Peking Univercity, People's Hospital
Beijing, Beijing Municipality, 100044, China
NCT Number: NCT07827469
This study is a single centre, open label, randomized controlled study to compare the efficacy and safety between steroids plus tofacitinib and steroids alone in active IgG4-related diseases patients. It is expected to enroll a total of 58 IgG4 RD patients. The sample size of two groups is 1:1.
The primary end points of this study is to compare the IgG4-RD response rate between two groups at 24 weeks.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100044, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
all subjects were trteated immediately after ranomized enrollment. Patients in experimental arm is treated with tofacitinib plus prednisone.
all subjects were trteated immediately with prednisone after ranomized enrollment.
Time frame: 24 week
Evaluate treatment response by assessing changes in the IgG4 RD RI score and categorize it into three types: complete response (CR), partial response (PR), and no effect (NE, including no improvement or deterioration). IgG4 RD RI score<3 and a decrease of ≥ 2 is considered CR; A decrease of ≥ 2 in IgG4 RD RI score but a maintenance of ≥ 3 is considered PR. If the patient's IgG4 RD RI score is initially 3 points, a decrease of 1 point after treatment is considered PR. Patients with no significant changes in tumor size and/or clinical presentation and a decrease in IgG4 RD RI score<2 are considered NE.
Time frame: 24 week
compare the recurrence rates between two groups
Time frame: 24 week
compare the value of serum IgG4 between two groups
Time frame: 24 week
Compare the incidence of treatment-related adverse events and treatment-related serious adverse events
Peking University People's Hospital
Other
A Randomized Open Label Clinical Study on the Efficacy of Tofacitinib in the Treatment of IgG4 Related Diseases
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07222553
Autoimmune Diseases, Immune System Diseases
Tampa, Florida, United States
View Trial DetailsNCT07719543
Autoimmune Diseases, Immune System Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT06573723
Abnormalities, Multiple, Adrenal Gland Diseases
Buenos Aires, Argentina
View Trial DetailsNCT06270524
Autoimmune Diseases, Immune System Diseases
View Trial Details