Current Research with Inclusion/Exclusion Criteria

Holzer Clinic Department of Research
Extension 3792/3990

Pfizer Inc
(Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients with or at High Risk for Cardiovascular Disease Comparing Celecoxib with Naproxen and Ibuprofen)

42 Months Study

Inclusion:

1. Men and women, 18 years if age or older at time of consent
2. Clinical diagnosis of OA or RA with a duration of at least 6 months
3. All subjects must have a required regimen for at least 6 months and taken chronic analgesic therapy > 50% of the time.
4. Subject with established or at high risk for CVD defined as one of the following:
• Coronary disease
• Occlusive disease of non-coronary arteries
• Diabetes mellitus: clinical diagnosis of Type I or Type II diabetes

Exclusion:

1. Acute joint trauma with active symptoms
2. Planned surgical or other invasive procedure to be performed during the course of the study
3. Receiving treatment with oral corticosteroids at a daily does > 20 mg prednisone or equivalent
4. Requires and is receiving treatment with >325 mg aspirin/day

Pfizer Protocol A0081247

(Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: The ExPAND Study)

Study will last 6 months

Inclusion Criteria:

1. Actively enrolled in a WellPoint health plan with medical and WellPoint pharmacy benefits whereby pregabalin is available only under PA.
2. Age = 18 years at time of study enrollment
3. Ability to read and understand English
4. A physician-confirmed diagnosis of pDPN (painful diabetic peripheral neuropathy) or FM (fibromyalgia), but not both
5. Initiation of a medication for pDPN or FM is clinically indicated, either as monotherapy or in combination with other treatments, as determined by the treating physician, and agreed to by the patient
6. No prior pregabalin use or pregabalin PA requests
7. Willingness to attend their physician’s office in follow-up and to complete several self-reported outcomes instruments (PROs) up to four times between study initiation and completion 6 months later.
8. Willingness to provide a personally signed and dated Informed Consent document indicating that they agree to participate and have been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. Females or are partners of males currently pregnant/lactating or intending to become pregnant in the next 6 months
2. Physician-confirmed diagnosis of both pDPN and FM
3. Concomitant diagnosis of other types of neuropathic pain, such as post-herpetic neuralgia
4. Pregabalin use at any time prior to study enrollment
5. Previous pregabalin PA requests filed at any time
6. Ongoing participation in any experimental study
7. Unable to provide Informed Consent
8. Anticipated survival (due to comorbidities) of less than 6 months from baseline

Eli Lilly Protocol 12R-MC-BIAJ

(A Comparison of LY 2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination with Oral Anti-Hyperglycemia Medications in Insulin-Naïve Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study)

Study will last 12 months

Inclusion Criteria:

Patients are eligible to be included in the study only if they meet all of the following criteria:

1. Have T2DM not treated with insulin
2. Are 18 years of age or older
3. Have had diabetes for at least 1 year
4. Have been receiving at least 2 OAMs for at least 3 months prior to the study. Two or more medications may be contained in 1 pill. Doses of any OAMs are required to have been stable for the 3 months prior to Visit 1 and at least 2 of the OAMs must be dosed at or above half the maximum daily dose allowed by local regulations or at the maximally tolerated dose of OAM.
5. Have HbA1c of 7.0% to 11.0%, inclusive, according to central lab at Visit 1.
6. Have BMI =45.0 kb/m2
7. Are capable of, and willing to do, the following:
   • Inject insulin with a vial and syringe and perform self blood glucose monitoring
   • Record keeping as required by this protocol, as determined by the investigator
8. Have given written informed consent to participate in this study in accordance with local regulations
9. Have access to a telephone
10. Have refrigeration in the home
11. This inclusion criterion applies to females of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) only:
    • Are not breastfeeding
    • Test negative for pregnancy at the time of screening (Visit 1) and randomization (Visit 3) based on a serum pregnancy test.
    • Intend not to become pregnant during the study.
    • Have practiced a reliable method of birth control for at least 6 weeks prior to screening.
    • Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug).

