Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis

Phase 3

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Placebo; Drug: Golimumab; Drug: Golimumab (placebo group)

• Registration Number: NCT01248793
• Lead Sponsor: Centocor, Inc.

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis

Detailed Description

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2011-05
• Study Completion: 2012-03
• Results First Submitted: 2012-05-25
• Results First Submitted QC: 2012-05-25
• Results First Posted: 2012-06-28
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-14
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

• Have a diagnosis of definite akylosing spondylitis for at least 3 months

• Have symptoms of active disease at screening and at baseline
• no active infections

Exclusion Criteria

• Have other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy
• Have complete ankylosis of the spine
• Have a history of latent or active granulomatous infection
• Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Placebo	Golimumab (placebo group)	-
Golimumab	Golimumab	-

Primary Outcome Measures

Name	Time	Method
Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14	Week 14	Number of patients who achieved a \>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation

Secondary Outcome Measures

Name	Time	Method
Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24	Week 24	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 Metrology Index (BASMI) at Week 14	Baseline and Week 14	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.
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14	Baseline and Week 14	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.