Clinical trial NCT00844805: Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)
Official title: Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Axial Spondyloarthritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-16
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 remission in the treatment phase were randomized to continued treatment with naproxen or to receive no treatment and were followed for an additional 24 weeks (follow-up phase).

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.

Primary outcomes:
measure: Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28
timeFrame: Week 28
Secondary outcomes:
measure: Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase
timeFrame: Week 52
measure: Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase
timeFrame: Week 52
measure: Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in the Sacroiliac Overall Score at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline of Berlin MRI Spine Overall Score at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in the Sacroiliac Overall Score at Week 52
timeFrame: Baseline, Week 28
measure: Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 28
timeFrame: Week 28
measure: Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 28
timeFrame: Week 28
measure: Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 28
timeFrame: Week 28
measure: Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 52
timeFrame: Week 52
measure: Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 52
timeFrame: Week 52
measure: Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 52
timeFrame: Week 52
measure: Median Duration of Maintaining ASAS Partial Remission in the Follow-Up Phase
timeFrame: Week 52
measure: Number of Participants Who Achieved ASAS Partial Remission That Experienced Disease Flare With Naproxen Maintenance Treatment in the Follow-Up Phase
timeFrame: Week 52
measure: Percentage of Participants That Achieved ASAS-40 Response at Week 28 in the Treatment Phase
timeFrame: Week 28
measure: Percentage of Participants That Achieved ASAS-20 Response at Week 28 in the Treatment Phase
timeFrame: Week 28
Other outcomes:
Locations:
Study officials:
References:
citation: Sieper J, Lenaerts J, Wollenhaupt J, Rudwaleit M, Mazurov VI, Myasoutova L, Park S, Song Y, Yao R, Chitkara D, Vastesaeger N; All INFAST Investigators. Efficacy and safety of infliximab plus naproxen versus naproxen alone in patients with early, active axial spondyloarthritis: results from the double-blind, placebo-controlled INFAST study, Part 1. Ann Rheum Dis. 2014 Jan;73(1):101-7. doi: 10.1136/annrheumdis-2012-203201. Epub 2013 May 21.
citation: Sieper J, Lenaerts J, Wollenhaupt J, Rudwaleit M, Mazurov VI, Myasoutova L, Park S, Song Y, Yao R, Chitkara D, Vastesaeger N; All INFAST Investigators. Maintenance of biologic-free remission with naproxen or no treatment in patients with early, active axial spondyloarthritis: results from a 6-month, randomised, open-label follow-up study, INFAST Part 2. Ann Rheum Dis. 2014 Jan;73(1):108-13. doi: 10.1136/annrheumdis-2013-203460. Epub 2013 Jun 5.
citation: Poddubnyy D, Listing J, Sieper J. Brief Report: Course of Active Inflammatory and Fatty Lesions in Patients With Early Axial Spondyloarthritis Treated With Infliximab Plus Naproxen as Compared to Naproxen Alone: Results From the Infliximab As First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial. Arthritis Rheumatol. 2016 Aug;68(8):1899-903. doi: 10.1002/art.39690.