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NCT01285752 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01285752
Other study ID # AK106 II-02
Secondary ID
Status Completed
Phase Phase 2
First received January 27, 2011
Last updated July 21, 2016
Start date February 2011
Est. completion date December 2012

Study information
Verified date April 2012
Source Asahi Kasei Pharma Corporation
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyCzech Republic: State Institute for Drug ControlPoland: Ministry of HealthSlovakia: State Institute for Drug ControlUkraine: Ministry of Health
Study type Interventional

Clinical Trial Summary

To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date December 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AK106-001616

• AK106-001616

• Active comparator

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Asahi Kasei Pharma Corporation

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Poland,  Slovakia,  Ukraine,  United Kingdom, 

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