Status:
COMPLETED
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active ank...
Detailed Description
This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the researchers ...
Eligibility Criteria
Inclusion
- Participants with diagnosis of definite ankylosing spondylitis for at least 3 months based on modified New York radiographic and clinical criteria
- Participants with symptoms of active disease at screening and at baseline
- Participant has either an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAID) over a 4 week period in total with maximal recommended doses of NSAIDs, or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs
- Participants with C- reactive protein (CRP) level of greater than or equal to (\>=) 0.3 milligram per deciliter (mg/dL) at screening
- Additional protocol-defined inclusion criteria apply
Exclusion
- Participant with other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy
- Pregnant or lactating females
- Participants with chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis
- Participants who had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis, or pyelonephritis), or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent
- Additional protocol-defined exclusion criteria apply
Key Trial Info
Start Date :
September 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2016
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT02186873
Start Date
September 3 2014
End Date
October 11 2016
Last Update
October 30 2025
Active Locations (45)
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1
Glendale, Arizona, United States
2
Mesa, Arizona, United States
3
La Palma, California, United States
4
Granger, Indiana, United States