chufangao/CTO huggingface dataset:
Clinical trial NCT03221634: Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668)
Official title: A Phase 2 Study of Pembrolizumab in Combination With Daratumumab (Anti CD38) in Participants With Relapsed Refractory Multiple Myeloma (rrMM)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Business Reasons
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-08-01
Primary completion date: 2019-03-20
Completion date: 2021-06-10
Clinical trial NCT06090318: Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss
Official title: A Phase 1b/2Study of Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss (MANTRA-4)
Sponsor: Rain Oncology Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-05-19
Primary completion date: 2023-05-30
Completion date: 2023-05-30
Clinical trial NCT03635047: A Phase I Study for Safety and Tolerability of AL002.
Official title: A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL002 in Healthy Participants and in Participants With Mild to Moderate Alzheimer's Disease
Sponsor: Alector Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 69.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-12
Primary completion date: 2020-08-03
Completion date: 2020-11-25
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04501679: A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
Sponsor: Galderma R&D (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 274.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-11
Primary completion date: 2022-03-30
Completion date: 2022-03-31
Baseline population: Intent-to-treat (ITT) population included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized data sets from which results presented are derived.
IPD time frame: Data availability will begin 6 months after approval of the indication by a regulatory body.~Data availability will end 5 years from publication of the primary study results article.
IPD access criteria: Data will be made available to qualified science and medical researchers upon formal request and submission of research proposal detailing planned analyses. Proposals should be directed to clinical.studies@galderma.com
Clinical trial NCT04081597: A Study of Single Ascending Doses of STAR-101 in Healthy Participants
Official title: A Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of STAR-101 in Healthy Subjects
Sponsor: Acanthas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Change in Clinical Strategy
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-29
Primary completion date: 2020-03-31
Completion date: 2020-03-31
Clinical trial NCT06281236: A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)
Official title: A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)
Sponsor: Sparrow Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Change of corporate priorities
Enrollment: 24.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2024-02-22
Primary completion date: 2024-10-01
Completion date: 2024-10-01
Plan to share individual participant data: NO
Clinical trial NCT05082493: A Multicenter, Study of the Safety and Pharmacokinetics of Intravenously Infused Berubicin in Pediatric Patients With Progressive, Refractory, or Recurrent High Grade Gliomas
Official title: A Phase 1, Multicenter, Open-label, Dose Escalation Study of the Safety and Pharmacokinetics of Intravenously Infused Berubicin in Pediatric Patients With Progressive, Refractory, or Recurrent High Grade Gliomas
Sponsor: WPD Pharmaceuticals Sp. z o.o. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-12-31
Primary completion date: 2023-12-30
Completion date: 2023-12-30
Plan to share individual participant data: NO
Clinical trial NCT05071183: A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors
Official title: A Phase 1b/2 Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Advanced Solid Tumors (TRIDENT-2)
Sponsor: Turning Point Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Inability to achieve and optimize a dose that could provide a positive benefit risk profile
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-23
Primary completion date: 2023-03-01
Completion date: 2023-03-01
Limitations and caveats: Study terminated early by sponsor before initiation of phase 2, so phase 2 outcome measures and endpoint data will not be reported.
Clinical trial NCT05251376: Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy
Official title: A Phase 1, Single Dose, Open-label, Safety, Tolerability, and Pharmacokinetic Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy
Sponsor: Lyndra Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor decision.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-28
Primary completion date: 2022-12-19
Completion date: 2022-12-19
Plan to share individual participant data: NO
Clinical trial NCT04570657: Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MEDI3506 in Adult Participants With Uncontrolled Moderate-to-severe Asthma
Acronym: FRONTIER-3
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 250.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-17
Primary completion date: 2022-12-12
Completion date: 2023-02-06
Limitations and caveats: 15 participants enrolled at 1 study centre were excluded from the final analysis due to inability to confirm the validity of the data reported by the site. The exclusion of data from this site did not change the interpretation of the primary endpoint, or results in a significant change to the interpretation of any other endpoint.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT03920631: Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas
Official title: MicroBLITZ: Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas
Acronym: MicroBLITZ
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Lack of accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-07-10
Primary completion date: 2023-03-15
Completion date: 2023-05-15
Plan to share individual participant data: NO
Clinical trial NCT02953379: Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
Official title: Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Adults
Sponsor: EMS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-31
Primary completion date: 2019-12-31
Completion date: 2020-03-31
Clinical trial NCT05692154: A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis
Official title: A Phase IIIb, Single-center, Double-blind, Two-arms, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of 2-day Pre-treatment With Fexofenadine in Patients Suffering From Seasonal Allergic Rhinitis
Acronym: FEXPRESAR
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 95.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-23
Primary completion date: 2023-03-14
Completion date: 2023-03-14
Baseline population: The mITT analysis set contained all eligible, ITT, and treated participants with Total Nasal Symptom Score of 3 symptoms (TNSS-3) evaluation Hour 0 (H0) at visit 4 (V4) and at least a further time point at Visit 4.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT05499416: Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis
Official title: Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis Who Have an Inadequate Skin Response to Anti-IL23 Therapy
Sponsor: Innovaderm Research Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Sponsor decision.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-01-31
Primary completion date: 2023-09-30
Completion date: 2024-04-30
Plan to share individual participant data: NO
Clinical trial NCT01718756: Continuous Lornoxicam Infusion for Orthopaedic Surgery
Official title: Efficacy of Continuous Intravenous Infusion vs. Scheduled Dosing of Lornoxicam on Patient Controlled Morphine Consumption After Orthopaedic Surgery: A Comparative Placebo Study
Sponsor: Mansoura University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: No enough fund or cases
Enrollment: 96.0 (ESTIMATED)
Number of arms: 3.0
Start date: 2013-06-30
Primary completion date: 2021-12-31
Completion date: 2022-02-28
Clinical trial NCT05040789: Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine
Official title: A Randomized, Observer-Blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18-49 Years of Age
Sponsor: Medicago (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Further development terminated
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-11-22
Primary completion date: 2022-05-31
Completion date: 2022-05-31
Clinical trial NCT04105998: Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV)
Official title: Effects of Intramuscular Oxytocin on Pupil Diameter and Heart Rate Variability
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-24
Primary completion date: 2021-11-01
Completion date: 2021-11-01
Plan to share individual participant data: NO
Clinical trial NCT03154827: Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)
Official title: An Open-Label, Single Arm, Study, To Evaluate the Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab Combination for Maintenance Treatment in Subjects With Acute Myeloid Leukemia Who Are 60 Years or Older - The BATTLE Study
Sponsor: BioLineRx, Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to lack of enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-08
Primary completion date: 2020-04-01
Completion date: 2020-04-01
Baseline population: All patients who were eligible to the study
Plan to share individual participant data: NO
Clinical trial NCT03818165: Phase 1b Study of CAR2Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases
Official title: Phase 1b Study of the Efficacy and Safety of CAR2 Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases Resistant to Standard Therapy Using the HITM Method and Pressure Enabled Delivery Device
Acronym: AntiCEA_CART
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Limited enrollment.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-29
Primary completion date: 2020-01-19
Completion date: 2021-05-21
Clinical trial NCT05124795: IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
Official title: Dose Escalation Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Single Agent IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
Sponsor: Immunic AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of Efficacy
Enrollment: 18.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-12-09
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Clinical trial NCT02927873: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants
Official title: A Phase 1/2, Randomized, Observer-blind, Controlled, Multi-center, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A), When Administered Intramuscularly According to a 0, 1-month Schedule to RSV-seropositive Infants Aged 12 to 23 Months
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 107.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-01-11
Primary completion date: 2019-02-19
Completion date: 2020-11-26
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT02073279: Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 95.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-08-05
Primary completion date: 2018-10-12
Completion date: 2022-01-31
Baseline population: Intent-to-treat (ITT) population included all participants randomized to the treatment groups.
Clinical trial NCT03640754: A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
Official title: Study to Assess the Safety and Effect of Repeated Administration of Granulocyte Colony-Stimulating Factor (G-CSF; Filgrastim) on Hot Flashes and Other Vasomotor Symptoms of Menopause in Postmenopausal Women
Sponsor: MenoGeniX, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 61.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-06
Primary completion date: 2022-01-21
Completion date: 2022-02-22
Plan to share individual participant data: NO
Clinical trial NCT05066230: A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
Official title: A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm Phase3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Acronym: GLOW
Sponsor: Kodiak Sciences Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: All patients completed the primary endpoint assessments. Additional follow-up after the primary endpoint was deemed not necessary by the Sponsor.
Enrollment: 253.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-07
Primary completion date: 2023-08-03
Completion date: 2023-08-31
Baseline population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Plan to share individual participant data: NO
Clinical trial NCT04417907: Perampanel Titration and Cognitive Effects
Official title: Effects of Titration Rate on Cognitive and Behavioral Side Effects of Perampanel
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study sponsor no longer provided funding.
Enrollment: 29.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-10-20
Primary completion date: 2023-05-01
Completion date: 2023-05-01
Limitations and caveats: Enrollment was delayed due to the COVID-19 pandemic. The sponsor then decided to no longer fund the study. These caused total enrollment to be low, preventing statistical analyses from being conducted.
Clinical trial NCT04551573: A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects
Official title: A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: COVID-19 Pandemic
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-31
Primary completion date: 2021-10-31
Completion date: 2021-11-30
Plan to share individual participant data: YES
Clinical trial NCT02293655: The Effects of ADHD Medication (TEAM) Study
Official title: The Effects of ADHD Medication (TEAM) Study: Neurobehavioral Effects of Abrupt Methylphenidate Discontinuation
Acronym: TEAM
Sponsor: Children's Hospital Medical Center, Cincinnati (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 204.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-01-12
Primary completion date: 2020-06-30
Completion date: 2021-06-30
Limitations and caveats: Note that the school direct observations outcome was not collected due to data collection not being feasible due to schools' privacy concerns about other students in the classroom. All other outcome measures that were pre-specified Primary or Secondary Outcome Measures have been reported in this ClinicalTrials.gov entry.
Clinical trial NCT03740919: A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
Official title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog With an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents With Type 1 Diabetes
Acronym: PRONTO-Peds
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 751.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-07
Primary completion date: 2021-07-02
Completion date: 2021-07-02
Baseline population: All participants who were randomly assigned to study treatment..
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT03619876: Effects of Abatacept on Myocarditis in Rheumatoid Arthritis
Official title: Effects of Abatacept on Myocarditis in Rheumatoid Arthritis
Acronym: AMiRA
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Lack of funding
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-10
Primary completion date: 2021-09-15
Completion date: 2021-09-15
Baseline population: Of the four participants that started in the Non-TNF inhibitor arm, three were included in baseline analysis as one participant withdrew. Of the six participants that started in the TNF inhibitor arm, four were included in baseline analysis, as two participants withdrew.