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

This study has been completed.
Information provided by (Responsible Party):
Ablynx Identifier:
First received: February 2, 2010
Last updated: March 10, 2016
Last verified: January 2013
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.

Condition Intervention Phase
Rheumatoid Arthritis Drug: ATN-103 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Ablynx:

Primary Outcome Measures:
  • 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 ]

Enrollment: 266
Study Start Date: February 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01063803

  Show 67 Study Locations
Sponsors and Collaborators
Study Director: Medical Director, MD Ablynx NV
  More Information

Responsible Party: Ablynx Identifier: NCT01063803     History of Changes
Other Study ID Numbers: 3242K1-2003
Study First Received: February 2, 2010
Last Updated: March 10, 2016

Keywords provided by Ablynx:
Long-term safety study of ATN-103 in RA

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 25, 2017