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Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

This study has been completed.
Information provided by (Responsible Party):
Helena Forsblad d'Elia, Göteborg University Identifier:
First received: May 6, 2013
Last updated: August 8, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Ankylosing Spondylitis Drug: Infliximab Phase 2 Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

Resource links provided by NLM:

Further study details as provided by Helena Forsblad d'Elia, Göteborg University:

Primary Outcome Measures:
  • Bath AS disease activity score (BASDAI) [ Time Frame: 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)

Biospecimen Retention:   Samples Without DNA
Serum samples

Enrollment: 19
Study Start Date: January 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with active AS defined as BASDAI score above 4 and no exclusion criteria were consecutively included in this single-armed unblinded trial.
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.
Other Name: Remicade


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with active ankylosing spondylitis with BASDAI>4

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.
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Please refer to this study by its identifier: NCT01850121

Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45
Sponsors and Collaborators
Göteborg University
Principal Investigator: Boel Morck, MD Sahlgrenska University Hospital, Sweden
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Helena Forsblad d'Elia, MD, PhD, Göteborg University Identifier: NCT01850121     History of Changes
Other Study ID Numbers: 2002-11-04 amended 2002-01-08
Study First Received: May 6, 2013
Last Updated: August 8, 2016

Keywords provided by Helena Forsblad d'Elia, Göteborg University:
Ankylosing Spondylitis
single armed trial

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents processed this record on August 23, 2017