CClinicalTrials.gg
CompletedNCT01063803Updated Apr 11, 2016

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

A Phase 2 interventional study of ATN-103 and ATN-103 in Rheumatoid Arthritis, sponsored by Ablynx, a Sanofi company. Completed at 67 sites in 8 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-04-11.

Sponsored by Ablynx, a Sanofi company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
266
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Open-label
  • Long-term safety study of ATN-103 in RA
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 266 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Ablynx, a Sanofi company is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
266 participants (actual)

Study arms

  • Experimental
    Arm 1: ATN-103_30mg

    Drug: ATN-103

  • Experimental
    Arm 2: ATN-103_80 mg

    Drug: ATN-103

Interventions

  • DrugATN-103

    A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)

  • DrugATN-103

    A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

67 sites
  • Investigational Site
    Birmingham, Alabama 35216, United States
  • Investigational Site
    Huntsville, Alabama 35801, United States
  • Investigational Site
    Peoria, Arizona 85381, United States
  • Investigational Site
    Riverside, California 92501, United States
  • Investigational Site
    Upland, California 91786, United States
  • Investigational Site
    Bridgeport, Connecticut 06606, United States
  • Investigational Site
    Newark, Delaware 19713, United States
  • Investigational Site
    Ocala, Florida 34474, United States
  • Investigational Site
    Port Orange, Florida 32127, United States
  • Investigational Site
    Vero Beach, Florida 32960, United States
  • Investigational Site
    Coeur d'Alene, Idaho 83814, United States
  • Investigational Site
    Frederick, Maryland 21702, United States
  • Investigational Site
    Lansing, Michigan 48910, United States
  • Investigational Site
    Freehold, New Jersey 07728, United States
  • Investigational Site
    Charlotte, North Carolina 28210, United States
  • Investigational Site
    Winston-Salem, North Carolina 27157, United States
  • Investigational Site
    Columbus, Ohio 43213, United States
  • Investigational Site
    Oklahoma City, Oklahoma 73103, United States
  • Investigational Site
    Tulsa, Oklahoma 74104, United States
  • Investigational Site
    Lake Oswego, Oregon 97035, United States
  • Investigational Site
    Columbia, South Carolina 29204, United States
  • Investigational Site
    Myrtle Beach, South Carolina 29572, United States
  • Investigational Site
    Nashville, Tennessee 37205, United States
  • Investigational Site
    Dallas, Texas 75231, United States
  • Investigational Site
    San Antonio, Texas 78217, United States
  • Investigational Site
    Winnipeg, Manitoba R3A 1M3, Canada
  • Investigational Site
    Kitchener, Ontario N2M 5N6, Canada
  • Investigational Site
    St. Catharines, Ontario L2N 7E4, Canada
  • Investigational Site
    Toronto, Ontario M9L 3A2, Canada
  • Investigational Site
    Quebec, G1W 4R4, Canada
  • Investigational Site
    Budapest, 1023, Hungary
  • Investigational Site
    Budapest, 1036, Hungary
  • Investigational Site
    Debrecen, 4032, Hungary
  • Investigational Site
    Nitona-cho, Chuoh-ku, Chiba-shi, Chiba, Japan
  • Investigational Site
    Bunkyoucho, Matsuyama, Ehime, Japan
  • Investigational Site
    Chuoh-ku, Fukuoka-shi, Fukuoka, Japan
  • Investigational Site
    Kurume, Fukuoka, Japan
  • Investigational Site
    Yoshio-machi Iizuka-shi, Fukuoka, Japan
  • Investigational Site
    Tohrimachi, Takasaki, Gunma, Japan
  • Investigational Site
    Kato, Hyogo, Japan
  • Investigational Site
    Kumamoto-shi, Kumamoto, Japan
  • Investigational Site
    Honmachi, Higashiyama, Kyoto, Japan
  • Investigational Site
    Miyazaki-city, Miyazaki, Japan
  • Investigational Site
    Nagano-shi, Nagano, Japan
  • Investigational Site
    Yamato, Sasebo, Nagasaki, Japan
  • Investigational Site
    Higashi-tyo, Kawachi Nagano, Osaka, Japan
  • Investigational Site
    Ureshino-machi, Ureshino-shi, Saga, Japan
  • Investigational Site
    Kawagoe, Saitama, Japan
  • Investigational Site
    Midori-cho 2 chome Tokorozawa-shi, Saitama, Japan
  • Investigational Site
    Kawada-cho, Shinjyuku-ku, Tokyo, Japan
  • Investigational Site
    Shinanomachi, Shinjuku, Tokyo, Japan
  • Investigational Site
    Takaoka-shi, Toyama, Japan
  • Investigational Site
    Kemerovo, 650066, Russian Federation
  • Investigational Site
    Moscow, 115522, Russian Federation
  • Investigational Site
    Novosibirsk, 630008, Russian Federation
  • Investigational Site
    Orenburg, 460018, Russian Federation
  • Investigational Site
    Ryazan, 390026, Russian Federation
  • Investigational Site
    Vladimir, 600023, Russian Federation
  • Investigational Site
    Yaroslavl, 150003, Russian Federation
  • Investigational Site
    Yaroslavl, 150062, Russian Federation
  • Investigational Site
    Belgrade, 11000, Serbia
  • Investigational Site
    Niska Banja, 18205, Serbia
  • Investigational Site
    Les Marais, Gauteng 0084, South Africa
  • Investigational Site
    Berea, KwaZulu-Natal 4001, South Africa
  • Investigational Site
    Panorama, Western Cape 7500, South Africa
  • Investigational Site
    Pinelands, Western Cape 7405, South Africa
  • Investigational Site
    Chur, 7000, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01063803
Lead sponsor
Ablynx, a Sanofi company
Responsible party
Sponsor
First posted
Feb 5, 2010
Start date
Feb 2010
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Apr 11, 2016

Study contacts

Medical Director, MD
study director · Ablynx NV

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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