A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
1 other identifier
interventional
130
6 countries
12
Brief Summary
This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started May 2009
Shorter than P25 for phase_2 rheumatoid-arthritis
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJuly 25, 2016
July 1, 2010
5 months
May 14, 2009
July 21, 2016
Conditions
Keywords
Study Arms (3)
AK106-001616
EXPERIMENTALPlacebo
PLACEBO COMPARATORPart1: AK106-001616 and Placebo
Active comparator
ACTIVE COMPARATORPart2: AK106-001616 and Active comparator
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of RA (class I to III)
- Stable dose of methotrexate (at least 12 weeks)
You may not qualify if:
- Pregnant or breastfeeding
- Abnormal screening laboratory test values considered to be clinically significant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Hlučín, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Uherské Hradiště, Czechia
Unknown Facility
Frankfurt am Main, Hesse, Germany
Unknown Facility
Berlin, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Budapest, Hungary
Unknown Facility
Érd, Hungary
Unknown Facility
Vilnius, Lithuania
Unknown Facility
Bucharest, Romania
Unknown Facility
Cambridge, Cambridgeshire, United Kingdom
Unknown Facility
Sheffield, South Yorkshire, United Kingdom
Related Publications (1)
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.
PMID: 25579091DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 15, 2009
Study Start
May 1, 2009
Primary Completion
October 1, 2009
Study Completion
July 1, 2010
Last Updated
July 25, 2016
Record last verified: 2010-07