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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT01063803
First received: February 2, 2010
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063803

  Show 67 Study Locations
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Josefin-Beate Holz, MD Ablynx NV
  More Information

No publications provided

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT01063803     History of Changes
Other Study ID Numbers: 3242K1-2003, B2271005
Study First Received: February 2, 2010
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013