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

This study has been completed.
Sponsor:
Information provided by:
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01285752
First received: January 27, 2011
Last updated: April 6, 2012
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Arms Assigned Interventions
Experimental: 1 Drug: AK106-001616
Experimental: 2 Drug: AK106-001616
Active Comparator: 3 Drug: Active comparator

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01285752     History of Changes
Other Study ID Numbers: AK106 II-02
Study First Received: January 27, 2011
Last Updated: April 6, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Slovakia: State Institute for Drug Control
Ukraine: Ministry of Health

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

ClinicalTrials.gov processed this record on July 24, 2014