Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis
Drug: Golimumab (placebo group)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing Spondylitis|
- Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14 [ Time Frame: Week 14 ] [ Designated as safety issue: No ]Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation
- Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation
- Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14 [ Time Frame: Baseline and Week 14 ] [ Designated as safety issue: No ]BASFI is a participant's self-assessment, represented as a mean (Visual Analogue Scale [Score]; 0 cm [easy] to 10 cm [impossible]) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. A negative change from baseline indicates improvement.
- Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14 [ Time Frame: Baseline and Week 14 ] [ Designated as safety issue: No ]BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement.
|Study Start Date:||October 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20Drug: Golimumab (placebo group)
Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48
Golimumab 50 mg SC injection every 4 weeks for 48 weeks
Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease by blocking the activity of TNF in the body and reducing inflammation and pain. Each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. Patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). The chance that the patient will get golimumab is 1 to 1, so 50% chance to receive golimumab and 50% change to receive placebo. Patients who do not have an improvement in total back pain and morning stiffness at the Week 16 visit compared to when the patients entered the study, and are in Group 1 (placebo group), will receive golimumab 50 mg every 4 weeks starting at Week 16. If the patient is in Group 2 (golimumab 50 mg), they will continue to receive golimumab every 4 weeks starting at Week 16. If the patient is in Group 1 and still receiving placebo injections, because there was improvement in total back pain at Week 16, they will receive golimumab 50 mg every 4 weeks starting from Week 24. If the patient is in Group 2 (golimumab 50 mg) or are already receiving golimumab injections at week 24, they will continue to receive golimumab every 4 weeks. Safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects). The patient will be in the study approximately 56 weeks. Patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks until Week 48.
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|