protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03913130 | 12.0 | ETHICAL AND REGULATORYOBLIGATIONS | 12.0 ETHICAL AND REGULATORYOBLIGATIONS | [] |
NCT03913130 | 12.1 | Ethical Considerations | 12.1 Ethical Considerations The Investigator agrees to conduct this study in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH GCP. The Investigator will conduct all aspects of this study in compliance with the protocol, ICH GCP and applicable regulator... | [] |
NCT03913130 | 12.2 | Informed Consent | 12.2 Informed Consent Before the start of required study procedures, the Investigator or his/her associate must obtain informed consent from each study participant (or the subject's legal representative) in accordance with ICH GCP, and country authority requirements. Age appropriate assent and permission from a minor s... | [] |
NCT03913130 | 12.3 | Ethics and Regulatory Review | 12.3 Ethics and Regulatory Review An IRB/EC should approve the final study protocol, including the final version of the Informed Consent Form, assent forms, parental permission forms and any other written information and/or materials to be provided to the subjects. The Investigator will ensure the distribution of these... | [] |
NCT03913130 | 12.4 | Subject Confidentiality | 12.4 Subject Confidentiality The Investigator must ensure that the subject's confidentiality is maintained. On the eCRFs or other documents submitted to the Sponsor, subjects should be identified by their date of birth (month and year) and subject number only. Documents that are not for submission to the Sponsor (eg, s... | [] |
NCT03913130 | 13.0 | STUDY ADMINISTRATION | 13.0 STUDY ADMINISTRATION | [] |
NCT03913130 | 13.1 | Investigator's Brochure | 13.1 Investigator's Brochure Before the study begins, the Investigator will receive the QR-110 IB describing all known contraindications, warnings, precautions, and adverse reactions associated with the administration of the study drug. If such information is revised while the study is in progress, the IB will be amend... | [] |
NCT03913130 | 13.2 | Protocol Amendments | 13.2 Protocol Amendments If there are any substantial changes to the study protocol, then these changes will be documented in a protocol amendment and in a new version of the protocol. Protocol amendments must be made only with the prior approval of the Sponsor. The Sponsor will inform the Investigator in writing of an... | [] |
NCT03913130 | 13.3 | Study Termination | 13.3 Study Termination Both the Sponsor and the Investigator reserve the right to terminate the study according to the study contract. The Investigator should notify the IRB/EC in writing of the study's completion or early termination and send a copy of the notification to the Sponsor. If the Sponsor, Sponsor Medical M... | [] |
NCT03913130 | 13.4 | Study Documentation and Storage | 13.4 Study Documentation and Storage • The Sponsor will provide the Investigator with records of drug shipments, eCRFs, and other forms as necessary. The Investigator and study staff are responsible for maintaining a comprehensive and centralized filing system of all study-related documentation, suitable for inspection... | [] |
NCT03913130 | 13.5 | Use of Information | 13.5 Use of Information All personal information pertaining to the subjects in this study and in any subsequent reports will be kept confidential. Subjects will be identified only by their month and year of birth and a subject number. It is the responsibility of the Investigator to keep a subject listing for crossrefer... | [] |
NCT03913130 | 13.6 | End of Study and Final Report | 13.6 End of Study and Final Report In North America, the Investigator or associate must notify the IRB/EC when the study is closed. If not initially provided by the Sponsor, a copy of the final study report must also be provided to Sponsor or its representative. In the European Union, the Sponsor or its designee must n... | [] |
NCT03913130 | 13.7 | Financing and Insurance | 13.7 Financing and Insurance Financing and Insurance are addressed separately in the Clinical Study Agreement. | [] |
NCT03913130 | 13.8 | Publication Policy | 13.8 Publication Policy Publication policy is addressed separately in the Clinical Study Agreement. | [] |
NCT03913130 | 14.0 | REFERENCES | 14.0 REFERENCES Avery RL, Bakri SJ, Blumenkranz MS, Brucker AJ, Cunningham ET, D'Amico DJ, et al. Intravitreal injection technique and monitoring: updated guidelines of an expert panel. Retina. 2014; 34:S1–S18. Cideciyan AV, Aleman TS, Jacobson SG, Khanna H, Sumaroka A, Aguirre GK, et al. Centrosomal-ciliary gene CEP29... | [] |
NCT03913130 | 15.0 | APPENDICES | 15.0 APPENDICES ProQR Therapeutics Page 63 of 66 17-Mar-2022 ProQR Therapeutics Page 64 of 66 17-Mar-2022 ProQR Therapeutics Page 65 of 66 17-Mar-2022
APPENDIX 2: CLINICAL LABORATORY ANALYTES
Serum Chemistry Panel Alanine aminotransferase Albumin Alkaline phosphatase Aspartate aminotransferase Bicarbonate Calcium Chl... | [
"APPENDIX 2: CLINICAL LABORATORY ANALYTES",
"Serum Chemistry Panel",
"Hematology",
"Pregnancy Testing"
] |
NCT03926130 | 1 | Protocol Summary | 1 Protocol Summary | [] |
NCT03926130 | 1.1 | Synopsis | 1.1 Synopsis Protocol Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease Acronym: VIVID-1
Rationale: Mirikizumab (LY3074828) is a humanized immunog... | [
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"Overall Design:",
"Disclosure Statement:",
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NCT03926130 | 1.2 | Schema | 1.2 Schema  Abbreviations: IV = intravenous; mg = milligram; kg = kilogram; SC = subcutaneous Note: From Week 8 through Week 20, all participants receive their assigned treatment and matching placebo via both IV and SC administration. LY3074828 15 Approved on 23 Feb 2022 GMT | [] |
NCT03926130 | 1.3 | Schedule of Activities (SoA) | 1.3 Schedule of Activities (SoA) | | Screening | | | | Period 1 | | | | | | | | Period 2 | | | | | | | | | UA/SVac Post-TreatmentFollow-up | |----------------------------------------------------------------------------|-----------|---------|--------|--------|----------|-----|-----|-----|-----|-----|-----|-----|--------... | [] |
NCT03926130 | 2 | Introduction | 2 Introduction | [] |
NCT03926130 | 2.1 | Study Rationale | 2.1 Study Rationale Mirikizumab (LY3074828) is a humanized immunoglobulin G4 (IgG4) monoclonal antibody that binds to the p19 subunit of interleukin-23 (IL-23), a cytokine that has been implicated in mucosal inflammation. Study I6T-MC-AMAM (AMAM) is a Phase 3 clinical trial designed to evaluate the safety and efficacy ... | [] |
NCT03926130 | 2.2 | Background | 2.2 Background | [] |
NCT03926130 | 2.2.1 | Disease State and Treatment Goals | 2.2.1 Disease State and Treatment Goals Crohn's disease (CD) is a chronic disease of unknown etiology with environmental, genetic, and immunologic influences. Transmural inflammation affecting any part of the gastrointestinal tract from the mouth to the anus, usually appearing as discontinuous lesions, are normal chara... | [] |
NCT03926130 | 2.2.2 | Currently Available Treatments and Unmet Need | 2.2.2 Currently Available Treatments and Unmet Need Medications used for the treatment of CD may include aminosalicylic acid (5-ASA)–containing medications (sulfasalazine, mesalazine, balsalazide, olsalazine), corticosteroids or budesonide, immunomodulator (example: azathioprine [AZA], 6-mercaptopurine [6-MP], and meth... | [] |
NCT03926130 | 2.2.3 | Interleukin-23 as a Therapeutic Target in Crohn's Disease | 2.2.3 Interleukin-23 as a Therapeutic Target in Crohn's Disease The contribution of IL-12 and IL-23 in driving the pathophysiology of CD have been explored in genetic and animal model studies. These studies would suggest that IL-23 plays a predominant role in inflammatory bowel disease (IBD) and, indeed, blocking IL-23... | [] |
