Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00439283
• Date of registration: 22/02/2007
• Prospective Registration: No
• Primary sponsor: Association de Recherche Clinique en Rhumatologie
• Public title: Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis
• Scientific title: Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand
• Date of first enrolment: April 2003
• Target sample size: 240
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00439283
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Maxime DOUGADOS, Professor
• Affiliation: ARCR

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients (> 18 years old)

- With a diagnosis of AS

- With at least one of the following evidences for active inflammation, present within
3 months before inclusion: a serum C-reactive protein (CRP) level above twice the
upper limit value of the normal range, a positive magnetic resonance imaging of the
spine or sacro-iliac joints, a vascularized enthesitis by power-Doppler ultrasound
technic.

- Presence of clinically active axial disease, as defined by 1) a Bath AS Disease
Activity Index (BASDAI) (18) of = 3/10, and 2) a score of = 3/10 for axial pain
(second item of BASDAI).

- Disease-modifying antirheumatic drugs (DMARDs), such as sulphasalazine, methotrexate,
hydroxychloroquine, intra-muscular gold, thiol compound, cyclosporin, intravenous
biphosphonate had to be discontinued for at least 4 weeks before inclusion.

- Dosages of NSAIDs and corticosteroid were required to remain stable for at least 4
weeks before inclusion.

- A negative pregnancy test result was required for non menopausal female patients, and
contraception during the study period and for six months after the last infusion of
infliximab was recommended to all patients of childbearing potential.

Exclusion Criteria:

- Pregnancy.

- Breastfeeding.

- Vaccination with a live organism during the last month.

- Present infection or any episode of serious infection within the last three months.

- Active malignancy within the previous five years.

- Alcohol or drug addiction.

- Severe chronic concomitant disease.

- Administration of an investigational drug within the last three months, or of any
known TNF inhibitor therapy in the past (such as thalidomide, infliximab or
etanercept).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: infliximab

Drug: methotrexate

Primary Outcome(s)

The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.

Secondary Outcome(s)

Schober test.

SF-36.

The area under the curves (AUCs) of the global pain scores recorded on a weekly basis on automatic phone server, calculated from week 0 through week 54.

Acute-phase reactants (erythrocyte sedimentation rate and C-reactive protein level).

BASDAI.

The area under the curves (AUCs) of the BASDAI recorded on a weekly basis on automatic phone server, calculated from week 0 through week 54.

Number of infusions administered after the loading regimen.

Finger to floor test.

Improvement in independent components of the ASAS response criteria.

Achievement of the ASAS50 and ASAS70.

Chest expansion score.

Number of patients requiring an increase in the dose of infliximab.

The proportion of patients who experienced a partial remission, according to ASAS definition.

Occiput-to-wall measurements.

Secondary ID(s)

A R C R 2003 - 01 / PO 3353

Source(s) of Monetary Support

Please refer to primary and secondary sponsors