EUCTR2019-000284-24-LT进行中（未招募）1 期
A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
- 入组人数
- 420
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Age and Sex:
- •1. Male or female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at Visit 1 (Screen 1). Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- •Type of Participant and Disease Characteristics:
- •2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •3. Diagnosis of rheumatoid arthritis (RA) based on 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA for at least a 4 month duration.
- •4. Moderately to severely active RA disease based on local standard of care.
- •5. Must have received oral, subcutaneous (SC), or intramuscular (IM) methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to first dose of investigational product on Day 1 of TP1. The stable dose must be 10 to 25 mg per week, with the exception of 6 to 25 mg per week where 6 mg per week is a recommended initial dose by local guidance or standard of care.
- •6. Stable dose of oral folic acid (at least 1 mg/day on =5 days per week) or oral folinic acid (=5 mg once per week) supplementation for at least 21 days prior to the first dose of investigational product on Day 1 of TP1. In countries which do not have approved folic acid 1 mg or folinic acid 5 mg presentations, a regimen of folic acid of =5 mg weekly is acceptable.
- •7. Prior lymphocyte depleting therapies (eg, rituximab, Campath) must have normal lymphocyte counts at the time of screening and no remaining depletion is documented.
- •8. Body mass index (BMI) of 18 to 45 kg/m2 and a total body weight of =40 kg (88 pounds) to =130 kg (287 pounds).
- •Informed Consent:
- •9. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions:
- •1. Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
- •2. History of seizure disorder requiring treatment in the previous 5 years prior to Screening.
- •3. History of significant infection defined by:
- •a. History of recurrent (more than one episode) limited herpes simplex which requires current chronic antiviral therapy, or disseminated (a single episode) herpes simplex.
- •b. History of disseminated or recurrent infection with Epstein Barr virus (EBV), human papilloma virus (HPV), or varicella zoster. A single, limited episode in the past is not exclusionary.
- •c. Any infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of investigational product.
- •d. History of an infected joint prosthesis at any time,with the prosthesis still in situ.
- •4. Known or Screen test positive for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C (HCV) virus (please see Section 8.2.8 for details on testing).
- •a. Positive for HIV.
- •b. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) without positive hepatitis B surface antibody (HBsAb) results.
- •c. Positive hepatitis C antibody (HCV Ab) results and positive confirmatory HCV riboneucleic acid (HCV RNA) results.
- •5. Evidence of current or recent history of uncontrolled, clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, infectious, psychiatric, neurologic, allergic, or cardiovascular disease including evidence or history of moderate or severe heart failure (NYHA Class III/IV) or Screening 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities which may affect participant safety, and participants who are contraindicated for treatment with adalimumab in accordance with the approved local label.
- •6. History of any lymphoproliferative disorder (eg, EBV related lymphoproliferative disorder, lymphoma, or leukemia). Evidence or history of a malignancy within the past 5 years (with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ with no evidence of recurrence).
- •7. History of recurrent inflammatory joint disease other than RA (eg, post infectious arthritis, gout, etc.) or history of any other autoimmune rheumatic diseases (eg, vasculopathies, spondyloarthropathies, etc.) other than Sjogren’s syndrome.
- •8. Significant trauma or surgical procedure within 4 weeks prior to first dose of investigational product.
- •9. History of severe allergic or hypersensitivity or anaphylactic reaction to a biologic drug or to active or inactive components of the investigational product.
- •10. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product (IP) administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- •Prior/Concomitant Therapy:
- •11. Prior/Current treatment with adalimumab.
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