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Completed

NCT Number: NCT01850121

Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Remicade

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
May 9, 2013
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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