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

Sponsor
Asahi Kasei Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01285752
Collaborator
(none)
240
Enrollment
26
Locations
3
Arms
22
Duration (Months)
9.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: AK106-001616
Experimental: 2

Drug: AK106-001616
Active Comparator: 3

Drug: Active comparator

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hlucin Czech Republic
    2 Hostivice Czech Republic
    3 Praha Czech Republic
    4 Uherske Hradiste Czech Republic
    5 Zlin Czech Republic
    6 Berlin Germany
    7 Frankfurt Germany
    8 Hamburg Germany
    9 Balatonfüred Hungary
    10 Budapest Hungary
    11 Debrecen Hungary
    12 Bialystok Poland
    13 Elblag Poland
    14 Lublin Poland
    15 Poznan Poland
    16 Warszawa Poland
    17 Bratislava Slovakia
    18 Martin Slovakia
    19 Donetsk Ukraine
    20 Kharkiv Ukraine
    21 Kyiv Ukraine
    22 Ternopil Ukraine
    23 Vinnytsa Ukraine
    24 Zaporizhzhia Ukraine
    25 Cambridge United Kingdom
    26 Sheffield United Kingdom

    Sponsors and Collaborators

    • Asahi Kasei Pharma Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Asahi Kasei Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT01285752
    Other Study ID Numbers:
    • AK106 II-02
    First Posted:
    Jan 28, 2011
    Last Update Posted:
    Jul 25, 2016
    Last Verified:
    Apr 1, 2012
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Jul 25, 2016