Combination Methotrexate and Infliximab

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00432432
• Date of registration: 06/02/2007
• Prospective Registration: No
• Primary sponsor: Chinese University of Hong Kong
• Public title: Combination Methotrexate and Infliximab
• Scientific title: The Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging Correlation
• Date of first enrolment: February 2005
• Target sample size: 38
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00432432
• 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
• Phase: Phase 4

Contacts

• Name: Edmund K Li, MD
• Affiliation: Chinese University of Hong Kong

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Infliximab and MTX

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

AS-2005-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors