protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04362137 | 6.1 | Study treatment | 6.1 Study treatment | [] |
NCT04362137 | 6.1.1 | Investigational and control drugs | 6.1.1 Investigational and control drugs Ruxolitinib 5 mg tablets or matching placebo will be administered orally twice per day approximately 12 hours apart (morning and night) without regards to food. Dose reductions or interruptions for any toxicity attributed to study drug are permitted in order to allow the patient ... | [] |
NCT04362137 | 6.1.2 | Supply of study treatment | 6.1.2 Supply of study treatment No additional treatment beyond ruxolitinib 5 mg or matching image placebo will be provided. | [] |
NCT04362137 | 6.1.3 | Treatment arms/group | 6.1.3 Treatment arms/group Participants will be assigned at randomization to one of the following treatment arms/groups in a ratio of 2:1: - ruxolitinib 5 mg tablets twice daily; or - matching image placebo tablets twice daily. | [] |
NCT04362137 | 6.1.4 | Treatment duration | 6.1.4 Treatment duration The planned duration of treatment is 14 days. An additional 14 days of study drug may be given, if in the opinion of the investigator, the patient's clinical signs and symptoms are not improved or worsen and the potential benefit outweighs the potential risk. Participants may be discontinued fr... | [] |
NCT04362137 | 6.2 | Other treatments | 6.2 Other treatments | [] |
NCT04362137 | 6.2.1 | Concomitant therapy | 6.2.1 Concomitant therapy All medications, procedures, and significant non-drug therapies (including physical therapy and blood transfusions) administered after the participant was enrolled into the study must be recorded on the appropriate electronic Case Report Forms (eCRFs). Each concomitant drug must be individuall... | [] |
NCT04362137 | 6.2.1.1 | Permitted concomitant therapy requiring caution and/or action | 6.2.1.1 Permitted concomitant therapy requiring caution and/or action Patients may receive: anti-virals, inhaled or systemic corticosteroids, heparin, low molecular weight heparin (LMWH), direct oral anticoagulants, anti-emetics, calcineurin inhibitors, azole fungal prophylaxis, broad spectrum antibiotics (either semi-... | [] |
NCT04362137 | 6.2.2 | Prohibited medication | 6.2.2 Prohibited medication The following medications are prohibited until treatment discontinuation: - Concomitant use of another JAK inhibitor - Aspirin in doses >150 mg/day - Fluconazole > 200 mg daily For additional information, please refer to the Investigator Brochure. | [] |
NCT04362137 | 6.3 | Participant numbering, treatment assignment, randomization | 6.3 Participant numbering, treatment assignment, randomization | [] |
NCT04362137 | 6.3.1 | Participant numbering | 6.3.1 Participant numbering Each participant is identified in the study by a Participant Number (Participant No.), that is assigned when the participant is enrolled for screening and is retained for the participant throughout his/her participation in the trial. The Participant No. consists of the Center Number (Center ... | [] |
NCT04362137 | 6.3.2 | Treatment assignment, randomization | 6.3.2 Treatment assignment, randomization At the randomization visit, all eligible participants will be randomized via Interactive Response Technology (IRT) to one of the treatment arms. The investigator or his/her delegate will contact the IRT after confirming that the participant fulfills all the inclusion/exclusion ... | [] |
NCT04362137 | 6.4 | Treatment blinding | 6.4 Treatment blinding Participants, investigator staff, persons performing the assessments, and CTT will remain blind to the identity of the treatment from the time of randomization until database lock, using the following methods: (1) Randomization data are kept strictly confidential until the time of unblinding and ... | [] |
NCT04362137 | 6.5 | Dose escalation and dose modification | 6.5 Dose escalation and dose modification Study drug dose adjustments and/or interruptions are described in Section 6.6.2. | [] |
NCT04362137 | 6.5.1 | Dose modifications | 6.5.1 Dose modifications Dose reductions or interruptions for patients that do not tolerate the dosing schedule and are attributed to study drug are permitted in order to allow the patient to continue on the study treatment (see Section 6.6.2 for more guidance). Dose modifications must be reported in the appropriate eC... | [] |
NCT04362137 | 6.5.1.1 | Follow up on potential drug-induced liver injury (DILI) cases | 6.5.1.1 Follow up on potential drug-induced liver injury (DILI) cases Participants with transaminase increase combined with total bilirubin increase may be indicative of potentially severe DILI, and should be considered as clinically important events and assessed appropriately to establish the diagnosis. The required c... | [] |
NCT04362137 | 6.6 | Additional treatment guidance | 6.6 Additional treatment guidance | [] |
NCT04362137 | 6.6.1 | Treatment compliance | 6.6.1 Treatment compliance Treatment will be recorded on the appropriate eCRF. | [] |
NCT04362137 | 6.6.2 | Recommended treatment of adverse events | 6.6.2 Recommended treatment of adverse events Dose reductions or interruptions for patients that do not tolerate the dosing schedule and are attributed to study drug are permitted in order to allow the patient to continue on the study treatment. Adverse events will be assessed and graded according to the Common Termino... | [
"AST/ALT elevation",
"Other adverse events (non-hematological) attributed to study drug"
] |
NCT04362137 | 6.6.3 | Emergency breaking of assigned treatment code | 6.6.3 Emergency breaking of assigned treatment code Emergency code breaks must only be undertaken when it is required to in order to treat the participant safely. Blinding codes may also be broken after a participant discontinues treatment due to disease progression if deemed essential to allow the investigator to sele... | [] |
NCT04362137 | 6.7 | Preparation and dispensation | 6.7 Preparation and dispensation Each study site will be supplied with study drug in packaging as described under investigational and control drugs section. A unique medication number is printed on the study medication label. | [] |
NCT04362137 | 6.7.1 | Handling of study treatment and additional treatment | 6.7.1 Handling of study treatment and additional treatment | [] |
NCT04362137 | 6.7.1.1 | Handling of study treatment | 6.7.1.1 Handling of study treatment Study treatment must be received by a designated person at the study site, handled and stored safely and properly and kept in a secured location to which only the investigator and designated site personnel have access. Upon receipt, all study treatment must be stored according to the... | [] |
NCT04362137 | 7 | Informed consent procedures | 7 Informed consent procedures Eligible participants may only be included in the study after providing (witnessed, where required by law or regulation), IRB/IEC-approved informed consent. If applicable, in cases where the participant's representative(s) gives consent (if allowed according to local requirements), the par... | [
"Table 8-1 Assessment Schedule"
] |
NCT04362137 | 8.1 | Screening | 8.1 Screening No rescreening will be allowed. | [] |
NCT04362137 | 8.1.1 | Information to be collected on screening failures | 8.1.1 Information to be collected on screening failures Participants who sign an informed consent form and subsequently found to be ineligible prior to randomization will be considered a screen failure. The reason for screen failure should be recorded on the appropriate Case Report Form. The demographic information, in... | [] |
NCT04362137 | 8.2 | Participant demographics/other baseline characteristics | 8.2 Participant demographics/other baseline characteristics Country-specific regulations should be considered for the collection of demographic and baseline characteristics in alignment with eCRF. Participant race and ethnicity are collected and analyzed to identify variations in safety or efficacy due to these factors... | [] |
NCT04362137 | 8.3 | Efficacy | 8.3 Efficacy | [] |
NCT04362137 | 8.3.1 | Clinical status (9-point ordinal scale) | 8.3.1 Clinical status (9-point ordinal scale) Assessment of clinical status using a 9-category ordinal scale (WHO 18-Feb-2020) will be recorded at baseline on Day 1 and then again once daily every morning (between 7AM and 12PM) through Day 29 of the Study Period. If a patient is discharged from the hospital, the assess... | [] |
NCT04362137 | 8.3.2 | Vital signs and oxygen saturation | 8.3.2 Vital signs and oxygen saturation Results from tests or examinations done as part of routine care may be used as specified in the table of assessments (See Table 8-1). Vital sign measurement include respiratory rate, pulse rate, systolic and diastolic blood pressure, and body temperature. Peripheral oxygen satura... | [] |
NCT04362137 | 8.3.3 | National Early Warning Score 2 (NEWS2) | 8.3.3 National Early Warning Score 2 (NEWS2) In addition to the vital signs, the patient's level of consciousness and the presence/absence of respiratory support must be recorded. The NEWS2 parameter for respiratory support is the selection of either air or "oxygen" can include other forms of ventilation to maintain ox... | [] |
NCT04362137 | 8.3.4 | In-hospital outcomes | 8.3.4 In-hospital outcomes In addition to endpoints mentioned above, the following in hospital outcomes will be captured on eCRFs: - Start and end date of mechanical ventilation - Start and end date of hospital stay  | [] |
NCT04362137 | 8.3.5 | Ventilatory status | 8.3.5 Ventilatory status Ventilatory status (mechanical ventilation, supplemental oxygen, intubation and non-invasive ventilation [e.g. CPAP, BIPAP, etc.]) will be collected at timepoints designated in Table 8-1 and recorded by the investigator in the appropriate eCRFs. | [] |
NCT04362137 | 8.3.6 | Appropriateness of efficacy assessments | 8.3.6 Appropriateness of efficacy assessments Efficacy endpoints are those employed in other studies of patients with COVID-19 pneumonia (WHO 2020; Cao et al 2020). | [] |
NCT04362137 | 8.4 | Safety | 8.4 Safety Safety assessments are specified below with the assessment schedule detailing when each assessment is to be performed. For details on AE collection and reporting, refer to Section 10.1.1. | [] |
NCT04362137 | 8.4.1 | Laboratory evaluations | 8.4.1 Laboratory evaluations Laboratory evaluations will be performed by a local laboratory. Results from tests or examinations done as part of routine care may be used as specified in the table of assessments (See Table 8-1).
Hematology Hemoglobin, hematocrit, red blood cell count, white blood cell count with differe... | [
"Hematology",
"Chemistry",
"Drug-induced liver injury monitoring"
] |
NCT04362137 | 8.4.2 | Physical Exam | 8.4.2 Physical Exam A physical examination will be performed at Screening and any abnormalities will be recorded in source documents. Results from tests or examinations done as part of routine care may be used as per Table 8-1. Information for all physical examinations must be included in the source documentation at th... | [] |
NCT04362137 | 8.4.3 | Height, weight, BMI | 8.4.3 Height, weight, BMI Results from tests or examinations done as part of routine care may be used as specified in the table of assessments (See Table 8-1). If possible, height will be measured at the Screening visit as specified in the table of assessments (See Table 8-1). Otherwise, patient or guardian/health prox... | [] |
NCT04362137 | 8.4.4 | Electrocardiogram (ECG) | 8.4.4 Electrocardiogram (ECG) Results from tests or examinations done as part of routine care may be used as specified in the table of assessments (See Table 8-1). An ECG will be taken at Screening and recorded in source documents. The ECG should be recorded after 10 minutes of rest in the supine position to ensure a s... | [] |
NCT04362137 | 8.4.5 | Pregnancy and assessments of fertility | 8.4.5 Pregnancy and assessments of fertility Results from tests or examinations done as part of routine care may be used as specified in the table of assessments (See Table 8-1). All women of child bearing potential will have a serum pregnancy test at Screening and at designated visits (Table 8-1). A positive pregnancy... | [] |
NCT04362137 | 8.4.6 | Appropriateness of safety measurements | 8.4.6 Appropriateness of safety measurements The safety assessments selected are appropriate for this protocol which utilizes a marketed compound where the safety profile has been established. The assessments are relevant to the critical care setting and will enable determination of therapeutic response in this setting... | [] |
NCT04362137 | 9 | Study discontinuation and treatment | 9 Study discontinuation and treatment | [] |
NCT04362137 | 9.1 | Discontinuation and completion | 9.1 Discontinuation and completion | [] |
NCT04362137 | 9.1.1 | Study treatment discontinuation and study discontinuation | 9.1.1 Study treatment discontinuation and study discontinuation Discontinuation of study treatment for a participant occurs when study treatment is stopped earlier than the protocol planned duration and can be initiated by either the participant or the investigator. The investigator must discontinue study treatment for... | [] |
NCT04362137 | 9.1.2 | Replacement policy | 9.1.2 Replacement policy Patients discontinuing the study will not be replaced. | [] |
NCT04362137 | 9.1.3 | Withdrawal of informed consent | 9.1.3 Withdrawal of informed consent Participants may voluntarily withdraw consent to participate in the study for any reason at any time. Withdrawal of consent occurs only when a participant: - Does not want to participate in the study anymore, and - Does not want any further visits or assessments and - Does not want ... | [] |
NCT04362137 | 9.1.4 | Lost to follow-up | 9.1.4 Lost to follow-up For participants whose status is unclear because they fail to appear for study visits without stating an intention to discontinue or withdraw, the investigator must show "due diligence" by documenting in the source documents steps taken to contact the participant, e.g. dates of telephone calls, ... | [] |
NCT04362137 | 9.1.5 | Early study termination by the sponsor | 9.1.5 Early study termination by the sponsor The study can be terminated by Novartis at any time. Reasons for early termination: - Unexpected, significant, or unacceptable safety risk to participants enrolled in the study - Decision based on recommendations from applicable board(s) after review of safety and efficacy d... | [] |
NCT04362137 | 9.2 | Study completion | 9.2 Study completion Study completion is defined as when the last participant finishes their Study Completion visit and any repeat assessments associated with this visit have been documented and followed-up appropriately by the Investigator or, in the event of an early study termination decision, the date of that decis... | [] |
NCT04362137 | 10 | Safety monitoring and reporting | 10 Safety monitoring and reporting | [] |
NCT04362137 | 10.1 | Definition of adverse events and reporting requirements | 10.1 Definition of adverse events and reporting requirements | [] |
NCT04362137 | 10.1.1 | Adverse events | 10.1.1 Adverse events An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or ... | [] |
NCT04362137 | 10.1.2 | Serious adverse events | 10.1.2 Serious adverse events An SAE is defined as any adverse event [appearance of (or worsening of any pre-existing)] undesirable sign(s), symptom(s), or medical conditions(s) which meets any one of the following criteria: - fatal - life-threatening Life-threatening in the context of a SAE refers to a reaction in whi... | [] |
NCT04362137 | 10.1.3 | SAE reporting | 10.1.3 SAE reporting To ensure participant safety, every SAE, regardless of causality, occurring after the participant has provided informed consent and until the last study visit must be reported to Novartis safety within 24 hours of learning of its occurrence. Detailed instructions regarding the submission process an... | [] |
NCT04362137 | 10.1.4 | Pregnancy reporting | 10.1.4 Pregnancy reporting
Pregnancies If a female trial participant becomes pregnant, the study treatment should be stopped, and the trial participant must be asked to read and sign pregnancy consent form to allow the Study Doctor ask about her pregnancy. To ensure participant safety, each pregnancy occurring after s... | [
"Pregnancies"
] |
NCT04362137 | 10.1.5 | Reporting of study treatment errors including misuse/abuse | 10.1.5 Reporting of study treatment errors including misuse/abuse Medication errors are unintentional errors in the prescribing, dispensing, administration or monitoring of a medicine while under the control of a healthcare professional, participant or consumer (EMA definition). Misuse refers to situations where the me... | [] |
NCT04362137 | 10.2 | Additional Safety Monitoring | 10.2 Additional Safety Monitoring Not applicable. | [] |
NCT04362137 | 10.2.1 | Liver safety monitoring | 10.2.1 Liver safety monitoring To ensure participant safety and enhance reliability in determining the hepatotoxic potential of an investigational drug, a standardized process for identification, monitoring and evaluation of liver events has to be followed. Please refer to Appendix 1 for complete definitions of liver l... | [] |
NCT04362137 | 10.2.2 | Data Monitoring Committee | 10.2.2 Data Monitoring Committee This study will include an internal data monitoring committee (DMC) which will function independently of all other individuals associated with the conduct of this clinical trial, including the site investigators participating in the study. Specific details regarding composition, respons... | [] |
NCT04362137 | 11 | Data Collection and Database management | 11 Data Collection and Database management | [] |
NCT04362137 | 11.1 | Data collection | 11.1 Data collection All data should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification. Designated investigator staff will enter the data required by the protocol and defined in the Assessment Schedule (Table 8-1) into the Electronic Case Report Forms (eCRF).... | [] |
NCT04362137 | 11.2 | Database management and quality control | 11.2 Database management and quality control Novartis personnel (or designated CRO) will review the data entered by investigational staff for completeness and accuracy. Electronic data queries stating the nature of the problem and requesting clarification will be created for discrepancies and missing values and sent to... | [] |
NCT04362137 | 11.3 | Site monitoring | 11.3 Site monitoring Before study initiation, at an initiation visit or at an investigator's meeting, a Novartis representative will review the protocol and data capture requirements (i.e. eSource DDE and/or eCRFs) with the investigators and their staff. During the study, Novartis employs several methods of ensuring pr... | [] |
NCT04362137 | 12 | Data analysis and statistical methods | 12 Data analysis and statistical methods Any data analysis carried out independently by the investigator should be submitted to Novartis before publication or presentation. | [] |
NCT04362137 | 12.1 | Analysis sets | 12.1 Analysis sets The Randomized Analysis Set (RAS) consists of all randomized participants. According to the intent to treat principle, participants will be analyzed according to the treatment they have been assigned to during the randomization procedure. The Safety Set includes all participants who received at least... | [] |
NCT04362137 | 12.2 | Participant demographics and other baseline characteristics | 12.2 Participant demographics and other baseline characteristics Demographic and other baseline data including disease characteristics will be listed and summarized descriptively by treatment group for the RAS. Categorical data will be presented as frequencies and percentages. For continuous data, mean, standard deviat... | [] |
NCT04362137 | 12.3 | Treatments | 12.3 Treatments The duration of exposure in days to ruxolitinib and standard of care therapies will be summarized by means of descriptive statistics using the Safety set. Concomitant medications and significant non-drug therapies prior to and after the start of the study treatment will be listed and summarized accordin... | [] |
NCT04362137 | 12.4 | Analysis of the primary endpoint(s)/estimand(s) | 12.4 Analysis of the primary endpoint(s)/estimand(s) The primary analysis for this study will be conducted on the RAS according the intention to treat principle. | [] |
NCT04362137 | 12.4.1 | Definition of primary endpoint(s)/estimand(s) | 12.4.1 Definition of primary endpoint(s)/estimand(s) The estimand framework for the primary objective is as follows: - Treatment ruxolitinib added to SoC therapy - Population Hospitalized patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test from the re... | [] |
NCT04362137 | 12.4.2 | Statistical model, hypothesis, and method of analysis | 12.4.2 Statistical model, hypothesis, and method of analysis The statistical hypothesis tested for clinical failure is that there is no difference in the proportion of subjects developing clinical failure by Day 29 with ruxolitinib + SoC versus placebo + SoC therapy. Let pi denote the proportion of clinical failures by... | [] |
NCT04362137 | 12.4.3 | Handling of remaining intercurrent events of primary estimand | 12.4.3 Handling of remaining intercurrent events of primary estimand Discontinuation of study treatment for any reason:Retrieved drop out (RDO) data after study treatment discontinuation will be collected. If RDO data is available up to Day 29 this will be used for analysis. If no RDO data was collected after study tre... | [] |
NCT04362137 | 12.4.4 | Handling of missing values not related to intercurrent event | 12.4.4 Handling of missing values not related to intercurrent event For patients who withdraw from the study, their clinical failure status will be handled similarly as in Section 12.4.3. Other missing data handling rules will be specified in the SAP. | [] |
