Sarcoidosis
Conditions
Keywords
pulmonary sarcoidosis
Brief summary
Sarcoidosis is a inflammatory disease affecting many parts of the body, especially the lungs. While most patients do well, there is a group of patients who require continuous doses of prednisone or other drugs. The current study will determine the role of Rituximab as new agent for patients with refractory disease.
Detailed description
Patients with refractory pulmonary sarcoidosis will be eligible for participation in this open label trial of Rituximab as additional therapy. The study will evaluate the efficacy of rituximab in improving the symptoms and functional capacity in patients with chronic sarcoidosis with pulmonary involvement who are symptomatic despite current treatment.
Interventions
DRUGRituximab
Rituximab will be administered by IV infusion at a dose of 1000 mg (1 g) on day 1 and 15
Sponsors
University of Chicago
University of Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women \> 18 years of age. 2. Sarcoidosis diagnosed at least 1 year prior to screening. 3. Histological proven sarcoidosis prior to screening. 4. Have a diagnosis of severe sarcoidosis with evidence of parenchymal disease on chest radiograph (Stage III) or abnormal PFT, with histologic and there should be an evidence of sarcoid (involvement by biopsy ( pulmonary or extrapulmonary)) . Subjects with concurrent extrapulmonary sarcoidosis particularly skin and eye involvement are encouraged to be enrolled. Patients with neurologic sarcoidosis will be excluded. 5. Have FVC \> 40 and \< 80% of predicted. 6. Have an ATS dyspnea score of \> Grade 1. 7. Have been receiving pre-study treatment that includes at least 10 mg/day of prednisone or equivalent dose of corticosteroids as a single agent, and/or methotrexate, or hydroxychloroquine for at least the 3-month period prior to screening. Subjects must be on a stable dose of these meds for \> 4 weeks before starting the study medication. 8. Adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) must be used for the duration of the study and should continue such precautions for 6 12 months after receiving the last study infusion. 9. Are considered eligible based on TB screening. 10. Are capable of reading and understanding subject assessment forms and providing written informed consent. 11. Are willing and able to adhere to the study visit schedule and other protocol-specified procedures.
Exclusion criteria
Laboratory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events by week 24 and by week 52 that are considered by the investigator to be reasonably or probably related to Rituximab. | 1 year |
| Change from baseline in 6-minute walk distance at Week 24 and 52. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Change in Borg's CR10 dyspnea score before 6 minute walk at weeks 12, 24, and 52 | 1 year |
| Change in FVC and percent of predicted FVC at weeks 24 and 52 | 1 year |
| To assess the effect of rituximab on B cell function as measured by markers of these cells in peripheral blood: CD19, CD27, IgD, and CD38 at baseline and weeks 24 and 52 and BAFF and IL-12p40 at baseline and weeks 12, 24, 36 and 52 | 1 Year |
Countries
United States
Outcome results
None listed