Phase 3 N=158 Randomized Quadruple-blind Treatment

Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

Ankylosing Spondylitis · Axial Spondyloarthritis

Bottom Line

View on ClinicalTrials.gov: NCT00844805 ↗

Enrolled (actual)

158

Serious AEs

5.0%

Results posted

Dec 2012

Primary outcome: Primary: Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28 — 65; 18; 40; 33 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Infliximab (Drug); Placebo (Drug); Naproxen (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28	65; 18; 40; 33	—
SECONDARY Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase	19; 16; 21; 24	—
SECONDARY Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase	40; 55	—
SECONDARY Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28	-0.5; 0.0	—
SECONDARY Change From Baseline in the Sacroiliac Overall Score at Week 28	-2.0; -3.0	—
SECONDARY Change From Baseline of Berlin MRI Spine Overall Score at Week 52	0.0; 0.0	—
SECONDARY Change From Baseline in the Sacroiliac Overall Score at Week 52	1.1; 1.0	—
SECONDARY Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 28	63; 23	=0.0884
SECONDARY Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 28	29; 3	=0.0013 sig
SECONDARY Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 28	19; 0	=0.0004 sig
SECONDARY Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 52	20; 16	=0.5005
SECONDARY Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 52	3; 4	=1.0000
SECONDARY Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 52	1; 1	=1.0000
SECONDARY Median Duration of Maintaining ASAS Partial Remission in the Follow-Up Phase	23.00; 12.57	=0.3802
SECONDARY Number of Participants Who Achieved ASAS Partial Remission That Experienced Disease Flare With Naproxen Maintenance Treatment in the Follow-Up Phase	1; 3	=0.6153
SECONDARY Percentage of Participants That Achieved ASAS-40 Response at Week 28 in the Treatment Phase	79; 29	=0.0263 sig
SECONDARY Percentage of Participants That Achieved ASAS-20 Response at Week 28 in the Treatment Phase	85; 37	=0.3011

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00844805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.