protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02531633 | 5.1 | Inclusion Criteria | A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- 1. Diagnosis of GCA defined by the following Revised GCA Diagnosis Criteria:
- Age ≥50 years.
- History of ESR ≥ 50 mm/hour or CRP ≥ 2.45 mg/dL.
- Presence of at least one of the following:
- Unequivocal cranial sym... | [
"Males:",
"Females:"
] |
NCT02531633 | 5.2 | Exclusion Criteria | A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- 1. Are pregnant or breastfeeding.
- 2. Recent (within the past 12 weeks) or planned major surgery that would impact on study procedures or assessments.
- 3. Organ transplantation recipients (except corneas within 3 mon... | [] |
NCT02531633 | 5.3 | Screening/Baseline/Run-in Failures | Screen failures are defined as subjects who consent to participate in the clinical trial but are never subsequently randomized. In order to ensure transparent reporting of screen failure subjects, to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing requirements, and respond to queries from Regul... | [
"Re-testing",
"Re-screening"
] |
NCT02531633 | 5.4 | Withdrawal/Stopping Criteria | [] | |
NCT02531633 | 5.4.1 | Study Withdrawal | A subject may withdraw from the study at any time at his/her own request, or may be withdrawn at any time at the discretion of the investigator for safety, behavioral or administrative reasons. If a subject withdraws from the study, he/she may request destruction of any samples taken, and the investigator must document... | [] |
NCT02531633 | 5.4.2 | Discontinuation of Study Drug | Permanent discontinuation of study drug will not require the subject to be withdrawn from the study. Subjects should continue where possible to be followed and disease status assessed. Upon permanent discontinuation of subcutaneously-administered blinded sirukumab or matching placebo, corticosteroid dose and treatment ... | [] |
NCT02531633 | 5.4.3 | Liver Chemistry Stopping Criteria | Liver chemistry stopping and increased monitoring criteria have been designed to assure subject safety and evaluate liver event etiology (in alignment with the FDA premarketing clinical liver safety guidance).
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid ances/UCM174090.pdf
Subjects... | [
"Phase III-IV Liver Chemistry Increased Monitoring Algorithm with Continued Therapy for ALT 3xULN but <8xULN"
] |
NCT02531633 | 5.4.3.1 | Study Treatment Restart or Rechallenge | Study treatment restart or rechallenge after liver chemistry stopping criteria are met by any subject participating in this study is not allowed. | [] |
NCT02531633 | 5.4.4 | QTc Stopping Criteria | An ECG is required only at screening. If an additional ECG is performed during study participation outside of study requirements and any of the bulleted criteria below are met, study treatment should be discontinued and the Medical Monitor should be contacted. There is no requirement for the subject to be withdrawn fro... | [] |
NCT02531633 | 5.5 | Subject and Study Completion | A completed subject is one who has completed both Part A and Part B (and the maximum of a 16-week follow-up upon completion of Part B, if applicable) of the study. As discussed in Section [4.1](#page-24-0), the up to 16-week follow-up visit is only for subjects who are withdrawn prematurely from the study or for those ... | [] |
NCT02531633 | 6 | STUDY TREATMENT | [] | |
NCT02531633 | 6.1 | Investigational Product and Other Study Treatment | The term 'study treatment' is used throughout the protocol to describe any combination of products received by the subject as per the protocol design. Study treatment may therefore refer to the individual study treatments or the combination of those study treatments. Study treatment specifically related to sirukumab an... | [] |
NCT02531633 | 6.2 | Treatment Assignment | Central randomization will be implemented in this study. Subjects will be assigned to 1 of 5 treatment arms in accordance with the computer-generated randomization schedule generated prior to the start of the study, using validated software. Randomization will be performed by an Interactive Response Technology System (... | [] |
NCT02531633 | 6.3 | Planned Dose Adjustments | No dose adjustment of sirukumab will be allowed in this study.
