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

NCT ID: NCT01248793

Last Updated: 2013-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-03-31

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.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20

Golimumab (placebo group)

Intervention Type: DRUG

Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48

Golimumab

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: DRUG

Golimumab 50 mg SC injection every 4 weeks for 48 weeks

Interventions

Placebo

Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20

Intervention Type: DRUG

Golimumab

Golimumab 50 mg SC injection every 4 weeks for 48 weeks

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

Beijing, , China

Chengdu, , China

Guangzhou, , China

Hefei, , China

Jinan, , China

Shanghai, , China

Xi'an, , China

Countries

China

References

Bao C, Huang F, Khan MA, Fei K, Wu Z, Han C, Hsia EC. Safety and efficacy of golimumab in Chinese patients with active ankylosing spondylitis: 1-year results of a multicentre, randomized, double-blind, placebo-controlled phase III trial. Rheumatology (Oxford). 2014 Sep;53(9):1654-63. doi: 10.1093/rheumatology/keu132. Epub 2014 Apr 11.

Reference Type: DERIVED

PMID: 24729398 (View on PubMed)

Other Identifiers

C0524T29

Identifier Type: OTHER

Identifier Source: secondary_id

CR015916

Identifier Type: -

Identifier Source: org_study_id