- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01285752
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
July 21, 2016 updated by: Asahi Kasei Pharma Corporation
To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hlucin, Czech Republic
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Hostivice, Czech Republic
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Praha, Czech Republic
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Uherske Hradiste, Czech Republic
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Zlin, Czech Republic
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Berlin, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Balatonfüred, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Bialystok, Poland
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Elblag, Poland
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Lublin, Poland
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Poznan, Poland
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Warszawa, Poland
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Bratislava, Slovakia
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Martin, Slovakia
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Ternopil, Ukraine
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Vinnytsa, Ukraine
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Zaporizhzhia, Ukraine
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Cambridge, United Kingdom
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Sheffield, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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Experimental: 2
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Active Comparator: 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
January 27, 2011
First Submitted That Met QC Criteria
January 27, 2011
First Posted (Estimate)
January 28, 2011
Study Record Updates
Last Update Posted (Estimate)
July 25, 2016
Last Update Submitted That Met QC Criteria
July 21, 2016
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK106 II-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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AmgenTerminated
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Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
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AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
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National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
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University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
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University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
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Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
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Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on AK106-001616
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Asahi Kasei Pharma CorporationCompletedRheumatoid ArthritisGermany, Romania, Hungary, Lithuania, Czech Republic, United Kingdom