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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00432432 |
Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of infliximab in patients with Ankylosing Spondylitis.
Condition | Intervention | Phase |
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Ankylosing Spondylitis |
Drug: Infliximab and MTX |
Phase II |
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 |
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 |
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2: Placebo Comparator
placebo with infliximab
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Drug: Infliximab and MTX
MTX 15mg weekly Infliximab 5mg/kg given at day 1, wk 2, wk6
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 History of Changes |
Health Authority: | Hong Kong: Department of Health |
Ankylosing Spondylitis MTX Infliximab |
Anti-Inflammatory Agents Antimetabolites Spinal Diseases Immunologic Factors Infliximab Joint Diseases Spondylarthropathy Folic Acid Antagonists Immunosuppressive Agents Bone Diseases |
Folic Acid Musculoskeletal Diseases Arthritis Spondylitis, Ankylosing Methotrexate Antirheumatic Agents Spondylarthritis Spondylitis Spondylarthropathies Ankylosis |
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Infliximab Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Infection Bone Diseases Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents |
Methotrexate Spondylitis, Ankylosing Spondylarthritis Dermatologic Agents Nucleic Acid Synthesis Inhibitors Spondylitis Ankylosis Spondylarthropathies Spinal Diseases Joint Diseases Gastrointestinal Agents Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents |