A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AK106-001616
Placebo
Active comparator
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring AK106-001616
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of RA (class I to III)
- Stable dose of methotrexate (at least 12 weeks)
Exclusion Criteria:
- Pregnant or breastfeeding
- Abnormal screening laboratory test values considered to be clinically significant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
AK106-001616
Placebo
Active comparator
Arm Description
Part1: AK106-001616 and Placebo
Part2: AK106-001616 and Active comparator
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00902369
First Posted
May 14, 2009
Last Updated
July 21, 2016
Sponsor
Asahi Kasei Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00902369
Brief Title
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asahi Kasei Pharma Corporation
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
AK106-001616
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AK106-001616
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Part1: AK106-001616 and Placebo
Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
Part2: AK106-001616 and Active comparator
Intervention Type
Drug
Intervention Name(s)
AK106-001616
Intervention Description
Part1: Dose escalation Part2: Dose expansion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Active comparator
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of RA (class I to III)
Stable dose of methotrexate (at least 12 weeks)
Exclusion Criteria:
Pregnant or breastfeeding
Abnormal screening laboratory test values considered to be clinically significant
Facility Information:
City
Hlucin
Country
Czech Republic
City
Praha 2
Country
Czech Republic
City
Uherske Hradiste
Country
Czech Republic
City
Frankfurt
State/Province
Hessen
Country
Germany
City
Berlin
Country
Germany
City
Hamburg
Country
Germany
City
Budapest
Country
Hungary
City
Érd
Country
Hungary
City
Vilnius
Country
Lithuania
City
Bucharest
Country
Romania
City
Cambridge
State/Province
Cambridgeshire
Country
United Kingdom
City
Sheffield
State/Province
South Yorkshire
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25579091
Citation
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.
Results Reference
derived
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A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
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