NCT04362137 | 12.4.5 | Sensitivity analyses for primary endpoint/estimand | 12.4.5 Sensitivity analyses for primary endpoint/estimand In order to determine the robustness of the logistic regression model used for the primary analysis of clinical failure by Day 29, a non-parametric regression model (Koch et al 1998) will also be evaluated using the same explanatory variables as the logistic reg... | [] |
NCT04362137 | 12.4.6 | Supplementary analysis | 12.4.6 Supplementary analysis To assess the effect of classifying patients' clinical failure status with missing data, a multiple imputation based analysis will be conducted. More details of this approach will be included in the study analysis plan. Other imputation approaches, for example, a worst case analysis, will ... | [] |
NCT04362137 | 12.4.7 | Supportive analyses | 12.4.7 Supportive analyses The primary analysis of the clinical failure will be repeated for each of the events in the composite endpoint: occurrence of death, mechanical ventilation, and ICU care. Separate logistic regression models will be fitted to compare the odds between treatment groups for each of the endpoints.... | [] |
NCT04362137 | 12.5 | Analysis of secondary endpoints/estimands | 12.5 Analysis of secondary endpoints/estimands | [] |
NCT04362137 | 12.5.1 | Efficacy and/or Pharmacodynamic endpoint(s) | 12.5.1 Efficacy and/or Pharmacodynamic endpoint(s) Full details of all planned analyses will be included in the study analysis plan. However, a brief description of the approaches used for each endpoint are given below. | [] |
NCT04362137 | 12.5.1.1 | 9-category ordinal scale | 12.5.1.1 9-category ordinal scale The odds of observing a better category (lower number) of clinical status (9-category ordinal scale, WHO 18-Feb-2020) at Day 15 will be analyzed with a proportional odds model (POM). The odds ratio for treatment group (ruxolitinib + SoC therapy vs. placebo + SoC therapy) estimated from... | [] |
NCT04362137 | 12.5.1.2 | Oxygen saturation | 12.5.1.2 Oxygen saturation The proportion of patients with no oxygen therapy (defined as oxygen saturation ≥ 94% on room air) at Days 15 and 29 will be analyzed separately using a logistic regression model with the same covariates as for the primary analyses, with baseline oxygen therapy status included. | [] |
NCT04362137 | 12.5.1.3 | In-hospital outcomes | 12.5.1.3 In-hospital outcomes Duration of hospitalization will be analyzed using a competing risk analysis framework (death will be treated as a competing risk). More details will be provided in the statistical analysis plan. The analyses of mortality rates at Day 15 and at Day 29, and proportion of patients requiring ... | [] |
NCT04362137 | 12.5.1.4 | National Early Warning Score (NEWS2) | 12.5.1.4 National Early Warning Score (NEWS2) Time to discharge or to a National Early Warning Score (NEWS2) of ≤2 and maintained for 24 hours (whichever comes first) will be analyzed using a competing risk analysis framework (death will be a competing risk) (Royal College of Physicians 2017). The model will also inclu... | [] |
NCT04362137 | 12.5.2.1 | Adverse events | 12.5.2.1 Adverse events All information obtained on adverse events will be displayed by treatment group and participant. The number (and percentage) of participants with treatment emergent adverse events (events started after the first dose of study medication or events present prior to start of double-blind treatment ... | [] |
NCT04362137 | 12.5.2.2 | Vital signs | 12.5.2.2 Vital signs All vital signs data will be listed by treatment group, participant, and visit/time and if ranges are available, abnormalities (and relevant orthostatic changes) will be flagged. Summary statistics will be provided by treatment and visit/time. | [] |
NCT04362137 | 12.5.2.3 | Clinical laboratory evaluations | 12.5.2.3 Clinical laboratory evaluations All laboratory data will be listed by treatment group, participant, and visit/time and if normal ranges are available abnormalities will be flagged. Summary statistics will be provided by treatment and visit/time.   | [] |
NCT04362137 | 12.8.1 | Primary endpoint(s) | 12.8.1 Primary endpoint(s) Assuming a true treatment difference in clinical failure rate of 15% for ruxolitinib added to SoC therapy compared to placebo added to SoC therapy, a sample size of approximately 402 participants provides at least 80% power that the primary analysis will be statistically significant at the tw... | [] |
NCT04362137 | 13 | Ethical considerations and administrative procedures | 13 Ethical considerations and administrative procedures | [] |
NCT04362137 | 13.1 | Regulatory and ethical compliance | 13.1 Regulatory and ethical compliance This clinical study was designed and shall be implemented, executed and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/20/EC, US CFR 21), and with the ethical pri... | [] |
NCT04362137 | 13.2 | Responsibilities of the investigator and IRB/IEC | 13.2 Responsibilities of the investigator and IRB/IEC Before initiating a trial, the investigator/institution must obtain approval/favorable opinion from the Institutional Review Board/Independent Ethics Committee (IRB/IEC) for the trial protocol, written informed consent form, consent form updates, participant recruit... | [] |
NCT04362137 | 13.3 | Publication of study protocol and results | 13.3 Publication of study protocol and results The protocol will be registered in a publicly accessible database such as clinicaltrials.gov and as required in EudraCT. In addition, after study completion (defined as last patient last visit) and finalization of the study report the results of this trial will be submitte... | [] |
NCT04362137 | 13.4 | Quality Control and Quality Assurance | 13.4 Quality Control and Quality Assurance Novartis maintains a robust Quality Management System (QMS) that includes all activities involved in quality assurance and quality control, to ensure compliance with written Standard Operating Procedures as well as applicable global/local GCP regulations and ICH Guidelines. Au... | [] |
NCT04362137 | 14 | Protocol adherence | 14 Protocol adherence | [] |
NCT04362137 | 14.1 | Protocol amendments | 14.1 Protocol amendments Any change or addition to the protocol can only be made in a written protocol amendment that must be approved by Novartis, health authorities where required, and the IRB/IEC prior to implementation. Only amendments that are required for participant safety may be implemented immediately provided... | [] |
NCT04362137 | 15 | References | 15 References Available upon request Ahmed, A., Merrill, S.A., Alsawah, F., Bockenstedt, P., Campagnaro, E., Devata, S., Gitlin, S.D., Kaminski, M., Cusick, A., Phillips, T. and Sood, S., (2019). Ruxolitinib in adult patients with secondary haemophagocytic lymphohistiocytosis: an open-label, single-centre, pilot trial.... | [] |
NCT04362137 | 16 | Appendices | 16 Appendices | [] |
NCT04362137 | 16.1 | Appendix 1: Liver event and laboratory trigger definitions & follow-up requirements | 16.1 Appendix 1: Liver event and laboratory trigger definitions & follow-up requirements Table 16-1 Liver event and laboratory trigger definitions | | Definition/ threshold | |-----------------------------------------------------|------------------------------------------------------------------------------------------... | [] |
NCT04362137 | 16.2 | Appendix 2: Clinical status 9-point scale | 16.2 Appendix 2: Clinical status 9-point scale Clinical status (9-point ordinal scale): | Patient State | Descriptor | Score | |---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04362137 | 16.3 | Appendix 3: National Early Warning Score 2 (NEWS2) | 16.3 Appendix 3: National Early Warning Score 2 (NEWS2) SpO2= oxygen saturation. The oxygen saturation should be scored according to either the SpO2 Scale 1 or 2 presented in the table above. The SpO2 Scale 2 is for patients with a target oxygen saturation requirement of 88%-92% (e.g., in patients with hypercapnic resp... | [
"Example Case Calculation:",
"Reference:"
] |
NCT04362137 | 16.4 | Appendix 4: List of CYP3A4 inhibitors and inducers | 16.4 Appendix 4: List of CYP3A4 inhibitors and inducers
Table 16-4 CYP3A4 inhibitors and inducers
Dual CYP2C9/CYP3A4 inhibitor: Fluconazole: Avoid the concomitant use of ruxolitinib with fluconazole doses ≥ 200 mg daily; If clinically necessary to use doses ≥ 200 mg daily consultation with Sponsor is required. Please... | [
"Table 16-4 CYP3A4 inhibitors and inducers",
"Dual CYP2C9/CYP3A4 inhibitor:"
] |
NCT04439149 | 1 | Introduction | 1. Introduction | [] |
NCT04439149 | 1.1 | Background | 1.1 Background The mechanisms underlying cancer are marked by complex aberrations that activate critical cellular signaling pathways in tumorigenesis. Identifying actionable molecular aberrations has been critical to several major therapeutic advances in cancer medicine. Examples include BCR-ABL fusion in chronic myelo... | [] |
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