Disabling pansclerotic morphea and localized scleroderma
Conditions
Interventions
Disabling pansclerotic morphea group:Baricitinib
Localized scleroderma:Baricitinib
Sponsors
Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
6 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.6-65 years old, male or female. 2.Clinical diagnosis of DPM or LS. 3.Requirements for pregnant or lactating women and male and female patients of childbearing age: Female patients must meet: (1)Menopause (defined as the absence of menstruation for at least 1 year);(2) or have undergone surgical sterilization; (3) or have fertility, but must meet: the pregnancy test must be negative within 7 days before enrollment; Use of appropriate contraception for 1 week after a dose of the investigational drug, which must include at least one barrier method; and no breastfeeding. Male patients must: must agree to use appropriate contraception, including at least one barrier method, throughout the trial. 4.Patients who have received treatment for DPM or LS before enrollment, such as systemic hormones or methotrexate, and whose disease is still poorly controlled after receiving stable doses of treatment for >=8 weeks. 5.Informed consent is signed voluntarily, the requirements of the trial must be fully understood, and all trial visits and evaluations must be complied with.
Exclusion criteria
Exclusion criteria: 1.Infection: (1)Latent or active tuberculosis or any previous history of tuberculosis. (2)History of recurrent (more than one attack) herpes zoster or disseminated (single attack) herpes zoster or disseminated (single attack) herpes simplex. (3)Any infection that requires hospitalization, parenteral antibiotic treatment, or opportunistic infection judged by the investigator within 6 months before taking the study drug for the first time. (4)History or current symptoms of any lymphoproliferative disease, including cytomegalovirus or Epstein-Barr virus-related lymphoproliferative disease, lymphoma, leukemia history or signs and symptoms suggestive of current lymphoid disease. (5)Any infection treated within 2 weeks. (6)chronic infection. 2.Patients with the following diseases within 6 months before enrollment: lower extremity deep vein thrombosis, pulmonary embolism, thyroid disease, liver disease, malnutrition, heart disease, nervous system disease, gastrointestinal dysfunction, tumor, tuberculosis, mental disease and history of other autoimmune diseases, unless the above disease investigator evaluation has no clinical significance. 3.HIV positive, active hepatitis B virus positive (HBsAg or HBeAg positive), and HCV antibody positive at screening. 4.Have taken orally or injected any drug for DPM treatment, such as mycophenolate mofetil, cyclosporine, azathioprine, biological preparations, Chinese herbal medicine, etc., except as permitted by the inclusion criteria, within 4 weeks before enrollment; Have phototherapy within 4 weeks before enrollment. 5.Patients who have received JAK inhibitors and biologics before enrollment; previously treated with the experimental drug or known to be unable to tolerate the experimental drug. 6.Those who participated in any drug or medical device clinical trial within 4 weeks before randomization. 7.Any situation that the investigator considers to constitute an inappropriate risk or contraindication to participating in the trial or that may interfere with the objectives, conduct or evaluation of the trial, including laboratory tests, medical history or other screening evaluation results. 8.Patients with drug addiction, alcoholism or mental disorders, unable to cooperate or adhere to treatment, and poor compliance; no legal capacity or limited legal capacity to provide informed consent or consent. 9.Abnormal blood cell analysis, including: 1.Hemoglobin 2 times the upper limit of normal or serum creatinine >3 times the upper limit of normal. 11.Subjects taking potent cytochrome P450 3A4 enzyme inhibitors, such as ketoconazole. 12.Subjects taking moderate cytochrome P450 3A4 enzyme inhibitors and cytochrome P450 2C19 inhibitors, such as fluconazole. 13.Subjects taking potent inducers of cytochrome P450 3A4 enzymes, such as rifampicin. 14.Any person who is considered inappropriate by the investigator to participate in this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Localized Scleroderma Assessment Tool Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| modified Localized Skin Severity Index;Localized Scleroderma Skin Damage Index ;Modified Rodnan Skin Score;Physician's Global Assessment;Dermatology Life Quality Index;The Localized Scleroderma Assessment Tool Score;Joint range of motion;Limb ulcers;Changes in skin thickness; | — |
Countries
China
Contacts
Public ContactLu Qianjin
Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed