Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helena Forsblad d'Elia, Göteborg University
ClinicalTrials.gov Identifier:
NCT01850121
First received: May 6, 2013
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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 Göteborg University:

Primary Outcome Measures:
  • Bath AS disease activity score (BASDAI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850121

Locations
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45
Sponsors and Collaborators
Göteborg University
  More Information

No publications provided by Göteborg University

Additional 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
Study First Received: May 6, 2013
Last Updated: May 8, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Göteborg University:
Ankylosing Spondylitis
infiximab
single armed trial

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014