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Combination Methotrexate and Infliximab
This study has been completed.
First Received: February 6, 2007   Last Updated: May 6, 2008   History of Changes
Sponsored by: Chinese University of Hong Kong
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00432432
  Purpose

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


Condition Intervention Phase
Ankylosing Spondylitis
Drug: Infliximab and MTX
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging Correlation

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • The number of patient exhibited an ASAS 20 response to treatment at week 20. [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: February 2005
Study Completion Date: October 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Placebo Comparator
placebo with infliximab
Drug: Infliximab and MTX
MTX 15mg weekly Infliximab 5mg/kg given at day 1, wk 2, wk6

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432432

Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Ddmund K Li, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: The Chinese University of Hong Kong ( Lai-Shan Tam )
Study ID Numbers: AS-2005-003
Study First Received: February 6, 2007
Last Updated: May 6, 2008
ClinicalTrials.gov Identifier: NCT00432432     History of Changes
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Ankylosing Spondylitis
MTX
Infliximab

Study placed in the following topic categories:
Anti-Inflammatory Agents
Antimetabolites
Spinal Diseases
Immunologic Factors
Infliximab
Joint Diseases
Spondylarthropathy
Folate
Folinic Acid
Folic Acid Antagonists
Immunosuppressive Agents
Bone Diseases
Vitamin B9
Folic Acid
Musculoskeletal Diseases
Arthritis
Spondylitis, Ankylosing
Methotrexate
Antirheumatic Agents
Spondylarthritis
Spondylitis
Spondylarthropathies
Ankylosis

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Infliximab
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Infection
Bone Diseases
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Methotrexate
Spondylitis, Ankylosing
Spondylarthritis
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Spondylitis
Ankylosis
Spondylarthropathies
Spinal Diseases
Joint Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 02, 2009