Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02531633
• Date of registration: 06/07/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
• Scientific 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
• Date of first enrolment: October 16, 2015
• Target sample size: 161
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02531633
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Bulgaria, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Spain, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Giant Cell Arteritis

Intervention(s)

Drug: Placebo to match prednisone

Drug: Prednisone

Drug: Sirukumab

Drug: Placebo to match sirukumab

Primary Outcome(s)

Part A: Number of Participants in Sustained Remission at Week 52 [Time Frame: Week 52]

Secondary Outcome(s)

Part A: Number of Disease Flares Over Time [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin [Time Frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

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 [Time Frame: 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 [Time Frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time [Time Frame: Baseline (Week 0) and Weeks 12, 24, 36, 52]

Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time [Time Frame: Weeks 12, 24 and 52]

Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin [Time Frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

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 [Time Frame: 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 A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time [Time Frame: Baseline (Week 0), Weeks 12, 24, 36, 52]

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 [Time Frame: 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 Never Received 100 mg Open Label Sirukumab in Part B [Time Frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Time Frame: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344]

Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 Free and Total Interleukin-6 (IL-6) Over Time [Time Frame: Baseline (Week 0) and up to 52 weeks]

Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time [Time Frame: 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 Temperature [Time Frame: 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 [Time Frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time [Time Frame: Baseline (Week 0), Weeks 12, 24, 36, 52]

Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time [Time Frame: Baseline (Week 0) and Weeks 12, 24, 36, 52]

Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

Part A: Mean Serum Concentrations of Sirukumab [Time Frame: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52]

Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time [Time Frame: Baseline (Week 0) and Weeks 12, 24, 36 and 52]

Part A: Number of Participants With at Least One Hospitalization for Disease Flare [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

Part A: Cumulative Prednisone Dose Over Time [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

Part A: Time to First Disease Flare After Clinical Remission [Time Frame: Week 52]

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 [Time Frame: 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 Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Time Frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time [Time Frame: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

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 [Time Frame: Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24]

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 [Time Frame: 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 Never Received 100 mg Open Label Sirukumab in Part B [Time Frame: 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 [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Time Frame: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)]

Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Time Frame: Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

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 [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

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 [Time Frame: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B [Time Frame: 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 Never Received 100mg OL Sirukumab in Part B [Time Frame: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24]

Part B: Number of Participants in Sustained Remission Over Time [Time Frame: Weeks 4, 8 and 12]

Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B [Time Frame: Baseline (Day 1)]

Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B [Time Frame: Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12]

Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume [Time Frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B [Time Frame: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36]

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 [Time Frame: 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 Never Received 100 mg Open Label Sirukumab in Part B [Time Frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

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 [Time Frame: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24]

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 [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B [Time Frame: 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 A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets [Time Frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Time Frame: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)]

Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Time Frame: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38]

Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Time Frame: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)]

Part A: Mean Serum Anti-sirukumab Antibodies [Time Frame: Baseline (Week 0) and up to 52 weeks]

Part A: Number of Hospitalizations for Disease Flare Over Time [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

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 [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 [Time Frame: Week 24]

Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs [Time Frame: Up to 52 weeks]

Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare [Time Frame: 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 Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

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 [Time Frame: 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 [Time Frame: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)]

Part B: Number of Disease Flares Over Time [Time Frame: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

Part A:Change From Baseline in Hematology Parameter- Erythrocytes [Time Frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

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 [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B [Time Frame: Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12]

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 [Time Frame: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

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 [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B [Time Frame: Up to 120 weeks]

Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Time Frame: 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 Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Time Frame: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)]

Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Time Frame: Day 87, 339, 344, Week 12, 24]

Part B: Number of Hospitalizations for Disease Flare Over Time [Time Frame: Up to Week 104]

Part A: Change From Baseline in Pulse Rate [Time Frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B [Time Frame: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36]

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 [Time Frame: 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 VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Time Frame: Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24]

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 [Time Frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

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 [Time Frame: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24]

Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B [Time Frame: 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: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Time Frame: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)]

Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Time Frame: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38]

Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Time Frame: Baseline (Day 1), Days 103 and 271]

Part B: Time to First Disease Flare for Participants in Sustained Remission [Time Frame: Week 52]

Secondary ID(s)

201677

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02531633