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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01063803 |
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Date of registration:
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02/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis
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Scientific title:
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An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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266 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01063803 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Hungary
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Japan
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Russian Federation
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Serbia
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South Africa
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Switzerland
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United States
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Contacts
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Name:
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Josefin-Beate Holz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ablynx NV |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: ATN-103
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Primary Outcome(s)
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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]
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Secondary ID(s)
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B2271005
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3242K1-2003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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