Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) (INFAST)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Axial Spondyloarthritis; Ankylosing Spondylitis

Treatments: Drug: Infliximab; Drug: Placebo; Drug: Naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00844805

2008-000982-51

P05336

Details and patient eligibility

About

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.

Full 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).

Enrollment: 158 patients

Sex: All

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 4 patient groups, including a placebo group

Infliximab + Naproxen

Experimental group

Description:

Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.

Treatment:

Drug: Naproxen

Drug: Infliximab

Placebo + Naproxen

Placebo Comparator group

Description:

Placebo administered intravenously on Day 1 at Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.

Treatment:

Drug: Placebo

Drug: Naproxen

Naproxen Only (Follow-Up)

Experimental group

Description:

For participants who achieved partial remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.

Treatment:

Drug: Naproxen

No Treatment (Follow-Up)

No Intervention group

Description:

For participants who achieved partial remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.