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临床试验/EUCTR2008-006917-25-DE
EUCTR2008-006917-25-DE进行中（未招募）不适用

A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).

uon Therapeutics, Inc.0 个研究点目标入组 250 人开始时间: 2009年1月22日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
250
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Inclusion Criteria
  • •1. Signed and dated written Institutional Review Board (IRB) or Independent Ethics
  • •Committee (IEC) approved informed consent obtained from the subject in
  • •accordance with the local regulations;
  • •2. Male or female subjects, =18 to =75 years of age, who have a diagnosis of RA
  • •(using the American Rheumatism Association 1987 Revised Criteria for at least 6
  • •months prior to screening, and are Functional Class 1-3 (as defined by the 1991
  • •Revised Criteria for the Classification of Global Functional Status in Rheumatoid
  • •Arthritis at baseline;
  • •3. Subjects must be receiving MTX (oral or parenteral) at a dose of at least 10
  • •mg/week for =6 months and at a stable dose and route of administration for =8
  • •weeks prior to randomization (Day 0);
  • •4. Subjects must receive at least 5 mg of folic acid or folinic acid per week at a stable
  • •dose for at least 4 weeks prior to randomization (Day 0);
  • •5. Subjects must have at least 8 painful/tender and 6 swollen joints (based upon
  • •68/66 joint counts) at screening and baseline (Day 0);
  • •6. Subjects must have an elevated CRP level (defined as > the upper limit of normal
  • •[ULN] for the central lab) or an elevated ESR (defined as > the upper limit of
  • •normal [ULN] for the local lab) at screening;
  • •7. Availability of normal chest X-ray within the last 6 months (i.e., no evidence of TB
  • •or chest infection). Patients who are clinically asymptomatic with minor changes
  • •consistent with rheumatoid lung are acceptable.
  • •# In Argentina, the chest X-ray must have been obtained within the last 1 month.
  • •8. Subjects may be receiving:
  • •# Oral steroids at a stable dose of <10 mg/day of prednisone (or equivalent
  • •corticosteroid dose) if previously taken for at least one month prior to
  • •randomization (Day 0);
  • •# Chronic NSAIDs if taken at a stable dose for at least one month prior to
  • •randomization (occasional use of NSAIDs for relief of headaches menstrual
  • •cramps, and minor pain unrelated to RA is allowed);
  • •# Hydroxychloroquine if taken at a stable dose of 200-400 mg PO daily or
  • •chloroquine if taken at a stable dose of up to 250 mg PO daily for at least 3
  • •months prior to randomization with no evidence of ocular toxicity as
  • •documented by ophthalmologic exam within the previous 12 months;
  • •# Sulfasalazine if taken at a stable daily dose of up to 3000 mg PO for at least 3
  • •months prior to randomization;
  • •9. Females of childbearing potential must agree to continue to use adequate
  • •contraception (i.e., hormonal [oral, depot, patch], IUD, or barrier and spermicide)
  • •throughout the study and for at least 1 month following their last study visit;
  • •# Females of childbearing potential in Argentina must agree to monthly urine
  • •pregnancy testing as well as the contraceptive measures described above
  • •10. In the opinion of the investigator, the subject will be compliant and have a high
  • •probability of completing the study and all required procedures.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •Exclusion Criteria
  • •1. Use of intra-articular corticosteroid injections within one month prior to
  • •randomization (Day 0);
  • •2. Use of other anti-arthritic treatments not mentioned in the above inclusion criteria,
  • •including approved or experimental oral, topical, or injectable biologics or drugs, or
  • •devices within 3 months or 5 half-lives (whichever is longer) prior to randomization
  • •3. Pregnant or nursing females;
  • •4. Subjects who have received prior treatment with tranilast;
  • •5. Subjects who have any known hypersensitivity to any of the excipients contained
  • •in the study drug formulation;
  • •6. Use of any of the following other medications: (a) oral hypoglycemic agents:
  • •tolbutamide, glipizide, glimepiride, glyburide, repaglinide, nateglinide, or a
  • •thiazolidenedione (glitazones”, e.g. rosiglitazone); (b) warfarin or coumarol; (c)
  • •phenytoin, paclitaxel, fluconazole, amiodarone, or isoniazid; (d) a uricosuric agent
  • •for gout; or (e) an investigational medication or participation in an investigational
  • •study within 3 months of Day 0
  • •7. Subjects with any laboratory test at screening considered significantly abnormal.
  • •The following will be considered significantly abnormal:
  • •# alanine transaminase (ALT), aspartate transaminase (AST), or alkaline
  • •phosphatase =1.25-times the upper limit of normal (ULN) or
  • •# cytopenia (to include any of the following: WBC <3.5x103/µL; Hgb <10 g/dL;
  • •platelets <100x103/µL; neutrophils absolute <1.5x103/µL; lymphocytes
  • •absolute <0.8x103/µL) or
  • •# Creatinine =1.25-times the upper limit of normal (ULN)
  • •8. Has an elevated total bilirubin (e.g., outside the upper limit of normal), which
  • •persists upon repeat or a history of Gilbert’s syndrome;
  • •9. History of clinically significant renal or hepatic dysfunction or disease;
  • •10. Has a history of or has a current, clinically significant major psychiatric disorder
  • •(e.g., major depressive disorder, psychosis, schizophrenia) according to the
  • •criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth
  • •Edition (DSM-IV-TR)
  • •[Exception; subjects with depression that has been adequately controlled for at
  • •least 6 months may enroll in the study];
  • •11. Has a history of alcohol or drug dependence or abuse as defined by DSM-IV-TR
  • •criteria within the last 2 years;
  • •12. Has a history of uric acid urolithiasis or gout;
  • •13. Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI,
  • •URI) within 30 days of Day 0, or a history or presence of recurrent or chronic
  • •infection (e.g., viral infections, including hepatitis B or C, HIV), bacterial
  • •infections, systemic fungal infections, or syphilis);
  • •14. Has evidence of tuberculosis as indicated by subjects with a positive tuberculin
  • •(TB) skin test at screening or within the 30 days prior to screening (defined as
  • •=10 mm induration);
  • •# For sites in Argentina and Czech Republic: A positive TB skin test will be
  • •defined as >5 mm induration. Additionally in Czech Republic, the TB skin test
  • •result must be assessed by a pneumonologist;
  • •15. Has any other significant medical disease, mental impairment or other clinically
  • •significant abnormality on physical, neurological, laboratory, vital signs or ECG
  • •examination that the investigator or Sponsor believes would be detrimental to
  • •the subject or compromise the study;

研究者

发起方
uon Therapeutics, Inc.

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