跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT02744755
NCT02744755已完成3 期

A Randomized, Double-blind, Parallel-group, Multicenter Study to Demonstrate Similar Efficacy and to Compare Safety and Immunogenicity of GP2017 and Humira® in Patients With Moderate to Severe Active Rheumatoid Arthritis

Sandoz166 个研究点 分布在 6 个国家目标入组 353 人开始时间: 2016年3月31日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
3 期
状态
已完成
发起方
Sandoz
入组人数
353
试验地点
166
主要终点
Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

详细描述

The purpose of this study is to demonstrate similar efficacy and safety of GP2017 and US-licensed Humira® in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to Disease modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • •Patients must have been diagnosed with RA ≥ 6 months prior to screening
  • •Patients must have active disease, defined as DAS28-CRP ≥ 3.2 at the time of screening
  • •Patients must have CRP levels above 5mg/l or ESR levels above the upper limits of normal
  • •Patients must have had inadequate clinical response to MTX 10 - 25 mg/week

排除标准

  • •Previous treatment with adalimumab, other anti-TNFα therapies or cell depleting agents, e.g. anti-CD20 therapy
  • •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during treatment
  • •Nursing (lactating) or pregnant women
  • •History of or ongoing inflammatory or autoimmune diseases other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
  • •Systemic corticosteroids > 7.5mg/day within 4 weeks prior to baseline
  • •History or presence of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or removed non-invasive colon polyps, with no evidence of recurrence
  • •History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke (within 3 months)
  • •Subject known to have immune deficiency, history of positive human immunodeficiency virus (HIV) status or immunocompromised for other reasons
  • •History of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis, cirrhosis, hepatitis)
  • •History of persistent chronic infection; recurrent infection or active infections
  • •History of tuberculosis, presence of active tuberculosis, latent tuberculosis as detected by imaging (e.g. chest X-ray, chest Computerized Tomography(CT) scan, Magnetic Resonance Imaging (MRI)) and/ or positive QuantiFERON-TB Gold test (QFT)
  • •History or evidence of opportunistic infections, e.g. histoplasmosis, listeriosis, legionellosis
  • •Positive serology Hepatitis B (either HBsAg or anti-HBc) or Hepatitis C (positive HCV-Ab or HCV-RNA) indicative of previous or current infections

结局指标

主要结局

Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira

时间窗: Study period 1: week 12

Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity (GDA) or general health (GH), values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value \>5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value \< 2.6 corresponds to remission DAS28-CRP = 0.56 \* sqrt(tender28) + 0.28\* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* GDA or GH + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm

次要结局

  • Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission(week 4, week 12 and week 24)
  • Study Period 1: Time-weighted Averaged Change From Baseline in DAS28-CRP Until Week 24 in Patients Treated With GP2017 and With Humira(Study period 1: week 24)
  • Study Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria(week 4, week 12, week 24)
  • Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response(week 4, week 12 and week 24)
  • Study Period 1- Proportion of Patients Achieving HAQ-DI© Score Improvement >0.3 at Weeks 4, 12 and 24(Weeks 4, 12 and 24;)
  • Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira(Treatment Period 1, 24 weeks)
  • Study Period 2 :Proportion of Patients Treated Continuously With GP2017 and Patients Treated With GP2017 After Switch From Humira Achieving HAQ-DI© Score in Normal Range ≤0.5 at Week 48(week 48)
  • Study Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Changes From Week 24 at Week 48 in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira(week 48)
  • Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response(week 4, week 12 and week 24)
  • Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24(Week 4, week 12 and week 24)
  • Study Period 1 - Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI©) at Weeks 4, 12 and 24;(Weeks 4, 12 and 24;)
  • Study Period 1: Change in DAS28-CRP and DAS28-ESR Scores From Baseline to Week 24 in Patients Treated With GP2017 and Patients Treated With Humira(study period 1: week 2, 4, 24)
  • Study Period 1- Proportion of Patients Achieving HAQ-DI© in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;(Weeks 4, 12 and 24;)
  • Study Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24 (Change From Baseline)(Weeks 4, 12 and 24;)
  • Study Period 1 -ESR (Erythrocyte Sedimentation Rate) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24(Week 4, week 12, week 24)
  • Study Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Week 48, in Patients Treated With GP2017 Who Continued GP2017 or Switched to GP2017 From Humira(week 48)
  • Study Period 2 - Health Assessment Questionnaire-Disability Index (HAQ-DI©) Changes From Week 24 at Week 48 in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira(Weeks 48)
  • Study Period 1 - CRP (C-reactive Protein) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24(Week 4, week 12, week 24)
  • Study Period 1 - Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Formation Against Adalimumab in Patients Treated With GP2017 or Humira (Positive Patients)(baseline, week 2, week 4, week 12, week 24)
  • Study Period 2 - Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Formation Against Adalimumab in Patients Treated With GP2017 Who Continued GP2017 or Switched to GP2017 From Humira (Positive Patients)(week 24, week 36, week 48)
  • Study Period 2: Changes From Week 24 at Week 48 in DAS28-CRP and DAS28-ESR Scores in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira(week 48)
  • Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira(up to 48 weeks)

研究者

发起方
Sandoz
申办方类型
Industry
责任方
Sponsor

研究点 (166)

Loading locations...

相似试验

已完成
3 期
To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque PsoriasisModerate to Severe Chronic Plaque Psoriasis
NCT05495568Celltrion367
终止
1 期
Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis PatientsRheumatoid Arthritis
NCT01559103Novo Nordisk A/S39
已完成
3 期
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid ArthritisRheumatoid Arthritis
NCT03789292Celltrion648
已完成
3 期
A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid ArthritisRheumatoid Arthritis
NCT00299130Genentech, Inc.511
终止
4 期
A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)Rheumatoid Arthritis
NCT01117129Hoffmann-La Roche2