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临床试验/NCT02531633
NCT02531633终止3 期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2015年10月16日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
161
试验地点
1
主要终点
Part A: Number of Participants in Sustained Remission at Week 52
研究概览研究设计入排标准研究组 & 干预措施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

Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active GCA. The study will be conducted in 2 distinct parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the option to receive open-label sirukumab based on disease status and a 16-week follow-up phase if applicable.

Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable only for those who are withdrawn prematurely from the study or whose open-label sirukumab treatment in Part B completes after Week 88.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • •Diagnosis of GCA defined by the following Revised GCA Diagnosis Criteria:
  • •Age >=50 years. History of ESR >=50 millimeter/hour (mm/hour) or CRP >=2.45 milligram/deciliter(mg/dL).
  • •Presence of at least one of the following: Unequivocal cranial symptoms of GCA; Unequivocal symptoms of polymyalgia rheumatic (PMR).
  • •Presence of at least one of the following: Temporal artery biopsy revealing features of GCA; Evidence of large-vessel vasculitis by angiography or cross-sectional imaging.
  • •Active GCA within 6 weeks of Randomization (Baseline) where active disease is defined by an ESR >=30 mm/hr or CRP >=1 mg/dL AND the presence of at least one of the following:
  • •Unequivocal cranial symptoms of GCA; Unequivocal symptoms of PMR; Other features judged by the clinician investigator to be consistent with GCA or PMR flares.
  • •At screening, receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.
  • •Clinically stable GCA disease at baseline such that the subject is able to safely participate in the blinded prednisone taper regimen in the opinion of the investigator.
  • •Practicing acceptable methods of birth control if a female of child-bearing potential.
  • •No evidence of active or latent infection with Mycobacterium tuberculosis (TB).

排除标准

  • •Are pregnant or breastfeeding.
  • •Recent (within the past 12 weeks) or planned major surgery that would impact on study procedures or assessments.
  • •Organ transplantation recipients (except corneas within 3 months prior to baseline visit).
  • •Had prior treatment with any of the following:
  • •Systemic immunosuppressives) within 4 weeks of baseline; Biologic agents targeted at reducing tumor necrosis factor-alpha (TNF-alpha) within 2-8 weeks of baseline, depending on the agent; Any prior use of tocilizumab or other anti-IL-6 agents; B-cell depleting agents (eg, rituximab) within 12 months prior to baseline or longer if B cell counts have not returned to normal range or baseline levels; Cytotoxic drugs such as cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents within 4 weeks of baseline; Abatacept within 8 weeks of baseline; Tofacitinib within 4 weeks of baseline; Methotrexate use within 2 weeks of baseline.
  • •Methylprednisolone > 100 mg/day intravenous (IV) (or equivalent) within 8 weeks of baseline.
  • •History of severe allergic reactions to monoclonal antibodies, human proteins, or excipients.
  • •Evidence of serious concomitant disease, which in the opinion of the investigator makes them unsuitable for participation in the study.
  • •Major ischemic event, unrelated to GCA, within 12 weeks of screening.
  • •Marked baseline prolongation of corrected QT (QTc) interval >= 450 milliseconds (msec) (QTc by Bazett's formula [QTcB ]or QTc by Fridericia's formula [QTcF] ), history of Torsade de Pointes, family history of long QT syndrome, history of second or third degree heart block.
  • •Current liver disease that could interfere with the trial
  • •History of or current active diverticulitis, inflammatory bowel disease, or other symptomatic gastrointestinal tract condition that might predispose to bowel perforation.
  • •History of known demyelinating diseases such as multiple sclerosis or optic neuritis.
  • •Active infections, or history of recurrent infections or have required management of acute or chronic infections, as follows:
  • •Currently on any suppressive therapy for a chronic infection, history or suspicion of chronic infection, hospitalization for treatment of infection within 60 days of the baseline visit, or use of parenteral (IV) or intra-muscular [IM]) antimicrobials within 60 days of baseline or oral antimicrobials within 30 days of baseline
  • •Primary or secondary immunodeficiency or any other autoimmune disease.
  • •Human immunodeficiency virus (HIV) infection, hepatitis C or hepatitis B infection
  • •Live virus or bacterial vaccination within 3 months before the first administration of study drug

研究组 & 干预措施

Part A: Sirukumab, Dose 1+prednisone (6-month taper)

Experimental

Subjects will receive blinded sirukumab 100 mg subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.

干预措施: Sirukumab (Drug)

Part A:Placebo to match sirutkumab+prednisone (6-month taper)

Placebo Comparator

Subjects will receive blinded placebo to match sirutkumab q2w for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.

干预措施: Placebo to match prednisone (Drug)

Part A: Sirukumab, Dose 1+prednisone (6-month taper)

Experimental

Subjects will receive blinded sirukumab 100 mg subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.

干预措施: Prednisone (Drug)

Part A: Sirukumab, Dose 1+prednisone (6-month taper)

Experimental

Subjects will receive blinded sirukumab 100 mg subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.

干预措施: Placebo to match prednisone (Drug)

Part A: Sirukumab, Dose 1+prednisone (3-month taper)

Experimental

Subjects will receive blinded sirukumab 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month oral prednisone taper regimen.

干预措施: Sirukumab (Drug)

Part A: Sirukumab, Dose 1+prednisone (3-month taper)

Experimental

Subjects will receive blinded sirukumab 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month oral prednisone taper regimen.

