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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
Asahi Kasei Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring AK106-001616

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 14, 2009
Last Updated
July 21, 2016
Sponsor
Asahi Kasei Pharma Corporation
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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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