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Clinical Trials/EUCTR2008-000170-20-CZ
EUCTR2008-000170-20-CZActive, not recruitingNot Applicable

A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 02, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008) and Amendment 07 (version 1.0 dated on 01-Jul-2008).

Bristol Myers Squibb International Corporation0 sites240 target enrollmentStarted: April 30, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
240
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1) Signed Written Informed Consent
  • •a) Subjects must be able to provide informed, written consent.
  • •2) Target Population
  • •a) Subjects must meet the criteria of the American Rheumatism Association (1987)
  • •for the diagnosis of RA (Arnett et al, 1988) (Appendix 3). The disease must have
  • •been diagnosed for = 6 months prior to screening.
  • •b) Subjects must have been taking MTX for at least 3 months at a weekly dose of 7.5
  • •to 20 mg, inclusive, and at a stable dose for 28 days prior to treatment (Day 1).
  • •Use of parenteral MTX is acceptable as clinically indicated if subjects cannot
  • •tolerate or absorb oral MTX.
  • •c) Subjects must be MTX inadequate responders defined as currently having 6 or
  • •more swollen joints and 8 or more tender joints at the screening visit (refer to
  • •Inclusion number 5, disease activity)
  • •3) Age and Sex
  • •a) Men and women at least 18 years of age. Men and women of childbearing
  • •potential are eligible if they are practicing effective contraceptive measures.
  • •Because subjects are taking background therapy such as methotrexate for
  • •treatment of RA, which has potential risks associated with its use in pregnancy,
  • •subjects will be re-advised on the use of reliable contraceptive methods and on the
  • •potential risks to a pregnancy. WOCBP include any female with experienced menarche , who has not undergone successful surgical sterilization or is not postmenopausal. Post menopause is defined as: • Amenorrhea = 12 consecutive months without another cause or • For women with irregular menstrual periods and on hormone replacement therapy, a documented FSH level = 35 mIU/mL. Women who are using oral contraceptives, other hormonal contraceptives or mechanical products such as an intrauterine device or barrier methods to prevent pregnancy, or are practicing abstinence or where their partner is sterile should be considered to be of childbearing potential. Acceptable methods of contraception include: oral contraceptives, hormonal contraceptives, intrauterine device, diaphragm, condoms, spermicides, or abstinence. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to the start of investigational product.
  • •4) Concomitant Medication (Anti-rheumatic Treatment)
  • •a) MTX alone: Subjects who are treated only with methotrexate will not require
  • •b) MTX plus DMARDs other than sulfasalazine or anti-malarials (eg
  • •hydoxychloroquine, chloroquine): Subjects who are treated with MTX in
  • •combination with another anti-rheumatic treatment (DMARD) will require
  • •washout of the other DMARDs.
  • •c) Drug stabilization requirements
  • •i) If subjects are taking sulfasalazine and/or anti-malarials, which are allowed as
  • •concomitant therapy in this study, they must be on a stable dose for 25 out of
  • •28 days prior to treatment (Day 1).
  • •ii) All DMARDs (except MTX, sulfasalazine and anti-malarials) must be
  • •discontinued at least 28 days prior to treatment (Day 1). In the case of
  • •leflunamide, the subject can be washed out with cholestyramine according to
  • •manufacturers recommendations.
  • •iii) Oral corticosteroid treatment must have been reduced to = 10 mg prednisone
  • •or equivalent per day for at least 14 days and stabilized for at least 11 out of
  • •14 days prior treatment (Day 1).
  • •iv) Subjects who have had previous treatment with any
  • •biologic/immunosuppresant therapy for RA require wash-out for a period of at
  • •least 28 days or 5 half lives whichever is longer or a minimum of 3 months for
  • •any biologic agent with an un

Exclusion Criteria

  • •1) Sex and Reproductive Status
  • •a) WOCBP who are unwilling or unable to use an acceptable method to avoid
  • •pregnancy for the entire study period and for up to 4 weeks after the last dose of
  • •investigational product.
  • •b) Women who are pregnant or breastfeeding
  • •c) Women with a positive pregnancy test on enrollment or prior to investigational
  • •product administration.
  • •d) Men who are unwilling or unable to use an acceptable method of birth control
  • •for the entire study period.
  • •2) Medical History and Concurrent Diseases
  • •a) Any clinically significant acute or chronic illness other than RA that is severe,
  • •progressive or uncontrolled at the time of screening. This includes any current
  • •signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
  • •hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic,
  • •musculoskeletal, genitourinary, or thyroid disease.
  • •b) Any major surgery within 4 weeks of screening or planned/scheduled surgery
  • •requiring hospitalization during the time of the study.
  • •c) Blood transfusion within 4 weeks of screening.
  • •d) Donation of blood or plasma to a blood bank or in a clinical study within 4 weeks of screening.
  • •e) Any condition that could impact upon the absorption of study drug. (ie, gastric
  • •ulcer requiring therapy, gastric stapling, duodenal surgery, malabsorption syndrome).
  • •f) Subjects (currently or within 3 months) requiring chronic or intermittent medical
  • •therapy or surgical intervention for gastrointestinal disease including
  • •gastrointestinal ulceration, chronic heartburn, esophageal reflux, gastric or
  • •duodenal ulcer and/or gastritis.
  • •g) Any infection requiring systemic anti-microbial treatment that completed within 4
  • •weeks of enrollment.
  • •h) Major infection requiring hospitalization or receipt of intravenous antibiotics
  • •within 2 months prior to enrollment.
  • •i) Subjects at risk for tuberculosis (TB).
  • •j) Have a history of opportunistic infection and/or evidence of active infection
  • •including but not limited to HIV, Hepatitis B or C viruses.
  • •k) History of lymphoproliferative disease, including lymphoma, or signs suggestive
  • •of possible lymphoproliferative disease, such as lymphadenopathy of unusual
  • •size, location, or clinically significant splenomegaly.
  • •l) Any known malignancy or history of malignancy within 5 years including
  • •carcinoma in situ prior to enrollment, with the exception of basal cell or
  • •squamous cell carcinoma of the skin that has been excised with no evidence of
  • •recurrence (squamous cell carcinoma of other location is exclusionary).
  • •m) Subjects who have received treatment with any investigational drug within the
  • •previous 30 days or 5 half-lives of the Day 1 dose, whichever is greater.
  • •n) Subjects who have received a live vaccine within 3 months of Day 1 dosing.
  • •3) Physical and Laboratory Test Findings
  • •a) Subjects at screening with PT and/or aPTT and/or INR values = 1.05 X ULN.
  • •b) Subjects at screening with ALT or AST elevations = 1.5 X ULN or with a history
  • •of frequent or recent ALT or AST elevations are excluded.
  • •c) Subjects at screening with CK elevations = 2 X ULN or with a history of frequent
  • •or recent CK elevations are excluded.
  • •d) Any clinically significant (as determined by the investigator) vital signs and/or physical examination finding.
  • •e) Positive blood screen for hepatitis B surface Ag and hepatitis C antibody.
  • +3 more not shown

Investigators

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