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临床试验/NCT00975130
NCT00975130已完成3 期

An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)

Merck Sharp & Dohme LLC0 个研究点目标入组 3,366 人开始时间: 2009年9月最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
入组人数
3,366
主要终点
Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2 will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC golimumab to retain remission is superior to continuing a SC regimen.

详细描述

Participants who had a good or moderate European League Against Rheumatism (EULAR) response but not achieve remission at the end of Part 1 were invited to participate in Part 2 and were randomized to either intravenous golimumab (IV GLM) + subcutaneous golimumab (SC GLM) or SC GLM alone.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •For Part 1:
  • •Age >=18 years, either sex, any race.
  • •Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria.
  • •Active disease despite DMARD treatment
  • •Subject must be taking at least one of the allowed DMARDs, and must be able to continue with it during the trial.
  • •Eligibility for anti tumor necrosis factor (TNF) use according to the following criteria:
  • •Participant must have failed conventional treatment according to the investigator's opinion OR local guidelines.
  • •Local guidelines regarding safety screening of anti TNF candidates (ie, tuberculosis [TB] screening and other safety screening such as vaccination, if applicable) must be met. Chest X-ray and either a PPD skin test or QuantiFERON®-TB Gold test are also required.
  • •Anamnesis and physical examination must make the participant eligible for anti TNF use and trial participation according to the investigator's judgment.
  • •For Part 2:
  • •Participant must have completed Part 1 of this trial.
  • •Participant must have:
  • •good or moderate response to SC golimumab at the end of Month 6 compared to Baseline, AND.
  • •no DAS28 ESR remission.
  • •Both the investigator and the subject must agree to switch the participant's treatment to IV administration as may be required in Part 2 of this trial.
  • •The investigator must judge that no safety events (eg, serious adverse events [SAEs], serious infections, marked injection-site reactions or intolerance to drug) have occurred that could reoccur or aggravate with increased drug exposure.

排除标准

  • •History of biologic drug use for RA.
  • •Evidence of active TB. or latent TB that is untreated.
  • •Moderate to severe heart failure
  • •Certain inflammatory rheumatic disease other than RA or certain systemic inflammatory condition
  • •Allergy to latex

结局指标

主要结局

Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12

时间窗: Start of Month 11, End of Month 12

The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6.

Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6

时间窗: Month 6

EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease \>1.2 units and a final DAS28-ESR \< 3.2 units, while a moderate response was defined as a decrease \> 1.2 units and final DAS28-ESR \>= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR \<= 5.1 units

次要结局

  • Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Number of Participants Who Achieved DAS28-ESR EULAR Response(Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Number of Participants Who Achieved DAS28-CRP EULAR Response(Month 2, Month 4, Month 6)
  • Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6(Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Number of Participants Who Achieved Minimal or Absence of Functional Impairment(Month 2, Month 4, Month 6)
  • Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8(Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6(Baseline, Month 2, Month 4, Month 6)
  • Mean Area Under the DAS28-ESR Curve From Study Month 6 to Month 12(End of Month 6, End of Month 12)
  • Percentage of Participants Achieving Remission(Start of Month 8, Start of Month 9, Start of Month 10, Start of Month 11, End of Month 12)

研究者

申办方类型
Industry
责任方
Sponsor

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