chufangao/CTO huggingface dataset:
Clinical trial NCT03562416: Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects
Official title: Nintedanib Plus Usual Transplant Care Compared to Usual Transplant Care Alone After Single Lung Transplantation in Patients With Idiopathic Pulmonary Fibrosis: a Pilot Randomized Controlled Trial
Sponsor: Temple University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-05
Primary completion date: 2021-12-21
Completion date: 2021-12-21
Plan to share individual participant data: NO
Clinical trial NCT05425732: Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
Official title: A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2663.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-07-13
Primary completion date: 2023-05-18
Completion date: 2023-05-18
Baseline population: All vaccinated participants. Includes two participants from Cohort 1 who had unplanned vaccinations with both V116 and PCV20
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT01506141: An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
Official title: An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Pediatric Patients With Hunter Syndrome and Cognitive Impairment
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2010-08-01
Primary completion date: 2024-04-30
Completion date: 2024-04-30
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT04370379: Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients
Official title: A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-28
Primary completion date: 2021-04-30
Completion date: 2021-05-08
Clinical trial NCT05007977: Effect of ZT-01 on Glucagon During Hypoglycemia in Type 1 Diabetes Mellitus
Official title: Pharmacodynamic Evaluation of ZT-01 in a Stepped Hypoglycemic Clamp Model in Subjects With Type 1 Diabetes Mellitus
Sponsor: Zucara Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was completed following review of the assumptions underlying the power calculation and it was deemed that enough subjects had been recruited to complete enrollment
Enrollment: 24.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-07-08
Primary completion date: 2022-04-12
Completion date: 2022-04-18
Plan to share individual participant data: NO
Clinical trial NCT03962725: Avoiding Neuromuscular Blockers to Reduce Complications
Official title: Eliminating Use of Non Depolarizing Neuromuscular Blocking Agents to Reduce Postoperative Pulmonary Complications: A Multi-center, Randomized Control Trial
Sponsor: Beth Israel Deaconess Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study terminated due to lack of enrollment.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-07
Primary completion date: 2022-12-19
Completion date: 2022-12-19
Plan to share individual participant data: NO
Clinical trial NCT04737109: Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer
Official title: A Single Arm, Phase I/II Trial of Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer Big Ten Cancer Research Consortium BTCRC-GU19-404
Acronym: ADDItion
Sponsor: Big Ten Cancer Research Consortium (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Funder Decision
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-13
Primary completion date: 2022-08-15
Completion date: 2022-08-15
Plan to share individual participant data: NO
Clinical trial NCT03426254: Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Solid Tumors
Official title: Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Advanced Solid Tumors ( Phase I )
Sponsor: Center Trials & Treatment (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: the company is liquidated
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-10
Primary completion date: 2023-12-10
Completion date: 2024-01-10
Clinical trial NCT04474314: A Study of IMR-687 in Subjects With Sickle Cell Disease
Official title: A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects With Sickle Cell Disease
Sponsor: Imara, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A recently conducted Interim analysis of IMR-SCD-301 demonstrated that while IMR-687 was generally well-tolerated, it failed to meet its primary efficacy endpoint. So, the sponsor has decided to discontinue this study.
Enrollment: 115.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-08-13
Primary completion date: 2022-03-02
Completion date: 2022-05-04
Baseline population: Intent to Treat Analysis set
Clinical trial NCT04594213: Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)
Acronym: ULTRA I
Sponsor: Merz North America, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 362.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-09-23
Primary completion date: 2021-04-15
Completion date: 2022-05-09
Baseline population: The full analysis set (FAS) included all randomized subjects.
Plan to share individual participant data: NO
Clinical trial NCT05835011: A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS)
Official title: A Phase 2 Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab for Previously Untreated Subjects With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS)
Sponsor: Astex Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Termination due to discontinuation of magrolimab development in MDS.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-06-27
Primary completion date: 2023-08-21
Completion date: 2023-08-21
Baseline population: The study was terminated by the Sponsor. Based on the low enrollment number (n=2), no data, except region of enrollment, is reported here to protect and maintain participant privacy/confidentiality.
Limitations and caveats: The study was terminated prematurely due to discontinuation of magrolimab development in MDS.
Plan to share individual participant data: NO
Clinical trial NCT06153186: Flunarizine for Treatment Resistant Absence Epilepsy
Official title: Flunarizine for Treatment Resistant Absence Epilepsy
Sponsor: University of British Columbia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The enrollment wasn't as predicted. We didn't have enough numbers to show statistical significance.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-20
Primary completion date: 2023-05-26
Completion date: 2023-05-26
Clinical trial NCT04042727: Controlling Rapid Atrial Fibrillation With Dexmedetomidine
Official title: Controlling Rapid Atrial Fibrillation With Dexmedetomidine (C-RAD) Trial
Acronym: C-RAD
Sponsor: Stony Brook University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Futility, as a result of COVID-19 impact
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-21
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Clinical trial NCT04364009: Anakinra for COVID-19 Respiratory Symptoms
Official title: Efficacy and Safety of ANAkinra During Adult  COVID-19  With Aggravating Respiratory Symptoms: a Multicenter Open-label Controlled Randomized Trial
Acronym: ANACONDA
Sponsor: University Hospital, Tours (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Efficiency and safety reasons
Enrollment: 71.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-27
Primary completion date: 2020-10-20
Completion date: 2020-11-03
Plan to share individual participant data: NO
Clinical trial NCT04005079: Pilocarpine After Combined Cataract/Trabectome Surgery
Official title: A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery
Acronym: PACCT
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: not performing Trabectomes
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-05
Primary completion date: 2021-01-21
Completion date: 2021-01-21
Plan to share individual participant data: NO
Clinical trial NCT04740034: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Official title: A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AMG 340, a Bispecific Antibody Targeting PSMA in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 42.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-29
Primary completion date: 2024-06-24
Completion date: 2024-06-24
Plan to share individual participant data: NO
Clinical trial NCT02901275: Enhancing Medication-based Analgesia in Humans
Official title: Using Dronabinol to Enhance the Analgesic Effect of Hydromorphone in Humans
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 5.0
Start date: 2016-12-31
Primary completion date: 2020-03-23
Completion date: 2020-03-23
Plan to share individual participant data: NO
Clinical trial NCT03296033: Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin
Official title: Evaluation of Residual Anti-Xa Activity As A Function Of Time Following The Last Treatment Dose of Enoxaparin In Patients Presenting For Elective Surgery
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: enrollment proved to be a challenge due to the changing of the guidelines for bridging off the new anticoagulants that are being prescribed
Enrollment: 122.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-24
Primary completion date: 2022-01-14
Completion date: 2022-01-14
Baseline population: Baseline characteristics only collected for subjects who completed
Plan to share individual participant data: NO
Clinical trial NCT05098509: A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome
Official title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader- Willi Syndrome
Sponsor: Radius Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Due to a change in corporate priorities, this study was voluntarily terminated by the Sponsor for reasons other than safety
Enrollment: 4.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-04-13
Primary completion date: 2022-10-06
Completion date: 2022-10-31
Baseline population: The Intent to Treat (ITT) Population included all randomized participants who received at least 1 dose of study drug. Due to the small sample size, data was not reported for confidentiality reasons.
Limitations and caveats: The study has been voluntarily terminated by the sponsor due to change in corporate priorities, for reasons other than safety. Due to early termination of study, no efficacy analyses were done.
Clinical trial NCT03225833: Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients With Huntington's Disease
Acronym: PRECISION-HD1
Sponsor: Wave Life Sciences Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Lack of Efficacy
Enrollment: 61.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-07-17
Primary completion date: 2021-05-11
Completion date: 2021-05-11
Clinical trial NCT03852979: Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
Official title: Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
Acronym: NEOCON-F
Sponsor: The Netherlands Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: study is merged with CONTESSA study
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-01
Primary completion date: 2020-01-01
Completion date: 2020-01-01
Plan to share individual participant data: UNDECIDED
IPD sharing description: to be determined
Clinical trial NCT04536181: Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome
Official title: Comparative Study of 3 or 6 Months Initial Steroid Treatment in Children Under 6 Years of Age With Steroid Sensitive Nephrotic Syndrome：a Randomized, Double-blind, Placebo-controlled Study
Sponsor: Children's Hospital of Fudan University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-01
Primary completion date: 2022-09-01
Completion date: 2022-10-01
Plan to share individual participant data: NO
Clinical trial NCT03301467: Controlled Trial Evaluating Avacopan in C3 Glomerulopathy
Official title: A Randomized, Double Blind, Placebo Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients With C3 Glomerulopathy
Acronym: ACCOLADE
Sponsor: ChemoCentryx (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 57.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-29
Primary completion date: 2021-03-03
Completion date: 2021-10-27
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT04405245: Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma
Official title: Phase 2 Multi-Center, Double-Masked, Randomized, 28-Day Study to Assess the Efficacy, Safety and Tolerability of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution as an Adjunct to Latanoprost in Patients With Ocular Hypertension (OHT) or Open Angle Glaucoma (OAG)
Sponsor: EyePoint Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 194.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-06
Primary completion date: 2020-11-05
Completion date: 2020-11-05
Baseline population: Each Baseline participant contributed one study eye and one fellow eye
Plan to share individual participant data: NO
Clinical trial NCT04732949: Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19
Official title: A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19
Acronym: SPRINTER
Sponsor: Synairgen Research Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 623.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-12
Primary completion date: 2021-12-15
Completion date: 2022-02-10
Baseline population: The Intent-to-Treat (ITT) analysis population consisted of all randomised patients.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04079881: Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes
Official title: Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Loss of funding
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-13
Primary completion date: 2020-07-01
Completion date: 2020-07-01
Baseline population: Trial was terminated due to COVID pandemic and loss of funding.
Limitations and caveats: Study was terminated before completion due to COVID pandemic and loss of funding.
Plan to share individual participant data: NO
Clinical trial NCT03957876: CPX-351 Therapy for MDS After Hypomethylating Agent Failure
Official title: A Phase II Study of CPX-351 as a Novel Therapeutic Approach for Patients With Myelodysplastic Syndromes (MDS) After Hypomethylating Agent Failure
Sponsor: Case Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow Accrual
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-25
Primary completion date: 2022-12-20
Completion date: 2022-12-20
Limitations and caveats: Early termination led to a small number of subjects analyzed.
Plan to share individual participant data: NO
IPD sharing description: The study team does not plan to share IPD collected in this study
Clinical trial NCT04725812: Complement Regulation to Undo Systemic Harm in Preeclampsia
Official title: Complement Regulation to Undo Systemic Harm in Preeclampsia: The CRUSH Study
Acronym: CRUSH
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PI moved institutions
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-13
Primary completion date: 2021-12-07
Completion date: 2021-12-07
Limitations and caveats: The PI, Dr. Richard Burwick left the institution where this research was being conducted in April 2022 and study activity halted at that time. Two subjects were consented to participate in the study and one withdrew participation before study procedures were completed. Study Funding was terminated by Sponsor.~Dr. Karumanchi is a co-investigator in this study who has been named as the Responsible Party within the PRS system solely for the purpose of reporting the results.
Plan to share individual participant data: NO
Clinical trial NCT03486457: Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB (CP-690,550) IN CHINESE SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE CONVENTIONAL SYNTHETIC DMARD
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 204.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-10
Primary completion date: 2021-04-28
Completion date: 2021-04-28
Baseline population: Safety analysis set: included all participants who received at least one dose of the study drug (tofacitinib or placebo)
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.