干预措施: Prednisone (Drug)

Part A:Placebo to match sirukumab+prednisone (12-month taper)

Placebo Comparator

Subjects will receive blinded placebo to match sirutkumab q2w for 52 weeks plus a pre-specified maximum of 12-month oral prednisone taper regimen.

干预措施: Placebo to match sirukumab (Drug)

Part A: Sirukumab, Dose 1+prednisone (3-month taper)

Experimental

Subjects will receive blinded sirukumab 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month oral prednisone taper regimen.

干预措施: Placebo to match prednisone (Drug)

Part A: Sirukumab, Dose 2+prednisone (6-month taper)

Experimental

Subjects will receive blinded sirukumab 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.

干预措施: Sirukumab (Drug)

Part A: Sirukumab, Dose 2+prednisone (6-month taper)

Experimental

Subjects will receive blinded sirukumab 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.

干预措施: Prednisone (Drug)

Part A: Sirukumab, Dose 2+prednisone (6-month taper)

Experimental

Subjects will receive blinded sirukumab 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.

干预措施: Placebo to match prednisone (Drug)

Part A:Placebo to match sirutkumab+prednisone (6-month taper)

Placebo Comparator

Subjects will receive blinded placebo to match sirutkumab q2w for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.

干预措施: Placebo to match sirukumab (Drug)

Part A:Placebo to match sirutkumab+prednisone (6-month taper)

Placebo Comparator

Subjects will receive blinded placebo to match sirutkumab q2w for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.

干预措施: Prednisone (Drug)

Part A:Placebo to match sirukumab+prednisone (12-month taper)

Placebo Comparator

Subjects will receive blinded placebo to match sirutkumab q2w for 52 weeks plus a pre-specified maximum of 12-month oral prednisone taper regimen.

干预措施: Prednisone (Drug)

Part A:Placebo to match sirukumab+prednisone (12-month taper)

Placebo Comparator

Subjects will receive blinded placebo to match sirutkumab q2w for 52 weeks plus a pre-specified maximum of 12-month oral prednisone taper regimen.

干预措施: Placebo to match prednisone (Drug)

Part B:Open-label sirukumab 100 mg SC (if applicable)

Experimental

Subjects completing Part A will receive open label 100 mg SC q2w for a maximum of 52 weeks based on remission status and disease activity at the primary 52-week endpoint or prednisone tapering status of subject during Part A. Methotrexate will be provided to subjects, alone or in addition to sirukumab treatment during Part B, based on the discretion of the investigator.

干预措施: Sirukumab (Drug)

结局指标

主要结局

Part A: Number of Participants in Sustained Remission at Week 52

时间窗: Week 52

Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) \[\<30 millimeters per hour\] and C-reactive Protein (CRP) \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis.

次要结局

  • Part A: Cumulative Prednisone Dose Over Time(Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24(Week 24)
  • Part A: Time to First Disease Flare After Clinical Remission(Week 52)
  • Part B: Time to First Disease Flare for Participants in Sustained Remission(Week 52)
  • Part A: Number of Disease Flares Over Time(Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Part B: Number of Participants in Sustained Remission Over Time(Weeks 4, 8 and 12)
  • Part A: Number of Participants With at Least One Hospitalization for Disease Flare(Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Part A: Number of Hospitalizations for Disease Flare Over Time(Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time(Baseline (Week 0), Weeks 12, 24, 36, 52)
  • Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time(Baseline (Week 0) and Weeks 12, 24, 36, 52)
  • Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time(Baseline (Week 0) and Weeks 12, 24, 36, 52)
  • Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time(Baseline (Week 0), Weeks 12, 24, 36, 52)
  • Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time(Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time(Baseline (Week 0) and Weeks 12, 24, 36 and 52)
  • Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time(Weeks 12, 24 and 52)
  • Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
  • Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs(Up to 52 weeks)
  • Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Change From Baseline in Pulse Rate(Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Change From Baseline in Temperature(Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets(Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin(Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Change From Baseline in Hematology Parameter-Hematocrit(Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume(Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A:Change From Baseline in Hematology Parameter- Erythrocytes(Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea(Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Part A: Mean Serum Concentrations of Sirukumab(Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52)
  • Part A: Mean Serum Anti-sirukumab Antibodies(Baseline (Week 0) and up to 52 weeks)
  • Part A: Change From Baseline in Free and Total Interleukin-6 (IL-6) Over Time(Baseline (Week 0) and up to 52 weeks)
  • Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Up to 120 weeks)
  • Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B(Up to 120 weeks)
  • Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120))
  • Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120))
  • Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120))
  • Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120))
  • Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120))
  • Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120))
  • Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24 and 36)
  • Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24 and 36)
  • Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24 and 36)
  • Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24 and 36)
  • Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24 and 36)
  • Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24 and 36)
  • Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24 and 36)
  • Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24 and 36)
  • Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24 and 36)
  • Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Baseline (Week 0) and Weeks 4,8,12,16,24 and 36)
  • Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B(Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38)
  • Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B(Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38)
  • Part B: Number of Disease Flares Over Time(Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare(Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Number of Hospitalizations for Disease Flare Over Time(Up to Week 104)
  • Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24)
  • Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B(Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12)
  • Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24)
  • Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B(Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12)
  • Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24)
  • Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B(Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24)
  • Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24)
  • Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B(Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24)
  • Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Day 87, 339, 344, Week 12, 24)
  • Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B(Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12)
  • Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344)
  • Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B(Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373)
  • Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40)
  • Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B(Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373)
  • Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Baseline (Day 1), Days 103 and 271)
  • Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B(Baseline (Day 1))
  • Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B(Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36)
  • Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40)
  • Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B(Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36)
  • Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B(Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24)
  • Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B(Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12)

研究者

申办方类型
Industry
责任方
Sponsor

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