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

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. Identifier: NCT00902369
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : July 25, 2016
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: AK106-001616 Drug: Placebo Drug: Active comparator Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AK106-001616 Drug: AK106-001616
Part1: Dose escalation Part2: Dose expansion
Placebo Comparator: Placebo
Part1: AK106-001616 and Placebo
Drug: Placebo
Active Comparator: Active comparator
Part2: AK106-001616 and Active comparator
Drug: Active comparator

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT00902369

Czech Republic
Hlucin, Czech Republic
Praha 2, Czech Republic
Uherske Hradiste, Czech Republic
Frankfurt, Hessen, Germany
Berlin, Germany
Hamburg, Germany
Budapest, Hungary
Érd, Hungary
Vilnius, Lithuania
Bucharest, Romania
United Kingdom
Cambridge, Cambridgeshire, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Sponsors and Collaborators
Asahi Kasei Pharma Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Asahi Kasei Pharma Corporation Identifier: NCT00902369     History of Changes
Other Study ID Numbers: AK106 II-01
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2010

Keywords provided by Asahi Kasei Pharma Corporation:

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