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Combination Methotrexate and Infliximab

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. Identifier: NCT00432432
Recruitment Status : Completed
First Posted : February 7, 2007
Last Update Posted : February 13, 2012
Information provided by (Responsible Party):
Lai-Shan Tam, Chinese University of Hong Kong

Brief Summary:
Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of infliximab in patients with Ankylosing Spondylitis.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Infliximab and MTX Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging Correlation
Study Start Date : February 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Placebo Comparator: 2
placebo with infliximab
Drug: Infliximab and MTX
MTX 15mg weekly Infliximab 5mg/kg given at day 0, wk 2, wk6
Other Name: remicade

Primary Outcome Measures :
  1. The number of patient exhibited an ASAS 20 response to treatment at week 20. [ Time Frame: wk52 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00432432

Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Edmund K Li, MD Chinese University of Hong Kong
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Responsible Party: Lai-Shan Tam, Professor, Chinese University of Hong Kong Identifier: NCT00432432    
Other Study ID Numbers: AS-2005-003
First Posted: February 7, 2007    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012
Keywords provided by Lai-Shan Tam, Chinese University of Hong Kong:
Ankylosing Spondylitis
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents