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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285752
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : July 25, 2016
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation

Brief Summary:
To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: AK106-001616 Drug: Active comparator Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: AK106-001616
Experimental: 2 Drug: AK106-001616
Active Comparator: 3 Drug: Active comparator

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01285752

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Czech Republic
Hlucin, Czech Republic
Hostivice, Czech Republic
Praha, Czech Republic
Uherske Hradiste, Czech Republic
Zlin, Czech Republic
Berlin, Germany
Frankfurt, Germany
Hamburg, Germany
Balatonfüred, Hungary
Budapest, Hungary
Debrecen, Hungary
Bialystok, Poland
Elblag, Poland
Lublin, Poland
Poznan, Poland
Warszawa, Poland
Bratislava, Slovakia
Martin, Slovakia
Donetsk, Ukraine
Kharkiv, Ukraine
Kyiv, Ukraine
Ternopil, Ukraine
Vinnytsa, Ukraine
Zaporizhzhia, Ukraine
United Kingdom
Cambridge, United Kingdom
Sheffield, United Kingdom
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
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Responsible Party: Asahi Kasei Pharma Corporation Identifier: NCT01285752    
Other Study ID Numbers: AK106 II-02
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: April 2012
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases