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SarcoidosisPhase 2RIPSNCT00855205

Rituximab for Pulmonary Sarcoidosis

A Phase 2 study testing Rituximab in people with Sarcoidosis, run by University of Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoidosis
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jul 2009to Dec 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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
Show all 41Show fewer
  • 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
  • Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or lactation
  • 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).
  • Have normal pulmonary function
  • Have any clinical evidence of intracranial lesions.
  • Have an abnormal neurological examination during baseline assessment
  • Have neurosarcoidosis
  • Have a known history of demyelinating disease such as multiple sclerosis or optic neuritis.
  • 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.
  • Have poor tolerability of intravenous infusion or lack of adequate venous access for required blood sampling.
  • History of transplanted organ (with the exception of a corneal transplant > 3 months prior to screening.
  • History of substance abuse or dependency, drug or alcohol within 3 years of screening
  • History of primary or secondary immunodeficiency
  • History of psychiatric disorder that would interfere with normal participation in this protocol
  • 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.
  • Inability to comply with study and follow-up procedures
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Cincinnati

    Cincinnati, Ohio, 45267

Other trials in United States

About this study

Official title: Rituximab as a Novel Therapy in Refractory Sarcoidosis: A Prospective Open-

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.

Read the 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.

Conditions
Sarcoidosis
Being tested
Rituximab
Keywords
pulmonary sarcoidosis
Medical subject headings
Sarcoidosis, Sarcoidosis, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

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

Study groups in NCT00855205
Study groupRoleWhat they receive
TreatmentExperimentalTreatment with rituximab
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events by week 24 and by week 52 that are considered by the investigator to be reasonably or probably related to Rituximab.

    Measured: 1 year

  2. Change from baseline in 6-minute walk distance at Week 24 and 52.

    Measured: 1 year

Secondary outcomes (3)

  1. Change in Borg's CR10 dyspnea score before 6 minute walk at weeks 12, 24, and 52

    Measured: 1 year

  2. Change in FVC and percent of predicted FVC at weeks 24 and 52

    Measured: 1 year

  3. 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

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00855205
Sponsor's protocol ID
14889A
Acronym
RIPS
Status last verified
Dec 2013
First submitted
3 Mar 2009
Last updated
11 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24488568

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab in people with Sarcoidosis, run by University of Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events by week 24 and by week 52 that are considered by the investigator to be reasonably or probably related to Rituximab. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00855205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013; AzTrials last refreshed its copy on 1 Nov 2026.

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