Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00844805
• Date of registration: 13/02/2009
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) INFAST
• Scientific title: Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial
• Date of first enrolment: September 2009
• Target sample size: 158
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00844805
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Denmark, France, Germany, Hungary, Korea, Republic of, Russian Federation, Ukraine, United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 48 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Axial Spondyloarthritis

Intervention(s)

Drug: Naproxen

Drug: Infliximab

Drug: Placebo

Primary Outcome(s)

Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28 [Time Frame: Week 28]

Secondary Outcome(s)

Change From Baseline in the Sacroiliac Overall Score at Week 28 [Time Frame: Baseline, Week 28]

Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 28 [Time Frame: Week 28]

Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 28 [Time Frame: Week 28]

Change From Baseline of Berlin MRI Spine Overall Score at Week 52 [Time Frame: Baseline, Week 52]

Number of Participants Who Achieved ASAS Partial Remission That Experienced Disease Flare With Naproxen Maintenance Treatment in the Follow-Up Phase [Time Frame: Week 52]

Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 52 [Time Frame: Week 52]

Change From Baseline in the Sacroiliac Overall Score at Week 52 [Time Frame: Baseline, Week 28]

Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 52 [Time Frame: Week 52]

Percentage of Participants That Achieved ASAS-20 Response at Week 28 in the Treatment Phase [Time Frame: Week 28]

Percentage of Participants That Achieved ASAS-40 Response at Week 28 in the Treatment Phase [Time Frame: Week 28]

Median Duration of Maintaining ASAS Partial Remission in the Follow-Up Phase [Time Frame: Week 52]

Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase [Time Frame: Week 52]

Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 52 [Time Frame: Week 52]

Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28 [Time Frame: Baseline, Week 28]

Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 28 [Time Frame: Week 28]

Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase [Time Frame: Week 52]

Secondary ID(s)

2008-000982-51

P05336

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/12/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00844805