NCT03926130 | 2.2.4 | IL-23p19 Blockade in Crohn's Disease | 2.2.4 IL-23p19 Blockade in Crohn's Disease The efficacy of IL-23p19 blockade in CD has been demonstrated in recent Phase 2 studies evaluating the short-term efficacy and safety of two different IL-23p19 mAbs, risankizumab and MEDI2070 (Feagan et al. 2017, 2018; Sands et al. 2017). These Phase 2 studies explored a range... | [] |
NCT03926130 | 2.2.5 | Preclinical and Clinical Studies of Mirikizumab | 2.2.5 Preclinical and Clinical Studies of Mirikizumab Mirikizumab binds the IL-23p19 subunit of human IL-23 and prevents binding of IL-23 to the IL-23R, neutralizing the activity of human IL-23 in vitro. Mirikizumab also neutralizes human IL-23 in vivo, ameliorating the development of psoriasis-like skin inflammation i... | [
"Clinical studies in ulcerative colitis",
"Clinical studies in Crohn's disease"
] |
NCT03926130 | 2.3 | Benefit/Risk Assessment | 2.3 Benefit/Risk Assessment At the time of this benefit/risk assessment, mirikizumab has demonstrated efficacy in blinded, placebo-controlled Phase 2 studies in psoriasis (Reich et al. 2017b), UC (Sandborn et al. 2018; D'Haens et al. 2019) and CD. In the Phase 2 CD study AMAG, treatment with mirikizumab has shown clini... | [] |
NCT03926130 | 3 | Objectives and Endpoints | 3 Objectives and Endpoints The study primary and secondary objectives will be assessed based on the Primary Analysis Set as defined in Section [9.3.](#page-87-0) | Objectives | Endpoints | |----------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03926130 | 4 | Study Design | 4 Study Design | [] |
NCT03926130 | 4.1 | Overall Design | 4.1 Overall Design
Design Summary Study AMAM is a Phase 3, multicenter, randomized, double-blind, double-dummy, parallel group, active- and placebo-controlled, treat-through design (see schema in Section [1.2\)](#page-15-0). Three intervention groups in the first period and four intervention groups in the second perio... | [
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"Stratification",
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"Placebo Responders"
] |
NCT03926130 | 4.2 | Scientific Rationale for Study Design | 4.2 Scientific Rationale for Study Design Study AMAM is designed to evaluate the safety and efficacy of mirikizumab in clinical remission and endoscopic response at Weeks 12 and 52 of treatment.
Endpoints To evaluate the effect of mirikizumab on decreasing intestinal mucosa inflammation and symptoms of CD, the followi... | [
"Endpoints",
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"Ustekinumab as an active comparator"
] |
NCT03926130 | 4.3 | Justification for Dose | 4.3 Justification for Dose The mirikizumab 900 mg IV Q4W induction and 300 mg SC Q4W maintenance dose regimens selected for this study were based primarily on analyses of interim pharmacokinetics (PK), safety, and efficacy data from the Phase 2 Study AMAG, safety data from other clinical studies evaluating mirikizumab,... | [
"Safety Considerations",
"Considerations of Efficacy and Exposure–Response Relationships"
] |
NCT03926130 | 4.4 | End of Study Definition | 4.4 End of Study Definition The end of the study is defined as the date of the LV or last scheduled procedure shown in the SoA (Section [1.3\)](#page-16-0) for the last participant participating in this global study. | [] |
NCT03926130 | 5 | Study Population | 5 Study Population Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions, is not permitted. The investigator will maintain a screening log to record details of all participants screened and to confirm eligibility or record reasons for screening ... | [] |
NCT03926130 | 5.1 | Inclusion Criteria | 5.1 Inclusion Criteria Participants with CD are eligible for enrollment only if they meet all of the following criteria during screening, unless otherwise specified below.
Informed Consent [1] have given written informed consent approved by the Ethical Review Board (ERB) governing the site.
