Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis

March 10, 2016 updated by: Ablynx

An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis

This open-label extension study will allow subjects who have completed either the 3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103 treatment and will provide data on the long-term safety and tolerability of ATN-103 in subjects with rheumatoid arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

266

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

  • Canada
      • Quebec, Canada, G1W 4R4
        • Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Investigational Site
    • Ontario
      • Kitchener, Ontario, Canada, N2M 5N6
        • Investigational Site
      • St. Catharines, Ontario, Canada, L2N 7E4
        • Investigational Site
      • Toronto, Ontario, Canada, M9L 3A2
        • Investigational Site
  • Hungary
      • Budapest, Hungary, 1023
        • Investigational Site
      • Budapest, Hungary, 1036
        • Investigational Site
      • Debrecen, Hungary, 4032
        • Investigational Site
  • Japan
    • Chiba
      • Nitona-cho, Chuoh-ku, Chiba-shi, Chiba, Japan
        • Investigational Site
    • Ehime
      • Bunkyoucho, Matsuyama, Ehime, Japan
        • Investigational Site
    • Fukuoka
      • Chuoh-ku, Fukuoka-shi, Fukuoka, Japan
        • Investigational Site
      • Kurume, Fukuoka, Japan
        • Investigational Site
      • Yoshio-machi Iizuka-shi, Fukuoka, Japan
        • Investigational Site
    • Gunma
      • Tohrimachi, Takasaki, Gunma, Japan
        • Investigational Site
    • Hyogo
      • Kato, Hyogo, Japan
        • Investigational Site
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
        • Investigational Site
    • Kyoto
      • Honmachi, Higashiyama, Kyoto, Japan
        • Investigational Site
    • Miyazaki
      • Miyazaki-city, Miyazaki, Japan
        • Investigational Site
    • Nagano
      • Nagano-shi, Nagano, Japan
        • Investigational Site
    • Nagasaki
      • Yamato, Sasebo, Nagasaki, Japan
        • Investigational Site
    • Osaka
      • Higashi-tyo, Kawachi Nagano, Osaka, Japan
        • Investigational Site
    • Saga
      • Ureshino-machi, Ureshino-shi, Saga, Japan
        • Investigational Site
    • Saitama
      • Kawagoe, Saitama, Japan
        • Investigational Site
      • Midori-cho 2 chome Tokorozawa-shi, Saitama, Japan
        • Investigational Site
    • Tokyo
      • Kawada-cho, Shinjyuku-ku, Tokyo, Japan
        • Investigational Site
      • Shinanomachi, Shinjuku, Tokyo, Japan
        • Investigational Site
    • Toyama
      • Takaoka-shi, Toyama, Japan
        • Investigational Site
  • Russian Federation
      • Kemerovo, Russian Federation, 650066
        • Investigational Site
      • Moscow, Russian Federation, 115522
        • Investigational Site
      • Novosibirsk, Russian Federation, 630008
        • Investigational Site
      • Orenburg, Russian Federation, 460018
        • Investigational Site
      • Ryazan, Russian Federation, 390026
        • Investigational Site
      • Vladimir, Russian Federation, 600023
        • Investigational Site
      • Yaroslavl, Russian Federation, 150062
        • Investigational Site
      • Yaroslavl, Russian Federation, 150003
        • Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Investigational Site
      • Niska Banja, Serbia, 18205
        • Investigational Site
  • South Africa
    • Gauteng
      • Les Marais, Gauteng, South Africa, 0084
        • Investigational Site
    • KwaZulu-Natal
      • Berea, KwaZulu-Natal, South Africa, 4001
        • Investigational Site
    • Western Cape
      • Panorama, Western Cape, South Africa, 7500
        • Investigational Site
      • Pinelands, Western Cape, South Africa, 7405
        • Investigational Site
  • Switzerland
      • Chur, Switzerland, 7000
        • Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Investigational Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Investigational Site
    • California
      • Riverside, California, United States, 92501
        • Investigational Site
      • Upland, California, United States, 91786
        • Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Investigational Site
    • Florida
      • Ocala, Florida, United States, 34474
        • Investigational Site
      • Port Orange, Florida, United States, 32127
        • Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Investigational Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Investigational Site
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Investigational Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Investigational Site
      • Winston-Salem, North Carolina, United States, 27157
        • Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Investigational Site
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Investigational Site
      • Myrtle Beach, South Carolina, United States, 29572
        • Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Investigational Site
      • San Antonio, Texas, United States, 78217
        • Investigational Site

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study.

Exclusion Criteria:

  • Pregnant or nursing women.
  • Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome, human immunodeficiency virus (HIV) infection], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator's judgment, will substantially increase the risk associated with the subject's developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subject's response.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1: ATN-103_30mg
Drug: ATN-103
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
EXPERIMENTAL: Arm 2: ATN-103_80 mg
Drug: ATN-103
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ablynx

Investigators

  • Study Director: Medical Director, MD, Ablynx NV

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

February 1, 2010

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (ESTIMATE)

February 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3242K1-2003
  • B2271005

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.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on ATN-103

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe