- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00902369
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
July 21, 2016 updated by: Asahi Kasei Pharma Corporation
This will be a Phase II, multi-centre study consisting of 2 parts.
Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
130
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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Praha 2, Czech Republic
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Uherske Hradiste, Czech Republic
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Berlin, Germany
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Hamburg, Germany
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Hessen
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Frankfurt, Hessen, Germany
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Budapest, Hungary
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Érd, Hungary
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Vilnius, Lithuania
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Bucharest, Romania
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom
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South Yorkshire
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Sheffield, South Yorkshire, 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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AK106-001616
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Part1: Dose escalation Part2: Dose expansion
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Placebo Comparator: Placebo
Part1: AK106-001616 and Placebo
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Active Comparator: Active comparator
Part2: AK106-001616 and Active comparator
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
May 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
May 14, 2009
First Submitted That Met QC Criteria
May 14, 2009
First Posted (Estimate)
May 15, 2009
Study Record Updates
Last Update Posted (Estimate)
July 25, 2016
Last Update Submitted That Met QC Criteria
July 21, 2016
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK106 II-01
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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