Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

Göteborg University

Status: Completed

Conditions: Ankylosing Spondylitis

Treatments: Drug: Infliximab

Study type: Observational

Funder types: Other

Identifiers

NCT01850121

2002-11-04 amended 2002-01-08

Details and patient eligibility

About

The aim of the study was to evaluate the efficacy of infliximab (IFX) treatment, 5 mg/kg every 6 weeks, in patients with active ankylosing spondylitis (AS) and to determine whether IFX dose reduction and interval extension, 3 mg/kg every 8 weeks during the second year sustained the treatment effect. The study was started in 2003 an finished in 2008.

Enrollment: 19 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The patients had to fulfill the following four inclusion criteria:

(I) Age between 18 and 60 years, (II) proven diagnosis according to the modified New York criteria 12 for definitive AS, (III) active disease with Bath AS Disease Activity Index (BASDAI) score above 4 and (IV) current or previous treatment with conventional non-steroidal anti-inflammatory drugs (NSAID) in adequate doses without sufficient effect.

Exclusion criteria

• current signs or symptoms of severe, progressive or uncontrolled hepatic, hematological, pulmonary, cardiac, neurological or cerebral disease;
• ongoing or past serious infection (including HIV and past or current tuberculosis);
• pregnancy or breast feeding;
• current malignancy or history of malignancy within the past five years;
• congestive heart failure and any contraindication to MRI.

Trial design

19 participants in 1 patient group

Infliximab

Description:

Patients with active AS defined as BASDAI score above 4 and no exclusion criteria were consecutively included in this single-armed unblinded trial.

Treatment:

Drug: Infliximab