Remicade in the Treatment of Patients With Active Ankylosing Spondylitis
Information source: Göteborg University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankylosing Spondylitis
Intervention: Infliximab (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Göteborg University
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.
Clinical Details
Official title: Remicade in the Treatment of Patients With Active Ankylosing Spondylitis
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Bath AS disease activity score (BASDAI)
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sahlgrenska University Hospital, Gothenburg S-413 45, Sweden
Additional Information
Starting date: January 2003
Last updated: May 8, 2013
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