EUCTR2008-000327-25-CZ进行中（未招募）不适用
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE
Pfizer Inc. 235 East 42nd Street NY100170 个研究点目标入组 78 人开始时间: 2008年4月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Any adult at least 18 years of age at Screening;
- •2. A diagnosis of RA based upon the American College of Rheumatology 1987 Revised
- •Criteria. The subject has a diagnosis of RA based upon the American College of
- •Rheumatology, ie, fulfilling at least 4 of the following 7 criteria, for at least 6 consecutive months preceding participation:
- •Morning stiffness in and around any joint for more than 1 hour;
- •Soft tissue swelling of 3 or more joint areas;
- •Swelling of the proximal interphalangeal (PIP), metacarpophalangeal (MCP), or
- •wrist joints;
- •Symmetrical joint swelling;
- •Rheumatoid nodules;
- •Serum rheumatoid factor positive;
- •Radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints;
- •3. Must have active disease at Screening despite ongoing methotrexate treatment
- •defined as:
- •=4 tender/painful joints on motion (28 joint count);
- •=4 swollen joints (28 joint count).
- •4. Regarding MTX treatment, subjects must comply with all of the following criteria:
- •Receiving =7.5 /week (oral or parenteral) for the last 3 months;
- •No interruption >2 weeks during the same 3-month period;
- •Has received a stable dose for at least 4 weeks prior to Screening; and
- •No expected MTX dose change for the 12-week treatment duration.
- •Concomitant therapy with folic acid in a minimum of 400 mcg daily (or
- •equivalent dosing on a less-than daily schedule) or folinic acid once weekly in
- •locally approved doses (typically 5 mg, 24 hrs after the methotrexate dose).
- •5. Other permitted DMARDS are: 1) Sulfasalazine at a dosage which has been stable for at least 8 weeks at randomization and does not exceed a total daily dose of 3 grams.
- •2) Leflunomide at a dosage which has been stable for at least 4 weeks at
- •randomization and does not exceed 20 mg daily (with the exception of a loading dose of up to 100 mg daily for 3 days at the initiation of therapy). 3) injectable or oral
- •(auranofin) gold in locally approved doses, stable for at least 8 weeks prior to
- •randomization 4) d-penicillamine in locally approved doses, stable for at least
- •8 weeks prior to randomization, 5) chloroquine or hyrdoxychloroquine in locally
- •approved doses, if it has been at a stable dose for at least 1 year prior to
- •randomization with no history of anti-malarial related retinal toxicity. NO MORE
- •THAN 2 OF THESE DMARDS, IN ADDITION TO METHOTREAXTE, MAY BE
- •GIVEN DURING THE TRIAL OR FOR AT LEAST 1 MONTH PRIOR TO
- •RANDOMIZATION.
- •6. Meets ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II,or III
- •7. Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures; and
- •8. Must provide written informed consent.
- •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
- •1. A diagnosis of any other inflammatory arthritis (eg, spondyloarthropathies) or
- •secondary, noninflammatory arthritis (eg, osteoarthritis, fibromyalgia) that, in the
- •opinion of the Investigator, would interfere with assessments for this trial.
- •2. 12-lead ECG demonstrating QTc >460 msec for males and >480 msec for females at Screening;
- •3. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least 14 days prior to the first dose of trial medication until completion of follow-up procedures. Subjects who will remain on MTX after study completion should avoid pregnancy since MTX can
- •cause birth defects.
- •4. Subjects who have received the following prior treatments:
- •Within prior 4 weeks of Randomization: Herbal supplements*, corticosteroids by
- •any route with the exception of a stabilized oral dose of =10 mg of prednisone or
- •equivalent/day [which is allowed], azathioprine, cyclosporine, anakrina
- •(Kineret®), etanercept (Enbrel®)
- •*Herbal supplements should be handled as follows: 1)Fish oil, flaxseed oil,
- •borage oil, evening primrose oil, and inert substances such as
- •glucosamine/chondroitin, as well as vitamin supplements may be continued as
- •long as doses have been stable for one month prior to randomization 2) Known
- •pharmacologically active herbal supplements such as St. John’s wort, red yeast
- •rice, etc. or those with unknown/poorly studied activity are excluded ;
- •Within prior 8 weeks of Randomization: Infliximab (Remicade®), adalimumab
- •Within prior 8 weeks of Randomization: Any experimental therapy for RA
- •(within or outside a clinical trial); with the exception of experimental
- •NSAID/COX-2 inhibitors or opioids for which a washout interval of not less than
- •5 half-lives shall apply. (Note: This excludes aspirin =325 mg/day for
- •nonarthritic reasons provided the dose has been continuous and stable for at least
- •2 weeks prior to the first dose of study medication.);
- •Within prior 3 months of Randomization: abatacept (Orencia®);
- •Within prior 12 months of Randomization: rituximab (Rituxan®); Such subjects
- •must also demonstrate normal CD 20+ lymphocyte counts.
- •5. Subjects who take lithium or warfarin within 1 month of randomization;
- •6. Subjects who take concomitant medications that are CYP3A4 inhibitors or CYP3A4
- •inducers (Appendix 1);
- •7. Subjects who take opioid analgesics at a dose of >30 mg oral morphine or
- •equivalent/day;
- •8. Any retinal abnormalities noted during ophthalmoscopic examination at Screening;
- •9. Subjects with a clinical diagnosis of glaucoma or other diseases affecting the
- •posterior segment of the eye such as choroiditis, retinitis, chorioretinitis, uveitis,
- •diabetic proliferative retinopathy, or diabetic macular edema; or any subject with
- •significant cataracts or other eye pathology which restricts the ability to view the
- •retina with ophthalmoscopy;
- •10. Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically
- •significant diabetic gastroenteropathy); Bariatric procedures (such as banding) that
- •effectively divide the stomach but do not affect digestive/absorptive surface area of
- •the stomach or intestines are NOT exclusionary;
- •11. Tuberculosis without treatment and/or positive tuberculin reaction by PPD test
- •without known history of vaccination with the Bacillus Calmette-Guérin (BCG)
- •vaccine [only in subjects whose last BCG was =50 years prior to screening who do
- •not have locally-defined risk factors
研究者
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