Participant Characteristic... | [
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"Disease-Specific Inclusion Criteria",
"Prior Medication Failure Criteria",
"AND",
"OR",
"OR",
"CD Medication Do... |
NCT03926130 | 5.2 | Exclusion Criteria | 5.2 Exclusion Criteria Participants will be excluded from study enrollment if they meet any of the following criteria within the screening period, unless otherwise specified below. For rescreening activities within the screening period, see Section [5.4.](#page-49-2)
Gastrointestinal Exclusion Criteria - [12] are part... | [
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"Criteria for Discontinuing Prohibited Medications",
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NCT03926130 | 5.2.1 | Rationale for Exclusion of Certain Study Candidates | 5.2.1 Rationale for Exclusion of Certain Study Candidates Both male and female participants are allowed to participate in this study. Participants will not be excluded on the basis of gender. Participants from ≥18 and ≤80 years of age at the time of screening will be eligible to be included in this study. Participants ... | [] |
NCT03926130 | 5.3 | Lifestyle Considerations | 5.3 Lifestyle Considerations Study participants should be instructed not to donate blood or blood products during the study and for 20 weeks following their last dose. To participate in the study, participants must agree to the contraception, reproduction, and breastfeeding criteria detailed in study entry criteria (Se... | [] |
NCT03926130 | 5.4 | Screen Failures | 5.4 Screen Failures Allowed rescreening of participants after initial screen failure Participants who have failed screening because of the following entry criteria may be rescreened when the reason for screen failure has resolved: - [4] - [5] - [6] - [8] - [9] - [10] only in situations out of control of the participant... | [
"Disallowed rescreening of participants after initial screen failure"
] |
NCT03926130 | 5.4.1 | Allowed Retesting of Screening Investigations | 5.4.1 Allowed Retesting of Screening Investigations Retesting of screening investigations within a screening period (without a requirement for screen failure and rescreening) is allowed as described below. The following screening investigations may be retested 1 time at the discretion of the investigator. - Screening h... | [] |
NCT03926130 | 6 | Study Intervention | 6 Study Intervention Study intervention is defined as any investigational intervention, marketed product, placebo, or medical device intended to be administered to a study participant according to the study protocol. | [] |
NCT03926130 | 6.1 | Study Intervention(s) Administered | 6.1 Study Intervention(s) Administered The study interventions used in this study are - Mirikizumab administered by IV infusion or SC injection - Ustekinumab administered by IV infusion or SC injection - Placebo administered by IV infusion or SC injection The doses and routes of administration reflect the multi-part st... | [
"Packaging and Labeling",
"Preparation and Administration",
"Time of Doses",
"Investigator Responsibilities"
] |
NCT03926130 | 6.2 | Preparation/Handling/Storage/Accountability | 6.2 Preparation/Handling/Storage/Accountability The investigator or his or her designee is responsible for the following: - confirming appropriate temperature conditions have been maintained during transit for all study treatment received and any discrepancies are reported and resolved before use of the study treatment... | [] |
NCT03926130 | 6.3 | Measures to Minimize Bias: Randomization and Blinding | 6.3 Measures to Minimize Bias: Randomization and Blinding
Randomization Assignment to treatment groups will be determined by a computer-generated random sequence using an IWRS. The stratification for randomization, as described in Section [9.4.1](#page-87-2) and Section [4.1,](#page-34-1) will be controlled by IWRS.
... | [
"Randomization",
"Blinding"
] |
NCT03926130 | 6.4 | Study Intervention Compliance | 6.4 Study Intervention Compliance All doses of study drug will be administered at the study site by site personnel. Deviations from the prescribed dosage regimen should be recorded in the eCRF. Every attempt will be made to select participants who have the ability to understand and comply with study instructions. The i... | [] |
NCT03926130 | 6.5 | Concomitant Therapy | 6.5 Concomitant Therapy
Recording of information about concomitant medications All concomitant medications, including endoscopy preparation medications taken during the study, must be recorded on the Concomitant Medication eCRF. This includes concomitant medications for CD as well as underlying conditions or diseases,... | [
"Recording of information about concomitant medications",
"Use of concomitant medications during the study"
] |
NCT03926130 | 6.5.1 | Permitted Therapy | 6.5.1 Permitted Therapy Participants taking permitted CD concomitant medications are to keep doses stable unless modifications are needed due to AEs or for appropriate medical management. Instructions regarding guidance for use are detailed in Appendix 10.7. | [] |
NCT03926130 | 6.5.2 | Prohibited Therapy | 6.5.2 Prohibited Therapy Use of such medications should not be withheld if, in the opinion of the investigator, failure to prescribe them would compromise participant safety. Participants who require a prohibited medication should be discontinued from study drug as described in Section [7.1.1](#page-60-2) and should co... | [
"Vaccinations",
"For more information"
] |
NCT03926130 | 6.5.3 | Corticosteroid Taper | 6.5.3 Corticosteroid Taper  | [] |
NCT03926130 | 6.5.4 | Rescue Medicine | 6.5.4 Rescue Medicine As noted in Section [6.5,](#page-55-0) participants who require a prohibited medication as described above to treat their CD should be discontinued from study drug as described in Section [7.1.1](#page-60-2) and should complete an ETV and post-treatment follow-up visits as described in the SoA (Se... | [] |
NCT03926130 | 6.6 | Dose Modification | 6.6 Dose Modification Dose modification of study drug is not permitted in this study. | [] |
NCT03926130 | 6.7 | Intervention after the End of the Study | 6.7 Intervention after the End of the Study | [] |
NCT03926130 | 6.7.1 | Study Extension | 6.7.1 Study Extension Participants who complete Study AMAM through Visit 17 will be assessed for eligibility to enter Study AMAX. If a participant does not meet enrollment criteria for Study AMAX or does not opt to continue into Study AMAX, he or she will be asked to complete the post-treatment followup period, as desc... | [] |
NCT03926130 | 6.7.2 | Treatment after Study Completion | 6.7.2 Treatment after Study Completion Mirikizumab and ustekinumab will not be made available to study participants after conclusion of the study; however, participants who are eligible may choose to participate in Study AMAX (Section [6.7.1\)](#page-57-2). | [] |
NCT03926130 | 6.7.3 | Special Treatment Considerations | 6.7.3 Special Treatment Considerations | [] |
NCT03926130 | 6.7.3.1 | Premedication for Infusions | 6.7.3.1 Premedication for Infusions Premedication for the study drug infusions or injections is not planned. Any premedication for infusions or injections should be discussed with the medical monitor. Any premedication given will be documented as a concomitant therapy (Section [6.5\)](#page-55-0). | [] |
NCT03926130 | 6.7.3.2 | Management of Hypersensitivity, Infusion-Related Events, Infusion Site Reactions, and Injection Site Reactions | 6.7.3.2 Management of Hypersensitivity, Infusion-Related Events, Infusion Site Reactions, and Injection Site Reactions During and after study drug administration, participants should be closely monitored for signs or symptoms of AEs, including hypersensitivity events, other infusion-related events, and infusion or inje... | [
"Hypersensitivity events",
"Other infusion-related events",
"Injection site reactions or infusion site reactions"
] |
NCT03926130 | 7 | Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | 7 Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal These sections describe reasons for - permanent or temporary discontinuation of study drug, or - participant's discontinuation (withdrawal) from the study. Discontinuation of the study as a whole or of particular study sites is described... | [] |
NCT03926130 | 7.1 | Discontinuation of Study Intervention | 7.1 Discontinuation of Study Intervention Study drug may be permanently discontinued or temporarily withheld during the study. Participants who permanently discontinue study drug early will undergo early termination procedures, which include - an ETV and, - post-treatment follow-up visits (Visit 801 and Visit 802). The... | [] |
NCT03926130 | 7.1.1 | Criteria for Permanent Discontinuation of Study Drug | 7.1.1 Criteria for Permanent Discontinuation of Study Drug Possible reasons leading to permanent discontinuation of study drug include, but are not limited to:
Subject Decision The participant requests to discontinue the study drug.
Disease Worsening - The participant requires treatment with a specified prohibited CD... | [
"Subject Decision",
"Disease Worsening",
"Safety Considerations",
"Hepatic Event or Liver Test Abnormality",
"Other Reasons"
] |
NCT03926130 | 7.1.2 | Criteria for Temporary Interruption (Withholding) of Study Drug | 7.1.2 Criteria for Temporary Interruption (Withholding) of Study Drug Cases that may merit temporary withholding of study drug should be discussed with the medical monitor. The medical monitor, in consultation with the investigator, will determine when it is appropriate to recommence study drug. Some possible reasons f... | [] |
NCT03926130 | 7.1.3 | Discontinuation of Inadvertently Enrolled Participants | 7.1.3 Discontinuation of Inadvertently Enrolled Participants If the sponsor or investigator identifies a participant who did not meet enrollment criteria and was inadvertently enrolled, the participant should be discontinued from study drug unless there are extenuating circumstances that make it medically necessary for... | [] |
NCT03926130 | 7.2 | Participant Discontinuation/Withdrawal from the Study | 7.2 Participant Discontinuation/Withdrawal from the Study Participants will be discontinued (withdrawn) from the study in the following circumstances: - enrollment in any other clinical study involving an investigational product or enrollment in any other type of medical research judged not to be scientifically or medi... | [] |
NCT03926130 | 7.3 | Lost to Follow up | 7.3 Lost to Follow up A participant will be considered lost to follow-up if he or she repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. Site personnel are expected to make diligent attempts to contact participants who fail to return for a scheduled visit or were otherwise ... | [] |
NCT03926130 | 8 | Study Assessments and Procedures | 8 Study Assessments and Procedures Study procedures and their timing, including tolerance limits for timing, are listed in the SoA (Section [1.3\)](#page-16-0). Adherence to the study design requirements, including those specified in the SoA, is essential and required for study conduct. The disease activity measurement... | [] |
NCT03926130 | 8.1 | Efficacy Assessments | 8.1 Efficacy Assessments The following table defines efficacy endpoints used in this study. | Endpoint | Definition | |-----------------------------------|----------------------------------------------------------------------------------------------| | Endoscopic response | ≥50% reduction from baseline in SES-CD total ... | [] |
NCT03926130 | 8.1.1 | Primary Efficacy Assessment | 8.1.1 Primary Efficacy Assessment The co-primary endpoints (mirikizumab versus placebo) are: - Proportion of participants achieving clinical response by PRO at Week 12 and endoscopic response at Week 52; and - Proportion of participants achieving clinical response by PRO at Week 12 and clinical remission by CDAI at Wee... | [
"Clinical Response by PRO",
"Endoscopic Response",
"Clinical Remission by CDAI"
] |
NCT03926130 | 8.1.1.1 | Crohn's Disease Activity Index (CDAI) | 8.1.1.1 Crohn's Disease Activity Index (CDAI) The CDAI is an 8-item disease activity measure comprised of a composite of 3 patient-reported and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Participant responses are summed over a 7-day period and all items are subsequen... | [] |
NCT03926130 | 8.1.1.2 | Simple Endoscopic Score for Crohn's Disease (SES-CD) | 8.1.1.2 Simple Endoscopic Score for Crohn's Disease (SES-CD) The SES-CD (Daperno et al. 2004) is an endoscopic scoring system for CD based on 4 endoscopic variables (presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis), w... | [] |
NCT03926130 | 8.1.1.3 | Endoscopy | 8.1.1.3 Endoscopy An endoscopy will be performed on all participants during screening, prior to randomization. The endoscopy report and histopathology report (if biopsies sent to the local histopathology laboratory) must be available in the source documents. Prior to performing the screening endoscopy, investigators sh... | [] |
NCT03926130 | 8.1.1.4 | Endoscopic Biopsies | 8.1.1.4 Endoscopic Biopsies Biopsies will be collected during the endoscopy procedure. Biopsies will be used for the assessment of exploratory biomarkers where permitted (Section [8.8\)](#page-84-2) and to support assessment of the histopathology endpoints (Section [8.1.3.2\)](#page-68-4). The biopsy samples will be se... | [] |
NCT03926130 | 8.1.2 | Secondary Efficacy Assessments | 8.1.2 Secondary Efficacy Assessments | [] |
NCT03926130 | 8.1.2.1 | Patient Reported Outcomes (PROs) | 8.1.2.1 Patient Reported Outcomes (PROs) The following PROs will be collected: - Via patient eDiary - o bowel movement count (BMC) - o CDAI-SF - Note: Bristol Stool Scale is used as a reference to complete CDAI-SF. - o CDAI-AP - o CDAI-Well-Being - o Abdominal Pain numeric rating scale (NRS) - o Urgency NRS - o Patient... | [] |
NCT03926130 | 8.1.2.2 | Inflammatory Biomarkers | 8.1.2.2 Inflammatory Biomarkers
High-sensitivity C-Reactive Protein (hsCRP) High-sensitivity C-reactive protein is an acute phase protein expressed by hepatocytes in response to inflammatory cytokines, particularly IL-6, TNF, and IL-1β (Sands 2015). High-sensitivity C-reactive protein will be obtained at time points d... | [
"High-sensitivity C-Reactive Protein (hsCRP)",
"Fecal Calprotectin"
] |
