Combination Methotrexate and Infliximab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lai-Shan Tam, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00432432
First received: February 6, 2007
Last updated: February 10, 2012
Last verified: February 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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
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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00432432

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

No publications provided

Responsible Party: Lai-Shan Tam, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00432432     History of Changes
Other Study ID Numbers: AS-2005-003
Study First Received: February 6, 2007
Last Updated: February 10, 2012
Health Authority: Hong Kong: Department of Health

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

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

ClinicalTrials.gov processed this record on September 18, 2014