Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

NCT01850121 | Completed

• 1 other identifier: 2002-11-04 amended 2002-01-08
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis; infiximab; single armed trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Infliximab DRUG

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.

Also known as: Remicade

Infliximab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with active ankylosing spondylitis with BASDAI\>4

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

Location

Related Publications (1)

• Morck B, Pullerits R, Geijer M, Bremell T, Forsblad-d'Elia H. Infliximab dose reduction sustains the clinical treatment effect in active HLAB27 positive ankylosing spondylitis: a two-year pilot study. Mediators Inflamm. 2013;2013:289845. doi: 10.1155/2013/289845. Epub 2013 Sep 5.

  PMID: 24089587 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Boel Morck, MD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 9, 2013
• Study Start: January 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

SE (1)