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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285752
First Posted: January 28, 2011
Last Update Posted: July 25, 2016
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.
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
  Purpose
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

  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01285752


Locations
Czech Republic
Hlucin, Czech Republic
Hostivice, Czech Republic
Praha, Czech Republic
Uherske Hradiste, Czech Republic
Zlin, Czech Republic
Germany
Berlin, Germany
Frankfurt, Germany
Hamburg, Germany
Hungary
Balatonfüred, Hungary
Budapest, Hungary
Debrecen, Hungary
Poland
Bialystok, Poland
Elblag, Poland
Lublin, Poland
Poznan, Poland
Warszawa, Poland
Slovakia
Bratislava, Slovakia
Martin, Slovakia
Ukraine
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
ClinicalTrials.gov Identifier: NCT01285752     History of Changes
Other Study ID Numbers: AK106 II-02
First Submitted: January 27, 2011
First Posted: January 28, 2011
Last Update Posted: July 25, 2016
Last Verified: April 2012

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases