PER-095-06已完成未知
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Male or female 18 years of age or older.
- •2. Diagnosis of AR performed at least 3 months before the selection.
- •3. Have received treatment with MTX at a dose of at least 15 mg / week for at least 3 months before selection, and have received a stable dose of MTX> 15 mg / week and <25 mg / week at least 4 weeks before the selection.
- •4. Present active AR.
- •5. If the subject receives NSAIDs or other analgesics for RA, they must have taken a stable dose for at least 2 weeks before the first administration of the study drug.
- •6. If the subject is receiving oral corticosteroids, they should have taken a stable dose equivalent to <10 mg of prednisone / day for at least 2 weeks before the first administration of the study drug.
- •7. Women and men with the potential to procreate should be using an adequate contraceptive method during the study and for 6 months after receiving the last dose.
- •8. Subjects considered candidates according to the following criteria for evaluating TB: a) They have no history of latent or active TB before selection. b) They do not present signs or symptoms that suggest active TB in the clinical history and / or in the physical examination. c) They have not had recent close contact with a person with active TB. d) Within the month prior to the first administration of the study drug, they must present negative results in the diagnostic tests of TB. e) They present a chest X-ray taken within 3 months prior to the first administration of the study drug and interpreted by a qualified radiologist, without evidence of current active TB or previous inactive TBC.
- •9. The results of laboratory analysis in the selection must meet the following criteria: a) Hemoglobin ≥ 8.5 g / dL. b) Leukocyte count ≥ 3.5 x 10-3 cells / uL. c) Neutrophils ≥ 1.5 x 10-3 cells / uL. d) Platelets ≥ 100 x 10-3 cells / uL. e) ALT and serum AST levels that do not exceed 1.5 times the upper limit of normal. f) Serum creatinine that does not exceed 1.5 mg / dL.
- •10. Subjects who wish and are able to comply with the program of study visits and other requirements of the protocol.
- •11. Subjects capable of giving informed consent, which must be obtained before carrying out any procedure related to the study.
排除标准
- •1. Subjects presenting other inflammatory diseases.
- •2. Subjects who received treatment with DMARD during the 4 weeks prior to the first administration of the study drug.
- •3. Subjects who received corticosteroids intra-articularly, intramuscularly or IV, including adrenocorticotrophic hormone, during the 4 weeks prior to the first administration of the study drug.
- •4. Subjects that have a confirmed hypersensitivity to human immunoglobulin proteins or other components of golimumab.
- •5. Subjects who have presented a clinically serious adverse reaction to a biological anti-TNFα agent.
- •6. Subjects who received infliximab in the 3 months prior to the first administration of the study drug.
- •7. Subjects who received etanercept or adalimumab in the 2 months prior to the first administration of the study drug.
- •8. Subjects who received rituximab or abatacept.
- •9. Subjects who received natalizumab or other agents directed to integrin-4-alpha.
- •10. Subjects who received anakinra during the 4 weeks prior to the first administration of the study drug.
- •11. Subjects who received alefacept or efalizumab in the 3 months prior to the first administration of the study drug.
- •12. Subjects who have used cytotoxic agents.
- •13. Subjects who received any drug under study, within the 5 half lives of said drug before the first administration of the study drug.
- •14. Pregnant women, breastfeeding women or men or women who plan pregnancies within 6 months after receiving the last administration of the study drug.
- •15. Subjects with a history of latent or active granulomatous infection.
- •16. Subjects who received a vaccine with Bacillus Calmette-Guerin (BCG) in the 12 months prior to selection.
- •17. Subjects with a chest x-ray within 3 months prior to the first administration of the study drug that shows an abnormality that suggests malignancy or active current infection.
- •18. Subjects who have had a non-tuberculous mycobacterial infection or opportunistic infection.
- •19. Subjects who received or will receive a live or bacterial virus vaccine within 3 months prior to the first administration of the study drug, during the study or within 6 months after the last administration of the study drug.
- •20. Subjects with a history of joint prosthesis infected or who received antibiotics for suspected joint prosthesis infection, if the prosthesis was not removed or replaced.
- •21. Subjects who presented a serious infection, were hospitalized for an infection or received intravenous antibiotic treatment for an infection during the 2 months prior to the first administration of the study drug.
- •22. Subjects with a history or presence of a chronic or recurrent infectious disease.
- •23. Subjects with infection confirmed by human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- •24. Subjects with a confirmed history of demyelinating disease.
- •25. Subjects with current signs or symptoms of renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric or severe cerebral disease, progressive or uncontrolled.
- •26. Subjects with a history or presence of congestive heart failure (CHF).
- •27. Subjects with a history of lymphoproliferative disease.
- •28. Subjects with any confirmed current malignancy or history of malignancy within the previous 5 years.
- •29. Subjects with a history of organ transplantation.
- •30. Subjects with a history of subs
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