Infliximab and Methotrexate in Ankylosing Spondylitis (SPAXIM)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Drug: infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00507403

PHRR/04/PG-SPAXIM

Details and patient eligibility

About

There is a great individual variability of pharmacokinetic of infliximab in patients treated for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate (MTX), others have not.

Thus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ankylosing spondylitis
• Needing anti-TNF drugs

Exclusion criteria

• Contra-indications to anti-TNF drugs

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Infliximab

Active Comparator group

Description:

Infliximab

Treatment:

Drug: infliximab

Infliximab +methotrexate

Experimental group

Description:

Infliximab +methotrexate

Treatment:

Drug: infliximab