Infliximab for Treatment of Axial Spondyloarthritis (Study P05336AM1)

Condition(s) targeted: Ankylosing Spondylitis; Axial Spondyloarthritis

Intervention: infliximab infusion (Drug); placebo infusion (Drug); naproxen (Treatment Phase) (Drug); naproxen (Follow-Up Phase) (Drug); no intervention (Follow-Up Phase) (Other)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Schering-Plough

This trial will enroll patients with active axial spondyloarthritis of less than 3 years duration.

In the first part of this trial, patients who qualify will be randomized to receive either infliximab plus naproxen or placebo plus naproxen. Patients will attend scheduled office visits to be medically evaluated for treatment progress (drug effectiveness, safety, disease progression). After 28 weeks of treatment, the primary assessment will be performed to determine whether or not more patients are in partial remission with infliximab versus placebo.

In the second part of this trial, patients who are in remission from the first part of this trial will be followed-up for approximately 6 more months. Patients will be randomized to either continue naproxen or to discontinue naproxen. Patients will attend scheduled office visits and be monitored for disease flare ups during this time.

Official title: Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Proportion of subjects in each study arm (Arm A and Arm B) meeting the ASAS partial remission criteria at Week 28.

Minimum age: 18 Years. Maximum age: 48 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

Subject 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:

Subjects 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.

Starting date: October 2009
Ending date: October 2011
Last updated: September 16, 2009