Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
NCT ID: NCT00838565
Last Updated: 2018-11-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2009-05-20
2012-02-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
NCT00550355
Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis
NCT00446784
Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
NCT00847886
A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate
NCT00620685
Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis
NCT01749787
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
intravenous infusion on three consecutive months
PF-04236921
dose level 1
intravenous infusion on three consecutive months
dose level 2
intravenous infusion on three consecutive months
dose level 3
intravenous infusion on three consecutive months
dose level 4
intravenous infusion on 3 consecutive months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
intravenous infusion on three consecutive months
dose level 1
intravenous infusion on three consecutive months
dose level 2
intravenous infusion on three consecutive months
dose level 3
intravenous infusion on three consecutive months
dose level 4
intravenous infusion on 3 consecutive months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Rheumatoid Arthritis disease activity as assessed by blood tests
Exclusion Criteria
* Current or recent treatment with disease-modifying drugs other than methotrexate including but not limited to leflunomide, sulfasalazine, etanercept, infliximab, adalimumab, abatacept, rituximab
* Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Allergy, Asthma, Arthritis, & Lung
Daytona Beach, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Inha University Hospital, Medicine/Rheumatology
Incheon, , South Korea
Seoul National University Hospital, Rheumatology, Internal Medicine
Seoul, , South Korea
Yonsei University College of Medicine, Severance Hospital, Clinical Trial Center
Seoul, , South Korea
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-009866-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B0151002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.