All subjects must be receiving prednisone (a minimum dose of 20 mg/day) at the start of Screening. Prednisone treatment must be initiated at Screening for subjects not currently receiving steroid treatment. A pre-specified prednisone tapering schedule outl... | [] |
NCT02531633 | 6.4 | Blinding | Blinding will be maintained during the 52-week double blind treatment phase of this study by the provision of sirukumab and matching placebo for sirukumab in pre-filled syringes in a matching presentation. Blinding to the prednisone dose during the taper will be maintained by providing prednisone dosages below 20 mg in... | [] |
NCT02531633 | 6.5 | Packaging and Labeling | The contents of the label will be in accordance with all applicable regulatory requirements. | [] |
NCT02531633 | 6.6 | Preparation/Handling/Storage/Accountability | Sirukumab and matching placebo should be stored at 2-8C and protected from light. Do not remove from the outer carton until ready to use. The storage temperature should be monitored and any excursions noted.
Prior to use the SmartJect autoinjector should be removed from the outer carton and allowed to sit at ambient t... | [] |
NCT02531633 | 6.7 | Compliance with Study Treatment Administration | Subjects will be provided with a worksheet to record the dates when they self-administer study treatments at home. Compliance with sirukumab or matched placebo and prednisone and matched placebo will be assessed through querying the subject's worksheet during the site visits and will be documented in the source documen... | [] |
NCT02531633 | 6.8 | Treatment of Study Treatment Overdose | Subjects in clinical studies with sirukumab have received up to 10 mg/kg sirukumab IV q2w and no dose-limiting toxicity has been observed. No clinical information is available for sirukumab doses greater than 10 mg/kg.
For this study, any dose of sirukumab >100 mg within a 7 day period will be considered an overdose.
... | [] |
NCT02531633 | 6.9 | Treatment after the End of the Study | Subjects will not receive any additional treatment from GSK after completion of the study. Upon study completion, decisions on treatment options for individual subjects will be at the discretion of the investigator.
The investigator is responsible for ensuring that consideration has been given to the poststudy care of... | [] |
NCT02531633 | 6.10 | Concomitant Medications and Non-Drug Therapies | All concomitant medications taken during the study will be recorded in the concomitant medications CRF. | [] |
NCT02531633 | 6.10.1 | Permitted Medications and Non-Drug Therapies | The following drugs are permitted during the study:
- The use of statins for the treatment of hyperlipidemia is permitted in this study. However, some statins such as simvastatin, atorvastatin, cerivastatin, and lovastatin are metabolized by cytochrome P450 enzymes and caution should be exercised when sirukumab is co-... | [] |
NCT02531633 | 6.10.2 | Prohibited Medications and Non-Drug Therapies | The following drugs and vaccines are prohibited within the specified time frames and with concomitant SC administration of study drug:
- Systemic immunosuppressives such as azathioprine, oral cyclosporine A, tacrolimus, mycophenolate mofetil, leflunomide, oral or parenteral gold, and IL-1ra (anakinra) within 4 weeks o... | [] |
NCT02531633 | 7 | STUDY ASSESSMENTS AND PROCEDURES | Protocol waivers or exemptions are not allowed with the exception of immediate safety concerns. Therefore, adherence to the study design requirements, including those specified in the Time and Events Tables, are essential and required for study conduct.
This section lists the procedures and parameters of each planned ... | [] |
NCT02531633 | 7.1 | Time and Events Tables | Table 2 Time and Events Table for Part A of the Study (52-week Double-blind Treatment Phase)
| | Wk -6+ 3d)Screening (~ | Wk 0)Baseline ( | 3dwk 2 | 3dwk 4 | 3dwk 8 | 3dwk 12 | 3dwk 16 | 3dwk 20 | 3dwk 24 | 3dwk 28 | 3dwk 32 | 3dwk 36 | 3dwk 40 | 3dwk 44 | 3dwk 48 | 3dwk... | [] |
NCT02531633 | 7.2 | Screening and Critical Baseline Assessments | Cardiovascular medical history/risk factors (as detailed in the CRF) will be assessed at Screening.
The following demographic parameters will be captured: year of birth, sex, race and ethnicity.
Medical/medication/family history will be assessed as related to the inclusion/exclusion criteria listed in Section [5](#pa... | [] |
NCT02531633 | 7.3 | Efficacy | Efficacy of sirukumab in GCA will be assessed from the presence of GCA activity including investigator assessment of signs and symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, reduced or absent pulsation in temporal artery, cord-like thickening of temporal artery, stroke, scalp necros... | [] |
NCT02531633 | 7.3.1 | Patient's and Physician's Global Assessment of Disease Activity | The Patient's and Physician's Global Assessments of Disease Activity will be recorded on a VAS. The scale for the subject's assessment ranges from "very well" to "very poor". The scale for the physician's assessment ranges from "no GCA activity" to "extremely active GCA". The evaluating physician and subject must compl... | [] |
NCT02531633 | 7.4 | Health Outcomes | In addition to the Patient's and Physician's Global Assessment of Disease Activity, other health outcome measures used in this study are PGIC, pain assessment using an 11-point numeric rating scale, HAQ-DI, FACIT-fatigue, Steroid Impact questionnaire, SF-36 v2 Acute health survey questionnaire, and EQ5D (5L). These que... | [] |
NCT02531633 | 7.4.1 | Patient Global Impression of Change (PGIC) | Patient-reported response to treatment will be assessed using the Patient Global Impression of Change (PGIC) measure, a single item completed by subjects to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at dif... | [] |
NCT02531633 | 7.4.2 | Pain Assessment | Subjects will be asked to rate the severity of their average pain now on an 11-point numeric rating scale with anchors ranging from 0, "no pain" to 10, "the worst pain imaginable". | [] |
NCT02531633 | 7.4.3 | Health Assessment Questionnaire – Disability Index (HAQ-DI) | The functional status of the subgroup of subjects with PMR will be assessed using the HAQ-DI [[Fries,](#page-100-0) 1980]. This 20-question instrument assesses the degree of difficulty encountered in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activiti... | [] |
NCT02531633 | 7.4.4 | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue [\[Cella](#page-99-0), 2002; [Yellen](#page-103-0), 1997]. The total FACIT-Fatigue score ranges from 0 to 52, with a higher score indicating less fatigue. | [] |
NCT02531633 | 7.4.5 | Steroid Impact Questionnaire | The benefits, side effects and impact of steroids on GCA symptoms and subjects will be assessed using a GCA disease specific patient reported questionnaire, the Steroid Impact Questionnaire. The Steroid Impact Questionnaire contains 50 items assessing steroid dose/duration (4 items), general impact (baseline burden; 19... | [] |
NCT02531633 | 7.4.6 | 36-item Short Form Version 2 Acute (SF-36v2 Acute) | The Medical Outcome Study health measure entitled the 36-item Short-Form Version 2 acute (SF-36v2 acute) health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of 8 multi-item scales.
- Limitations in physical functioning due to health problems.
- Limitations in usual ro... | [] |
NCT02531633 | 7.4.7 | EuroQoL-5D (EQ-5D) (5L) | The EQ-5D is a standardized measure of health status developed by the EuroQoL Group to provide a simple, generic measure of health for clinical and economic appraisal ([EuroQol Group](#page-99-0), 1990). The EQ-5D is applicable to a wide range of health conditions
and treatments. EQ-5D essentially consists of 2 elemen... | [] |
NCT02531633 | 7.5 | Safety | Safety will be assessed from the documentation of adverse events and review of vital signs and laboratory assessments including complete blood counts, serum chemistry profiles, fasting serum lipids, HbA1c, hepatitis B and C serologies, and markers of bone turnover. The Columbia-Suicide Severity Rating Scale (C-SSRS) wi... | [] |
NCT02531633 | 7.5.1 | Adverse Events (AE) and Serious Adverse Events (SAEs) | The definitions of an AE or SAE can be found in [Appendix](#page-113-0) 4.
The investigator and their designees are responsible for detecting, documenting and reporting events that meet the definition of an AE or SAE. | [] |
NCT02531633 | 7.5.1.1 | Time period and Frequency for collecting AE and SAE information | - AEs and SAEs will be collected from the start of Study Treatment until the follow-up contact (see Section [7.5.1.3](#page-74-0)), at the time points specified in the Time and Events Tables (Section [7.1](#page-58-0)).
- Medical occurrences that begin prior to the start of study treatment but after obtaining informed ... | [] |
NCT02531633 | 7.5.1.2 | Method of Detecting AEs and SAEs | Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and non-leading verbal questioning of the subject is the preferred method to inquire about AE occurrence. Appropriate questions include:
- "How are you feeling?"
- "Have you had any (other) medical problems since your last visit/contac... | [] |
NCT02531633 | 7.5.1.3 | Follow-up of AEs and SAEs | After the initial AE/SAE report, the investigator is required to proactively follow each subject at subsequent visits/contacts. All SAEs, and non-serious AEs of special interest (as defined in Section [4.6.1](#page-31-0)) will be followed until resolution, until the condition stabilizes, until the event is otherwise ex... | [] |
NCT02531633 | 7.5.1.4 | Cardiovascular and Death Events | For any cardiovascular events detailed in [Appendix](#page-113-0) 4and all deaths, whether or not they are considered SAEs, specific Cardiovascular (CV) and Death sections of the CRF will be required to be completed. These sections include questions regarding CV (including sudden cardiac death) and non-CV death.
The C... | [] |
NCT02531633 | 7.5.1.5 | Other Adverse Events of Special Interest for Sirukumab |
IL-6 is a pleiotropic cytokine necessary for hematopoiesis and IL-6 inhibition has been shown to cause a reduction in both neutrophils and platelets. In addition, IL-6 inhibition has been associated with reversible elevation in liver enzymes. Mechanisms by which
this might occur include inhibition of the hepatoprote... | [
"Laboratory parameter abnormalities",
"Other Events of Interest"
] |
NCT02531633 | 7.5.1.6 | Events That Occur With Biologics |
An injection site reaction is any unfavorable or unintended sign that occurs at the study drug injection site. All subjects must be carefully observed for symptoms of an injection site reaction. Prior to and including through Week 4, subjects will be observed for at least 30 minutes after the SC injection of study dr... | [
"Injection Site Reactions",
"Allergic/Hypersensitivity Reactions"
] |
NCT02531633 | 7.5.1.7 | Regulatory Reporting Requirements for SAEs | Prompt notification by the investigator to GSK of SAEs and non-serious AEs related to study treatment (even for non- interventional post-marketing studies) is essential so that legal obligations and ethical responsibilities towards the safety of subjects and the safety of a product under clinical investigation are met.... | [] |
NCT02531633 | 7.5.2 | Pregnancy | - Details of all pregnancies in female subjects and female partners of male subjects will be collected after the start of dosing and until the Follow-up visit.
- If a pregnancy is reported then the investigator should inform GSK within 2 weeks of learning of the pregnancy and should follow the procedures outlined in [A... | [] |
NCT02531633 | 7.5.3 | Physical Exams | - A complete physical examination will be conducted at screening and will include, at a minimum, assessment of the Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. Height and weight will also be measured and recorded.
- A brief physical examination will be conducted at all other time points and i... | [] |
NCT02531633 | 7.5.4 | Vital Signs | Vital signs will be measured in semi-supine position after 5 minutes rest and will include temperature, systolic and diastolic blood pressure and pulse rate. | [] |
NCT02531633 | 7.5.5 | Electrocardiogram (ECG) | Triplicate 12-lead ECGs will be obtained at the Screening visit using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The screening ECG will ensure that a comparative ECG is available prior to study drug administration in order to detect any changes should a subj... | [] |
NCT02531633 | 7.5.6 | Clinical Safety Laboratory Assessments | All protocol required laboratory assessments, as defined in [Table 6,](#page-80-0) must be conducted in accordance with the Laboratory Manual, and Protocol Time and Events Schedules. Laboratory requisition forms must be completed and samples must be clearly labelled with the subject number, protocol number, site/centre... | [] |
NCT02531633 | 7.5.7 | Suicidal Risk Monitoring | Sirukumab is considered to potentially be a CNS-active drug. There has been some concern that some CNS-active drugs may be associated with an increased risk of suicidal thinking or behaviour when given to some patients with certain conditions. Although this drug or other similar drugs in this class have not been shown ... | [] |
NCT02531633 | 7.5.8 | Tuberculosis Evaluation | A QuantiFERON-TB Gold Test will be performed at Screening. This test can be performed at any time during the study if TB is suspected.
A TB questionnaire will be completed at the times specified in Section [7.1](#page-58-0), Time and Events Tables. This questionnaire will evaluate signs and symptoms of active TB in or... | [] |
NCT02531633 | 7.5.9 | Chest Radiograph | all subsequent scheduled study visits.