NCT03926130 | 8.1.2.3 | Extraintestinal Manifestations (EIMs) | 8.1.2.3 Extraintestinal Manifestations (EIMs) Review of EIMs will be performed at the time points described in the SoA (Section [1.3\)](#page-16-0). Extraintestinal manifestations include ankylosing spondylitis, anal fissure, fistula or abscess, other fistulae, arthritis/arthralgia, cholelithiasis, erythema nodosum, ne... | [] |
NCT03926130 | 8.1.2.4 | Fistulas | 8.1.2.4 Fistulas Additional data on bowel fistulas will be collected on an eCRF at the time points described in the SoA (Section [1.3\)](#page-16-0). | [] |
NCT03926130 | 8.1.3 | Exploratory Assessments | 8.1.3 Exploratory Assessments Other exploratory endpoints will be defined in the SAP. | [] |
NCT03926130 | 8.1.3.1 | Disease Severity Index-Crohn's Disease (DSI-CD) | 8.1.3.1 Disease Severity Index-Crohn's Disease (DSI-CD) The DSI-CD is a clinician's reported 16-item measurement scored by reviewing participant symptoms, physical assessment, labs, medications, physical activity, and pain. Scores range from 0 to 100, with a higher score indicating worse disease severity. This assessme... | [] |
NCT03926130 | 8.2 | Safety Assessments | 8.2 Safety Assessments
Visits and order of safety assessments Safety assessments occur at visits specified in the SoA (Section [1.3\)](#page-16-0). When multiple assessments are scheduled for the same visit, the preferred order of completion is: - vital signs first, - ECG (if applicable), and then - blood sampling las... | [
"Visits and order of safety assessments",
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"Safety monitoring"
] |
NCT03926130 | 8.2.1 | Vital Signs | 8.2.1 Vital Signs Measurements of vital signs (body temperature, blood pressure, and pulse rate) will be conducted at the study visits specified in the SoA (Section [1.3\)](#page-16-0). Sitting blood pressure and pulse rate should be measured after the participant has been sitting for at least 5 minutes. Any clinically... | [] |
NCT03926130 | 8.2.2 | Physical Examinations | 8.2.2 Physical Examinations Physical examinations are mandated and will be performed as specified in the SoA (Section [1.3\)](#page-16-0). Physical examinations can also be performed at the discretion of the investigator at any additional time points, for example, to assist in the evaluation of a new symptom during the... | [] |
NCT03926130 | 8.2.3 | Electrocardiograms | 8.2.3 Electrocardiograms Electrocardiograms (12-lead) will be conducted at the study visits specified in the SoA (Section [1.3\)](#page-16-0). Electrocardiograms should be completed prior to any blood draw. Participants should be supine for approximately 5 to 10 minutes before ECG collection and should remain supine an... | [] |
NCT03926130 | 8.2.4 | Chest Radiography | 8.2.4 Chest Radiography A posterior-anterior CXR, interpreted and reported by a radiologist or pulmonologist, will be obtained at screening, as specified in the SoA (Section [1.3\)](#page-16-0). A lateral CXR can also be obtained if, in the opinion of the investigator, a lateral view is indicated. Participants need not... | [] |
NCT03926130 | 8.2.5 | Stool Testing | 8.2.5 Stool Testing
Stool Culture A stool sample for culture will be obtained at screening. In order to be randomized, participants must have a negative stool culture from which no enteric pathogens are isolated. Retesting is allowed within the screening period if there is a technical difficulty in performing or repor... | [
"Stool Culture",
"C. difficile Toxin"
] |
NCT03926130 | 8.2.6 | Tuberculosis Testing | 8.2.6 Tuberculosis Testing
Initial screening All participants will be screened for active TB and LTBI.
Screening for LTBI will include the following: - Thorough medical and social history to determine risk factors for TB infection over lifetime, symptoms or signs of active TB, and physical examination, including body... | [
"Initial screening",
"Screening for LTBI will include the following:",
"Tests for immune response to mycobacterial antigens",
"Interpretation of screening tests for LTBI",
"Retesting and confirmatory testing",
"Monitoring for TB during the study",
"Diagnosis of LTBI during the study",
"Household conta... |
NCT03926130 | 8.2.7 | Clinical Laboratory Tests | 8.2.7 Clinical Laboratory Tests
Visits and times The clinical laboratory tests listed in Appendix [10.2](#page-102-0) will be conducted at the study visits specified in the SoA (Section [1.3\)](#page-16-0). Retesting is allowed during the screening period (see Section [5.4.1\)](#page-51-0). Additional clinical laborat... | [
"Visits and times",
"Central and local Testing",
"Provision of laboratory test results",
"Investigator responsibilities"
] |
NCT03926130 | 8.2.7.1 | Pregnancy Testing | 8.2.7.1 Pregnancy Testing Pregnancy testing is to be performed on all women unless they meet the criteria describing women not of childbearing potential, as outlined Section [5.1.](#page-39-1) Participants who are pregnant will be discontinued from the study (Section [7.1.1\)](#page-60-2).
