.D|
|Sub-Investigator: WEI TU, M.D|
|Sub-Investigator: RUI XING, M.D|
|Sub-Investigator: MEI YU, M.D|
|Sub-Investigator: CONG YE, M.D|
|Sub-Investigator: FEI YU, M.D|
|Sub-Investigator: GUIFEN SHEN, M.D|
|Sub-Investigator: XIAOFANG LUO, M.D|
|Study Chair:||AIHUA DU, M.D||Tongji Hospital|