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Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01850121
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Helena Forsblad d'Elia, Göteborg University

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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Infliximab Phase 2 Phase 3

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Remicade in the Treatment of Patients With Active Ankylosing Spondylitis
Study Start Date : January 2003
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Group/Cohort Intervention/treatment
Infliximab
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



Primary Outcome Measures :
  1. 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


Information from the National Library of Medicine

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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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850121


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helena Forsblad d'Elia, MD, PhD, Göteborg University
ClinicalTrials.gov Identifier: NCT01850121     History of Changes
Other Study ID Numbers: 2002-11-04 amended 2002-01-08
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016

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

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents