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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 August 2016 |
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Main ID: |
NCT01850121 |
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Date of registration:
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06/05/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Remicade in the Treatment of Patients With Active Ankylosing Spondylitis
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Scientific title:
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Remicade in the Treatment of Patients With Active Ankylosing Spondylitis |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01850121 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Boel Morck, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sahlgrenska University Hospital, Sweden |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: Infliximab
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Primary Outcome(s)
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Bath AS disease activity score (BASDAI)
[Time Frame: 16 weeks]
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Secondary ID(s)
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2002-11-04 amended 2002-01-08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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