Combination Methotrexate and Infliximab - Full Text View

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

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Methotrexate Infliximab

U.S. FDA Resources

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

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

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
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:

Spinal Diseases
Infliximab
Joint Diseases
Spondylarthropathy
Bone Diseases
Folic Acid
Musculoskeletal Diseases

Arthritis
Spondylitis, Ankylosing
Methotrexate
Spondylarthritis
Spondylitis
Spondylarthropathies
Ankylosis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists

Infection
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Bone Diseases, Infectious
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009