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Combination Methotrexate and Infliximab

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Infliximab and MTX
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis, MTX, Infliximab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fulfilled the AS:meeting the modified New York criteria
  • Active disease despite NSAID treatment defined as:
  • Spinal inflammation ≧ 30 and a score of 30 on at least two of the other three domains
  • Back pain
  • Patient global assessment of disease activity
  • Physical function
  • Informed consent

Exclusion Criteria:

  • Complete ankylosis of the spine
  • On sulphasalazine
  • Previous use of TNF inhibitors
  • Multiple use of NSAIDS
  • Prednisolone > 10mg/day
  • Changes of NSAIDS or dose of prednisolone within 2 weeks of baseline
  • Little or no ability for self-care
  • Received intra-articular,intramuscular, or intravenous corticosteroids in the 4 weeks before screening
  • Infected joint prosthesis during the previous 5 years
  • Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months
  • Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis
  • Active tuberculosis requiring treatment within the previous 3 years
  • Opportunistic infections such as herpes zoster within the previous 2 months
  • Any evidence of active cytomegalovirus; active Pneumocystis carinii; or drug-resistant atypical mycobacterial infection
  • Known hypersensitivity to murine proteins
  • Current signs or symptoms of severe,progressive,or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease
  • A history of lymphoproliferative disease including lymphoma or signs suggestive of disease, such as lymphadenopathy of unusual size or location (ie,lymph nodes in the posterior triangle or the neck, infraclavicular epitrochlear, or periaortic areas); splenomegaly;
  • Any known malignant disease except basal cell carcinoma currently or in the past 5 years.
  • A hemoglobin level < 8.5 gm/dl, a white blood cell count < 3.5 × 10^9/liter, a platelet count < 100 × 10^9/liter, a serum creatinine level > 150 µmol/l, serum transaminase levels 1.25 times the upper limit of normal, or alkaline phosphatase levels > 2 times the upper limit of normal.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Placebo Comparator

    Arm Label

    2

    Arm Description

    placebo with infliximab

    Outcomes

    Primary Outcome Measures

    The number of patient exhibited an ASAS 20 response to treatment at week 20.

    Secondary Outcome Measures

    Proportion of patients with 50% and 70% improvement in disease activity.Patient global assessment of disease activity and pain;BASFI;early morning stiffness;physician global assessment of disease activity.Changes in the pre and post infusion MRI.

    Full Information

    First Posted
    February 6, 2007
    Last Updated
    February 10, 2012
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00432432
    Brief Title
    Combination Methotrexate and Infliximab
    Official Title
    The Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging Correlation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2005 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of infliximab in patients with Ankylosing Spondylitis.
    Detailed Description
    Forty consecutive patients will be recruited from the rheumatology clinic of the Prince of Wales Hospital with AS meeting the modified New York criteria with active disease as defined (see below). They will be randomized to receive MTX 7.5 mg/week initially with a weekly 2.5mg increment until 15mg/week dosage is reached,( i.e by week 6) or a placebo together with folic acid 5mg daily for a period of 16 week. After 16 weeks, all patients will receive infliximab at 5 mg/kg per dose, at weeks 16, 18, and 22 (3 doses), and will continue with MTX 15 mg/week or placebo. Thereafter, they will be followed up at week 30, 38 weeks. MRI changes in the sacroiliac joints (SI) before and after infliximab treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankylosing Spondylitis
    Keywords
    Ankylosing Spondylitis, MTX, Infliximab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    placebo with infliximab
    Intervention Type
    Drug
    Intervention Name(s)
    Infliximab and MTX
    Other Intervention Name(s)
    remicade
    Intervention Description
    MTX 15mg weekly Infliximab 5mg/kg given at day 0, wk 2, wk6
    Primary Outcome Measure Information:
    Title
    The number of patient exhibited an ASAS 20 response to treatment at week 20.
    Time Frame
    wk52
    Secondary Outcome Measure Information:
    Title
    Proportion of patients with 50% and 70% improvement in disease activity.Patient global assessment of disease activity and pain;BASFI;early morning stiffness;physician global assessment of disease activity.Changes in the pre and post infusion MRI.
    Time Frame
    wk52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Fulfilled the AS:meeting the modified New York criteria Active disease despite NSAID treatment defined as: Spinal inflammation ≧ 30 and a score of 30 on at least two of the other three domains Back pain Patient global assessment of disease activity Physical function Informed consent Exclusion Criteria: Complete ankylosis of the spine On sulphasalazine Previous use of TNF inhibitors Multiple use of NSAIDS Prednisolone > 10mg/day Changes of NSAIDS or dose of prednisolone within 2 weeks of baseline Little or no ability for self-care Received intra-articular,intramuscular, or intravenous corticosteroids in the 4 weeks before screening Infected joint prosthesis during the previous 5 years Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis Active tuberculosis requiring treatment within the previous 3 years Opportunistic infections such as herpes zoster within the previous 2 months Any evidence of active cytomegalovirus; active Pneumocystis carinii; or drug-resistant atypical mycobacterial infection Known hypersensitivity to murine proteins Current signs or symptoms of severe,progressive,or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease A history of lymphoproliferative disease including lymphoma or signs suggestive of disease, such as lymphadenopathy of unusual size or location (ie,lymph nodes in the posterior triangle or the neck, infraclavicular epitrochlear, or periaortic areas); splenomegaly; Any known malignant disease except basal cell carcinoma currently or in the past 5 years. A hemoglobin level < 8.5 gm/dl, a white blood cell count < 3.5 × 10^9/liter, a platelet count < 100 × 10^9/liter, a serum creatinine level > 150 µmol/l, serum transaminase levels 1.25 times the upper limit of normal, or alkaline phosphatase levels > 2 times the upper limit of normal.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edmund K Li, MD
    Organizational Affiliation
    Chinese University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Combination Methotrexate and Infliximab

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