PER-043-99已完成未知
Multicenter, Randomized, Controlled Placebo Study measuring Effectiveness and Safety of TENOVIL (rHulL-10, SCH 52000) plus a Stable Dose of Methotrexate in Subjects with Active RHEUMATOID Arthritis.
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
入选标准
- •Man or woman of at least 18 years of age.
- •Diagnosis of RA that matches the criteria of the American College of Rheumatology (ACR), for at least 6 months prior to entering the study (see Appendix C).
- •Inadequate response to MTX of 12.5-25 mg / week (unless there is documented toxicity in which doses of> 10 mg / week have been used), as the active RA is defined according to the ACR criteria.
- •Active RA is defined as: six or more tender joints, six or more swollen joints, and at least one of the following two points:
- •duration of morning stiffness equal to or greater than 45 minutes, or rate of
- •erythrocyte sedimentation equal to or greater than 28 mm / hr® ^ or a protein C reagent equal to or greater than 20 mg / l.
- •Functional Classes 1, 11 or III
- •Willingness to participate in this study and complete all follow-up evaluations. Women of childbearing age will agree to practice adequate birth control measures during and at least one month after treatment with TENOVIL.
- •Ability to give written informed consent.
- •Read and understand your native language.
- •All subjects may be receiving stable therapy with a non-DMARD antirheumatic medication, at least one month before entering the study. These medications may include non-steroidal anti-inflammatory agents (NSAIDs) or salicylates or low oral doses of corticosteroids.
- •Doses and scheduling of all antirheumatic agents should remain unchanged throughout the study. Some subjects may have been treated with oral prednisone or its equivalent (<10 mg / day) as long as the subject has been on a stable dose basis for at least one month before entering the study.
- •An Independent Blind Evaluator will evaluate the counts of sensitive and inflamed joints
- •All subjects must be receiving concomitant metrotrexate therapy as follows:
- •Treatment at least 4 months before entering the study (oral or parenteral)
- •Stable dosage during the last two months with 12.5 to 25 mg / week (oral or parenteral) unless there is documented toxicity and doses as low as 10 mg / week can be used.
- •The route of administration (oral, parenteral) should not change at least 2 months before entering the study and throughout the study.
- •In case of documented MTX toxicity, the dose of MTX can be reduced to> 10 mg / week.
- •All subjects should be under stable dose of folic acid (minimum 1 mg / day or 5 mg / week) or folinic acid (minimum 5 mg / week) at least one month before entering the study and throughout the period of the study.
- •All subjects must have left all other DMARDs (hydroxychloroquine, cyclosporine, azathioprine, sulfasalazine, gold salts, and penicillamine-D) for a period of at least 4 weeks prior to the administration of the study drug.
排除标准
- •Women of childbearing age who do not use an effective method of birth control, pregnant women or lactating women.
- •Any subject who has received other drugs in experimentation (including biological agents) during the previous 3 months.
- •Any subject who has received ARA VA in the previous 3 months, but who has not received therapy with cholestyramine or any subject who has received ARAVA in the previous 6 months.
- •Any subject who has received anti-TNF therapy in the last 3 months.
- •Severe physical disability or clinical evidence of ankylosis of the joints or functional Class IV.
- •Hemoglobin <9.0 g / dl; WBC <3.5 x 10® / i; platelets <100 x 109 / l; LFT> 2 times above the normal limit; creatinine> 150 umol / l or 1.8 mg / dl.
- •History of cancer: treatment of neoplasia in the last five years, except basal cells or squamous cell carcinoma of the skin or cervical carcinoma In situ. Duke A colorectal carcinoma is allowed, if cured with resection, more than five years previously.
- •A positive test for double-stranded DNA antibodies or a history of systemic lupus erythematosus, or signs and symptoms suggestive of systemic lupus erythematosus.
- •History of clinically significant opportunistic infection in the three months prior to admission.
- •Subjects with a clinically significant neurological condition that could interfere with the subjects´ compliance with the requirements of the protocol or with the researcher´s interpretation of the study´s findings (for example: active Parkinson´s disease, attacks in the last 5 years, take anti-crisis medication, active immune mediated diseases such as MS).
- •Subjects with any clinically significant disease (apart from defined active RA) that could interfere with the subjects´ compliance with the requirements of the protocol or with the researcher´s interpretation of the findings of! study.
- •Subjects who have had osteomyelitis or infection in the joints in the last 6 months.
- •History of prosthetic infection in the joints if you still have the prosthesis.
- •Subjects with known abuse of substances, including alcohol abuse.
- •Pre-treatment with TENOVIL.
- •Severe adverse events due to MTX or inability to tolerate a stable regimen of at least 10 mg / week.
- •Use of injected asteroids (IM, IV, intra-articular, epidural) for one month before admission.
研究者
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