pulmonary sarcoidosis
Conditions
Interventions
MMF group:Mycophenolate morpheate given orally
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1) Male or female aged >= 18, <==90 years at the time of screening; 2) Female subjects must be infertile, postmenopausal, or agree to use effective pregnancy avoidance measures throughout the study; 3) Willing to comply with all study protocol requirements, good compliance, and conditions to complete all study follow-up; Study participants had the reading, understanding, and writing skills to complete the study materials and signed a written informed consent prior to participating in the study; 4) Meet the diagnostic criteria for refractory pulmonary sarcoidosis: (1) Evidence of active pulmonary sarcoidosis: obvious respiratory symptoms; Progressive deterioration of lung function; Progressive exacerbation of pulmonary shadow; There is the involvement of important organs outside the lungs, such as the heart, nervous system, eyes, liver, etc. (2) After glucocorticoid therapy is not effective or can not tolerate glucocorticoid therapy.
Exclusion criteria
Exclusion criteria: 1) Known MMF drug allergies and contraindications; 2) There are other serious persistent diseases or organ dysfunction diagnosed by a physician that may impair the safety evaluation; 3) Have participated in other clinical studies within 3 months prior to the screening date; 4) Clinically significant infection within 4 weeks prior to screening; 5) A known immunocompromised state that is not related to the disease/condition under study; 6) Medication history of MMF for sarcoidosis; 7) Patients who have a live vaccination program during MMF treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| STS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effect & Adverse event;physical examination;Clinical laboratory examination;High resolution Computed Tomography (HRCT);Chest X-ray; | — |
Countries
China
Contacts
Public ContactQian Yao
Shanghai Pulmonary Hospital
Outcome results
None listed