Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Rituximab on the Progression of Type 1 Diabetes in New Onset Subjects
Brief Summary: Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Without these beta cells, the body cannot maintain proper blood glucose levels in response to daily activities such as eating or exercise. With fewer insulin producing cells blood glucose increases, causing hunger, thirst, and unexplained weight loss. By the time these symptoms develop, 80-90% of a person's beta cells have already been destroyed. However, this also means that between 10-20% of these cells remain that continue to produce insulin.

Scientists have learned that two types of immune cells, B cells and T cells, are involved in causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells that make insulin. Although they don't attack insulin producing cells, B cells may be what trigger the T cells to attack.

This study will investigate the use of rituximab to see if it can help lower the number of immune B cells thereby preventing the destruction of any remaining insulin producing beta cells that remain at diagnosis. Rituximab is approved by the Food and Drug Administration (FDA) for the treatment of a condition called B-lymphocyte lymphoma. Its effects on the immune system are well understood through its use in organ transplantation. Research has shown that rituximab might be helpful in treating other conditions caused by T cells and B cells, including type 1 diabetes. The goal of this study is to find out if rituximab can preserve residual insulin secretion and prevent further beta cell destruction in type 1 diabetes.


Options:
A: Inclusion Criteria:

* Definitive diagnosis of PPMS
* Disease duration of ≥ 1 year
* EDSS at baseline between 2.0 and 6.5 points, inclusive
* Score of ≥ 2.0 on the Functional Systems (FS) scale for the pyramidal system or gait that is due to lower extremity findings
* Presence of at least one of the following in a CSF specimen obtained during the screening period and analyzed by the central laboratory or results from a CSF sample obtained during the previous 24 months:
* For subjects of reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) during study treatment and for 1 year following the last dose of study drug

Exclusion Criteria:

* Pregnancy or lactation
* Incompatibility with MRI
* Lack of peripheral venous access
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Known active bacterial, viral, fungal, mycobacterial, or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds or recurrent herpes zoster or simplex infections) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 30 days prior to screening or oral antibiotics within 14 days prior to screening
* History or presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, syphilis)
* History of cancer, including solid tumors and hematologic malignancies (except resected and fully resolved cutaneous basal cell and squamous cell carcinomas)
* History of alcohol or drug abuse within 6 months prior to screening
* History of or currently active primary or secondary immunodeficiency
* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
* Presence of other significant, uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease that might interfere with a subject's ability to participate and to complete approximately 2.5 years of study participation
* History or presence of MS relapse or exacerbation
* History or presence of vascular disease potentially affecting the brain or spinal cord (e.g., stroke, transient ischemic attack, carotid stenosis, aortic aneurysm, intracranial aneurysm, hemorrhage, arteriovenous malformation)
* History or presence of myelopathy due to spinal cord compression by disk or vertebral disease
* History of severe, clinically significant central nervous system trauma (e.g., cerebral contusion, spinal cord compression)
* History of intracranial or intraspinal tumor (e.g., meningioma, glioma)
* History or presence of potential metabolic cause of myelopathy or encephalopathy (e.g., vitamin B12 deficiency, thyroid abnormalities)
* History or presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-cell lymphotropic virus type 1 \[HTLV-1\], or herpes zoster myelopathy)
* History of genetically inherited progressive CNS degenerative disorder (e.g., X-linked adrenoleukodystrophy, hereditary spastic paraparesis)
* Neuromyelitis optica
* History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sj�gren syndrome, Beh�et disease)
* History or presence of sarcoidosis
* Previous treatment with rituximab (MabThera(R)/Rituxan(R))
* Previous treatment with lymphocyte-depleting therapies (e.g., cyclophosphamide, Campath(R), anti-CD4, cladribine, total body irradiation, bone marrow transplantation), except mitoxantrone, which should not be used 12 months prior to randomization
* Treatment with an investigational agent within 90 days or 5 half-lives of the investigational drug (whichever is longer) prior to randomization
* Receipt of a live vaccine within 30 days prior to randomization
* Systemic corticosteroid therapy within 30 days prior to randomization
* Treatment with IFN-\&#x3B2;, glatiramer acetate, IVIg, or plasmapheresis within 60 days prior to randomization
* Treatment with non-lymphocyte-depleting immunosuppressive therapies (e.g., azathioprine, mycophenolate mofetil \[MMF\], cyclosporine) within 90 days prior to randomization
* Statins or hormone replacement therapy started within 30 days prior to randomization
B: DISEASE CHARACTERISTICS:

* Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification

  * Diagnosed within the past 6 weeks
  * CD20+ disease
  * Ann Arbor stage II, III, or IV disease or stage I bulky disease
* International Prognostic Index (IPI) score of 0 or 1

  * Score 0 defined by all of the following:

    * Stage I or II disease
    * ECOG performance status of 0 or 1
    * Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN)
  * Score 1 defined by 1 of the following:

    * Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater than ULN
    * Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater than ULN
    * Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater than ULN
* Previously untreated disease
* Mediastinal B-cell lymphoma allowed
* No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies
* No transformed lymphoma
* No primary CNS lymphoma
* No primary gastrointestinal (MALT) lymphoma
* No post-transplant lymphoproliferative disorder

PATIENT CHARACTERISTICS:

Age

* 18 to 60

Performance status

* See Disease Characteristics
* ECOG 0-3

Life expectancy

* At least 3 months

Hematopoietic

* Not specified

Hepatic

* Bilirubin no greater than 2.0 mg/dL\*
* Transaminases no greater than 3 times normal\*
* No active chronic hepatitis B or C infection NOTE: \*Unless related to lymphoma

Renal

* Creatinine no greater than 2 times normal\* NOTE: \*Unless related to lymphoma

Cardiovascular

* No myocardial infarction within the past 6 months
* No uncompensated heart failure
* No dilatative cardiomyopathy
* No coronary heart disease with ST segment depression on ECG
* No severe uncompensated hypertension

Pulmonary

* No chronic lung disease with hypoxemia

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No known allergic reactions against foreign proteins
* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No concurrent disease that would preclude study treatment
* No active infections requiring systemic antibiotics or antiviral medications
* No severe uncompensated diabetes mellitus
* No clinical signs of cerebral dysfunction
* No severe psychiatric disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior murine antibodies

Chemotherapy

* No other concurrent anticancer chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No concurrent response-adapted (slow response or unconfirmed complete response) radiotherapy

Surgery

* Not specified

Other

* No prior lymphoma-specific treatment
* More than 12 weeks since prior participation in another clinical trial
* No prior participation in this study
* No other concurrent study medication
C: Inclusion Criteria:

* Between the ages of 8 and 45 years
* Within 3 months of diagnosis of type 1 diabetes
* Have presence of at least one diabetes-related autoantibody
* Must have stimulated C-peptide levels of at least 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) within one month of randomization
* If female with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing while participating in the study
* Have not received an immunization for at least one month
* Must be willing to comply with intensive diabetes management
* Must weigh at least 25 kg at study entry

Exclusion Criteria:

* Are immunodeficient or have clinically significant chronic lymphopenia
* Have an active infection or positive purified protein derivative (PPD) test result
* Currently pregnant or lactating; or anticipate becoming pregnant.
* Require chronic use of steroids
* Have current or past HIV, hepatitis B, or hepatitis C infection
* Have any complicating medical issues that interfere with study conduct or cause increased risk
* Have a history of malignancies
* Currently using non-insulin pharmaceuticals that effect glycemic control
* Currently participating in another type 1 diabetes treatment study
D: Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis

Answer: C