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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01850121
Other study ID # 2002-11-04 amended 2002-01-08
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received May 6, 2013
Last updated August 8, 2016
Start date January 2003
Est. completion date May 2008

Study information

Verified date August 2016
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Drug:
Infliximab
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.

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bath AS disease activity score (BASDAI) 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) 16 weeks No
See also
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