Clinical trial NCT02531633: Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Giant Cell Arteritis
Keywords: Giant Cell Arteritis, Sirukumab, Prednisone
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-08-24
Enrollment: 161
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Part A: Number of Participants in Sustained Remission at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24
timeFrame: Week 24
measure: Part A: Cumulative Prednisone Dose Over Time
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Part B: Number of Participants in Sustained Remission Over Time
timeFrame: Weeks 4, 8 and 12
measure: Part A: Time to First Disease Flare After Clinical Remission
timeFrame: Week 52
measure: Part B: Time to First Disease Flare for Participants in Sustained Remission
timeFrame: Week 52
measure: Part A: Number of Disease Flares Over Time
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Part A: Number of Participants With at Least One Hospitalization for Disease Flare
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Part A: Number of Hospitalizations for Disease Flare Over Time
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
timeFrame: Baseline (Week 0), Weeks 12, 24, 36, 52
measure: Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
timeFrame: Baseline (Week 0) and Weeks 12, 24, 36, 52
measure: Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
timeFrame: Baseline (Week 0) and Weeks 12, 24, 36, 52
measure: Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
timeFrame: Baseline (Week 0), Weeks 12, 24, 36, 52
measure: Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
timeFrame: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
timeFrame: Baseline (Week 0) and Weeks 12, 24, 36 and 52
measure: Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
timeFrame: Weeks 12, 24 and 52
measure: Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs
timeFrame: Up to 52 weeks
measure: Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
timeFrame: Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Change From Baseline in Pulse Rate
timeFrame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Change From Baseline in Temperature
timeFrame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
timeFrame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
timeFrame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Change From Baseline in Hematology Parameter-Hematocrit
timeFrame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
timeFrame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
timeFrame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A:Change From Baseline in Hematology Parameter- Erythrocytes
timeFrame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
timeFrame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Part A: Mean Serum Concentrations of Sirukumab
timeFrame: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52
measure: Part A: Mean Serum Anti-sirukumab Antibodies
timeFrame: Baseline (Week 0) and up to 52 weeks
measure: Part A: Change From Baseline in Free and Total Interleukin-6 (IL-6) Over Time
timeFrame: Baseline (Week 0) and up to 52 weeks
measure: 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
timeFrame: Up to 120 weeks
measure: Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B
timeFrame: Up to 120 weeks
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
measure: Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
measure: Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
measure: Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
timeFrame: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
measure: Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: 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
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: 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
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: 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
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: 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
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: 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
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: 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
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
measure: 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
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: 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
timeFrame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
measure: Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
timeFrame: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
measure: Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
timeFrame: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
measure: Part B: Number of Disease Flares Over Time
timeFrame: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare
timeFrame: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: Part B: Number of Hospitalizations for Disease Flare Over Time
timeFrame: Up to Week 104
measure: 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
timeFrame: Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24
measure: 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
timeFrame: 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
measure: 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
timeFrame: Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24
measure: Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
timeFrame: Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12
measure: 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
timeFrame: Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24
measure: Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
timeFrame: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
measure: 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
timeFrame: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
measure: 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
timeFrame: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
measure: Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
timeFrame: Day 87, 339, 344, Week 12, 24
measure: Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
timeFrame: Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12
measure: Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
timeFrame: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344
measure: Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
timeFrame: 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
measure: Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
timeFrame: 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
measure: Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
timeFrame: Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373
measure: Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
timeFrame: Baseline (Day 1), Days 103 and 271
measure: Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
timeFrame: Baseline (Day 1)
measure: 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
timeFrame: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
timeFrame: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
measure: 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
timeFrame: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
measure: Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
timeFrame: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
measure: 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
timeFrame: Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24
measure: Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
timeFrame: Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12
Other outcomes:
Locations:
city: Aurora
country: United States
facility: GSK Investigational Site
state: Colorado
city: Boca Raton
country: United States
facility: GSK Investigational Site
state: Florida
city: Naples
country: United States
facility: GSK Investigational Site
state: Florida
city: Iowa City
country: United States
facility: GSK Investigational Site
state: Iowa
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Jackson
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Vancouver
country: United States
facility: GSK Investigational Site
state: Washington
city: Camperdown
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Kogarah
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Woodville
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Heidelberg
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Malvern East
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Victoria Park
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Bobigny
country: France
facility: GSK Investigational Site
city: Orleans
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Tuebingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Jena
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Bad Abbach
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Kirchheim unter Teck
country: Germany
facility: GSK Investigational Site
city: München
country: Germany
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Reggio Emilia
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Rozzano
country: Italy
facility: GSK Investigational Site
city: Almelo
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
city: Hamilton
country: New Zealand
facility: GSK Investigational Site
city: Timaru
country: New Zealand
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Bilbao
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: La Laguna
country: Spain
facility: GSK Investigational Site
city: Westcliff-on-Sea
country: United Kingdom
facility: GSK Investigational Site
state: Essex
city: Wirral
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Bury St. Edmunds
country: United Kingdom
facility: GSK Investigational Site
state: Suffolk
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
state: Yorkshire
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
city: Leeds
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
city: Reading
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schmidt WA, Dasgupta B, Luqmani R, Unizony SH, Blockmans D, Lai Z, Kurrasch RH, Lazic I, Brown K, Rao R. A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis. Rheumatol Ther. 2020 Dec;7(4):793-810. doi: 10.1007/s40744-020-00227-2. Epub 2020 Aug 25.