Ankylosing Spondylitis
Conditions
Keywords
Ankylosing Spondylitis, infiximab, single armed trial
Brief summary
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.
Interventions
DRUGInfliximab
5 mg/kg every 6 weeks during the first year and 3 mg/kg every 8 weeks during the second year. Concomitant treatment with methotrexate 7.5 mg/week.
Sponsors
Göteborg University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bath AS disease activity score (BASDAI) | 16 weeks | The proportion of responders at week 16 defined as a reduction of 50% and/or 2 units improvement from baseline of Bath AS disease activity score (BASDAI) |
Countries
Sweden
Outcome results
None listed