A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
NCT ID: NCT00902369
Last Updated: 2016-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2009-05-31
2010-07-31
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.
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
NCT01285752
Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis
NCT00959036
A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients
NCT00920608
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
NCT02387762
A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate
NCT01636843
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
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AK106-001616
AK106-001616
Part1: Dose escalation Part2: Dose expansion
Placebo
Part1: AK106-001616 and Placebo
Placebo
Active comparator
Part2: AK106-001616 and Active comparator
Active comparator
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AK106-001616
Part1: Dose escalation Part2: Dose expansion
Placebo
Active comparator
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stable dose of methotrexate (at least 12 weeks)
Exclusion Criteria
* Abnormal screening laboratory test values considered to be clinically significant
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Asahi Kasei Pharma Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hlučín, , Czechia
Prague, , Czechia
Uherské Hradiště, , Czechia
Frankfurt am Main, Hesse, Germany
Berlin, , Germany
Hamburg, , Germany
Budapest, , Hungary
Érd, , Hungary
Vilnius, , Lithuania
Bucharest, , Romania
Cambridge, Cambridgeshire, United Kingdom
Sheffield, South Yorkshire, United Kingdom
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.
Kozaki T, Tagashira M, Yamanishi K, Ellis B, Kayanoki T, Ooishi R, Sugiyama K, Matsuda S, Tsuruta K, Kohira T, Tsurui K. Evaluation of drug-drug interaction between the novel cPLA2 inhibitor AK106-001616 and methotrexate in rheumatoid arthritis patients. Xenobiotica. 2015;45(7):615-24. doi: 10.3109/00498254.2014.1000430. Epub 2015 Jan 12.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AK106 II-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.