A randomized, double-blind, parallel group study of the safetyand prevention of structural joint damage during treatment withMRA versus placebo, in combination with methotrexate, inpatients with moderate to severe active rheumatoid arthritis.

F Hoffmann La-Roche Ltd.0 个研究点目标入组 1,170 人开始时间: 2004年12月7日最近更新: 2013年3月18日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: F Hoffmann La-Roche Ltd.
入组人数: 1,170

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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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. Able and willing to give written informed consent and comply with the
•requirements of the study protocol.
•2. Patients with rheumatoid arthritis of =6 months duration, diagnosed according to
•the revised 1987 American College of Rheumatology (ACR; formerly American
•Rheumatism Association) criteria
•3. Receiving treatment on an outpatient basis.
•4. Prior to randomization, will have discontinued etanercept for =2 weeks, infliximab
•or adalimumab for =8 weeks (see exclusion #5), anakinra for =1 week,
•leflunomide for =12 weeks (or =4 weeks after 11 days of standard cholestyramine
•5. Have received methotrexate for at least 12 weeks immediately prior to baseline, of
•which the last 8 weeks must have been at a stable dose of between 10 and
•25 mg/week (p.o. or parenteral).
•6. All DMARDs, other than MTX, withdrawn prior to baseline.
•7. Swollen joint count (SJC) =6 (66 joint count) and tender joint count (TJC) =8 (68
•joint count) at screening and baseline.
•8. At screening either CRP =1 mg/dL (10 mg/L) or ESR =28 mm/hr
•9. Radiographic evidence of at least one joint with a definite erosion attributable to
•rheumatoid arthritis, as determined by the central reading site. Any joint of the
•hands, wrist, or feet can be considered with the exception of the DIP joints of the
•10. Age =18 years.
•11. Oral corticosteroids (=10 mg/day prednisone or equivalent) and NSAIDs (up to
•the maximum recommended dose) are permitted if the dose has been stable for at
•least 6 weeks prior to baseline.
•12. Females of child-bearing potential and males with female partners of childbearing
•potential may participate in this trial only if using a reliable means of
•contraception (e.g. physical barrier (patient and partner), contraceptive pill or
•patch, spermicide and barrier, or IUD).
•13. Must be willing to receive oral folate.
•14. If female and of childbearing potential, the patient must have a negative urine
•pregnancy test within three weeks prior to baseline.
•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. Major surgery (including joint surgery) within eight weeks prior to screening or
•planned major surgery within six months following randomization.
•2. Rheumatic autoimmune disease other than RA, including SLE, MCTD,
•scleroderma, polymyositis or significant systemic involvement secondary to RA
•(e.g., vasculitis, pulmonary fibrosis or Felty’s syndrome). Sjögren’s Syndrome
•with RA is allowable.
•3. Functional class IV as defined by the ACR Classification of Functional Status in
•Rheumatoid Arthritis.
•4. Prior history of or current inflammatory joint disease other than RA (e.g., gout,
•reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme
•Excluded Previous or Concomitant Therapy
•5. Unsuccessful treatment with an anti-TNF agent (i.e. significant safety issues or
•lack of efficacy. Patients who terminated previous anti-TNF treatment due to cost
•or discomfort with the subcutaneous injections, may participate in this study) (see
•Inclusion #4 for anti-TNF agent washouts).
•6. Treatment with any investigational agent within four weeks (or five half-lives of
•the investigational drug, whichever is longer) of screening.
•7. Previous treatment with any cell depleting therapies, including investigational
•agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-
•8. Treatment with intravenous gamma globulin, plasmapheresis or Prosorba ™
•column within six months of baseline.
•9. Intra-articular or parenteral corticosteroids within six weeks prior to baseline.
•10. Immunization with a live/attenuated vaccine within four weeks prior to baseline.
•11. Previous treatment with MRA. (An exemption to this exclusion may be granted
•for single dose exposure upon application to the sponsor on a case by case basis.)
•12. Any previous treatment with alkylating agents such as cyclophosphamide or
•chlorambucil or with total lymphoid irradiation.
•Exclusions for General Safety
•13. History of severe allergic or anaphylactic reactions to human, humanized or
•murine monoclonal antibodies.
•14. Evidence of serious uncontrolled concomitant cardiovascular, nervous system,
•pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine
•(including uncontrolled diabetes mellitus) or gastrointestinal disease.
•15. Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel
•disease, where flares are commonly treated with oral or parenteral corticosteroids.
•15a History of diverticulitis, diverticulosis requiring antibiotic treatment or chronic
•ulcerative lower GI disease such as Crohn’s disease, ulcerative colitis or other
•symptomatic lower GI conditions that might predispose to perforations.
•16. Current liver disease as determined by principal investigator. (Patients with prior
•history of ALT elevation will not be excluded.)
•17. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial
•or other infections (including but not limited to tuberculosis and atypical
•mycobacterial disease, clinically significant abnormalities on chest X-ray as
•determined by the investigator, Hepatitis B and C, and herpes zoster, but
•excluding fungal infections of nail beds) or any major episode of infection
•requiring hospitalization or treatment with IV antibiotics within four weeks of
•screening or oral antibiotics within two weeks prior to screening.
•18. Primary or secondary immunodeficiency (history of or currently active).
•19. Evidence of active malignant disease, malignancies diagnosed with

研究者

发起方

F Hoffmann La-Roche Ltd.

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