Visits and times Serum pregn... | [
"Visits and times"
] |
NCT03926130 | 8.2.7.2 | Immunogenicity Assessment | 8.2.7.2 Immunogenicity Assessment
Visits and times At the visits and times specified in the SoA (Section [1.3\)](#page-16-0), venous blood samples will be collected to determine antibody production against mirikizumab. - Predose samples will be obtained per the SoA. - The actual date and time (24-hour clock time) of e... | [
"Visits and times",
"Sample collection, handling, and use",
"Sample retention"
] |
NCT03926130 | 8.2.8 | Hepatitis B Testing | 8.2.8 Hepatitis B Testing
HBV screening and interpretation Participants with acute or chronic hepatitis B infection are excluded from the study (see Section [5.2\)](#page-44-0). Screening for HBV in this study is performed as follows: an initial test for hepatitis B surface antigen (HBsAg) and hepatitis B core antibod... | [
"HBV screening and interpretation",
"Exclusion based on HBV serology and HBV DNA testing",
"Participants potentially allowed into the study, based on HBV serology and HBV DNA testing"
] |
NCT03926130 | 8.2.9 | Hepatitis C Testing | 8.2.9 Hepatitis C Testing Participants with current hepatitis C infection are excluded from the study (see Section [5.2\)](#page-44-0). Screening for HCV in this study is performed as follows: an initial test for HCV antibody, followed by a test for HCV RNA if the HCV antibody test is positive. Participants with a posi... | [] |
NCT03926130 | 8.2.10 | Hepatic Safety Monitoring | 8.2.10 Hepatic Safety Monitoring If a study participant experiences elevated ALT ≥3 × ULN, ALP ≥2 × ULN, or elevated TBL ≥2 × ULN, liver testing (described in Appendix [10.3\)](#page-104-0) should be repeated within 3 to 5 days including ALT, AST, ALP, TBL, direct bilirubin, gamma-glutamyl transferase, and creatine kin... | [
"Hepatic Safety Data Collection"
] |
NCT03926130 | 8.2.11 | Depression, and Suicidal Ideation and Behavior | 8.2.11 Depression, and Suicidal Ideation and Behavior Suicide-related events (behavior and/or ideations) will be assessed at screening with the administration of the C-SSRS. Depressive symptomology will be assessed with the QIDS-SR16 at the visits specified in the SoA (Section [1.3\)](#page-16-0). These assessments are... | [] |
NCT03926130 | 8.3 | Adverse Events and Serious Adverse Events | 8.3 Adverse Events and Serious Adverse Events Investigators are responsible for monitoring the safety of participants who have entered this study and for alerting Lilly or its designee to any event that seems unusual, even if this event may be considered an unanticipated benefit to the participant. The investigator is ... | [] |
NCT03926130 | 8.3.1 | Serious Adverse Events | 8.3.1 Serious Adverse Events An SAE is any AE from this study that results in one of the following outcomes: - death - initial or prolonged inpatient hospitalization - a life-threatening experience (that is, immediate risk of dying) - persistent or significant disability/incapacity - congenital anomaly/birth defect - i... | [] |
NCT03926130 | 8.3.1.1 | Suspected Unexpected Serious Adverse Reactions | 8.3.1.1 Suspected Unexpected Serious Adverse Reactions Suspected unexpected serious adverse reactions (SUSARs) are serious events that are not listed in the IB and that the investigator identifies as related to investigational product or procedure. United States 21 Code of Federal Regulations (CFR) 312.32 and European ... | [] |
NCT03926130 | 8.3.2 | Time Period and Frequency for Collecting AE and SAE Information | 8.3.2 Time Period and Frequency for Collecting AE and SAE Information AEs that begin before the first dose of study drug but after signing of the ICF will be recorded on the Adverse Event eCRF. Investigators are not obligated to actively seek AEs or SAEs in participants once the participant has discontinued and/or comp... | [] |
NCT03926130 | 8.3.2.1 | Adverse Event Monitoring with a Systematic Questionnaire | 8.3.2.1 Adverse Event Monitoring with a Systematic Questionnaire Spontaneous AE collection should occur prior to the collection of the C-SSRS or QIDS-SR16. If a suicide-related event is discovered during the C-SSRS but was not captured during the spontaneous AE collection, sites should not change the AE form. However, ... | [] |
NCT03926130 | 8.3.3 | Follow-up of AEs and SAEs | 8.3.3 Follow-up of AEs and SAEs The investigator responsibility for follow-up of AEs sand SAEs is described in Section [8.3.](#page-78-0) | [] |
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