Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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-to-severe active axial spondyloarthritis and disease duration of ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission criteria.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Infliximab; Naproxen

Criteria

Inclusion Criteria:

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 Criteria:

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.