NL-OMON30362已完成4 期
IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic Disease;A randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent. - IMPROVED
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 610
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
- 18 至 99（—）
入选标准
- •1. minimum age of 18 years
- •2. at least one swollen joint
- •3. at least one other painful joint
- •4. symptom duration shorter than 2 years
- •5. diagnosis rheumatoid arthritis according to the ACR classification criteria or
- •6. diagnosis undifferentiated arthritis, suspected for rheumatoid arthritis by the rheumatologist, as no classification criteria exist.
- •7. patients naive for treatment with corticosteroids or disease modifying anti-rheumatic drugs (DMARDs).
排除标准
- •1. previous therapy with DMARDs or with corticosteroids (exception: one dose of parenteral corticosteroids within the last 6 months, but not within the last 2 months, or an oral dose of prednisone of =<10 mg/day for =< 2 weeks within the same period allowed).
- •2. pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception
- •3. concomitant treatment with another experimental drug
- •4. history or presence of malignancy within the last five years
- •5. bone marrow hypoplasia
- •6. elevated hepatic enzyme levels (ASAT, ALAT > 3 times normal value)
- •7. serum creatinine level > 150 umol/l or estimated creatinine clearance of < 75%
- •8. uncontrolled diabetes mellitus (according to the rheumatologist)
- •9. uncontrolled hypertension or moderate to severe heart failure (NYHA class III/IV)
- •10. alcohol or drug abuse
- •11. history of infected joint prothesis within the previous 3 months
- •12. serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months
- •13. chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis
- •14. history of active tuberculosis requiring treatment within previous 3 years, or signs and symptoms of latent infection with tuberculosis, based on medical history, physical examination, tuberculin (PPD) skin test or chest radiograph (see 9.3.1).
- •15. history of other granulomatous infections as histoplasmosis or coccidiomycosis
- •16. evidence of active cytomegalovirus, active pneumocystis carinii, active aspergillosis, or drug resistant atypical mycobacterium infection
- •17. history of opportunistic infections such as herpes zoster within previous 2 months.
- •18. history of active hepatitis B infection or evidence of a latent infection (see 9.3.1).
- •19. documented HIV infection, AIDS related complex (ARC) or AIDS.
- •20. history of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease.
- •21. Multiple sclerosis or neurological symptoms suspect for demyelinising disease.
- •22. Hypersensitivity to human immunoglobuline or other constituents of adalimumab
研究者
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