|
|
View Clinical Trial (Medical Research Study)
|
Rituximab as a Novel Therapy in Refractory Sarcoidosis: A Prospective Open-Label Trial of Rituximab in Progressive Sarcoidosis - NCT00855205-45267 (Clinical Trial 275522)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy275522.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Cincinnati |
|
State:
|
|
OH |
| Zip Code: |
|
45267 |
| Conditions: |
|
Sarcoidosis |
| Purpose: |
|
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.
|
| Study summary: |
|
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. |
| Criteria: |
|
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 Exclusion Criteria
1. Hemoglobin: < 8.5 gm/dL
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)
General Safety Exclusion Criteria
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
- |
|
|
|
| Study is available at: |
|
University of Cincinnati
Cincinnati, OH 45267
United States
Primary Contact:
Rebecca Ingledue
Email: rebeccie@ucmail.uc.edu
Phone: 513-584-6252
Secondary Contact:
Robert P Baughman, MD
Email: bob.baughman@uc.edu
Phone: 513-584-5225 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 16, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|