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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 27, 2011
Last Updated Date	April 6, 2012
Start Date ^ICMJE	February 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01285752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
Official Title ^ICMJE	Not Provided
Brief Summary	To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: AK106-001616 Drug: Active comparator
Study Arm (s)	Experimental: 1 Intervention: Drug: AK106-001616 Experimental: 2 Intervention: Drug: AK106-001616 Active Comparator: 3 Intervention: Drug: Active comparator
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	240
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Czech Republic, Germany, Hungary, Poland, Slovakia, Ukraine, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01285752
Other Study ID Numbers ^ICMJE	AK106 II-02
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Asahi Kasei Pharma Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Asahi Kasei Pharma Corporation
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top