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临床试验/PER-022-05
PER-022-05已完成未知

Phase III study, 12 weeks long, Multicentric, Double Blind, Randomized, controlled with Placebo and an active comparator, in parallel groups, that will investigate the Efficacy and Safety of GW 406381, 5 mg, 10 mg, 25 mg and 50 mg administered orally once a day, in adults with rheumatoid arthritis.

GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 0 人开始时间: 2005年6月8日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
发起方
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

入排标准

入选标准

  • •1. The person is an outpatient male or female, not under 18 years of age.
  • •2. The person is trained and willing to give written informed consent.
  • •3. The person can read, understand and memorize information required in the protocol.
  • •4. AR onset in> 16 years of age and duration of symptoms> 12 months.
  • •5. Diagnosis of RA according to the American Rheumatism Association, 1987 criteria.
  • •6. Class I, II or II Functional of AAR.
  • •7. An NSAID or COX-2 inhibitor was needed to treat their RA for at least 5 of the 7 days of each week for the 4 weeks prior to selection.
  • •8. It satisfies all definitions of active disease and criteria of
  • •initial evaluation.

排除标准

  • •1. Known history of hypersensitivity or intolerance to NSAIDs, aspirin, COX-2 inhibitors.
  • •2. Any biological or clinical abnormality discovered at the screening visit.
  • •3. History of perforations and / or gastroduodenal obstructions.
  • •4. History of some gastric or duodenal operation.
  • •5. Active gastrointestinal ulceration of the upper gastrointestinal tract within the previous 6 months, bleeding from the upper gastrointestinal tract within the previous year.
  • •6. History of bleeding of the lower gastrointestinal tract within
  • •of the previous year.
  • •7. History of inflammatory digestive diseases.
  • •8. Use of proton pump inhibitors.
  • •9. History of congestive heart failure, coronary instability, stenosis of the renal artery or any of the following: myocardial infarction, angina, stoppage, or transient ischemic attack.
  • •10. Uncontrolled hypertension.
  • •11. Use of a diuretic combination with angiotensin-converting enzyme (AGE) inhibitor or an angiotensin receptor blocker (ARB).
  • •12. Use of anticoagulants (warfarin, heparin) or antiplatelet aggregation agents.
  • •13. Identification of creatinine, bilirubin, alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT)> 1.5 times the upper limit of normal (LNS).
  • •14. History of clinically significant drug or alcohol abuse.
  • •15. Proven allergic-type reactions to sulfonamides.
  • •16. Participation in another model or drug research study during the previous 3 months.
  • •17. Previous participation in a research study of GW406381.
  • •18. Initiation or change in the dose of a standard disease-modifying antirheumatic drug (DMARD) within 12 months before the initial evaluation.
  • •19. Use of methotrexate at doses of> 20 mg / week or initiation or change of methotrexate dose within 8 weeks before the initial evaluation.
  • •20. Use of targeted anti-cytokine biological therapeutics.
  • •21. Use of therapies for B cells if it is not stable for 6 months
  • •before the selection visit.
  • •22. Use of oral corticosteroids at a dose greater than the equivalent of 10 mg / day prednisolone / prednisone or initiation of corticosteroid therapy within 4 weeks prior to commencement
  • •of the consumption of the study drug.
  • •23. Intra-articular injections within 4 weeks before starting to take the study drug.
  • •24. Start or change to a physiotherapeutic program established within 2 weeks before or during the study period.

研究者

发起方
GLAXOSMITHKLINE PERU S.A.,

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