A chest radiograph will be performed at the Screening visit only for the detection of TB. A chest radiograph taken up to 3 months prior to Week 0 may be used to qualify as the screening radiograph. | [] |
NCT02531633 | 7.6 | Pharmacokinetics and Immunogenicity | Blood samples for PK analysis of sirukumab serum concentrations and for analyses of antibodies to sirukumab will be collected at the time points specified in Section [7.1](#page-58-0), Time and Events Tables. The actual date and time of each blood sample collection will be recorded. Blood samples for PK analyses of sir... | [] |
NCT02531633 | 7.7 | Biomarkers/Pharmacodynamic Markers | [] | |
NCT02531633 | 7.7.1 | Exploratory Biomarkers | Blood samples will be taken at the times indicated in Time and Events [Table 2](#page-58-0), Section [7.1](#page-58-0) for assessment of changes in the biomarkers of bone formation or resorption, CTX1 and P1NP, and for changes in biomarkers indicative of Th1 and Th17 cell function, IFN-γ and IL-17A. An additional sampl... | [] |
NCT02531633 | 7.7.2 | Optional Exploratory Biomarkers | Subjects will also have the option to provide blood and urine samples for future evaluation of biomarkers related to GCA disease activity and transcriptomic analyses to further elucidate the biology of the disease. These samples will be stored in a biobank for a period of up to 5 years. Provision of these samples is op... | [] |
NCT02531633 | 7.7.3 | Pharmacodynamic Markers | Blood samples will be taken at the times indicated in Time and Events [Table 2](#page-58-0), Section [7.1](#page-58-0) for assessment of changes in free and total IL-6 as a pharmacodynamic marker of sirukumab activity. Analyses of serum IL-6 levels will be performed using validated assays by Janssen Research and Develo... | [] |
NCT02531633 | 7.8 | Genetics | A blood sample for genetic research will be collected from consenting subjects at the baseline visit. Refusal to participate in the genetic research will not preclude the subject from participating in the study. | [] |
NCT02531633 | 7.9 | Exploratory Ultrasound Imaging | [] | |
NCT02531633 | 7.9.1 | Background and Rationale | The results of three recent meta-analyses have provided evidence to support the utility of US imaging in the diagnosis of GCA [[Ball,](#page-99-0) 2010; [Arrida,](#page-99-0) 2010; [Karassa,](#page-101-0) 2005]. Additional data from a multicenter study, TABUL (Temporal Artery Biopsy versus ULtrasound), conducted at cen... | [] |
NCT02531633 | 7.9.2 | Synopsis | A cohort of subjects with new onset GCA from participating imaging centers who have consented to participate in the US imaging portion of this study will be evaluated. These subjects will undergo US scans of their temporal and axillary arteries at the specified time points for assessment of changes in vascular inflamma... | [] |
NCT02531633 | 8 | DATA MANAGEMENT | - For this study (eDM) subject data will be entered into GSK defined CRFs, transmitted electronically to GSK or designee and combined with data provided from other sources in a validated data system.
- Management of clinical data will be performed in accordance with applicable GSK standards and data cleaning procedures... | [] |
NCT02531633 | 9 | STATISTICAL CONSIDERATIONS AND DATA ANALYSES | [] | |
NCT02531633 | 9.1 | Hypotheses | The primary null hypothesis (H0) for this study is that there is no difference between sirukumab 100mg SC q2w plus 6 month prednisone (Treatment Arm A) and placebo plus 6 month prednisone (Treatment Arm D) in the proportions of subjects with sustained disease remission at 52 weeks.
The alternative hypothesis (H1) for ... | [] |
NCT02531633 | 9.2 | Sample Size Considerations | [] | |
NCT02531633 | 9.2.1 | Sample Size Assumptions | The sample size has been calculated assuming a 30% sustained remission rate on the placebo plus 6 month prednisone arm, versus a 70% rate on the sirukumab plus 6 month prednisone arms at 52 weeks. To be able to detect that difference using a 5% significance level, the sample size of N=51 on sirukumab 100mg SC q2w, N=34... | [] |
NCT02531633 | 9.2.2 | Sample Size Sensitivity | A sample size sensitivity analysis was performed to assess the effect on power if the sirukumab plus 6 month prednisone response rate was lower than expected at 65%, 60% or 55%.
| Response RateSirukumab 100 mg+ 6m Pred | DifferenceActive-Placebo | NPlacebo +6m Pred | NSirukumab100mg+ 6mPred | Power |
|----------------... | [] |
NCT02531633 | 9.2.3 | Sample Size Re-estimation or Adjustment | No sample size re-estimation will be performed. | [] |
NCT02531633 | 9.3 | Data Analysis Considerations | For statistical analysis, all tests will be two-sided with significance interpreted at the α=0.05 significance level. | [] |
NCT02531633 | 9.3.1 | Analysis Populations | The analysis populations will include:
Intent to Treat (ITT) population: The ITT population is defined as all subjects who were randomised to treatment and who received at least one dose of study medication. This population will be the primary population for statistical comparisons for efficacy.
