EUCTR2011-002392-41-HU进行中（未招募）不适用
A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •1. Prior to Screening, have voluntarily signed the Informed Consent Form. Completing patients from Protocol Z102-008 will sign informed consent for Protocol Z102-009 prior to their termination visit in Protocol Z102-008.
- •2. Have completed all 12 weeks of Protocol Z102-008 or discontinued after participating in at least 6 weeks of the randomized withdrawal portion of Z102-008 for acceptable reasons (i.e., for reasons other than AE, protocol violation, or non-compliance). If Protocol Z102-008 participation terminated early, the full 12-week period (inclusive of study participation period) must elapse before participants in Z102-008 may be considered for participation in the 52-week extension study (Z102-009).
- •3. Have met all inclusion/exclusion criteria for enrollment into Protocol Z102-008.
- •4. Have been on DMARD therapy for at least 90 days and have been on a stable DMARD dose without dosage adjustment or modification for 6 weeks prior to enrollment into Protocol Z102-008, and be able to maintain the same dose of conventional DMARD therapy during Protocol Z102-009 participation (with or without glucocorticoid therapy); stable DMARD therapy may include a combination of DMARD agents (methotrexate and azulfidine or methotrexate and hydroxychloroquine as examples).
- •5. At Screening, female patients of childbearing potential (18 to 55 years of age, inclusive) must have negative urinary beta human chorionic gonadotropin (beta hCG) tests.
- •6. Female patients of childbearing potential (18 to 55 years of age, inclusive) must use acceptable methods of birth control (including, but not limited to, intrauterine device [IUD], oral or injectable contraceptives, barrier methods, or abstinence) for the duration of Protocol Z102-009.
- •7. If currently taking the following medications, she/he has been on a stable dose of the same drug for at least 3 months prior to entering into Protocol Z102-008, continued on the same dose during Protocol Z102-008, and should be able to continue on the same dose for the duration of Protocol Z102-009: statins, diuretics, thyroid hormone, hypoglycemic medications, and cardiovascular medications.
- •8. Have no general or specific changes in his/her condition unacceptable for further treatment in the judgment of the investigator.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Did not complete 6 weeks of the double-blind section of Protocol Z102-008, or was discontinued from Protocol Z102-008 for reasons of an AE, protocol violation, or non-compliance.
- •2. Female patient who is pregnant or lactating or of childbearing potential not using acceptable methods of birth control (including, but not limited to, IUD, oral or injectable contraceptives, barrier methods, or abstinence).
- •3. Patients who do not respond to therapies that include a dose less than 10 mg prednisone and either a DMARD combination, DMARD/biologic combination, or biologics alone.
- •4. Active cardiovascular disease, unless well controlled by appropriate treatment, for a minimum of 3 months prior to screening for enrollment into Protocol Z102-008.
- •5. Currently taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg.
- •6. Taking oral steroids at a daily prednisone dose, or the equivalent, of >10 mg/day within the past 2 weeks.
- •7. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering study Protocol Z102-008 or Protocol Z102-009, at any time during the study, or be anticipated to be given at any time during the study.
- •8. The need to continue the use of one or multiple NSAIDs at the same time, or use acetaminophen on a chronic basis. Acetaminophen/paracetamol is permitted episodically for pain during the titration and stable dose treatment period for Protocol Z102-009, not exceeding 1.5 g/day for any 3 days in any 7-day interval. There are no exclusions during the 30-day follow-up period.
- •9. All opiate use is prohibited. Such agents include oxycodone, hydrocodone, codeine, morphine sulfate, Demerol (meperidine/pethidine), Dilaudid (hydromorphone), tramadol, combination products including Percocet (oxycodone and acetaminophen), Hydrocet (dihydrocodeine and acetaminophen), Tylenol (acetaminophen or paracetamol) with codeine, Vicodin (hydrocodone and acetaminophen), Lorcet (hydrocodone and acetaminophen), Lortabs (hydrocodone and acetaminophen) extended-release formulations.
- •10. Use of any other medications or herbs or non-pharmacological treatments (e.g., acupuncture) used for the treatment of pain is prohibited.
- •11. Excluded medications include systemic anticoagulants, including dipyridamole, Coumadin (warfarin), clopidogrel, ticlopidine, and aspirin exceeding 325 mg/day (whether or not taken for cardiovascular prophylaxis). All systemic antifungal agents are excluded, including (but not limited to) the polyene macrolides (amphotericin B), the azoles (ketoconazole, miconazole, itraconazole, and fluconazole), and the allylamines (terbinafine). All anti-HIV drugs belonging to the following classes are prohibited: members of the nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside/nucleotide reverse transcriptase inhibitors, protease inhibitors, fusion and entry inhibitors, and integrin inhibitors. These agents include (but are not limited to) abacavir, zidovudine, didanosine, tenofovir, and efavirenz.
- •12. Has, or has had any active severe infections, such as osteomyelitis, sepsis, active infectious hepatitis, endocarditis, systemic fungal infection, or recent invasive surgical procedures within 30 days of Protocol Z102-008 or Protocol Z102-009 initiation.
- •13. Known HIV, hepatitis B, or hepatitis C infection.
- •14. Has undergone administration of any investigational drug within 30 days of study Proto
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