Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2009-07-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
Treatment with rituximab
Rituximab
Rituximab will be administered by IV infusion at a dose of 1000 mg (1 g) on day 1 and 15
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rituximab
Rituximab will be administered by IV infusion at a dose of 1000 mg (1 g) on day 1 and 15
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Platelets: \< 100,000/mm
3. Serum Creatinine: \> 1.4
4. Neutrophils: \< 1.5 x mm3
5. IgG: \< 5.6 mg/dl and IgM: \< .55 mg/dl
6. AST or ALT \>2.5 x Upper Limit of Normal unless related to primary disease.
7. Positive Hepatitis B or C serology (Hep B surface antigen and Hep C antibody)
1. Previous Treatment with Rituximab (MabThera® / Rituxan®)
2. Previous administration of a treatment with any other therapeutic agent targeted at depleting B cells within 12 months prior to screening.
3. Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
4. Current treatment with TNF inhibitors, cyclosporine, tacrolimus or leflunomide.
5. Treatment with TNF inhibitors within (8 weeks prior to screening), cyclosporine or tacrolimus ( 4 weeks prior to screening) or leflunomide ( 8 weeks prior to screening, or 25 days after cholestyramine washout).
6. Previous treatment within 6 months with IVIg.
7. Parenteral corticosteroids within 4 weeks prior to screening visit.
8. Receipt of live virus or bacterial vaccinations within the 4 weeks before the first dose of the study agent or are expected to receive any live virus or bacterial vaccinations during the trial or up to 3 months after the last dose of the study agent
9. History of severe allergic or anaphylactic reactions associated with the administration of humanized or murine monoclonal antibodies
10. History of New York Heart Association (NYHA) Class III or IV congestive heart failure(CHF)
11. History of severe right-sided heart failure or cor pulmonale
12. Known active bacterial, viral, fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 2 months of screening or oral antibiotics within 2 weeks prior to screening
13. History of recurrent significant infection or history of recurrent bacterial infections
14. History of opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis and aspergilloma, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
15. History of known infection with human immunodeficiency virus (HIV)
16. Considered ineligible according to the USA-specific TB screening
17. Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or lactation
18. Current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases (with the exception of sarcoidosis).
19. Have normal pulmonary function
20. Have any clinical evidence of intracranial lesions.
21. Have an abnormal neurological examination during baseline assessment
22. Have neurosarcoidosis
23. Have a known history of demyelinating disease such as multiple sclerosis or optic neuritis.
24. Concomitant malignancies or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
25. Have poor tolerability of intravenous infusion or lack of adequate venous access for required blood sampling.
26. History of transplanted organ (with the exception of a corneal transplant \> 3 months prior to screening.
27. History of substance abuse or dependency, drug or alcohol within 3 years of screening
28. History of primary or secondary immunodeficiency
29. History of psychiatric disorder that would interfere with normal participation in this protocol
30. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
31. Inability to comply with study and follow-up procedures
\-
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Chicago
OTHER
University of Cincinnati
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert P Baughman
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert P Baughman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Cincinnati
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sweiss NJ, Lower EE, Mirsaeidi M, Dudek S, Garcia JG, Perkins D, Finn PW, Baughman RP. Rituximab in the treatment of refractory pulmonary sarcoidosis. Eur Respir J. 2014 May;43(5):1525-8. doi: 10.1183/09031936.00224513. Epub 2014 Jan 31. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14889A
Identifier Type: -
Identifier Source: org_study_id
NCT00552318
Identifier Type: -
Identifier Source: nct_alias