Safety population: Th... | [] |
NCT02531633 | 9.3.2 | Analysis Datasets | Observed: Observed data is the data collected or observed for the subject with no imputation for missing data.
Further details are included in the RAP. | [] |
NCT02531633 | 9.3.3 | Treatment comparisons | Primary comparison of interest is the comparison between sirukumab 100 mg SC q2w plus 6 month prednisone (Treatment Arm A) and placebo plus 6 month prednisone (Treatment Arm D) for the proportion of subjects in sustained disease remission at Week 52 in the ITT population at the 0.05 significance level. The analysis wil... | [] |
NCT02531633 | 9.3.4 | Interim Analysis | Since sirukumab is as yet untested in GCA, the study may employ a futility interim analysis to enable a decision to stop the study early should there be no or little effect of sirukumab. Dependent on the recruitment rate, the interim analysis may be carried out when approximately 30% of subjects have completed 52 weeks... | [] |
NCT02531633 | 9.4 | Key Elements of Analysis Plan | [] | |
NCT02531633 | 9.4.1 | Primary Efficacy Analyses | The primary endpoint is a proportion of subjects in sustained remission at Week 52, defined as having:
- 5. Achieved remission (absence of clinical signs and symptoms of GCA and normalization of ESR [As a supportive of the primary endpoint, the percentage of subjects meeting each of the components of the primary endpo... | [] |
NCT02531633 | 9.4.2 | Secondary Efficacy Analyses | For the analysis of secondary endpoints, all major continuous endpoints such as cumulative prednisone dose in Part A and Part B will be analysed using repeated measures mixed effects model. The analysis will be adjusted for the stratification factors applied at randomisation, as well as the baseline value for the param... | [] |
NCT02531633 | 9.4.3 | Safety Analyses | Safety in Part A and Part B will be evaluated by adverse events, and changes in laboratory parameters. All safety analyses will be performed on the safety population.
Complete details of the safety analyses are provided in the RAP. | [] |
NCT02531633 | 9.4.3.1 | Extent of Exposure | The number of day's exposure to study drug will be summarized by treatment group. | [] |
NCT02531633 | 9.4.3.2 | Adverse Events | The proportion of subjects reporting AEs will be tabulated for each treatment group. The following summaries of AEs will be provided:
- All AEs
- Treatment-related AEs
- AEs leading to withdrawal
- AEs leading to discontinuation of study drug
- Serious AEs
- Serious CV events adjudicated by the CEC.
- AEs of special i... | [] |
NCT02531633 | 9.4.3.3 | Laboratory Parameters | Laboratory data (absolute values and changes from baseline) will be summarized by visit and treatment group. In addition, the number and percent of subjects with values of clinical concern will be summarized by treatment group. | [] |
NCT02531633 | 9.4.3.4 | Other Safety Measures | Reason for withdrawal/treatment discontinuation will be summarized. Summary statistics for vital signs evaluations at each visit will be presented by treatment group. In addition, summary statistics for change from baseline for vital signs evaluations will be presented by treatment group.
ECG findings will be summariz... | [] |
NCT02531633 | 9.4.4 | Health Outcomes Analyses | All continuous endpoints such as SF-36 will be analysed using repeated measures mixed effects model. The analysis will be adjusted for the stratification factors applied at randomisation, as well as the baseline value for the parameter being tested.
Health outcomes endpoints will also be summarised appropriately.
Fur... | [] |
NCT02531633 | 9.4.5 | Pharmacokinetic and Immunogenicity Analyses | Serum concentrations of sirukumab in Part A will be summarized descriptively by time and treatment group. All data will be listed.
Possible relationships between serum concentrations and efficacy or safety endpoints may be investigated in an exploratory manner, if appropriate.
Immunogenicity (serum anti-sirukumab ant... | [] |
NCT02531633 | 9.4.6 | Pharmacodynamic/Exploratory/Biomarker Analyses | Pharmacodynamic and biomarker data in Part A will be presented in graphical and/or tabular form and will be summarised descriptively. As appropriate, exploratory statistical analyses may be conducted where the distribution of biomarker data will be investigated.
201677
Possible relationships between biomarker data an... | [] |
NCT02531633 | 9.4.7 | Pharmacogenetic Analyses | Any PGx analyses will be described separately from the main clinical study report. GSK may summarize the PGx research results in the clinical study report, or separately, or may publish the results in scientific journal. | [] |
NCT02531633 | 10 | STUDY GOVERNANCE CONSIDERATIONS | [] | |
NCT02531633 | 10.1 | Posting of Information on Publicly Available Clinical Trial Registers | Study information from this protocol will be posted on publicly available clinical trial registers before enrollment of subjects begins. | [] |
NCT02531633 | 10.2 | Regulatory and Ethical Considerations, Including the Informed Consent Process | Prior to initiation of a site, GSK will obtain favourable opinion/approval from the appropriate regulatory agency to conduct the study in accordance with ICH Good Clinical Practice (GCP) and applicable country-specific regulatory requirements.
The study will be conducted in accordance with all applicable regulatory re... | [] |
NCT02531633 | 10.3 | Quality Control (Study Monitoring) | - In accordance with applicable regulations including GCP, and GSK procedures, GSK (or designee) monitors will contact the site prior to the start of the study to review with the site staff the protocol, study requirements, and their responsibilities to satisfy regulatory, ethical, and GSK requirements.
- When reviewin... | [] |
NCT02531633 | 10.4 | Quality Assurance | - To ensure compliance with GCP and all applicable regulatory requirements, GSK (or designee) may conduct a quality assurance assessment and/or audit of the site records, and the regulatory agencies may conduct a regulatory inspection at any time during or after completion of the study.
- In the event of an assessment,... | [] |
NCT02531633 | 10.5 | Study and Site Closure | - Upon completion or premature discontinuation of the study, the GSK (or designee) monitor will conduct site closure activities with the investigator or site staff, as appropriate, in accordance with applicable regulations including GCP, and GSK Standard Operating Procedures.
- GSK reserves the right to temporarily sus... | [] |
NCT02531633 | 10.6 | Records Retention | - Following closure of the study, the investigator or the head of the medical institution (where applicable) must maintain all site study records (except for those required by local regulations to be maintained elsewhere), in a safe and secure location.
- The records must be maintained to allow easy and timely retrieva... | [] |
NCT02531633 | 10.7 | Provision of Study Results to Investigators, Posting of Information on Publically Available Clinical Trials Registers and Publication | Where required by applicable regulatory requirements, an investigator signatory will be identified for the approval of the clinical study report. The investigator will be provided reasonable access to statistical tables, figures, and relevant reports and will have the opportunity to review the complete study results at... | [] |
NCT02531633 | 10.8 | Review Committees | An IDMC will be utilized in this study to ensure external objective medical and/or statistical review of safety and/or efficacy issues in order to protect the ethical and safety interests of subjects and to protect the scientific validity of the study. The schedule of any planned interim analysis and the analysis plan ... | [] |
NCT02531633 | 11 | REFERENCES | Achkar, A.A., Lie, J.T., Hunder, G.G., O'Fallon, W.M., and Gabriel, S.E. (1994). How does previous corticosteroid treatment affect the biopsy findings in giant cell (temporal) arteritis? Annals of Internal Medicine *120*, 987-992.
ACTEMRA [prescribing information]. South San Francisco, CA: Genentech, Inc; 2011.
Arrid... | [] |
NCT02531633 | 12 | APPENDICES | [] | |
NCT02531633 | 12.1 | Appendix 1: Abbreviations and Trademarks |
| ACR | American College of Rheumatology |
|---------------|----------------------------------------------------------|
| AE | Adverse Event |
| AION | Acute IschemicOptic Neuropathy |
| ALT ... | [
"Abbreviations",
"Trademark Information"
] |
NCT02531633 | 12.2 | Appendix 2: Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) and Collection of Pregnancy Information | [] | |
NCT02531633 | 12.2.1 | Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) | This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penilevaginal intercourse on a long term and persistent basis.
- Contraceptive subdermal implant
- Intrauterine device or intrauterine system
- Oral Co... | [] |
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