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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
AK106-001616
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

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

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 27, 2011
Last Updated
July 21, 2016
Sponsor
Asahi Kasei Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01285752
Brief Title
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
December 2012 (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
To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AK106-001616
Intervention Type
Drug
Intervention Name(s)
AK106-001616
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
Hostivice
Country
Czech Republic
City
Praha
Country
Czech Republic
City
Uherske Hradiste
Country
Czech Republic
City
Zlin
Country
Czech Republic
City
Berlin
Country
Germany
City
Frankfurt
Country
Germany
City
Hamburg
Country
Germany
City
Balatonfüred
Country
Hungary
City
Budapest
Country
Hungary
City
Debrecen
Country
Hungary
City
Bialystok
Country
Poland
City
Elblag
Country
Poland
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Warszawa
Country
Poland
City
Bratislava
Country
Slovakia
City
Martin
Country
Slovakia
City
Donetsk
Country
Ukraine
City
Kharkiv
Country
Ukraine
City
Kyiv
Country
Ukraine
City
Ternopil
Country
Ukraine
City
Vinnytsa
Country
Ukraine
City
Zaporizhzhia
Country
Ukraine
City
Cambridge
Country
United Kingdom
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

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