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

1. Insulin therapy: have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks. Insulin use of any duration during pregnancy is not considered an exclusion criteria.
2. Concomitant medications: rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist (for example, exenatide, exanatide once weekly, or liraglutide) used concurrently or within 3 months prior to Visit 1 (screening).
3. Local OAM restrictions: for patients on OAMs, restrictions for cardiac, renal, and hepatic diseases, local product regulations must apply.
4. Weight loss medications: are currently taking, or have taken within the 3 months preceding Visit 1, prescription or over-the-counter medications to promote weight loss.
5. Sever hypoglycemia history: have had any episodes of severe hypoglycemia within 6 months prior to Visit 1.
6. Diabetic ketoacidosis (DKA) or hyperclycemic hyperosmolar nonketotic coma (HHNKC): have had 1 or more episodes of ketoacidosis or hypersmolar state/coma in the past 6 months.
7. Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV.
8. Renal: have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine =2 mg/dL (177 µmol/L).
9. Hepatic: have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements as indicated below:
   • Total bilirubin =2 x the upper limit of normal (ULN) as defined by the central laboratory, or
   • Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT) >2.5 x ULN as defined by the central laboratory, or
   • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT) > 2.5 x ULN as defined by the central laboratory.
10. Hematologic: have had a blood transfusion or severe blood loss within 3 months prior to Visit 1 or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormities know to interfere with the measurement of HbA1c.
11. Malignancy: have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator.
12. Allergy: have know hypersensitivity or allergy to any of the study insulins or their excipients.
13. Glucocorticoid therapy: are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding Visit 1.
14. Triglycerides: have fasting triglycerides >400 mg/dL (>4.5 mmol/L) at Visit 1 as determined by the central laboratory.
15. Sleep cycle: have irregular sleep/awake cyle (for example, patients who sleep during the day and work during the night) in the investigator’s opinion.
16. Adherence to protocol: have any conditions (including know drug or alcohol abuse or psychiatric disorder) that preclude the patient from following and completing the protocol.
17. Prior study participation: are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device other than LY2605541, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
18. General restrictions: are unable and/or unwilling to provide informed consent, make themselves available for the duration of the study, or abide by study procedures and restrictions.
19. Lipid-lowering medications:
    • Are using niacin preparations as lipid-lowering medication and bile acid sequestrants within 90 days prior to Visit 1; or,
    • Are using lipid-lowering mediation at a dose that has not been stable for =90 days prior to Visit 1.

Novartis Protocol CAIN457 F2302

( A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFα agents)

Study will last 2 years

Inclusion Criteria:

1. Patient must be able to give a written, signed and dated informed consent before any study assessment is performed.
2. Male or non-pregnant, non-lactating female patients at least 18 years of age
3. Presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening
4. At baseline: Disease activity criteria defined by =6 tender joints out of 68 and = 6 swollen joints out of 66 with at least 1 of the following at screening: (a) anti-CCP antibodies positive or (b) Rheumatoid Factor positive; and with at least 1 of the following at screening: (a) hsCRP = 10 mg/L or (b) ESR = 28 mm/1st hr
5. Patients must have been taking at least one anti-TNF-α agent such as etancercept, adalimumab, infliximab, certolizumab or golimumab given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent
6. Patients who have been on anti-TNF-? agent will be allowed entry into study after appropriate wash-out period prior to randomization
7. Patients must be taking MTX for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization
8. Patients must be taking folic acid supplementation before randomization
9. Patients who were taking other DMARDs (in combination with or without MTX) will be allowed entry into study after appropriate washout period (except for MTC) prior to baseline
10. Patients taking systemic corticosteroids have to be on a stable dose of = 10 mg/d prednisone or equivalent for at least 4 weeks before randomization
11. Patients who are regularly taking NSAIDs are required to be on a stable dose for at least 4 weeks before randomization

Exclusion Criteria:

1. Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
2. RA patients functional status class IV according to the ACR 1991 revised criteria
3. Patients taking high potency opioid analgesics
4. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
5. Use of any investigational drug and/or devices within 4 weeks before randomization, or a period of 5 half-loves of the investigational drug, whichever is longer
6. History of hypersensitivity to the study drug or it excipient or to drugs of similar classes
7. Any therapy by intra-articular injections required for treatment of arthritis within 4 weeks before randomization
8. Any intramuscular corticosteroid injection within 4 weeks before randomization
9. Patients who have ever received biologic immunomodulating agents except for those targeting TNFα
10. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents
11. Pregnant or nursing women
12. Women of child-bearing potential, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment. Effective contraception is defined as either:
    1. Barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicide.
    2. Total abstinence
    3. Female sterilization: have had a surgical bilateral oophorectomy or tubal ligation at least 6 weeks before taking study treatment
    4. Male partner sterilization
    5. Use of established oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD) or intrauterine system (IUS)

Note: Women are considered post-menopausal and not of child-bearing potential is they have had 12 months of natural amenorrhea with an appropriate clinical profile or six months of spontaneous amenorrhea as defined by the Central lab FSH and/or estradiol levels.

13. Active ongoing inflammatory diseases other than RA that might confound the evaluation of the benefit of secukinumab therapy
14. Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy. In particular, clinical evidence or history of Felty’s Syndrome
15. Significant medical problems or diseases, including not limited to the following: (a) Uncontrolled Hypertension; (b) Congestive Heart Failure; (c) Uncontrolled Diabetes
16. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests such as SGOT, SGPT, alkaline phosphatase, or serum bilirubin
17. History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum creatinine level exceeding 1.5 mg/dL
18. Screening total WBC count <3,000/µL, or platelets <100,000/µL or neutrophils <1,500/µL or hemoglobin <8.5 g/dL
19. Active systemic infections during the last two weeks (exception: common cold) prior to randomization
20. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by either a positive PPD skin test or a positive QuantiFERON TB-Gold test
21. Known infection with HIV, hepatitis B or C at screening or randomization
22. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed
23. Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the patient unsuitable for the trial
24. Inability or unwillingness to undergo repeated venipuncture
25. Any medical or psychiatric condition which, in the investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol
26. Donation or loss of 400 mL or more of blood within 8 weeks before randomization
27. History or evidence of ongoing alcohol or drug abuse, within the last six months before randomization
28. Plans for administration of live vaccines during the study period or 6 weeks prior to randomization