Rituximab for Pulmonary Sarcoidosis

Completed · Phase 2

Conditions studied: Sarcoidosis

In brief

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.

Key facts

Study ID

NCT00855205

Run by

University of Cincinnati

People needed

10

Starts

2009-07-01

Expected to finish

2012-12-01

Last updated by the study team

2013-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women > 18 years of age.
• Sarcoidosis diagnosed at least 1 year prior to screening.
• Histological proven sarcoidosis prior to screening.
• 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.
• Have FVC > 40 and < 80% of predicted.
• Have an ATS dyspnea score of > Grade 1.
• 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.
• 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.
• Are considered eligible based on TB screening.
• Are capable of reading and understanding subject assessment forms and providing written informed consent.
• Are willing and able to adhere to the study visit schedule and other protocol-specified procedures.

You may not qualify if…

• Laboratory Exclusion Criteria
• Hemoglobin: < 8.5 gm/dL
• Platelets: < 100,000/mm
• Serum Creatinine: > 1.4
• Neutrophils: < 1.5 x mm3
• IgG: < 5.6 mg/dl and IgM: < .55 mg/dl
• AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.
• Positive Hepatitis B or C serology (Hep B surface antigen and Hep C antibody)
• General Safety Exclusion Criteria
• Previous Treatment with Rituximab (MabThera® / Rituxan®)
• Previous administration of a treatment with any other therapeutic agent targeted at depleting B cells within 12 months prior to screening.
• Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
• Current treatment with TNF inhibitors, cyclosporine, tacrolimus or leflunomide.
• 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).
• Previous treatment within 6 months with IVIg.
• Parenteral corticosteroids within 4 weeks prior to screening visit.
• 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
• History of severe allergic or anaphylactic reactions associated with the administration of humanized or murine monoclonal antibodies
• History of New York Heart Association (NYHA) Class III or IV congestive heart failure(CHF)
• History of severe right-sided heart failure or cor pulmonale
• 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
• History of recurrent significant infection or history of recurrent bacterial infections
• 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
• History of known infection with human immunodeficiency virus (HIV)
• Considered ineligible according to the USA-specific TB screening

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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