Combination Methotrexate and Infliximab - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 6, 2007

Last Updated Date

May 6, 2008

Start Date ^†

February 2005

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00432432 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Combination Methotrexate and Infliximab

Official Title ^†

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

Brief Summary

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

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Ankylosing Spondylitis

Intervention ^†

Drug: Infliximab and MTX

Study Arms / Comparison Groups

Placebo Comparator: placebo with infliximab

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

October 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00432432

Responsible Party

Lai-Shan Tam, The Chinese University of Hong Kong

Secondary IDs ^††

Study Sponsor ^†

Chinese University of Hong Kong

Collaborators ^††

Investigators ^†

Principal Investigator:

Ddmund K Li, MD

Chinese University of Hong Kong

Information Provided By

Chinese University of Hong Kong

Verification Date

May 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.