An interventional study of placebo and mycophenolate mofetil in Autoimmune Diseases, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
This study has been designed as a 52-week, randomized double blind placebo controlled multicenter clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with re-elevation of serum IgG4 level during maintenance remission period: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD).
108 IgG4-RD patients with re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period are to be enrolled in this study after screening period, and then double blind randomly in an 1:1 ratio into two groups: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD plus placebo) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD). The follow-up period will be 52 weeks. During the follow-up period, clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded. The primary endpoint is the difference of relapse rate between two groups at 52 weeks. Meanwhile, this study will also explore and study different biomarkers in IgG4-RD patients, to better understand the mechanisms, as well as prognostic factors of IgG4-RD.
672 studies on the registry are indexed under Autoimmune Diseases; 272 are open to participants now.
This study's planned enrollment of 108 is above the median of 44 across 433 interventional studies indexed under Autoimmune Diseases.
Browse Autoimmune Diseases studies →Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
4. Patients with malignancies or a history of malignancies within 5 years, except:
11. Meeting any of the following blood test finding on screening:
Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
Drug: placebo
Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
Drug: mycophenolate mofetil
Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
The difference of relapse rate of IgG4-RD between two groups in week 52.
The primary endpoint is the difference of relapse rate between two groups at 52 weeks. The definition of relapse: elevation of IgG4-RD Responder Index ≥ 2 points; new organ involvement or recurrence, with or without elevation of serum IgG4 levels.
Time frame: 52 weeks
The difference of relapse rate of IgG4-RD between two groups in the week 12.
Time frame: 12 weeks
The difference of relapse rate of IgG4-RD between two groups in the week 24
Time frame: 24 weeks
The difference of relapse rate of IgG4-RD between two groups in the week 36.
Time frame: 36 weeks
The time and duration of relapse
Time frame: 52 weeks
The changes of IgG4-RD Responder Index at week 52
Time frame: 52 weeks
The changes of serum IgG level at week 52
Time frame: 52 weeks
The changes of serum IgG4 level at week 52
Time frame: 52 weeks
The changes of erythrocyte sedimentation rate at week 52
Time frame: 52 weeks
The changes of serum C-reactive protein level at week 52
Time frame: 52 weeks
Adverse effect events
Time frame: 52 weeks
The changes of Physician Global Assessment score at week 52
Time frame: 52 weeks
Plan to share: Yes
Start is estimated for Aug 2023; primary completion for Dec 2025, 28 months later.
Of 75 non-industry interventional studies with no phase under Autoimmune Diseases, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 28 months is below that.
Counting every sponsor, half of 86 studies reached it within 35 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mycophenolic Acid
Peking Union Medical College Hospital →