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Combination Methotrexate and Infliximab

Information source: Chinese University of Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis

Intervention: Infliximab and MTX (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Chinese University of Hong Kong

Official(s) and/or principal investigator(s):
Edmund K Li, MD, Principal Investigator, Affiliation: Chinese University of Hong Kong

Summary

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

Clinical Details

Official title: The Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging Correlation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome: 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.

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: February 2005
Last updated: February 10, 2012

Page last updated: August 23, 2015

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