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

Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248793
• Other study ID #: CR015916
• Secondary ID: C0524T29
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2010
• Last updated: March 14, 2013
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2013
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: March 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Placebo
Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20
• Golimumab
Golimumab 50 mg SC injection every 4 weeks for 48 weeks
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14	Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation	Week 14	No
Secondary	Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24	Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation	Week 24	No
Secondary	Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at 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.	Baseline and Week 14	No
Secondary	Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at 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.	Baseline and Week 14	No