Rituximab for Pulmonary Sarcoidosis

NCT00855205 | Completed Phase 2 DMC

• 1 other identifier: 14889A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis

Keywords

pulmonary sarcoidosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with rituximab

Drug: Rituximab

Interventions

Rituximab DRUG

Rituximab will be administered by IV infusion at a dose of 1000 mg (1 g) on day 1 and 15

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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)
• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• University of Chicago: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

• 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.

  PMID: 24488568 DERIVED

MeSH Terms

Conditions

Sarcoidosis; Sarcoidosis, Pulmonary

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Robert P Baughman, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

US (1)