Status:
COMPLETED
Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Ankylosing Spondylitis
Axial Spondyloarthritis
Eligibility:
All Genders
18-48 years
Phase:
PHASE3
Brief Summary
The primary objective of this study was to assess the proportion of participants in the infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of participants with moderate...
Detailed Description
In the 28-week treatment phase, participants were randomized to receive either infliximab plus naproxen or placebo plus naproxen. After 28-weeks of treatment, participants that achieved partial remis...
Eligibility Criteria
Inclusion
- Participant must:
- be 18 to 48 years of age
- have diagnosis of active axial spondyloarthritis, with disease duration of less than or equal to 3 years.
- have active disease during trial enrollment
- have limited treatment history for axial spondyloarthritis (must meet certain criteria)
- agree to an acceptable method of contraception (for women of childbearing potential and all men)
- must meet certain tuberculosis screening requirements
- must meet certain laboratory screening safety requirements
- have an x-ray of the sacroiliac joints available from within the previous 12 months (or have one performed during the Screening visit if site is outside of Germany).
Exclusion
- Participant will be excluded:
- for certain medical conditions and/or recent history of certain medical disorders
- for current or recent treatment with certain other medications and certain vaccinations.
- for being a woman who is breastfeeding, pregnant, or intending to become pregnant.
- if known to have had a substance abuse problem within the previous 3 years prior to screening.
- if currently participating in any other clinical study.
- for other administrative reasons.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00844805
Start Date
September 1 2009
End Date
September 1 2011
Last Update
April 12 2017
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