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

This study has been completed.
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation Identifier:
First received: January 27, 2011
Last updated: July 21, 2016
Last verified: April 2012
To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.

Condition Intervention Phase
Rheumatoid Arthritis Drug: AK106-001616 Drug: Active comparator Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Asahi Kasei Pharma Corporation:

Estimated Enrollment: 240
Study Start Date: February 2011
Study Completion Date: December 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AK106-001616
Experimental: 2 Drug: AK106-001616
Active Comparator: 3 Drug: Active comparator


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01285752

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
  More Information

Responsible Party: Asahi Kasei Pharma Corporation Identifier: NCT01285752     History of Changes
Other Study ID Numbers: AK106 II-02
Study First Received: January 27, 2011
Last Updated: July 21, 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017