protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02690714 | 9.1 | Quality Control by the Monitoring Team | 9.1 Quality Control by the Monitoring Team The Clinical Research Associates (CRA) will monitor the data collected throughout the study thus providing Quality Control (QC) of the study. Independent monitoring of the clinical study for protocol and GCP compliance will be conducted periodically at selected sites by qualif... | [] |
NCT02690714 | 9.2 | Quality Assurance by an Audit Team | 9.2 Quality Assurance by an Audit Team Any study site may be selected for audit at any time by an audit team originating from the sponsor or from an external organization acting on behalf of the sponsor. The investigator agrees to cooperate with the auditor to ensure that any problems detected in the course of these au... | [] |
NCT02690714 | 9.3 | Quality Assurance by Data Management | 9.3 Quality Assurance by Data Management The CRO or delegate will be responsible for QA and QC of the database and data management. Version 5 Page 61 of 75 Confidential IND Number: 16186 Protocol Number: 2002C011G | [] |
NCT02690714 | 10 | Ethics and Responsibility | 10 Ethics and Responsibility | [] |
NCT02690714 | 10.1 | Investigational Review Board/Ethics Committee | 10.1 Investigational Review Board/Ethics Committee Where possible a list of IRB/EC members should be obtained by the investigator and provided to the sponsor. The investigator/sponsor will obtain prior approval for this clinical trial, its corresponding ICFs, and any material viewed by the subject. The IRB/EC will be p... | [] |
NCT02690714 | 10.2 | Ethical Conduct of the Trial | 10.2 Ethical Conduct of the Trial The clinical study will be conducted in accordance with the current IRB/EC-approved clinical protocol; ICH E6 Guidelines on GCP; and relevant policies, requirements, and regulations of the IRB/EC and applicable federal agencies. Any violations by sites, CRO, or sponsor will also be sub... | [] |
NCT02690714 | 10.3 | Informed Consent and Assent | 10.3 Informed Consent and Assent The investigator must explain to each subject the nature of the study, the purpose, the procedures involved, the expected duration, the potential risks and benefits involved, and any discomfort it may entail. The investigational product(s) should be identified as "experimental" and that... | [] |
NCT02690714 | 10.4 | Changes in the Conduct of the Study | 10.4 Changes in the Conduct of the Study The investigator may change the protocol without IRB/EC or sponsor approval only if it is necessary in order to safeguard the safety or rights of the subjects (i.e., in emergent situations). Any protocol amendment must be submitted for information or consideration to the applica... | [] |
NCT02690714 | 11 | Confidentiality | 11 Confidentiality The collection and processing of personal data from subjects enrolled in this study will be limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of the IMP used in this study. The investigator will ensure that the subjects' anonymity will be maintained. T... | [] |
NCT02690714 | 12 | Publication Policy | 12 Publication Policy In collaboration with the sponsor, the CRO will prepare a draft study report after the completion of the study. The final draft study report will be submitted to the selected investigators for information, review, and comments. Publication of data generated in the study is governed by the Investig... | [] |
NCT02690714 | 13 | Liabilities and Insurance | 13 Liabilities and Insurance The sponsor will pay for all study related costs. A separate financial agreement will be made (as appropriate) with the investigator and/or institutions. The sponsor also carries insurance coverage for incidents of damage or injury to study subjects while participating in the study or takin... | [] |
NCT02690714 | 14 | References | 14 References Bateman JB, Pettit TH, Isenberg SJ, Simons KB. (1986) Ligneous conjunctivitis: an autosomal recessive disorder. J Pediatr Ophthalmol Strabismus. 23(3):137-40. Bugge TH, Flick MJ, Daugherty CC, Degen JL. (1995) Plasminogen deficiency causes severe thrombosis but is compatible with development and reproduct... | [] |
NCT02690714 | 15 | Appendices | 15 Appendices | [] |
NCT02690714 | 15.1 | Declaration of Helsinki | 15.1 Declaration of Helsinki
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975 35th WMA General Assembly, Venice, Italy, October ... | [
"WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects",
"Preamble",
"General Principles",
"Risks, Burdens and Benefits",
"Vulnerable Groups and Individuals",
"Scientific Requirements and Research Protocols",
"Research Ethics Committees",
"Privacy and Confident... |
NCT02690714 | 15.2 | Clinical Laboratory Tests | 15.2 Clinical Laboratory Tests | Hematology | red blood cell count (RBC), white blood cell count (WBC), platelets,hemoglobin, and hematocrit | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------... | [] |
NCT02690714 | 15.3 | Clinical Global Impression – Global Improvement (CGI-I) | 15.3 Clinical Global Impression – Global Improvement (CGI-I) | PatientName: | | Date: | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | Clinician Name: | | | | P... | [] |
NCT02690714 | 15.4 | Quality of life assessment | 15.4 Quality of life assessment  Version 5 Page 75 of 75 Confidential | [] |
NCT02706847 | 1.1 | Protocol Amendment: Summary of Changes | 1.1 Protocol Amendment: Summary of Changes
Previous Protocol Versions | Protocol | Date | |---------------------------------|-------------------| | Original | 21 January 2016 | | Amendment 1 | 29 February 2016 | | Amendment 1.01 (Sweden Only) | 06 May 2016 | | Amendment1.02 (France Only) | 09 May 2016 | | Amendment 1.... | [
"Previous Protocol Versions",
"The purpose of this amendment is to:",
"○ Clinical Laboratory Tests"
] |
NCT02706847 | 1.2 | Synopsis | 1.2 Synopsis | AbbVie | Protocol Number: M13-542 | | |-----------------------------------------|------------------------------------------------|--| | Name of Study Drug: Upadacitinib | Phase of Development: 3 | | | Name of Active Ingredient: Upadacitinib | Date of Protocol Synopsis: 08December 2020 | | Protocol Title:... | [
"Objectives:",
"Period 1",
"Period 2",
"Study Population:",
"Methodology:",
"Methodology (Continued):",
"Diagnosis and Main Criteria for Inclusion/Exclusion:",
"Main Inclusion:",
"Diagnosis and Main Criteria for Inclusion/Exclusion (Continued):",
"Main Exclusion:",
"Criteria for Evaluation:",
... |
NCT02706847 | 1.3 | List of Abbreviations and Definition of Terms | 1.3 List of Abbreviations and Definition of Terms
Abbreviations ACR American College of Rheumatology AE adverse event ALC absolute lymphocyte count ALT alanine transaminase ANC absolute neutrophil count anti-CCP anti-cyclic citrullinated peptide AST aspartate transaminase BCG Bacille Calmette-Guérin bDMARD biologic di... | [
"Abbreviations",
"Upadacitinib M13-542 Protocol Amendment 6 EudraCT 2015-003335-35",
"M13-542 Protocol Amendment 6 EudraCT 2015-003335-35",
"Upadacitinib M13-542 Protocol Amendment 6 EudraCT 2015-003335-35",
"List of Tables"
] |
NCT02706847 | 3.0 | Introduction | 3.0 Introduction
Rheumatoid Arthritis Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease of unknown etiology. The hallmark feature of RA is an inflammatory process manifested by persistent symmetric polyarthritis of synovial joints which can ultimately lead to bone erosions, deformity, and disability... | [
"Rheumatoid Arthritis",
"JAK Inhibitor",
"Phase 2 Studies with Upadacitinib"
] |
NCT02706847 | 3.1 | Differences Statement | 3.1 Differences Statement Study M13-542 differs from other upadacitinib studies as it is the first study to evaluate the safety and efficacy of upadacitinib in subjects with inadequate response to or intolerance to any bDMARDs.  | [] |
NCT02706847 | 3.2 | Benefits and Risks | 3.2 Benefits and Risks Despite the availability of various RA therapies, including csDMARDs and bDMARDs, many patients still do not respond adequately to these treatments, or gradually lose response over time. Upadacitinib is a novel selective JAK1 inhibitor with the ability to decrease joint inflammation and damage me... | [] |
NCT02706847 | 4.0 | Study Objectives | 4.0 Study Objectives
Period 1 To compare the safety and efficacy of upadacitinib 30 mg QD and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of RA in bDMARD-inadequate response (bDMARD-IR) or bDMARD-intolerant subjects with moderately to severely active RA.
Period 2 To e... | [
"Period 1",
"Period 2"
] |
NCT02706847 | 5.0 | Investigational Plan | 5.0 Investigational Plan | [] |
NCT02706847 | 5.1 | Overall Study Design and Plan: Description | 5.1 Overall Study Design and Plan: Description This is a Phase 3, multicenter study that includes two periods. Period 1 is the 24-week randomized, double-blind, parallel-group, placebo-controlled period designed to compare the safety and efficacy of upadacitinib 30 mg QD and 15 mg QD versus placebo for the treatment of... | [
"Screening Period",
"Period 1 (24-Week Randomized, Double-Blind Treatment Period)",
"Period 2 (Long-Term Extension Period [236 Weeks])",
"Discontinuation of Study Drug and Continuation of Study Participation Period 1 and Period 2)",
"Premature Discontinuation of Study (Withdrawal of Informed Consent) (Perio... |
NCT02706847 | 5.2 | Selection of Study Population | 5.2 Selection of Study Population It is anticipated that approximately 450 subjects with moderately to severely active RA will be randomized at approximately 300 study centers, globally. A subject may be enrolled in this study provided that he/she has met all of the inclusion criteria specified in Section [5.2.1](#page... | [] |
NCT02706847 | 5.2.1 | Inclusion Criteria | 5.2.1 Inclusion Criteria - 1. Adult male or female, at least 18 years old. - 2. Diagnosis of RA for ≥ 3 months who also fulfill the 2010 ACR/EULAR classification criteria for RA. - 3. Subjects have been treated with bDMARD therapy for RA in the past and failed at least 1 bDMARD therapy prior to first dose of study drug... | [
"Rationale for Inclusion Criteria"
] |
NCT02706847 | 5.2.2 | Exclusion Criteria | 5.2.2 Exclusion Criteria - 1. Prior exposure to any JAK inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). - 2. History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus er... | [
"Rationale for Exclusion Criteria"
] |
NCT02706847 | 5.2.3 | Prior, Concomitant, and Prohibited Therapy | 5.2.3 Prior, Concomitant, and Prohibited Therapy Any medication or vaccine (including over-the-counter or prescription medicines, vitamins and/or herbal supplements including folic acid) that the subject is receiving within 28 days prior to Screening, or receives during the study, must be recorded along with the reason... | [
"csDMARD Washout"
] |
NCT02706847 | 5.2.3.1 | Permitted Background RA Therapy | 5.2.3.1 Permitted Background RA Therapy Subjects should continue on their stable (≥ 4 weeks prior to the first dose of study drug) background csDMARD therapy (restricted to oral or parenteral MTX, [7.5 to 25 mg/week], sulfasalazine [≤ 3000 mg/day], hydroxychloroquine, [≤ 400 mg/day], chloroquine [≤ 250 mg/day], and lef... | [] |
NCT02706847 | 5.2.3.2 | Prohibited Therapy | 5.2.3.2 Prohibited Therapy
JAK Inhibitor Prior exposure to JAK inhibitors and concurrent use during the study (including but not limited to tofacitinib [Xeljanz®], baricitinib, and filgotinib) is not allowed. 
Corticosteroids Oral corticosteroids > 10 mg prednisone/day or equivalent and intra-... | [
"JAK Inhibitor",
"Corticosteroids",
"Biologic Therapies",
"Strong CYP3A Inhibitors or Inducers",
"Opiates",
"Investigational Drugs",
"Vaccines",
"Traditional Chinese Medicine"
] |
NCT02706847 | 5.2.4 | Contraception Recommendations | 5.2.4 Contraception Recommendations
Contraception Recommendation for Females A woman who is postmenopausal or permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy) is not considered to be a woman of childbearing potential and is not required to follow contraception recommenda... | [
"Contraception Recommendation for Females",
"Contraception Recommendation for Males"
] |
NCT02706847 | 5.3.1.1 | Study Procedures | 5.3.1.1 Study Procedures The study procedures outlined in [Appendix](#page-155-1) D and [Appendix](#page-161-1) F are discussed in detail in this section, with the exception of in vivo pharmacodynamic biomarkers (discussed in Section [5.3.1.2.1\)](#page-76-1), exploratory research and validation studies (discussed in S... | [
"Informed Consent",
"Inclusion/Exclusion Criteria",
"Medical and Surgical History",
"Patient Questionnaires",
"Period 1",
"Period 2",
"TB Testing/TB Prophylaxis",
"TB test:",
"TB prophylaxis:",
"Of note: Rifampicin or Rifapentine are not allowed for TB prophylaxis.",
"Chest X-Ray (CXR)",
"12-L... |
NCT02706847 | 5.3.1.2 | Collection and Handling of In Vivo Pharmacodynamic Biomarker and Optional Samples for Exploratory Research and Validation Studies | 5.3.1.2 Collection and Handling of In Vivo Pharmacodynamic Biomarker and Optional Samples for Exploratory Research and Validation Studies | [] |
NCT02706847 | 5.3.1.2.1 | In Vivo Pharmacodynamic Biomarker Samples | 5.3.1.2.1 In Vivo Pharmacodynamic Biomarker Samples Blood samples will be collected at the visits indicated in [Appendix](#page-155-1) D and [Appendix](#page-161-1) F and will be utilized to assess effects of upadacitinib inhibition on certain lymphocyte subsets, including but not limited to T (CD4+ and CD8+) cells, B ... | [] |
NCT02706847 | 5.3.1.2.2 | Optional Samples for Exploratory Research and Validation Studies | 5.3.1.2.2 Optional Samples for Exploratory Research and Validation Studies In Period 1, subjects will have the option to provide samples for exploratory research and validation studies. Subjects may still participate in the study even if they decide not to participate in this optional exploratory research/validation st... | [
"DNA Samples for Pharmacogenetic or Epigenetic Analyses",
"RNA Samples for Transcriptomic and/or Epigenetic Analyses",
"Serum and Plasma Samples for Systemic Analyses, Including but Not Limited to Proteomic and Metabolomic"
] |
NCT02706847 | 5.3.2 | Drug Concentration Measurements | 5.3.2 Drug Concentration Measurements | [] |
NCT02706847 | 5.3.2.1 | Collection of Samples for Analysis | 5.3.2.1 Collection of Samples for Analysis Blood samples for assay of upadacitinib and possibly other concomitant medications will be collected as follows: - Weeks 1 and 2 prior to dosing; - Weeks 4, 8, 12, 16, 20, and 24/PD at any time during the visit. On Week 1 and Week 2 visit days, if possible, subjects should tak... | [] |
NCT02706847 | 5.3.2.2 | Measurement Methods | 5.3.2.2 Measurement Methods Plasma concentrations of upadacitinib will be determined by the Drug Analysis Department at AbbVie using a validated liquid chromatography/mass spectrometry method. | [] |
NCT02706847 | 5.3.3 | Efficacy Variables | 5.3.3 Efficacy Variables | [] |
NCT02706847 | 5.3.3.1 | Period 1 Variables | 5.3.3.1 Period 1 Variables | [] |
NCT02706847 | 5.3.3.1.1 | Primary Variable | 5.3.3.1.1 Primary Variable The primary endpoint is the proportion of subjects achieving ACR20 response (US/FDA regulatory purposes) or the proportion of subjects achieving LDA (EU/EMA regulatory purposes) at Week 12. Analyses will be conducted separately for US/FDA regulatory purposes and EU/EMA regulatory purposes; fo... | [] |
NCT02706847 | 5.3.3.1.2 | Key Secondary Variables | 5.3.3.1.2 Key Secondary Variables Ranked key secondary endpoints (at Week 12) for US/FDA regulatory purposes are: - 1. Change from baseline in DAS28 (CRP); - 2. Change from baseline in HAQ-DI; - 3. LDA as measured by DAS28 (CRP); - 4. Change from baseline in SF-36 Physical Component Score (PCS); Ranked key secondary en... | [
"3. ACR20 response rate at Week 1."
] |
NCT02706847 | 5.3.3.1.3 | Additional Variables | 5.3.3.1.3 Additional Variables Additional endpoints at all visits are: - Change from baseline in individual components of ACR response; - ACR20/50/70 response rates; - Change from baseline in DAS28 (CRP) and DAS28 (erythrocyte sedimentation rate [ESR]); - Change from baseline in CDAI and SDAI; - Change from baseline in... | [] |
NCT02706847 | 5.3.3.2 | Period 2 Variables | 5.3.3.2 Period 2 Variables Assessments to evaluate efficacy of treatment in Period 2 will be analyzed for the following measures at Weeks 36, 48, every 12 weeks through Week 240, and Week 260/PD: - ACR20/50/70 response rates; - Change from baseline in individual ACR components; - Change from baseline in DAS28 (CRP); - ... | [] |
NCT02706847 | 5.3.4 | Safety Variables | 5.3.4 Safety Variables Safety evaluations include adverse event monitoring, physical examinations, vital sign measurements, ECG, and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration.  | [] |
NCT02706847 | 5.3.5 | Pharmacokinetic Variables | 5.3.5 Pharmacokinetic Variables Plasma upadacitinib concentrations will be obtained at the times indicated in [Appendix](#page-155-1) D. A non-linear mixed-effects modeling approach will be used to estimate the population central values and the empirical Bayesian estimates of the individual values of upadacitinib oral ... | [] |
NCT02706847 | 5.3.6 | In Vivo Pharmacodynamic Biomarker Samples and Exploratory Research Variables and Validation Studies | 5.3.6 In Vivo Pharmacodynamic Biomarker Samples and Exploratory Research Variables and Validation Studies | [] |
NCT02706847 | 5.3.6.1 | In Vivo Pharmacodynamic Biomarker Samples | 5.3.6.1 In Vivo Pharmacodynamic Biomarker Samples Blood samples will be collected to assess the effects of upadacitinib inhibition on lymphocyte subsets including but not limited to: T (CD4+ and CD8+) cells, B (CD19+) cells, NK cells, and NKT cells. | [] |
NCT02706847 | 5.3.6.2 | Exploratory Research Variables and Validation Studies | 5.3.6.2 Exploratory Research Variables and Validation Studies Optional samples may be collected to conduct exploratory investigations into known and novel biomarkers. The types of biomarkers to be analyzed may include, but are not limited to nucleic acids, proteins, lipids, or metabolites. Biomarker assessments may be ... | [] |
NCT02706847 | 5.4 | Removal of Subjects from Therapy or Assessment | 5.4 Removal of Subjects from Therapy or Assessment | [] |
NCT02706847 | 5.4.1 | Discontinuation of Individual Subjects | 5.4.1 Discontinuation of Individual Subjects Subjects can request to be discontinued from participating in the study at any time for any reason including but not limited to disease progression or lack of response to treatment. The Investigator may discontinue any subject's participation for any reason, including an AE,... | [
"Lost to Follow-Up"
] |
NCT02706847 | 5.4.2 | Discontinuation of Entire Study | 5.4.2 Discontinuation of Entire Study AbbVie may terminate this study prematurely, either in its entirety or at any study site, for reasonable cause provided that written notice is submitted in advance of the intended termination. The Investigator may also terminate the study at his/her site for reasonable cause, after... | [] |
NCT02706847 | 5.5 | Treatments | 5.5 Treatments | [] |
NCT02706847 | 5.5.1 | Treatments Administered | 5.5.1 Treatments Administered Study drug will be taken orally once daily, beginning on Day 1 (Baseline), and should be taken at approximately the same time each day. The study drug can be taken with or without food. Subjects will continue their weekly stable background therapy of csDMARD(s). AbbVie will not supply csDM... | [] |
NCT02706847 | 5.5.2 | Identity of Investigational Product | 5.5.2 Identity of Investigational Product The individual study drug information is presented in [Table](#page-87-6) 3. Table 3. Identity of Investigational Product | Investigational Product | Mode of Administration | Formulation | Strength | Manufacturer | |--------------------------------------------|-----------------... | [] |
NCT02706847 | 5.5.2.1 | Packaging and Labeling | 5.5.2.1 Packaging and Labeling Upadacitinib (ABT-494) and matching placebo will be packaged in bottles with quantities sufficient to accommodate study design. Each kit label will contain a unique kit number. This kit number is assigned to a subject via IRT and encodes the appropriate study drug to . The investigational products are for investigational use only and are to be used only within the context of this study. The study drug supplied for this study must be maintained under adeq... | [] |
NCT02706847 | 5.5.3 | Method of Assigning Subjects to Treatment Groups | 5.5.3 Method of Assigning Subjects to Treatment Groups All subjects will be randomized using IRT. Before the study is initiated, IRT directions will be provided to each site. All subjects will be assigned a unique identification number by the IRT at the Screening Visit. For subjects that re-screen, the Screening number... | [] |
NCT02706847 | 5.5.4 | Selection and Timing of Dose for Each Subject | 5.5.4 Selection and Timing of Dose for Each Subject Subjects should take study drug as outlined in Section [5.5.1.](#page-87-0) On dosing days that occur on study visit days, subjects should follow the regular dosing schedule (refer to Section [5.3.2.1](#page-78-1) regarding Week 1 and Week 2 visits). Each subject's do... | [] |
NCT02706847 | 5.5.5 | Blinding | 5.5.5 Blinding | [] |
NCT02706847 | 5.5.5.1 | Blinding of Investigational Product | 5.5.5.1 Blinding of Investigational Product All AbbVie personnel with direct oversight of the conduct and management of the trial (with the exception of AbbVie Drug Supply Management Team), the Investigator, study site personnel, and the subject will remain blinded to each subject's treatment throughout the study. Star... | [] |
NCT02706847 | 5.5.5.2 | Blinding of Data for Data Monitoring Committee (DMC) | 5.5.5.2 Blinding of Data for Data Monitoring Committee (DMC) An external Data Monitoring Committee (DMC) comprised of persons independent of AbbVie and with relevant expertise in their field will review unblinded safety data from the ongoing study. The primary responsibility of the DMC will be to protect the safety of ... | [] |
NCT02706847 | 5.5.6 | Treatment Compliance | 5.5.6 Treatment Compliance The Investigator or his/her designated and qualified representatives will administer/dispense study drug only to subjects enrolled in the study in accordance with  the protocol. The study drug must not be used for reasons other than that described in the protocol. Subj... | [] |
NCT02706847 | 5.5.7 | Drug Accountability | 5.5.7 Drug Accountability The Investigator or his/her representative will verify that study drug supplies are received intact and in the correct amounts. This will be documented by signing and dating the Proof of Receipt or similar document and by registering the arrival of drug through the IRT. The original Proof of R... | [] |
NCT02706847 | 5.6 | Discussion and Justification of Study Design | 5.6 Discussion and Justification of Study Design | [] |
NCT02706847 | 5.6.1 | Discussion of Study Design and Choice of Control Groups | 5.6.1 Discussion of Study Design and Choice of Control Groups This study includes two periods: Period 1 is a 24-week, randomized, double-blind, placebo-controlled period to compare safety and efficacy of upadacitinib versus placebo in subjects with moderately to severely active RA who have an inadequate response to or ... | [] |
NCT02706847 | 5.6.2 | Appropriateness of Measurements | 5.6.2 Appropriateness of Measurements Standard statistical, clinical, and laboratory procedures will be utilized in this study. All efficacy measurements in this study are standard for assessing disease activity in subjects with RA. All clinical and laboratory procedures in this study are standard and generally accepte... | [] |
NCT02706847 | 5.6.3 | Suitability of Subject Population | 5.6.3 Suitability of Subject Population The intended study population is moderately to severely active RA patients who have had an inadequate response to or intolerance to prior bDMARD treatment. Key entry criteria are to enroll adult female and male subjects who are at least 18 years of age with a diagnosis of RA for ... | [] |
NCT02706847 | 5.6.4 | Selection of Doses in the Study | 5.6.4 Selection of Doses in the Study Two doses of the once-daily formulation of upadacitinib will be evaluated: upadacitinib 15 mg QD and 30 mg QD. The dose selection in this study is based on extrapolation of pre-clinical efficacy models and analyses of PK, pharmacodynamic, safety, and efficacy data from the Phase 1 ... | [] |
NCT02706847 | 6.0 | Complaints | 6.0 Complaints A Complaint is any written, electronic, or oral communication that alleges deficiencies related to the physical characteristics, identity, quality, purity, potency, durability, reliability, safety, effectiveness, or performance of a product/device after it is released for distribution. Complaints associa... | [] |
NCT02706847 | 6.1 | Medical Complaints | 6.1 Medical Complaints The Investigator will monitor each subject for clinical and laboratory evidence of AEs on a routine basis throughout the study. The Investigator will assess and record any AE in detail including the date of onset, event diagnosis (if known) or sign/symptom, severity, time course (end date, ongoin... | [] |
NCT02706847 | 6.1.1 | Definitions | 6.1.1 Definitions | [] |
NCT02706847 | 6.1.1.1 | Adverse Event | 6.1.1.1 Adverse Event An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal ... | [] |
NCT02706847 | 6.1.1.2 | Serious Adverse Events | 6.1.1.2 Serious Adverse Events If an AE meets any of the following criteria, it is to be reported to AbbVie as an SAE within 24 hours of the site being made aware of the SAE. | Death of Subject | An event that results in the death of a subject. | |----------------------------------------------------------|-------------... | [] |
NCT02706847 | 6.1.1.3 | Adverse Events of Special Interest | 6.1.1.3 Adverse Events of Special Interest The following AEs of special interest will be monitored during the study (see detailed toxicity management in Section [6.1.7\)](#page-103-0): - Serious infections - Opportunistic infections - Herpes zoster - Active tuberculosis - Malignancy (all types) - Adjudicated gastrointe... | [] |
NCT02706847 | 6.1.2 | Adverse Event Severity | 6.1.2 Adverse Event Severity The Investigator will classify adverse events according to the Rheumatology Common Toxicity Criteria v.2.0 ([Appendix](#page-185-1) Q).[22](#page-134-1) | [] |
NCT02706847 | 6.1.3 | Relationship to Study Drug | 6.1.3 Relationship to Study Drug The Investigator will use the following definitions to assess the relationship of the AE to the use of study drug: | ReasonablePossibility | After consideration of factors including timing of the event,biologic plausibility, clinical judgment, and potential alternativecauses, there is s... | [] |
NCT02706847 | 6.1.4 | Adverse Event Collection Period | 6.1.4 Adverse Event Collection Period All AEs reported from the time of study drug administration until 30 days following discontinuation of study drug administration have elapsed will be collected, whether solicited or spontaneously reported by the subject. Subjects who discontinue study drug treatment but continue to... | [] |
NCT02706847 | 6.1.5 | Serious Adverse Event Reporting | 6.1.5 Serious Adverse Event Reporting In the event of an SAE, whether associated with study drug or not, the Investigator will notify Clinical Pharmacovigilance within 24 hours of the site being made aware of the SAE by entering the SAE data into the electronic data capture (EDC) system (RAVE®). SAEs that occur prior t... | [
"Phone: +1 (973) 784-6402"
] |
NCT02706847 | 6.1.7 | Toxicity Management | 6.1.7 Toxicity Management The toxicity management of the AEs including AEs of special interest consists of safety monitoring (review of AEs on an ongoing basis, and periodical/ad hoc review of safety issues by a safety data monitoring committee), interruption of study drug dosing with appropriate clinical management if... | [
"[Table](#page-105-1) 4. Specific Toxicity Management Guidelines for Abnormal Laboratory Values (Continued)",
"Period 1",
"Period 2"
] |
NCT02706847 | 6.1.8 | Data Monitoring Committee | 6.1.8 Data Monitoring Committee An external DMC will review unblinded safety data. See Section [5.5.5.2](#page-91-0) for details. | [] |
NCT02706847 | 6.1.9 | Cardiovascular Adjudication Committee | 6.1.9 Cardiovascular Adjudication Committee An independent committee of physician experts in cardiovascular adjudication will be utilized to assess potential cardiovascular AEs in a blinded manner as defined by the Cardiovascular Adjudication Committee charter. | [] |
NCT02706847 | 6.2 | Product Complaint | 6.2 Product Complaint | [] |
NCT02706847 | 6.2.1 | Definition | 6.2.1 Definition A Product Complaint is any Complaint (see Section [6.0](#page-95-0) for the definition) related to the biologic or drug component of the product. For a product this may include, but is not limited to, damaged/broken product or packaging, product appearance whose color/markings do not match the labeling... | [] |
NCT02706847 | 6.2.2 | Reporting | 6.2.2 Reporting Product Complaints concerning the investigational product must be reported to the Sponsor within 24 hours of the study site's knowledge of the event via the Product Complaint form. Product Complaints occurring during the study will be followed-up to a satisfactory conclusion. Product Complaints occurrin... | [] |
NCT02706847 | 7.0 | Protocol Deviations | 7.0 Protocol Deviations AbbVie does not allow intentional/prospective deviations from the protocol unless when necessary to eliminate an immediate hazard to study subjects. The Principal Investigator is responsible for complying with all protocol requirements, and applicable global and local laws regarding protocol dev... | [
"Size 8.1 Statistical and Analytical Plans"
] |
NCT02706847 | 8.1.1 | Analysis Populations | 8.1.1 Analysis Populations | [] |
NCT02706847 | 8.1.1.1 | Full Analysis Set | 8.1.1.1 Full Analysis Set The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug. The FAS will be used for all efficacy and baseline analyses. | [] |
NCT02706847 | 8.1.1.2 | Per Protocol Analysis Set | 8.1.1.2 Per Protocol Analysis Set The Per Protocol Analysis Set represents a subset of the FAS and consists of all FAS subjects who did not meet any major protocol violations during the study. Definitions of major protocol violations will be detailed in the SAP. Additional analysis may be conducted on the Per Protocol ... | [] |
NCT02706847 | 8.1.1.3 | Safety Analysis Set | 8.1.1.3 Safety Analysis Set The Safety Analysis Set consists of all subjects who received at least one dose of study drug. For the Safety Analysis Set, subjects are assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. | [] |
NCT02706847 | 8.1.2 | Subject Accountability, Disposition and Study Drug Exposure | 8.1.2 Subject Accountability, Disposition and Study Drug Exposure | [] |
NCT02706847 | 8.1.2.1 | Subject Accountability | 8.1.2.1 Subject Accountability The following will be summarized by site and by treatment group as well as overall, separately for Period 1 and Period 2: number of subjects randomized, the number of subjects who received at least one dose of study drug, the number of subjects who completed, the number of subjects who pr... | [] |
NCT02706847 | 8.1.2.2 | Subject Disposition | 8.1.2.2 Subject Disposition Separately for Period 1 and Period 2, the number and percentage of subjects who are randomized, received at least one dose of study drug, prematurely discontinued study drug, prematurely discontinued study participation, and completed will be summarized by treatment group and overall. Reason... | [] |
NCT02706847 | 8.1.2.3 | Study Drug Exposure | 8.1.2.3 Study Drug Exposure Exposure to study drug will be summarized for the Safety Analysis Set for Period 1 alone as well as for Period 1 and Period 2 combined. The exposure to study drug (days) will be summarized with the mean, standard deviation, median, and range for each treatment group. Study drug compliance wi... | [] |
NCT02706847 | 8.1.3 | Analysis of Demographic and Baseline Characteristics | 8.1.3 Analysis of Demographic and Baseline Characteristics Demographic and baseline characteristics will be summarized by treatment group and overall for the FAS. For the purpose of this analysis, baseline data for each subject will be the data collected immediately prior to the first dose of study drug in Period 1. Su... | [] |
NCT02706847 | 8.1.4 | Efficacy Analyses | 8.1.4 Efficacy Analyses All efficacy analyses will be carried out using the FAS population, which includes all randomized subjects who receive at least one dose of study drug. | [] |
NCT02706847 | 8.1.4.1 | Efficacy Analysis for Period 1 | 8.1.4.1 Efficacy Analysis for Period 1 For all efficacy analysis in Period 1, the two placebo groups (Groups 3 and 4) will be combined and treated as one placebo group for analysis purposes. Each upadacitinib dose will be compared with the combined placebo group. | [] |
NCT02706847 | 8.1.4.1.1 | Primary Efficacy Variable | 8.1.4.1.1 Primary Efficacy Variable The primary endpoint (at Week 12) for US/FDA regulatory purposes is listed in Section [5.3.3.1.1.](#page-79-3) The primary endpoint (at Week 12) for EU/EMA regulatory purposes is also listed in Section [5.3.3.1.1](#page-79-3). Analyses will be conducted separately for US/FDA regulato... | [] |
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